(1_personnel_non_uva.doc) Non-UVA Personnel Explain the duties of non-UVA personnel on this protocol. Explain your plans for training and oversight of these personnel. How do you plan to access any study records the non-UVA personnel might maintain? Will the non- UVA personnel be exposed to any additional risk while working on this protocol? If yes, what training, precautions will be taken to protect them?
(2_support_source.doc) Support Source: The support source is any source outside of UVA providing support such as supplies/drug/device’s that will NOT receive any data prior to publication. Do not enter a company/ organization as a supply source unless the support has been secured. The IRB-HSR must be notified and the consent form revised if a support source changes. (Example-the NIH or an investigator-initiated study in which the pharmaceutical company is only providing drug free of charge, but will not be receiving data prior to publication.)
(3_conflict_of_interest.doc)
Is there a possible conflict of interest?
When a person or an organization has a financial or other interest large enough to seem as if it could affect their judgment, it is called a conflict of interest. The study doctor/leader in this study has a conflict of interest in connection with this study and the following paragraph(s) tell(s) you about it. Enter any information regarding potential conflict of interest here.
(4_background_database.doc) Background: Provide an explanation for the necessity of establishing this database/central registry. Study Support
Provide an explanation of any support for this study, including financial, supplies, etc that will be received from outside or inside UVa. Also list any company, institute or foundation with whom you have a grant and or contract.
(5_background.doc) Background and Brief Summary: Background: i. Discuss the scientific background, rationale and relevance of the proposed project. This should include a referenced systematic evidenced-based review when possible. If this study involves qualitative research explain the major constructs of your study. ii. Please do not state in this section what you plan to do in this study. This information should be entered later under “What will be done in this protocol?” iii. Please do not include the bibliography in this section. Brief Summary: Provide a very brief summary of this protocol.
Additional Information A. Investigators Experience Provide a brief description of the investigators experience in working with this population NOTE: If this study will be done in a foreign country, add their experience working within the foreign country. B. Study Support Provide an explanation of any support for this study, including financial, supplies, free drug etc that will be received from outside or inside UVa. Please list names of companies, institutes, foundations with which you have a grant and or contract. If the study is being done in the GCRC please list the NIH. Example: This study is funded via a contract with the University of New York, which has a grant from the NIH to conduct this study. We will be receiving free drug from Glaxo. Glaxo will not receive any data prior to publication.
C. International Research a. Will this study be done outside the U.S. under the oversight of a UVA PI?
YES
NO- If yes, please answer the following questions: 1. Provide the name and contact information for your onsite advisor (e.g. the person who will be available where you are doing your research to advise you on issues relevant to research in that country). 2. Provide the name and contact information for the local ethics committee or IRB. 3. Who are the "stakeholders" or "community leaders" in the region you are visiting? 4. If this is a student project: Do you confirm that the PI of this protocol has experience in this field of research and also has experience in the country in which you plan to do your research? 5. YES NO If no- please explain your plan to obtain oversight NA- not a student project
D. Has another IRB ever not given approval to this protocol? Yes No If Yes, Please list name and address of IRB and attach documentation from the IRB which includes their reasons for not approving this protocol.
(6_drug.doc) Drug Information List drug name, source and IND# if available
Please list the phase or stage of this study (e.g. Phase 1,2 or 3, pivotal, pilot, post-marketing) Does this study involve research on a drug, biologic, supplement or food additive? Yes No If yes, is this study investigator initiated? Yes If yes, answer questions # 1 and 2 If no, answer question # 2 only. No
1. Do the following criteria apply? YES No The investigation is intended to be reported to FDA as a well-controlled study in support of a new indication for use or intended to be used to support any other significant change in the labeling for the drug;
YES No If the drug that is undergoing investigation is lawfully marketed as a prescription drug product, the investigation is intended to support a significant change in the advertising for the product; YES No The investigation does involve a route of administration or dosage level or use in a patient population or other factor that significantly increases the risks (or decreases the acceptability of the risks) associated with the use of the drug product. If No- please explain why you believe the risk to subjects is not increased: YES The investigation will be conducted in compliance with the requirements for institutional review set part in part 21CFR56 and with the requirements for informed consent set forth in part 21CFR50 ; and YES The investigation will be conducted in compliance with the requirements of 21CFR312.7 (Promotion and charging for investigational drugs)
2. Please answer the following questions if you are using a drug/ supplement / food additive in a manner not approved by the FDA. You may reference the non-IRB protocol to answer these questions. Describe pertinent animal data that is available regarding the toxicity/safety of this drug. Describe pertinent human data that is available regarding the toxicity/safety of this drug. Have there been any human deaths associated with this drug? In how many humans has this drug been used previously? If this protocol will be used in minors please describe any previous use of this drug with minors of a similar age range.
(7_device.doc) Device Information 1. List name of device: You may reference the non-IRB protocol to answer questions 2-6. 2. Describe pertinent animal data that is available regarding the toxicity/safety of this device.
3. Describe pertinent human data that is available regarding the toxicity/safety of this device. 4. Have there been any human deaths associated with this device? 5. In how many humans has this device been used previously? 6. If this protocol will be used in minors please describe any previous use of this drug/device with minors of a similar age range. 7. Does this device have an IDE# from the FDA? Yes No If yes, list IDE # If no, is the device exempt from an IDE? Yes No If yes, check criteria under which you feel it is exempt: A legally marketed device when used in accordance with its labeling A diagnostic device if it complies with the labeling requirements in §809.10(c) and if the testing: is noninvasive; does not require an invasive sampling procedure that presents significant risk; does not by design or intention introduce energy into a subject; and is not used as a diagnostic procedure without confirmation by another medically established diagnostic product or procedure;
Additional guidance for an in vitro diagnostic device studies can be found in "Regulating In Vitro Diagnostic Device (IVD) Studies." http://www.fda.gov/cdrh/comp/ivdreg.html
Consumer preference testing, testing of a modification, or testing of a combination of devices if the device(s) are legally marketed device(s) [that is, the devices have an approved PMA, cleared Premarket Notification 510(k), or are exempt from 510(k)] AND if the testing is not for the purpose of determining safety or effectiveness and does not put subjects at risk; A device intended solely for veterinary use; A device shipped solely for research with laboratory animals and contains the labeling "CAUTION – Device for investigational use in laboratory animals or other tests that do not involve human subjects." A custom device :
According to 21CFR812.2(c) (7) a custom device as defined in 812.3(b) is exempt unless the device is being used to determine safety or effectiveness for commercial distribution. A custom device means a device that: (1) Necessarily deviates from devices generally available or from an applicable performance standard or premarket approval requirement in order to comply with the order of an individual physician or dentist; (2) Is not generally available to, or generally used by, other physicians or dentists; (3) Is not generally available in finished form for purchase or for dispensing upon
prescription; (4) Is not offered for commercial distribution through labeling or advertising; and (5) Is intended for use by an individual patient named in the order of a physician or dentist, and is to be made in a specific form for that patient, or is intended to meet the special needs of the physician or dentist in the course of professional practice.
If no, do you feel the device is non-significant risk? Yes No According to 21CFR812.3(m) a Significant Risk (SR) device study is one that presents a potential for serious risk to the health, safety, or welfare of a subject and is intended as an implant; or is used in supporting or sustaining human life; or is for use of substantial importance in diagnosing, curing, mitigating or treating disease, or otherwise prevents impairment of human health; or otherwise presents a potential for serious risk to the health, safety, or welfare of a subject.
Note: If the participant must undergo a procedure as part of the investigational study, e.g., a surgical procedure to implant the device, the IRB-HSR must consider the potential harm that could be caused by the procedure in addition to the potential harm caused by the device.
(8_hypothesis_to_be_tested.doc) Hypothesis to be Tested: If this study involves biomedical research clearly state the objectives and hypotheses and clearly define the primary and any secondary outcome measures. If this study involves qualitative research clearly state your research hypothesis or question.
(9_gcrc_abstract.doc) ABSTRACT The abstract is an NIH requirement and should describe briefly the purpose of the protocol. Include hypothesis being tested, a brief description of the experiment, and the data analysis. Please be aware that the Abstract will be on public display at the NIH CRISP website.
(10_human_participants.doc) Human Participants:
Ages Sex Race Subjects- see below NOTE_ for question 1-4 below insert an exact #. Ranges or OPEN is not allowed. This # should be the maximum # you expect to need to enroll (i.e. sign consent) If you are only collecting specimens the number of participants should equate to the # of specimens you need. If you are collecting only data from a chart review the number should designate the number of subjects whose medical records you plan to review. Age/ Sex/Race criteria should designate the demographics of participants from whom you will obtain the specimen/data.
1. Provide target # of subjects (at all sites) needed to complete protocol to obtain statistically significant results. 2. Describe expected rate of screen failure/ dropouts/withdrawals from all sites. 3. How many subjects will be enrolled at all sites? Note- this number must be the same or higher than the # from question # 1 in order to account for the # of screen failures, dropouts, withdrawals described in question # 2. 4. How many subjects will sign a consent form under this UVa protocol?
Will you be obtaining data from the UVa Clinical Data Repository (CDR)? Yes No If yes, check the categories of data elements below that you plan to obtain from the CDR. You are advised to talk to CDR personnel prior to completing this section.
CATEGORY DATA ELEMENTS CHECK ALL THAT APPLY
Demographics Administrative
Financial Clinical Data
e.g. Gender, race, age e.g. Includes payor, payscale, length of stay, fact of visits (inpatient or outpatient), locations of service (inpatient or outpatient), providers e.g. Charges or costs associated with care e.g. Diagnoses e.g. Procedures e.g. Mortality
Narrative Reports
e.g. Laboratory / Microbiology Results e.g. Medications e.g. Vitals, Height / Weight, Other Clinical Parameters e.g. Other (specify) e.g. Includes discharge summaries, pathology reports, operative notes, etc.
(11_human_participants_chart_review.doc) Human Participants: Ages Sex Race Number: At UVA protocol sites:_______ At other sites not being done under this UVA protocol:_______ Insert an exact #. Ranges or OPEN is not allowed. This # should be the maximum # you expect to need to enroll (i.e. sign consent) If you are only collecting specimens the number of participants should equate to the # of specimens you need. If you are collecting only data from a chart review the number should designate the number of subjects whose medical records you plan to review. Age/ Sex/Race criteria should designate the demographics of participants from whom you will obtain the specimen/data. Describe expected rate of screen failure/ dropouts/withdrawals. Provide target # of subjects needed to complete protocol to obtain statistically significant results.
Will you be obtaining data from the UVa Clinical Data Repository (CDR)? Yes No If yes, check the categories of data elements below that you plan to obtain from the CDR. You are advised to talk to CDR personnel prior to completing this section.
CATEGORY
DATA ELEMENTS
CHECK ALL THAT APPLY
Demographics Administrative
e.g. Gender, race, age e.g. Includes payor, payscale, length of stay, fact of visits (inpatient or
Financial
Clinical Data
Narrative Reports
outpatient), locations of service (inpatient or outpatient), providers e.g. Charges or costs associated with care e.g. Diagnoses e.g. Procedures e.g. Mortality e.g. Laboratory / Microbiology Results e.g. Medications e.g. Vitals, Height / Weight, Other Clinical Parameters e.g. Other (specify) e.g. Includes discharge summaries, pathology reports, operative notes, etc.
(12_human_participants_mental_impairment.doc) List additional safeguards that will be employed to protect the cognitively impaired subjects. Examples of possible safeguards are listed below: Use of an Independent Monitor to observe the recruitment, assessment, and the informed consent process. Use of a Surrogate decision-maker when permitted by law, i.e. a legally authorized representative via use of power of attorney/advance directive for research. Use of Assent Use of Informational/Educational Techniques, i.e. use of single sheet summaries of important information, frequently asked questions sheet. Use of Waiting Periods: Individuals who are decisionally impaired may need more time to consider the information they are given. Planning a built-in waiting period within the consent process also may be useful to allow potential participants time to consult with family members about whether or not to participate.
(13_minor_participation.doc) Participation of Minors 1. Explain why this research topic is relevant to minors. 2. Is the knowledge being sought in this study already available for children or is it currently being acquired through another ongoing study?
3. Provide data that is available in adults in order that the IRB may judge the potential risk in minors. If there is no adult data available, please provide reasons why not. If this information is available in a sponsor’s protocol, you may reference the section # here and not duplicate the information.
(14_inclusion_exclusion_criteria_database.doc) Inclusion/Exclusion Criteria Criteria for inclusion of data into database: Criteria for exclusion of data from database:
(15_inclusion_exclusion_criteria.doc) Inclusion/Exclusion Criteria The inclusion and exclusion criteria should be written in bullet format. Criteria for inclusion: Criteria for exclusion: If the study includes a gadolinium enhanced MRI/MRA insert the following exclusion criteria Estimated GFR less than 60 mL/min based on a serum creatinine drawn within 90 days of the MRI if any of the following conditions exist: o Greater than 70 years of age o A history or indication of renal insufficiency o History of diabetes o History of paraproteinemia syndromes such as multiple myeloma o History of vascular disease (CAD, MI, carotid disease, PVD, or known visceral artery disease)
Restrictions (if any) on use of other drugs or treatments:
(16_recruitment.doc) Recruitment How will participants be recruited? (check all that apply) _____ Posters/Flyers _____ Television _____ Radio
_____ Newspaper Ads _____ Internet _____ Medical Record/ Database Review. NOTE- potential subjects will be contacted after obtaining the approval of their attending physician and IRB-HSR approval of method of contacting potential subjects ( i.e. letter) _____ Medical Record/ Database Review. NOTE- subjects will not be contacted _____ Referrals from other health care professionals _____ Discuss protocol with patients of PI or sub-investigators during a standard clinical visit Please note: Finder’s fees paid to an individual are not allowed by UVA Policy. IRB-HSR must approve all methods of advertisement that will be seen by a potential subject ( i.e. poster, ads, etc.) prior to use. Please submit advertisements to IRB after the protocol has been approved. If subjects will be contacted, explain in detail how this will be done. (Please Note: The investigator is required to submit for separate approval any type of recruitment material including cover letters, phone call scripts/ email/ posters ads etc. to the IRB following approval of the protocol) Do you plan to ask the subjects to do anything for the study prior to signing a consent? (e.g. come to the first visit fasting, stop taking medications that may be an exclusion criteria, change diet) NOTE: Only those members of the study team with a DEA# (license to prescribe drugs) are allowed to determine if a potential subject may be asked/informed to stop taking a drug which is an exclusion criteria. It is recommended that the potential subject notify their health care provider if they plan to stop a prescription drug. YES NO If YES, please explain what you will ask them to do.
PLEASE NOTE: You must document their verbal consent in the study records. If a subject is asked to stop taking a drug, please document the date and name of the person on the study team giving the verbal order to stop medications (again- must be a person with a DEA#) . Explain the consenting process: Address setting, privacy, time, how subject's understanding will be assessed, how much time will pass between obtaining written consent and initiation of study procedures. Example: Potential subjects will be given a consent form to take home and read. They will bring it back with them to their next appointment at which time their questions will be answered. If they decide to go into the study, they will then sign the consent form and study appointments will be made.
Do you plan to enroll your own students, patients, staff, employees? Yes No
Do you plan to enroll students, patients, staff, employees of any of the other personnel listed on this protocol? Yes No Do you plan to enroll yourself or any other personnel listed on this protocol? Yes No If yes, which groups?
If yes, explain how these potential subjects will be recruited to avoid the appearance of coercion.
(17_recruitment_database.doc) Recruitment Database How will data be obtained? Would proposed data be collected as part of usual clinical practice at UVA? Yes No
(18_recruitment_database_specimens.doc) Recruitment Specimens
How will data be obtained? How will specimens be obtained? Is there a relationship between the investigators and those from whom specimens will be obtained (e.g. patients of investigators)? Yes No If yes, do you confirm that no additional specimens will be taken at the time the clinical specimen is obtained? Yes No Were specimens collected during other research studies at UVA? If Yes, list IRB-HSR # of protocols: Yes No
(19_recruitment_chart_review.doc) Recruitment Chart Review From what sources will you be obtaining information? (Examples: medical record, CAS, departmental shadow chart, pharmacy database etc)
(20_recruitment_specimens.doc) Recruitment Specimens How will specimens be obtained? Is there a relationship between the investigators and those from whom specimens will be obtained (e.g. patients of investigators)? Yes No If yes, do you confirm that no additional specimens will be taken at the time the clinical specimen is obtained? Yes No
(21_done_to_participants_biomedical.doc) Biomedical Research List what will be done in this protocol:
If there is a non- IRB Protocol- simply state See non-IRB protocol section: If there is not a non-IRB protocol this should include everything that will be done as part of this protocol. This should include an indication of which research interventions if any offer a prospect for direct benefit and which interventions (invasive measurements, collection of blood, tissue, data, surveys, etc.) are being done solely to answer a research question and generate generalizable knowledge. If the interventions done solely for research purposes are associated with greater than minimal risk they need to be justified. Describe and justify any control and experimental arm and include method, dose, and duration of drug administration. Reference any claim of clinical equipoise if applicable. If you are only obtaining specimens or data, provide information regarding the type of specimen/data, amount of specimen needed and how the specimen/data will be obtained and what analysis will be done with the specimen/data. Note: The following questions must be answered for all protocols. If a potential subject does not meet the inclusion/ exclusion criteria will you repeat any of the screening procedures/ tests? Yes No If yes, please explain. If this includes blood drawing- please note amount of blood to be drawn. Explain process if potential subject will be asked to do anything different before re-screening (e.g. change diet, change medications)
If clinically meaningful results are obtained during the course of the study, explain how you will notify the participant. What treatments, normally used, will be omitted for the study? Will any of the treatments/ procedures be done for research purposes only? If yes, describe: What details of the study are best kept secret from the participants?
(22_done_to_participants_qualitative.doc) Qualitative Research What will the participants do in the study? Describe all steps the participants will follow. What do the data consist of? (Please submit one copy of all instruments, surveys, interview questions or outlines, observation checklists, etc.) Describe what will be done with the data and resulting analysis and who will have access to this information. Are any aspects of the study kept secret from the participants? No Yes
If yes, describe. Is any deception used in the study? No Yes
If yes, describe the deception involved and the debrief procedures. Attach a postexperiment debriefing statement and consent form offering participants the option of having data destroyed.
(23_done_to_participants_taping.doc) Taping/Photography Will participants be recorded on audiotape? No Yes If yes, What steps will be taken to protect the privacy of the subjects?
What data will be captured from the audiotapes? When will data from the tapes be transcribed? When will the audiotapes be destroyed?
Will participants be photographed or recorded on videotape? No Yes If yes, Will their faces be shown? What steps will be taken to protect the privacy of the subjects? What data will be captured from the photo or videotape that could not be obtained in other ways? How is this data critical to this research? When will data from the tapes be transcribed? When will the tapes be destroyed?
If a subject withdraws from the study how will you withdraw them from the audiotape, videotape or photograph?
If yes in either case, will participants be recorded or photographed without their knowledge? No Yes
If yes, include a post-experiment release form offering the participants the option of having their tape erased.
(24_done_to_participants_chart_review.doc) Data to be Collected Provide type of data that will be collected.
(25_payment.doc)
Payment Total possible compensation should reflect the true value of the total possible dollar amount per participant for one year involvement in the study whether it be cash, check, gift card, goods, etc. or a combination of these items. Is money paid from UVa or State funds (including grant funds)? Yes No
Examples of when to say no: Participant payment or other compensation will come directly from sponsor of research trial.(funds for participant payments will not go through UVa's grants and contracts office) Researcher is using their own personal funds (non-UVa, state or grant) to compensate participants. Payment to participant is for reimbursement for travel, lodging, or other study related expenses (receipts required). Compensation is coming from a UVa Foundation not subject to UVA financial policies and procedures. If No- Are subjects being reimbursed for travel expenses? Yes No If Yes, explain rate/ amount/ upper limits of reimbursements
If Yes, continue to check all that apply below Will researcher use any of the following to compensate participants (check all that apply)? _____ Check issued to participant via UVA Oracle or State system _____ Petty cash account _____ Gift card _____ Other type of compensation: specify :_______ Check all categories that apply based on each participant group in the study: _____ < $50 TOTAL possible compensation for participating in the research study over one year _____ >= $50 TOTAL possible compensation for participating in the research study over one year and check issued to participant via UVA Oracle or State system _____ >= $50 TOTAL possible compensation for participating in the research study over one year and researcher unable to issue checks through UVA or State system, but able to gather IRS information No payments of >= $50 will be approved if IRS information cannot be obtained. Justify why you are unable to issue checks through the UVa Oracle or state system. Additional Comments/ Explanation:
(26_family_history_pedigree.doc) If you are gathering data about a subject’s pedigree as part of your study, please answer the following questions. While requesting family history is
routine in clinical practice, it raises special issues in research and the rules are in flux. In general, no identifiable information should be gathered about any family member who has not consented to the research as well. This means that routine identifiers, e.g. initials, should not be used. Special care should be used where the data may involve information that could expose third parties to confidentiality risks (e.g. insurance risk) or where the information is sensitive (e.g. alcoholism). What kind of information is being sought? (attach any questionnaires being used) What identifiers will be recorded with the info (e.g. names, initials, relationship such as mother, father, brother, sister, random number)? Does any of the information sought potentially expose the subject or a family member to additional risk? You should say yes if you are collecting sensitive information such as diagnosis of HIV, mental illness, alcoholism, abuse. You should say no if you are collecting non-sensitive information that is already in the family members medical record. This information is also known to all parties ( e.g. family, insurance, employer) such as diabetes or cancer diagnosis. If yes: Will other family members be asked to sign a consent form? Will the proposed recruitment process place undue pressure on other family members? Will steps be taken to avoid the disclosure of information among family members? If yes, please explain: Will steps be taken to avoid the disclosure of information outside the research team? If yes, please explain:
(27_specimens.doc) Specimens: Type of specimen to be used: Please list the information and identifiers that will be with the specimen when it is given to you.
(For example, what information will be listed on the sample label? What additional information will be sent?) If you are using discarded tissue do you confirm that it will be obtained either from pathology, a clinical lab or the UVa Tissue Procurement Facility? Yes No If no- describe the process for obtaining the discarded tissue. Will you be using viable embryos? Yes No If yes, attach approval from UVA General Counsel's Office Will you be using embryonic stem cells Yes No If yes, attach approval from UVA General Counsel's Office Do you plan to ship any specimens outside of UVA? Yes No
If yes, personnel performing this function must take the appropriate Department of Transportation training. The School of Medicine Clinical Trials Office has the training available. They can be reached at 924-8530. If yes, please list the information and identifiers that will be sent outside UVa with the specimen. (For example, what information will be listed on the sample label? What additional information will be sent?)
Will the specimen be obtained before a subject has signed a consent form? Yes
No
Please note: If yes, or if consent or documentation of consent is waived and the specimen is identifiable per HIPAA regulations, the research team will be required to track this disclosure with Health Information Services.
(28_study_design_biomedical.doc) Study Design: Biomedical What kind of controls will be used? Single-blind, double-blind, other: If randomized, how? Include when appropriate the method used to generate the random sequence, details of restriction such as stratification or blocking, and methods to implement random allocation sequence – allocation concealment.
Does the study involve a placebo? Yes No If yes, please provide the justification for the use of a placebo:
(29_study_design_biomedical_stats.doc) Plans for statistical analysis: Include when appropriate how sample size was determined, and statistical methods to compare groups for primary outcome(s) and additional analyses.
(30_gcrc_study_design_biomedical.doc) Bio-statistical Analysis Explain bio-statistical analysis to be done: Provide the statistical power (or precision) of the study design to demonstrate that the proposed sample size is sufficiently large to answer the research question or adequately address the investigator’s hypothesis. In general, your proposed statistical methods should correspond with the methods used to calculate statistical power. Every GCRC protocol needs to address the questions: “What is the primary outcome variable upon which a sample size estimate is based?” “Do I have an adequate sample size, or is my sample size larger than necessary?” In general, your proposed statistical methods should correspond with the methods used to calculate statistical power. The calculation of sample size also allows the GCRC to properly budget for adequate resources to help you complete your proposal. If statistical help is needed contact Jim Patrie at 924-8576 or David Boyd at 924-5232) What is the primary outcome variable upon which a sample size estimate is based? Do I have an adequate sample size, or is my sample size larger than necessary? The calculation of sample size also allows the GCRC to properly budget for adequate resources to help you complete your proposal.
(31_study_design_qualitative.doc) Study Design: Qualitative Methodology From where/whom will the data be collected? How will the data advance your research hypothesis or question? Taping/Photography
Will participants be recorded on audiotape? Yes No If yes, What steps will be taken to protect the privacy of the subjects? What data will be captured from the audiotapes? When will data from the tapes be transcribed? When will the audiotapes be destroyed?
Will participants be photographed or recorded on videotape? Yes No If yes, Will their faces be shown? What steps will be taken to protect the privacy of the subjects? What data will be captured from the photo or videotape that could not be obtained in other ways? How is this data critical to this research? When will data from the tapes be transcribed? When will the tapes be destroyed?
If a subject withdraws from the study how will you withdraw them from the audiotape, videotape or photograph?
If yes in either case, will participants be recorded or photographed without their knowledge? Yes No
If yes, include a post-experiment release form offering the participants the option of having their tape erased.
(32_chart_review_statistical_plan.doc) Plan for Statistical Analysis ( Include when appropriate how sample size was determined, and statistical methods to compare groups for primary outcome(s) and additional analyses.)
(33_risk_benefit_analysis.doc) Risk/ Benefit Analysis:
What are the potential benefits for the participant as well as benefits which may accrue to society in general, as a result of this study? Analyze the risk-benefit ratio: Analyze the risk- benefit of interventions offering potential health benefit separately from those done solely to answer a research question or generate generalizable knowledge. Clarify risk-benefit for direct benefit to individual participant versus benefit to society. IF you wish to use MRI with Gadolinium in subjects with a GFR<60 please insert here the risk/benefit analysis for this decision.
(34_dsmp_full.doc) Data and Safety Monitoring Plan
(If you have any questions completing this section please call 982-4311, 924-8660 or 243-9847)
Note: A Sponsor-is defined as entity that will receive data prior to publication. 1. Definition: 1.1 How will you define adverse events (AE)) for this study? (Check all that apply) An adverse event will be considered any undesirable sign, symptom or medical or psychological condition even if the event is not considered to be related to the investigational drug/device/intervention. Medical condition/diseases present before starting the investigational drug/intervention will be considered adverse events only if they worsen after starting study treatment/intervention. An adverse event is also any undesirable and unintended effect of research occurring in human subjects as a result of the collection of identifiable private information under the research. Adverse events also include any problems associated with the use of an investigational device that adversely affects the rights, safety or welfare of subjects. Will use definitions provided in the non IRB Protocol (Sponsor's, Investigator-Initiated, CTEP etc.) located in Section (insert section #). Other: (insert definition: )
1.2 How will you define serious adverse events? (Check all that apply) A serious adverse event will be considered any undesirable sign, symptom, or medical condition which is fatal, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability/incapacity, constitutes a congenital anomaly or birth defect, is medically significant and which the investigator regards as serious based on appropriate medical judgment. An important medical event is any AE that may not result in death, be life-threatening, or require hospitalization but may be considered an SAE when, based upon appropriate medical
judgment, it may jeopardize the patient and may require medical or surgical intervention to prevent one of the outcomes listed in the definitions of SAEs. OR Any serious psychological and emotional distress resulting from study participation (suggesting need for professional counseling or intervention). Will use definitions provided in the non IRB Protocol (Sponsor's, InvestigatorInitiated, CTEP etc.) located in Section (insert section # ). Other: (specify) 1.3 This is the definition of an unanticipated problem:
An unanticipated problem is any event, experience that meets ALL 3 criteria below: Is unexpected in terms of nature, severity or frequency given the research procedures that are described in the protocol-related documents AND in the characteristics of the subject population being studies Related or possibly related to participation in research. This means that there is a reasonable possibility that the incident may have been caused by the procedures involved in the research study. The incident suggests that the research placed the subject or others at greater risk of harm than was previously known or recognized OR results in actual harm to the subject or others 1.4 This is the definition of a protocol violation:
A protocol violation is defined as any change, deviation, or departure from the study
design or procedures of research project that is NOT approved by the IRB-HSR prior to its initiation or implementation, OR deviation from standard operating procedures, Good Clinical Practices (GCPs), federal, state or local regulations. Protocol violations may or may not be under the control of the study team or UVa staff. These protocol violations may be major or minor violations. Major Protocol Violation: All major protocol violations must be reported to the IRB-HSR immediately upon discovering them, and no later than seven (7) calendar days from the time the study team receives knowledge of the event. A major violation is a protocol violation that meets the following criteria: Represent a serious or continuing failure on the part of the study team to comply with the protocol, standard operating procedures, GCPS, federal, state or local regulations Impacts subject safety or substantially alter risks to subjects. May or may NOT result in actual harm (clinical, emotional, social, financial, etc) Significantly damages the completeness, accuracy and reliability of the data collected for the study Is under control of the investigator/study team/ UVa staff
Examples of MAJOR violations may include, but are not limited to: Evidence of willful or knowing misconduct on the part of the investigator(s), or study team
Failure to obtain informed consent, i.e., there is no documentation of informed consent, or informed consent is obtained after initiation of study procedures. (Note: Data for subjects where consent is not documented may not be used in data analysis.) Enrollment of a subject who did not meet all inclusion/exclusion criteria which would affect subject safety or would negatively impact data integrity Performing study procedure not approved by the IRB-HSR Failure to report serious unanticipated problems/adverse events to the IRB-HSR and (if applicable), the sponsor Failure to perform study procedures outlined in the protocol where subject safety or data integrity may be negatively impacted. (Ex. Safety labs not done per protocol) Drug/study medication dispensing or dosing error under control of Investigators, study team or UVa staff. Study visit or procedure conducted outside of required time frame that may negatively affect subject safety Failure to follow Data Safety Monitoring Plan
Minor Protocol Violations: Reporting of minor violations to IRB is not required by IRB-HSR.
REMOVE THE FOLLOWING PARAGRAPH IF THIS STUDY DOES NOT HAVE AN OUTSIDE SPONSOR:
Protocol Enrollment Exceptions: An enrollment exception is the sponsor’s prospective approval for the enrollment of a research subject that fails to meet current IRB-HSR approved protocol inclusion criteria, or falls under protocol exclusion criteria. Enrollment exceptions only apply to a single individual. Such a request should be rare and justified in terms of serving the best interests of the potential study participant.
2. Identified risks and plans to minimize risk 2.1 What risks are expected due to the intervention in this protocol? Expected: is identified in nature, severity or frequency in the study documentation (protocol, consent, Investigator Brochure, package insert etc) is considered an expected.
The risks should be consistent with those in the consent form and the investigator’s brochure (if applicable), although they should be written in technical terms in the protocol and in lay terminology in the consent form. Separate risks by source of risk: (example: Risk of Radiation, Risk of Study Drug, Risk of investigational device, etc.) If there is more than one source of risk- please insert a separate table for each risk. TO ADD A TABLE READ THESE INSTRUCTIONS FIRST: click Tools – Unprotect document. Once you have added the table and relevant risk information, click “Yes, start enforcing protection” in the Protect document dialog box to the right of this document (this will appear after you unprotect the document). Click OK when the password dialog box appears- Do not enter a password. List the most serious risk first. If there is a non- IRB Protocol (Sponsor's, Investigator-Initiated, CTEP etc.) - you may reference the risk section from the non-IRB protocol. (Note For Cancer Center studies the table must include the maximum expected grade.) Frequency Please pick one frequency from each box below Occurs frequently, Occurs infrequently
Expected Risks related to study participation.
Occurs rarely Frequency unknown Occurs frequently, Occurs infrequently Occurs rarely Frequency unknown Occurs frequently, Occurs infrequently Occurs rarely Frequency unknown
Delete the following table on minimizing risks of gadolinium if the study does not include the administration of gadolinium-enhanced MRI for research purposes. READ INSTRUCTIONS BEFORE DELETING TABLE. Click Tools – Unprotect document. Once you have deleted the table, click “Yes, start enforcing protection” in the Protect document dialog box to the right of this document. Click OK when the password dialog box appears- Do not enter a password.
Risk of Gadolinium: NSF/NFD
An extremely rare disease called Nephrogenic Systemic Fibrosis (NSF) or Nephrogenic Fibrosing Dermopathy (NFD) has been linked with the use of gadolinium in people with: moderate kidney failure (glomerular filtration rate (GFR) less than 60 mL/min) end-stage kidney disease (GFR less than 15 mL/min). NSF/NFD causes hardening and thickening (fibrosis) of the skin, connective tissues like muscles, tendons, ligaments, and blood vessels throughout the body. In addition, those who develop NSF/NFD may have scarring of their body organs. NSF/NFD may be progressive (may worsen) and may be fatal. There is no known treatment for NSF/NFD. Skin biopsy is the only true means of diagnosis.
Extremely Rare
2.2 List by bullet format a summary of safety tests/procedures/observations to be performed.
Particularly list those tests or procedures that screen out ineligible research subjects and those that monitor toxicity and other adverse outcomes. For example: Adequate screening, pregnancy testing, AE monitoring at each visit, etc.)
Refer to the non- IRB Protocol (Sponsor's, Investigator Initiated protocol etc.) Section (section #: ) Delete the following information on minimizing risks of gadolinium if the study does not include the administration of gadolinium-enhanced MRI for research purposes. READ INSTRUCTIONS FIRST. Click Tools – Unprotect document. Once you have deleted the
text, click “Yes, start enforcing protection” in the Protect document dialog box to the right of this document. Click OK when the password dialog box appears- Do not enter a password.
To minimize the risk of receiving gadolinium: In addition to the exclusion criteria in this protocol, all subjects will be screened by UVa Department of Radiology staff prior to receiving gadolinium. If radiology screening indicates that it might be unsafe for a subject to receive this contrast, then the subject should not be given the contrast for research purposes. If screening indicates that the subject may receive gadolinium, the subject will receive a brand of contrast that has thus far not been linked to reported cases of NSF per the FDA. 2.3 Check the criteria below under which an INDIVIDUAL SUBJECT’S study treatment or study participation would be stopped or modified [For example: At subject, PI or sponsor’s request Treatment would be stopped if the subject had a Serious adverse event deemed related to study, or study drug will be increased if the subject tolerates dosing (insert details: ) Refer to the non- IRB Protocol (Sponsor's, Investigator-Initiated, CTEP protocol etc.) Section (section # ) 2.4 Check the criteria under which THE ENTIRE STUDY would need to be stopped. These are called stopping rules for early termination of the entire study. (regardless of whether the study is sponsored or not, be sure to include any criteria for which the UVa PI would halt the study at UVa.) (Check all that apply) Per IRB, PI, DSMB, or sponsor discretion Refer to the non- IRB Protocol (Sponsor's, Investigator Initiated protocol etc.) Section (Insert section #) Other (specify) 2.5 Describe the criteria for breaking the blind/mask Description: Refer to the non- IRB Protocol (Sponsor's, Investigator Initiated protocol etc.) Section (section # ) NA – Not blinded/masked
2.6 How will subject withdrawals/dropouts be reported to the IRB prior to study completion? (Check all that apply) IRB-HSR continuation status form Other type of list/form (please attach) 3. Adverse Event / Unanticipated Problem Recording and Reporting 3.1 Will all adverse events, as defined in section 1.1, be collected/recorded? Yes No- If no, describe criteria for which adverse events will be collected/recorded Only adverse events deemed related/possibly related to study Only adverse events that are deemed serious Only adverse events that are deemed related AND serious If protocol requires oversight by Cancer Center DSMC and the protocol is Investigator Initiated- will use tables from Question #8 to document what will be recorded.(If unsure if Cancer Center DSMC will have oversight see Question #6 for guidance.) Other- specify: 3.2 How will adverse event data be collected/recorded? (Check all that apply) Paper AE forms/source documents (please attach a copy of this form if possible) Spreadsheet (paper or electronic) Database (specify name/type of database(s): 3.3. How will AEs be classified/graded? (Check all that apply) World Health Organization Criteria (WHO) NCI Common Toxicity Criteria, Version 2.0/ NCI Common Terminology Criteria, Version 3.0 Mild/Moderate/Severe
Serious/Not serious (required for all protocols)
Will use classifications/ grades provided in the non IRB Protocol (Sponsor's, Investigator-Initiated, CTEP etc.) see Section (insert section # ) Other: (specify)
3.4 What scale will the PI use when evaluating the relatedness of adverse events to the study participation? (Check all that apply.) The PI will determine the relationship of adverse events to the study using the following scale: Related: Possibly related: Unrelated: AE is clearly related to the intervention AE may be related to the intervention AE is clearly not related to intervention
Will use attribution scale provided in the non IRB Protocol (Sponsor's, InvestigatorInitiated, CTEP etc.) The PI will use an alternative attribution scale. (specify) 3.5 When will recording/reporting of adverse events/unanticipated problems begin? After subject signs consent After subject begins study drug/ device placement/intervention /study-related procedure/specimen collection Other: (specify) 3.6 When will the recording/reporting of adverse events/unanticipated problems end? End of study drug/device/intervention/participation 30 days post study drug/device/intervention Subject completes intervention and follow up period of protocol Other: (specify) See non IRB Protocol (Sponsor's, Investigator-Initiated, CTEP et.) for additional information- Section (section # ) Two years past last exposure to Gadolinium ONLY if diagnosed with NSF/NSD (This must be checked if protocol involves administration of Gadolinium for research purposes) 3.7 Please complete the following table to describe details of Adverse event, Unanticipated Problem, and Protocol Violation reporting. (Complete and modify as
appropriate. To modify the table, click Tools – Unprotect document. Once you have modified the table to fit your study, click “Yes, start enforcing protection” in the Protect document dialog box. Simply click OK when the password dialog box appears- Do not enter a password) To whom will it be reported: Any internal event resulting in death that is deemed IRB-HSR DEFINITELY related to (caused by) study participation Type of Event Time Frame for Reporting Within 24 hours How reported? IRB Online and phone call www.irb.virginia.edu/
(Note: An internal event is one that occurs in a subject enrolled in a UVa protocol.) Internal, Serious, Unexpected adverse event
IRB-HSR
Within 7 calendar days from the time the study team received knowledge of the event. Timeline includes submission of signed hardcopy of AE form. Within 10 day calendar days of the study team receiving knowledge of the event Within 7 calendar days from the time the study team received knowledge of the event.
IRB Online www.irb.virginia.edu/
For Device Studies: Unanticipated adverse device effects (internal)
IRB-HSR
IRB Online www.irb.virginia.edu/
Unanticipated Problems that are not adverse events or protocol violations
IRB-HSR GCRC
(Note: This GCRC reporting requirement should be listed ONLY if this protocol is reviewed by GCRC)
Unanticipated Problem report form. http://www.virginia.edu/vprgs/ir b/HSR_docs/Forms/Reporting_R equirementsUnanticipated_Problems.doc )
Protocol Violations (Note the IRB-HSR only requires that MAJOR violation be reported, unless otherwise required by your sponsor, if applicable.) Or Enrollment Exceptions
IRB-HSR GCRC
(Note: This GCRC reporting requirement should be listed ONLY if this protocol is reviewed by GCRC)
Within 7 calendar days from the time the study team received knowledge of the event.
Protocol Violation and Enrollment Exception Reporting Form
http://www.virginia.edu/vprgs/ir b/hsr_forms.html Go to 3rd bullet from the bottom.
OUTSIDE SPONSOR INSTRUCTIONS: COMPLETE THIS SECTION ONLY IF YOU HAVE AN OUTSIDE SPONSER, OTHERWISE DELETE. Note: The section below may be modified to match the sponsor's protocol or you may simply delete and supply a reference to the sponsor's protocol. (*Sponsor- an entity that will be receiving data prior to publication) This section should remainif this is a study reviewed by the GCRC, if there is a commercial sponsor, if there is a coordinating center with whom UVa has a contract and reporting responsibilities, or if the PI has their own grant funding for this study. All Serious adverse events Sponsor (Insert time frame) (Insert name of form and method of report) GCRC Insert time frame) (Note: This GCRC (Insert name of form and method reporting of report)
requirement should be listed ONLY if this protocol is reviewed by GCRC AND NOT by PRC- otherwise delete.
External, Serious and Unexpected adverse event resulting in change to safety profile. (Note: An external event is one that occurs in a subject enrolled at a site other than UVa.)
IRB-HSR
Within 7 calendar days from the time the study team received knowledge of the event. Timeline includes submission of signed hardcopy of AE form Within 15 calendar days of the study team receiving knowledge of the event.
IRB Online www.irb.virginia.edu/
External, Serious and Unexpected adverse event not resulting in change to safety profile
IRB-HSR
Will be submitted using one of the following methods: 1. IRB Online www.irb.virginia.edu/ Non UVa Batch Submission Form http://www.virginia.edu/vpr gs/irb/hsr_forms.html Hard copy of external AE report from sponsor (Insert reporting method) 3. 2.
For Device Studies: Unanticipated adverse device effects (internal)
Sponsor
Unanticipated Problem
Sponsor
Protocol violations
Sponsor
Within 10 day of the study team receiving knowledge of the event (Insert required timeframe) If there is no information from the sponsor use the same time frames as abovein reporting External, serious and unexpected AE resulting in Change to safety profile to the IRB. (Insert required timeframe)
(Insert reporting method)
(Insert reporting method)
INDEPENDENT DSMB/DSMC INSTRUCTIONS: COMPLETE THIS SECTION IF YOU HAVE AN INDEPENDENT DSMB/DSMC OR YOU MAY REFER TO THE NON- IRB PROTOCOL(IF APPLICABLE) OTHERWISE DELETE DSMB/DSMC Insert what items the DSMB/DSMC wants to (Insert (Insert reporting Review (AEs, SAEs, early withdrawals, etc) timeframe) method) Unanticipated Problem DSMB/DSMC Reports DSMB/DSMC IRB (Insert required timeframe) 15 calendar days of the study team (Insert reporting method) Copy of DSMB/ DSMC report
GCRC
(Note: This GCRC reporting requirement should be listed ONLY if this protocol is reviewed by GCRC AND NOT by PRC- otherwise delete.
receiving the report
UVa PI Held IND/IDE INSTRUCTIONS: COMPLETE THIS SECTION IF THE PI HOLDS THE IND/IDE- OTHERWISE DELETEOR YOU MAY REFER TO THE NON-IRB PROTOCOL (IF APPLICABLE) Life-threatening and/or fatal unexpected events FDA Within 7 calendar Form FDA 3500A (MedWatch) related or possibly related to the use of the days of the study or narrative investigational agent. team learning of the event Serious, unexpected and related or possibly related FDA Within 15 calendar Form FDA 3500A (MedWatch) adverse events days after the study or narrative team receives knowledge of the event For Device Studies: Unanticipated adverse device FDA Within 10 working effects (internal or external) days of the study Form FDA 3500A (MedWatch) team receiving or narrative knowledge of the event All adverse events FDA Annually IND annual report UVa PI Held IND/IDE OR UVA PI of Multi-Site Trial INSTRUCTIONS: COMPLETE THIS SCTION IF THE IND/IDE IS HELD BYA UVA PI OR THE UVA PI IS THE OVERALL PI OF THIS MULTI-SITE STUDY Serious, unexpected and related or possibly related ALL Within 15 days after IND/IDE Safety Report adverse events the Overall PI (Cover letter, copy of PARTICIPAT receives knowledge MedWatch/narrative) ING of the event. REAEARCH SITES For Device Studies: Unanticipated adverse device effects (internal or external)
ALL PARTICIPAT ING
RESEARCH SITES
Within 15 calendar days from the time the Overall PI receives knowledge of the event.
Letter to Participating PIs, Copy of MedWatch or narrative
Unanticipated Problem
Within 15 calendar Letter to Participating PIs, ALL days from the time Copy of MedWatch or narrative PARTICIPAT the Overall PI ING receives knowledge RESEARCH of the event. SITES The IRB-HSR strongly encourages PIs that are also holding their own IND/IDE to utilize the IRB-HSR IRB online adverse events database for RECORDING all adverse events. The principal investigator can then use this database to produce a report of all adverse events on the study to do an aggregate review, which is helpful since an annual report to the FDA containing this information is required by the FDA.
Note: If the Cancer Center Protocol and Review Committee (PRC) will review this protocol additional
reporting requirements are found in the PRC section of this protocol.
GENE TRANSFER INSTRUCTIONS: COMPLETE THIS SECTION IF THE STUDY INVOLVES GENE TRANSFER OTHERWISE DELETEOR YOU MAY REFER TO THE NON-IRB PROTOCOL (IF APPLICABLE)
Life-threatening and/or fatal unexpected events related or possibly related to the use of the investigational agent. Serious, unexpected and related or possibly related adverse events NIH OBA UVa IBC Within 7 calendar days of the study team learning of the event Within 15 calendar days after the study team receives knowledge of the event Within 15 calendar days after the study team receives knowledge of the event Annually Narrative- per NIH OBA Appendix M-I-C-4a. Narrative- per NIH OBA Appendix M-I-C-4a.
NIH OBA UVa IBC
Any finding from tests in laboratory animals that suggests a significant risk for human research participants including reports of mutagenicity, teratogenicity, or carcinogenicity All adverse events
NIH OBA UVa IBC
Narrative- per NIH OBA Appendix M-I-C-4-a.
NIH OBA
Annual Report
4. How will the endpoint data be collected/recorded. (Check all that apply) Protocol specific case report forms (attach if in-house) Source documents Database: specify Other: specify
5. Data and Safety Oversight Responsibility
5.1. Who is responsible for overseeing safety data for this study (i.e., Who is looking at data in aggregate form to identify trends?)(Check all that apply) No additional oversight body other than PI (skip question 5.2) The UVa Cancer Center Data and Safety Monitoring Committee (If your study involves cancer patients, see Question # 6 to help you decide if you should check this box) Industry Sponsored-designated DSMB/DSMC/Medical Monitor Non-Industry Sponsored (other academic center, NIH) designated DSMB/DSMC/Medical Monitor (If your study is NIH funded, please check with the center to determine if they require a DSMB for this study) Other: specify 5.2. What is the composition of the reviewing body and how is it affiliated with the sponsor? Note: Members of the study team may NOT also be members of the DMSB.
Information may be found in the UVa Cancer Center Institutional DSMP OR Other- specify 5.3. Answer this question ONLY if the PI is the ONLY person overseeing the safety data for this study. (Note: in this case you will have checked the first box for question #5.1 "No additional oversight body other than PI.”) Please check aggregate reviews that will occur by the PI (Check all that apply) All adverse events Unanticipated Problems Protocol violations Audit results Application of dose finding escalation/de-escalation rules (these should be outlined under 2.4) Application of study designed stopping/decision rules Early withdrawals Whether the study accrual pattern warrants continuation/action Endpoint data Other: (specify) 5.4. Answer this question ONLY if the PI is the ONLY person responsible for overseeing the safety if the study. (Note: in this case you will have checked the first box for question #5.1 "No additional oversight body other than PI.") How often will aggregate review occur? Annually Monthly Other: (specify ) 5.5. Answer this question ONLY if this study has someone besides the PI is overseeing the safety data. (Note: in this case you will have checked a choice other than the first box for Question #5.1, for example “Industry Sponsored-designated DSMB/DSMC/Medical Monitor.”) How often will a report, regarding the outcome of the reviews, be sent to the PI from the oversight body listed in 5.1.
Every six months Once a year Other: (specify) Note: A copy of these reports must be sent to the IRB and GCRC if applicable as soon as they are received by the PI. Do not wait until the next continuation to submit them to the IRB. 5.6. How will a report of the information discussed in question 5.4 OR 5.5 be submitted to the IRB? Part of IRB-HSR continuation status form Separate report from sponsor/DSMB/DSMC Other: (specify)
(35_dsmp_prc.doc) 6. Designate type of study (check only one) CHECK ONE TYPE of SPONSOR Oversight by CC DSMC? External DSMB Required? ** If determined by NIH or IRB If determined by sponsor or IRB If determinedby PRC, NIH or IRB Yes if: Phase IIIMedium or High Risk; or determined by PRC, NIH or IRB IRB to Determine
1.
Cooperative Group
No
2
Industry sponsored
No
3
UVa Investigator Initiated- Single site at UVa UVa Investigator Initiated (Multi-site)
Yes*
4
Yes* if: Pilot: Low, Medium or High Risk Phase I or II Low, Medium or High Risk Phase III- Low Risk No
5
Non- UVa Investigator Initiated (Multi-site)
*Oversight required by either CC DSMC or an External Board. To be determined by Cancer Center PRC. **The PI will be notified by the PRC, CC DSMC or the IRB as to what should be entered in this column. NOTE: The IRB, the PRC or the CC DSMC has the authority to overrule the oversight required as listed in the table above. If this study DOES NOT require oversight by the CC DSMC, delete the following section including Question 7 and 8 and Table A, B and C.
If the Cancer Center DSMC has oversight of this study answer questions # 7 and 8. 7. Is this study therapeutic or non-therapeutic Therapeutic: Institutional clinical trials proposing any form of treatment of a cancer patient population. This includes all primary forms of anti-neoplastic therapy (chemical, biological, internal and external radiation, surgery and also includes all forms of supportive treatments, prophylactic or otherwise (hematologic growth factor support, anti-infectives, anti-fungals, narcotics, etc.) Non-therapeutic: Studies in this category do involve treatment of human subjects, but may not involve a physical intervention. Examples include biopsy, phlebotomy, wound healing, smoking cessation, cancer risk assessment and quality of life studies.
8. PLEASE CHECK ONE TYPE FROM THE NEXT TWO TABLES Therapeutic (High or Medium Risk) Risk Types of Studies Monitoring Frequency by Check Level VPRGS Compliance Monitors ONE High Pilot, Every 6 months Phase I studies, See Table A below for Gene Therapy or Reporting Requirements NIH has designated as High Risk Medium All other therapeutic Every 12 months interventions See Table B below for (typically Phase II Reporting Requirements trials) NOTE: If you checked either box above, the PRC requires that you submit a protocol in CTEP type format in addition to the abbreviated IRB protocol. OR Therapeutic (Low Risk) or Non-therapeutic Risk Level Types of Studies Monitoring Frequency by VPRGS Compliance Monitors Therapeutic Therapeutic-Intervention Every 12 months Low Risk/ Studies: See Table C below for Reporting Nutritional or Requirements behavioral Studies Therapeutic Low Risk/ TherapeuticNon-Intervention Studies: Cancer Prevention Palliative Diagnostic Cancer Prevention Counseling Palliative Biopsy/Blood/ Tissue Collection Diagnostic Every 12 months See Table C below for Reporting Requirements Every 12 months See Table D below for Reporting Requirements
Check ONE
Nontherapeutic Low Risk
NOTE: The IRB, the PRC or the CC DSMC has the authority to overrule the monitoring frequency required as listed in these tables.
THE FOLLOWING TABLES MAY BE MODIFIED AS APPROPRIATE
TO MODIFY, READ INSTRUCTIONS BEFORE BEGINNING. Click Tools – Unprotect document. Once you have made your modifications, click “Yes, start enforcing protection” in the Protect document dialog box to the right of this document (this will appear after you unprotect the document). Click OK when the password dialog box appearsDo not enter a password.
Table A
Table A: Therapeutic High Risk Studies Reporting requirements for AEs that occur within 30 days of the last dose of protocol specified treatment Grade 1 Grade 2 Grade 3 Grade 4&5
Expected and unexpected Unrelated Unlikely Possible Probable Definite C3TO 30 days C3TO 30 days Expected Expected Unexpected Without hospitalization C3TO 30 days C3TO 30 days With hospitalization C3TO 15 days C3TO 15 days Without hospitalization C3TO 30 days C3TO 7 days With hospitalization C3TO 15 days C3TO 7 days Unexpected Expected and Unexpected C3TO 7 days C3TO (24-hrs)* 7 days
C3TO 30 days C3TO 30 days
C3TO 30 days C3TO 15 days
*Enter into Cancer Center database within 24 hours if unexpected and definitely related to protocol specified treatment Hospitalization defined as an inpatient hospital stay or prolongation of a hospital stay equal to or greater than 24 hours
Table B
Table B: Therapeutic Medium Risk Phase II Studies Reporting requirements for AEs that occur within 30 days of the last dose of protocol specified treatment
Grade 1 Expected and unexpected Unrelated Unlikely Possible Probable Definite Not required C3TO 30 days Grade 2 Expected Unexpected Expected Without hospitalization C3TO 30 days C3TO 30 days With hospitalization C3TO 15 days C3TO 15 days Grade 3 Unexpected Expected Without hospitalization C3TO 30 days C3TO 15 days With hospitalization C3TO 15 days C3TO 15 days Unexpected Grade 4 & 5
Not required C3TO 30 days
Not required C3TO 15 days
C3TO 15 days C3TO 15 days
C3TO 15 days C3TO (24-hrs)* 7 days
*Enter into Cancer Center database within 24 hours if unexpected and definitely related to protocol specified treatment Hospitalization defined as an inpatient hospital stay or prolongation of a hospital stay equal to or greater than 24 hours
Table C
Table C: Therapeutic low risk Reporting requirements for AEs that that occur within 30 days of the last protocol specified treatment/intervention
Grade 1-2 Expected Without hospitalization Not required Not required Grade 1-2 Unexpected With hospitalization Not required C3TO Grade 3 Expected or Unexpected Grade 4-5 Expected or Unexpected
Unrelated Unlikely Possible
Not required Not required
Not required C3TO
C3TO 15 days C3TO
Probable 30 days 15 days Definite *Enter into Cancer Center database within 24 hours if unexpected and definitely related to protocol specified treatment Hospitalization defined as an inpatient hospital stay or prolongation of a hospital stay equal to or greater than 24 hours
(24-hrs)* 15 days
Table D
Table D: Non-therapeutic low risk Reporting requirements for AEs that occur within the protocol specified time frame of the last protocol intervention
Grade 1-2 Expected Without hospitalization Not required Not required Grade 1-2 Unexpected With hospitalization Not required C3TO 30 days Grade 3-5 Expected or Unexpected
Unrelated Unlikely Possible Probable Definite
Not required Not required
Not required C3TO (24-hrs)* 30 days
* Enter into Cancer Center database within 24 hours if unexpected and definitely related to protocol specified intervention Hospitalization defined as an inpatient hospital stay or prolongation of a hospital stay equal to or greater than 24 hours
(36_dsmp_database.doc) Data and Safety Monitoring Plan This study poses minimal risk to the individual subject because the study only involves data/specimens that are being stored to create a data/specimen vault for future studies. There will be no direct interaction with human subjects, therefore no adverse events are anticipated. Any unanticipated problems that occur, will be reported to the IRB-HSR, using the IRB Unanticipated Report Form, within 7 days from the time the study team received knowledge of the event. 1. Definitions An unanticipated problem is any issue that involves increased risk(s) to participants or others. This means issues or problems that cause the subject or others to be placed at greater risk than previously identified, even if the subject or others do not incur actual harm. For example if a subject’s confidentiality is compromised resulting in serious negative social, legal or economic ramifications, an unanticipated problem would need to be reported. (e.g serious loss of social status, loss of job, interpersonal conflict.) 2. What risks are anticipated secondary to participation related to this study? (Check all that apply) There is a small risk that breaches of privacy and/or confidentiality might occur. Other: (specify)
3. When will recording and reporting of unanticipated problems begin? After subject signs consent When data collection begins Other: (specify) 4. Unanticipated problems will be collected and reported to the IRB-HSR until: After data is destroyed. Information linking identifiers to de-identified data are destroyed. Other: (specify) 5. Explain the plan for safety monitoring Safety monitoring and aggregate review of unanticipated problems will be performed by the PI and IRB-HSR through continuation review at least annually. Other (specify)
(37_dsmp_expedited.doc) Data and Safety Monitoring Plan This study has been deemed minimal risk. Because this study poses minimal risk to the subject, adverse events will only be collected or recorded if a causal relationship to the study intervention is suspected. If any adverse event is considered serious and unexpected, the event must be reported to the IRB-HSR within 7 days from the time the study team receives knowledge of the event. 1. Definitions:
An adverse event will be considered any undesirable sign, symptom or
medical condition considered related to the intervention. Medical condition/diseases present before starting the intervention will be considered adverse events only if they worsen after starting the study and that worsening is considered to be related to the study intervention. An adverse event is also any undesirable and unintended effect of research occurring in human subjects as a result of the collection of identifiable private information under the research. In addition, any unanticipated problems that occur will be reported to the IRB-HSR within 7 days from the time the study team received knowledge of the event.
An unanticipated problem is any issue that involves increased risk(s)
to participants or others. This means issues or problems that cause the subject or others to be placed at greater risk than previously identified, even if the subject or others do not incur actual harm. For example if a subject’s confidentiality is compromised resulting in serious negative social, legal or
economic ramifications, an unanticipated problem would need to be reported. (e.g serious loss of social status, loss of job, interpersonal conflict.) 2. What risks are expected due to the intervention in this protocol? The risks should be consistent with those in the consent form (if applicable), although they should be written in technical terms in the protocol and in lay terminology in the consent form. List the most serious or most frequent risk first
There is a small risk that breaches of privacy and/or confidentiality might
occur.
Please insert the following table if any additional risks are expected. Expected Risks related to study Pick One participation Occurs frequently, Occurs infrequently Occurs rarely Occurs frequently, Occurs infrequently Occurs rarely Occurs frequently, Occurs infrequently Occurs rarely (Add as many lines as necessary to adequately capture expected risks. 3. When will recording and reporting of unanticipated problems/adverse events begin? After subject signs consent After subject begins study intervention Other (specify) 4. Unanticipated problems/adverse events will be recorded and reported to the IRBHSR until: Subject completes participation in the protocol End of intervention 30 days post intervention Subject completes intervention and follow up period of protocol Other: (specify) Note: Safety monitoring and aggregate review of adverse events and unanticipated problems will be performed by the PI and IRB-HSR through continuation review at least annually.
(38_dsmp_chart_review.doc) Data and Safety Monitoring Plan This study poses minimal risk to the subjects because data are being collected from records and there is no direct contact with human subjects. No adverse events are anticipated. All unanticipated problems will be reported to the IRB, using the IRB Unanticipated Problem Report form, within 7 days from the time the study team has knowledge of the event. 1. Definitions An unanticipated problem is any issue that involves increased risk(s) to
participants or others. This means issues or problems that cause the subject or others to be placed at greater risk than previously identified, even if the subject or others do not incur actual harm. For example if a subject’s confidentiality is compromised resulting in serious negative social, legal or economic ramifications, an unanticipated problem would need to be reported. (e.g serious loss of social status, loss of job, interpersonal conflict.) 2. What risks are anticipated secondary to participation related to this study? (Check all that apply) There is a small risk that breaches of privacy and/or confidentiality might occur.
Other: (specify)
3.
When will recording and reporting of unanticipated problems begin?
After subject signs consent When data collection begins Other: (specify)
4.
Unanticipated problems will be collected and reported to the IRB-HSR until:
After data are destroyed. Information linking identifiers to de-identified data are destroyed. Other: (specify)
5. Explain the plan for safety monitoring Safety monitoring and aggregate review of unanticipated problems will be performed by the PI and IRB-HSR through continuation review at least annually. Other (specify)
(39_uva_database.doc) Plan for Protecting Data at UVa Which is Held Outside of Medical Records What data/specimens will be collected? Who will be responsible for storing the data/specimens? For how long will the data/specimens be stored? What is the long term intended use of the data/specimens? Will another research institution ever have control over the data/specimens? Who else might have access to the data/specimens?
Describe your plan/policies for releasing the data/specimens. Can the participants specify how the data/specimens will be used in future research? Can the participants withdraw their specimens or request that they be destroyed? If participants withdraw their specimens will information and/or cell lines created prior to withdrawal continue to be used?
(40_central_registry_database.doc) Central Registry/ Database outside of UVA Collection and/or Storage of Data/Specimens What data/specimens will be stored at UVA? What data/specimens will be sent to the central registry? Who will be responsible for storing the data/specimens at UVA? Who will be responsible for storing the data/specimens at the central registry? Does the central registry have a policy regarding confidentiality? If yes, attach policy. For how long will the data/specimens be stored? What is the long term intended use of the data/specimens? Will another research institution ever have control over the data/specimens? Who else might have access to the data/specimens? Describe the central registry plan/policies for releasing the data/specimens. Yes NO
(41_tissue_banking.doc) Tissue Banking Note to investigators: Please make sure that the information regarding tissue banking contained in the protocol matches the information in the consent. The IRB strongly encourages you to review the Learning Shot on HIPAA Terminology for additional information BEFORE completing this section.
Information Accompanying Specimens or Data 1. What information will be on the label of the specimen? The IRB advises that you do not include HIPAA identifiers such as name, medical record number, subject initials on the label. Instead, the IRB recommends using the study number, day and month collected or Visit number. 2. What information will be "linked to" or will accompany the specimen? (e.g. type of clinical information, type of demographic data, HIPAA identifiers such as name, Medical Record Number) 3. If the samples are identifiable please explain why they cannot be coded or de-identified. Collection and/or Storage of Specimens 4. How much material (e.g. blood, tissue) will be collected and how will it be collected?
5. Who will be responsible for storing the specimens (e.g. sponsor, UVa PI, tissue bank/procurement facility, tissue bank outside of UVa)?
6. Where will the specimens be stored? (e.g. a refrigerator/freezer in a lab, a room-provide room number, or specific location). Note: To protect confidentiality, whenever possible, you should consider using a central facility/repository such as the UVa Biorepository and Tissue Research Facility. 7. Could the loss of confidentiality of the subject's health information potentially have a negative impact decisions of health coverage, employment, insurability or any other benefit, or cause social stigmatization? (e.g. If the data has information about a sensitive issue such as HIV status or Alzheimer’s disease your answer to this question should be yes). Yes No If yes, explain the sensitivity of the issue and describe the security precautions that will be implemented at UVa. Security precautions may include using a password protected computer database to link identifiers, and limiting access to password or coded identifiers. Using a third party to code the specimens further ensures confidentiality. 8. Will another research institution or entity outside of UVa ever have control over the specimens? Yes No If yes, please list the name of outside institution/entity. If yes, what are the policies of the outside institution/entity for protecting the confidentiality of the subject?
If yes, what identifiers will be "linked to" or on the specimen when it is sent outside of UVa? Note: If you plan to ship specimens outside of UVa, personnel performing this function must have taken the appropriate training from the Department of Transportation. Contact SOM CTO for training information. 9. Can participants withdraw their specimens or request that they be destroyed? Note: the answer to this question must be yes unless the specimens are stripped of all HIPAA identifiers.
(42_tb_deidentified.doc)
(43_tb_linked_coded.doc)
(44_tb_identifiable.doc)
(45_tb_payment.doc) Payment Payment amount for participants:
(46_genetic_testing.doc) Genetic Testing Purpose: Is the research related to the clinical care of the participants? What is the current state of technology regarding the gene or disease to be studied? Is there any treatment or therapy for the disease under study? Risks: Describe the potential risks of the research: Some things to keep in mind:
Where the genetic study is linked to an already diagnosed disease, the risk to the subject may be minimal, but there may still be some significant risk to the subject’s family members. Many risks associated with genetic testing are related to breaches in confidentiality. You should consider the mechanisms through which breaches might occur and the consequences of those breaches. Risk is related to the amount of data stored about a subject, the security of the data storage, the more likely linkages, and the seriousness of any condition related to the data. Most genetic risk is probably future risk. It may be difficult now to anticipate confidentiality risks that participants may face one, five or ten years from now by being in this study at this time because the technology is not yet developed. In the future, it is possible that genetic testing results will be used more broadly by employers or insurers or considered by them. Since it is difficult to assess that risk now, participants should be provided with information that informs them of that uncertainty and the possibility that risk not present now may exist in the future. Sometimes the actual study will be important in determining the future uses of such testing; in that case, provisions should be made to inform participants of any risks that become more apparent as the study progresses. Consider documented correlations or associations that might be outside the study (for example a study focusing on correlations between APOE-4 and brain trauma may reveal information about a participant’s risk for early-onset Alzheimers Disease even though that information is not part of the actual study) Keep in mind generally-held public misconceptions as well as scientific realities. Misconceptions are often an important source of potential discrimination. Recent studies have shown that employers often fail to distinguish between having a genetic mutation and the possibility of becoming symptomatic with a disease. Social risks: Examples of types of social risks: health insurance, life insurance, disability insurance, employment, stigmatization, stress upon family relationships, change in reproduction plans, immigration status, forensic implications, and mistaken paternity. Keep in mind that these risks may vary; a condition that implicates disability insurance may have a minimal impact on life insurance. Psychological risks:
Examples of types of psychological risks: impact of results, impact of disease knowledge without treatment, disclosure of vague or uncertain results, stress related to other family members Incidental information may be generated (e.g., other disease markers) Inadvertent disclosure of personal information outside the research team Harm to the community: Could the genetic information be used to cause a group or community of people to be vulnerable to discrimination based on actual or perceived associations, e.g. Ashkenazy Jews and the BRCA genes, or alcoholism or other addictions within ethnic or cultural groups? Where a study may raise community risk, it may be a good idea to conduct focus group discussions with community representatives before the protocol is finalized. How will these risks be minimized? How will these risks be communicated to participants? What is the risk to participants that personal medical information will be disclosed outside the research team? What are the risks associated with an accidental disclosure of personal information?
If identifiers will be linked to specimens/ data, when will the identifiers be destroyed? _____ NA _____ After specimen is linked to clinical data but before genetic analysis is completed. _____ After specimen is linked to clinical data and immediately after the genetic analysis for the individual participant is completed. _____ After specimen is linked to clinical data and immediately after the genetic analysis for all participants is completed _____ Link to identifiers will not be destroyed _____ Other – describe: Confidentiality Will any information/ this consent form/ results be placed in the participant’s medical record? What information will be shared outside the research team (including results)? With whom will this information be shared? How will confidentiality be maintained? Disclosure of Study Results to Participants Some genetic testing is directly related to a patient’s medical care (e.g. HLA testing in bone marrow transplant or immune therapy). For many studies, however, it is unrelated to their current care. It would be unethical to provide results to subjects before clinical significance is definitively established. On the other hand, if there is a good chance that the research will yield results that could affect the subjects’ medical care, it may be appropriate to tell subjects that they may choose to receive results. In those situations, care should be taken to implement security procedures that will provide assurance that the genetic information will remain strictly confidential. In many cases, however, it may be more appropriate to refer subjects to genetic testing laboratories that are better equipped to deal with both testing and counseling. If providing subjects with results, care must be taken in how that information is conveyed and, if necessary, counseling should be offered. Any disclosure of results to participants must be approved by the IRB-HSR. Explain why it is appropriate to provide participants with results. If the participants will not receive information, why won’t they? What information will study participants receive? At what point during the research will the results be disclosed?
Who will disclose the results to participants? Will anyone other than the participant be informed of the results (e.g., physician)? If the study involves minors, will the minors also be informed of the results? Will genetics counseling be provided? Will genetics counseling be provided before the results are disclosed? If future research yields results that are clinically meaningful or significant, would those results be disclosed to the participant? Third Party Concerns Will family members be directly involved in the research? If yes, how and by whom (e.g., an investigator, the participant, a support group) will those family members be recruited? If no, does this study have any implications for the participant’s family members? If yes, will that information be shared with relevant family members? Are any vulnerable participants or populations involved in the research?
(47_gt_minors.doc) Disclosing Test Results to Minors Does the study involve research where predictive genetic information may be obtained about children that is unrelated to their current medical care? While parents may legally consent to such genetic research, in most cases children should not be included in such research if results will be provided and it is unrelated to their current medical care. This sets up a situation where children or their parents are provided with information that the child, had he or she been an adult, would have elected not to know and/or that the child might not want to know when he or she reaches adulthood. The potential harm to the emotional health and well-being of the child, and the parents’ interactions with that child if identified to have the disease later in life, could be significant. Is there is an intervention to treat, cure, or prevent the disease? Will the intervention be more effective if begun before age 18? Will a parent give consent and will the child give assent to the disclosure?
If the answer to any of the above is NO, results relating to minor participants should not be disclosed. Parents should be reminded that the research is not a substitute for clinical care, including genetic counseling and testing.
(48_waiver_documentation_consent.doc) Waiver of Documentation of Consent Does this study involve: High risk genetic testing in which samples are not de-identified? Yes No Use or disclosure of psychotherapy notes for research purposes? Yes No If either question is answered yes, this study will not qualify for waiver of documentation of consent. Does this study meet either of the following criteria? That the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research and the subject’s wishes will govern; Yes No If yes, please explain
OR That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context. Yes No If yes, please explain
If neither question is answered yes, this study will not qualify for waiver of documentation of consent.
Provide a short paragraph describing the study which will be given to the potential subject either verbally or in writing.
(49_bibliography.doc) Bibliography
Provide a current bibliography supporting the hypothesis, background and methodology including references to papers and abstracts that have resulted from pervious work by the investigator and references to the work of others.
(50_hipaa_criteria.doc) HIPAA Criteria (45CFR164) For clarification on the HIPAA terminology used in this section view "HIPAA & WAIVER OF CONSENT PART 1: TERMINOLOGY" and "HIPAA&WAIVER OF CONSENT PART 2: PRIVACY PLAN" Will you be using specimens, data from patients or health information from normal volunteers? (Note- if this is in reference to a Screening Log-please answer this question YES Yes No IF YES and this is in reference to a Screening Log, skip to A2) IF YES, and this is NOT in reference to a screening log, answer the following questions: A(1) If this protocol has a sponsor, will the sponsor be coming to UVA to monitor this study? Yes No NA- No sponsor If No or NA- Skip to A2 If Yes, will the monitor see any of the following HIPAA identifiers? (Check the HIPAA identifiers the Monitor will see.) Table A(1)
YES YES NO NO 1. Name 2. All geographic subdivisions smaller than a state, including street address, city, county, precinct, zip code, and their equivalent geocodes, except for the initial three digits of the zip code if, according to the current publicly available data from the Bureau of the Census: (1) The geographic unit formed by combining all zip codes with the same 3 initial digits contains more than 20,000 people and (2) The initial 3 digits of a zip code for all such geographic units containing 20,000 is changed to 000. 3. All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, date of death; and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older. (e.g. full dates –month/day/year) 4. Telephone numbers 5. Fax numbers 6. Electronic mail addresses 7. Social Security number 8. Medical Record number 9. Health plan beneficiary numbers 10. Account numbers 11. Certificate/license numbers 12. Vehicle identifiers and serial numbers, including license plate numbers 13. Device identifiers and serial numbers 14. Web Universal Resource Locators (URLs) 15. Internet Protocol (IP) address numbers 16. Biometric identifiers, including finger and voice prints 17. Full face photographic images and any comparable images
YES
NO
YES YES YES YES YES YES YES YES YES YES YES YES YES YES
NO NO NO NO NO NO NO NO NO NO NO NO NO NO
YES
NO
YES
NO
18. Any other unique identifying number, characteristic, code that is derived from or related to information about the individual (e.g. initials, last 4 digits of Social Security #, mother’s maiden name, first 3 letters of last name.) 19. Any other information that could be used alone or in combination with other information to identify an individual. (e.g. rare disease, researcher has access to a code. )
If you answered No to all items in the Table go to A2. If you answered yes to any item above, the data will be considered identifiable. Tracking of disclosures will be required. Please answer ALL QUESTIONS UNDER A(2) ,B,C,D,E,F,G,AND H. Do NOT skip any questions.
A(2). Will you record any of the HIPAA identifiers found in the table below? Yes No Please answer yes if: You are recording any of these items for a potential subject, an enrolled subject, a subject’s relative, household member or employer along with the data (which may include health information or be a specimen) If any of the HIPAA identifiers in the table below will be recorded with the health information or in a separate linked* file. Note: *linked file- means that your subject code (e.g. subject #1) are “linked” to HIPAA identifier(s). You may have this link in a separate list, but if you are keeping information anywhere that connects subject codes to Identifiers, ( e.g. subject # 1 is John Doe or medical record # 123456) then you are maintaining a linked file. If yes, please answer yes or no for each row in the table below. (Identifiers per HIPAA under 164.514(b)(2)(i) and (ii)) Table A(2)
YES YES NO NO 1. Name 2. All geographic subdivisions smaller than a state, including street address, city, county, precinct, zip code, and their equivalent geo-codes, except for the initial three digits of the zip code if, according to the current publicly available data from the Bureau of the Census: (1) The geographic unit formed by combining all zip codes with the same 3 initial digits contains more than 20,000 people and (2) The initial 3 digits of a zip code for all such geographic units containing 20,000 is changed to 000. 3. All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, date of death; and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older. (e.g. full dates –month/day/year) 4. Telephone numbers 5. Fax numbers 6. Electronic mail addresses 7. Social Security number 8. Medical Record number 9. Health plan beneficiary numbers 10. Account numbers 11. Certificate/license numbers 12. Vehicle identifiers and serial numbers, including license plate numbers 13. Device identifiers and serial numbers 14. Web Universal Resource Locators (URLs) 15. Internet Protocol (IP) address numbers 16. Biometric identifiers, including finger and voice prints 17. Full face photographic images and any comparable images 18.Any other unique identifying number, characteristic, code that is derived from or related to information about the individual (e.g. initials, last 4 digits of Social Security #, mother’s maiden name, first 3 letters of last name.) 19.Any other information that could be used alone or in combination with other information to identify an individual. (e.g. rare disease, researcher has access to a code. ) Do you have actual knowledge that the information could be used alone or in combination with other information to identify an individual who is a subject of the information? (Note- if you have answered YES to any item, except # 2 or 3 in tables A1 or A, then the response for Table B must be YES.)
YES
NO
YES YES YES YES YES YES YES YES YES YES YES YES YES YES YES
NO NO NO NO NO NO NO NO NO NO NO NO NO NO NO
YES
NO
Table B: Please answer the following question to the best of your ability.
YES NO
If you answered NO to all items in A and B, the data meets the criteria of de-identified under HIPAA. You are done-please sign and date the last page.
If you checked YES to any of the items in A2 do you plan to disclose the health information outside of UVA with any HIPAA identifiers found in Table A(2)? Yes No If Yes, to whom will you disclose to (check all that apply)? ____ Sponsor ____ Central Registry ____ Colleagues at other institutions not listed on the protocol ____ Other (specify) If you checked YES to any item is A2 ANSWER QUESTIONS C AND D C. Will you record any of the HIPAA identifiers found in the table below? Yes No Please answer yes if: You are recording any of these items for a potential subject, an enrolled subject, a subject’s relative, household member or employer along with the data (which may include health information or be a specimen) If any of the items in the table below will be recorded with the health information or in a separate linked* file. Note: *linked file- means that your subject code (e.g. subject #1) are “linked” to identifier(s). You may have this link in a separate list, but if you are keeping information anywhere that connects subject codes to Identifiers, ( e.g. subject # 1 is John Doe or medical record # 123456) then you are maintaining a linked file. If yes, please answer yes or no for each row in the table below. Table C (Limited Data Set criteria per HIPAA under 164.514(e)) YES N 1. Name O YES N 2. Postal address information, other than town or city, state, and zip code O YES N 3. Telephone numbers O YES N 4. Fax numbers O YES N 5. Electronic mail addresses O YES N 6. Social Security number O YES N 7. Medical Record number O YES N 8. Health plan beneficiary numbers O
YES YES YES YES YES YES YES YES YES
N O N O N O N O N O N O N O N O N O
NO
9. Account numbers 10. Certificate/license numbers 11. Vehicle identifiers and serial numbers, including license plate numbers 12. Device identifiers and serial numbers 13. Web Universal Resource Locators (URLs) 14. Internet Protocol (IP) address numbers 15. Biometric identifiers, including finger and voice prints 16. Full face photographic images and any comparable images 17. Any other unique identifying number, characteristic, code that is derived from the identifiers(#1 and #4-17) listed in Table A2 (e.g. initials, last 4 digits of Social Security #, mother’s maiden name, first 3 letters of last name, license plate #). 18.Any other information that could be used alone or in combination with other information to identify an individual. (e.g. rare disease, researcher has access to a code. )
YES
D. Please answer the following question to the best of your ability.
YES NO Will this information be disclosed for purposes other than research, public health, or health care operations of the University of Virginia Health System?
If you answered NO to all items in C and D your data meets the criteria of a Limited Data Set. Please delete all remaining sections and sign and date the last page. If you answered YES to any of the items in C or D do you plan to disclose health information outside of UVA with any HIPAA identifiers from Table ? No If Yes, please list here the identifiers from Table C that you will disclose outside of UVA. If Yes, to whom will you disclose to (check all that apply)? ____ Sponsor ____ Central Registry ____ Colleagues at other institutions not listed on the protocol ____ Other (specify) If you answered YES to any item in C or D your data is considered “Identified” under HIPAA and requires a waiver. Please answer E, F, G and H. Any disclosure outside of UVA will require tracking. Yes
E. Provide a brief description of the health information you need to access: Health information includes items like diagnosis, hematology lab results, MRI results. Health information does not refer to the HIPAA identifiers such as name, medical record #, full dates, initials that might be affiliated with the health information.
F. Explain why the research could not practicably be conducted without a waiver of consent. You may use the following sample wording if it applies to your protocol: This study will review patient charts and other records. Attempting to contact patients would be difficult. G. Explain why the research could not practicably be conducted without access to the identifiable data (health information and HIPAA identifiers). You may use the following sample wording if it applies to your protocol: This data cannot be evaluated without access to both the health information and the HIPAA identifiers.
H. Privacy Plan 1. Describe your/central registry’s plan to protect the identifiable data from improper use and disclosure. Check one of the options below
Option # 1: Data used for research purposes only. Health information will NOT be stored with HIPAA identifiers. Instead, they will be stored in two separate locations: (See Table A for full list of HIPAA identifiers)
_____
Health information with a code to the subject’s identity will be stored on paper or on a computer that has been secured according to, at a minimum, security guidelines described at http://itc.virginia.edu/security/checklistforPCs.html.Any health information stored on paper documents will be stored separately from the HIPAA identifiers and kept in a secure location with limited access. Only investigators for this study will have access to the data, and they will each use a unique log-in ID and password that they will keep confidential.
Subjects’ names or other HIPAA identifiers, except full dates and or address information (if needed), will not be stored on a computer at any time. Instead, the HIPAA identifiers with the code (e.g.- John Doe=subject #1) will be stored on paper files, memory stick or CD and kept in a locked file drawer with limited access. The researcher is allowed to combine the HIPAA identifiers and the health information temporarily while new data is downloaded. Each investigator will sign the University’s Electronic Access Agreement available at http://www.itc.virginia.edu/policy/form/eaa.pdf and forward the signed agreement to the appropriate department as instructed on the form. If you currently have access to clinical data it is likely that you have already signed this form. You are not required to sign it again. The study team may temporarily move data out of the research data files for analysis under the following conditions: o HIPAA identifiers, such as name, SS#, WILL NEVER be transported at the same time as the health information. o If analysis is done on another computer: that computer will be secured according to, at a minimum, security guidelines described at http://itc.virginia.edu/security/checklistforPCs.html. if the HIPAA identifiers and health information are combined on an additional computer off UVa premises, the researcher will follow the UVa "Guideline for Safeguards When Removing PHI Off- Premises for Work" https://www.healthsystem.virginia.edu/intranet/privacyoffice/Policies/PHI _Off_Premises.doc the data will be deleted from the hard drive of the additional computer as soon as possible. the data will be securely removed from the main computer, the additional computer, and/or electronic media (memory stick, CD etc) according to the University's Electronic Data Removal Policy described at https://etg07.itc.virginia.edu/policy/policydisplay?id=IRM-004 The data may not be analyzed for any other study without additional IRB approval.
Option # 2-Data used for clinical and research purposes. Health information may be stored with HIPAA identifiers.
_____
(See Table A for full list of HIPAA identifiers) NOTE: this option is approved in rare circumstances for very large databases used for both clinical and research purposes. This database is currently being used as a clinical database. Data including health information and HIPAA identifiers may be extracted from the clinical/research database for research purposes. The clinical/research data will be stored on (check one):
_____ a Health Systems Computing Services (HS/CS) managed server that is configured to store data regulated by HIPAA, _____ an Information Technology and Communications (ITC) managed server that is configured to store data regulated by HIPAA, _____ a server managed by the principal investigator’s department or school that is configured to store data regulated by HIPAA . The Principal Investigator should verify with their department that the server they plan to use is configured to store data regulated by HIPAA. Only investigators for this study will have access to the research data, and they will each use a unique log-in ID and password that they will keep confidential. Each investigator will sign the University’s Electronic Access Agreement available at http://www.itc.virginia.edu/policy/form/eaa.pdf and forward the signed agreement to the appropriate department as instructed on the form. If you currently have access to clinical data it is likely that you have already signed this form. You are not required to sign it again. Accessing the database holding the HIPAA identifiers and health information from an external site will be done only via the use of a VPN#. No identifiable data (data with health information and HIPAA identifiers) will be transferred to any other location such as a desktop, laptop, memory stick, CD etc. The researcher will follow all health system security policies found at https://www.healthsystem.virginia.edu/Intranet/security/Security_Policies/home.cfm If the HIPAA identifiers and health information are combined on an additional computer off UVa premises, the researcher will follow the UVa "Guideline for Safeguards When Removing PHI Off- Premises for Work" https://www.healthsystem.virginia.edu/intranet/privacyoffice/Policies/PHI_Off_Premises. doc The study team may temporarily move data out of this clinical database for analysis under the following conditions: o HIPAA identifiers, such as name, SS#, (see Table A for full list HIPAA identifiers) WILL NEVER be transported at the same time as the health information. o HIPAA identifiers will be kept in a secure location with limited access. o If analysis of data is done on another computer-: that computer will be secured according to, at a minimum, security guidelines described at http://itc.virginia.edu/security/checklistforPCs.html. the HIPAA identifiers and health information WILL NEVER be stored on the additional computer ,
the data will be deleted from the hard drive of the additional computer as soon as possible. the data will be securely removed from the server, additional computer(s), and electronic media according to the University's Electronic Data Removal Policy described at https://etg07.itc.virginia.edu/policy/policydisplay?id=IRB-004
The data may not be analyzed for any other study without additional IRB approval
2. Describe your/central registry’s plan to destroy the HIPAA identifiers at the earliest opportunity consistent with the conduct of the research. Check one option below: NA- the identifiers will not be destroyed. The identifier will be needed to be able to continue to add data in the future. .
_____
_____The
HIPAA identifiers (except full dates and or address information if needed) will be destroyed as soon as all data analysis is complete.
_____The
HIPAA identifiers (except full dates and or address information if needed) will be destroyed as soon as all publications are complete. Note: This wording would allow the researcher to keep HIPAA identifiers until all queries/ request for additional information from publisher are addressed
3. Do you confirm that you will not reuse the identifiable data (HIPAA identifiers or health information) or disclose any of this information to any other person or entity, except as required by law, for authorized oversight of the research study, or use it for other research unless approved by the IRB-HSR? This means: 1. You cannot contact the subject by any method (you cannot call them, send a letter, talk to them in person about the study, etc) without additional IRB approval 2. You cannot use the data for any research that is not already described in your IRB protocol without additional IRB approval (if you change your hypothesis you must modify your protocol) 3. You cannot share your research data with another researcher outside of your study team without additional IRB approval YES NO
(51_tb_uva_tb_confidentiality_policy.doc) UVA Tissue Banking Confidentiality Policy
This policy refers to any type of specimen obtained from a living human being such as tissue, blood or other material obtained by invasive means. Specimens must be de-identified. Although it is understood that it is very difficult to assure that anything can be truly de-identified, the standard of “ reasonable basis to believe that the information can be used to identify the individual” must be accepted. Therefore the following steps must be taken to attempt to deidentify the specimen. 1. The specimen will not be stored with direct identifiers as defined by HIPAA. 2. The entity that de-identified the specimen has the authority to re-identify it under the following guidelines. The document which links the specimen to the identity of the donor is kept in a secure location with limited access. (For example, a computer with pass-code protection and limited access or a locked file cabinet with limited access.) In addition the name(s) of the person(s) having access to the code is disclosed in the protocol. The identity is not released to anyone outside the research group unless authorized by law (ie public health disclosures, victims of abuse, neglect or domestic violence, judicial and administrative proceedings, disclosures for law enforcement purposes, victims of crimes). The identity cannot be released for any other reason such as a request by a family member. The donor is never contacted unless he/she has given prior approval to be contacted for future studies. If a surrogate gave consent he/she would never be contacted for future studies, since studies requiring additional consent would pose more than minimal risk and not be allowed. Results from studies are never put in the donor’s medical records or released to anyone outside the research group such as the surrogate, other family members or an insurance company. The specimen/ or part of the specimen is never released to anyone outside the research group with identifiers (i.e. the specimen would not be allowed to be given to anyone outside the research group along with the code to identify the donor).
(52_signature_protocol.doc)
____________________________ Principal Investigator (Print)
____________________________ Principal Investigator (Signature)
_______ Date