VIEWS: 12 PAGES: 14 POSTED ON: 9/17/2011
IUPUI AND CLARIAN INSTITUTIONAL REVIEW BOARDS & SUBCOMMITTEES REVIEWS SUMMARY SAFEGUARD STATEMENT Principal Investigator: IRB Study Number: THIS FORM MUST BE NEATLY TYPED. (DO NOT TYPE ON THE REVERSE SIDE OF ANY FORMS). Note: To check a box on this form, double-click the box and select “Checked” under “Default Value.” TITLE: SECTION I: STUDY DESCRIPTION A. Describe the general purpose and nature of the study (in lay terms), including a description of the usual method(s), if any, that were considered and why they were not chosen. B. Are you a covered entity or are you involving a covered entity in your research and thus subject to HIPAA regulations? See Checklist to determine if you are subject to HIPAA. No. Submit a copy of the Checklist and proceed to Section II. Yes. Proceed to item C. below C. Will health information be utilized, accessed, collected, or generated as part of the study or for recruitment purposes? No. Proceed to Section II. Yes. Answer item D. below. D. Is the health information individually identifiable? No. Is the health information: De-identified? In a Limited Data Set as defined by HIPAA? Check here if the data will be received from a covered entity (e.g. division, department, or practice plan) separate from that of the investigator. If this is the case, a data use agreement must be established between the entity(ies) supplying the data and the investigator. Check here if the data will be obtained from within the investigator’s own covered entity (e.g. his/her own data or that of the department). No data use agreement is necessary. Yes. You will be required to obtain either an authorization from the subject or a waiver of authorization for the study from the IRB. SECTION II: PERFORMANCE SITE Bell Flower Clinic Methodist-Affiliated Centers/Private Practices Clarian North Midtown Mental Health* Clarian West Regenstrief Institute General Clinical Research Center (GCRC)* Rehabilitation Hospital of Indiana IU School of Dentistry Riley Hospital IU Cancer Center* University Hospital IU Medical Group Primary Care Clinic (IUMG-PC), Veterans Affairs Medical Center* including Wishard primary care clinics Wishard Memorial Hospital* IU Medical Group Specialty Clinic (IUMG-SC) Hospital/ER IUPUI Campus, Location: Non-primary care Krannert Institute of Cardiology Regenstrief Health Center Larue Carter Hospital Wishard Specialty Clinics Lilly Clinic OB/GYN Clinics Methodist Beltway Centers Other: Methodist Hospital * Additional information or submission may be required prior to initiating the study. Please check with the specific performance site for additional information. 1 Rev. 06/05 SECTION III: SUBJECT POPULATION A. Check all subject population categories below that will be targeted for enrollment into this research study: Children (Complete item 1. below) Cognitively Impaired (Complete item 2. below) Economically/Educationally Disadvantaged Pregnant Women, Human Fetuses, or Fetal Material (Complete and submit the Pregnant Women, Human Fetuses, Neonates, and Fetal Material request form) Prisoners (See SOP on Prisoners for additional requirements) Students (Complete item 3. below) If any of the subject populations have been checked, state the necessity for involving such populations in the research: 1. Children. If you identified “Children” in item A. above, indicate below in which category the research belongs and respond to the corresponding questions.. a. Category 1 (§46.404): Research not involving greater than minimal risk to children. i. Explain how adequate provisions are made for soliciting the assent of the children and the permission (parental/guardian informed consent) of their parents or guardians: b. Category 2 (§46.405): Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual child. The anticipated benefit must justify the risk and the relation of the anticipated benefit to the risk must be at least as favorable as that of alternative approaches. i. Explain why the risk is justified by the anticipated benefit to the child: ii. Explain why the relation of the anticipated benefit to the risk is at least as favorable to the subjects as that presented by available alternative approaches: iii. Explain how adequate provisions are made for soliciting the assent of the children and the permission (parental/guardian informed consent) of their parents or guardians: c. Category 3 (§46.406): Research involving greater than minimal risk and no prospect of direct benefit to the individual child, but likely to yield generalizable knowledge about the child’s disorder or condition. The risk must represent only a minor increase over minimal risk, the intervention or procedure must present experiences to the children that are reasonably commensurate with those inherent in their actual, or expected medical, dental, psychological, social, or educational situations, and the intervention or procedure must be likely to yield generalizable knowledge about the children’s disorder or condition which is a vital importance for understanding or amelioration of the disorder or condition. i. Explain why the risk represents a minor increase over minimal risk: ii. Explain why the intervention or procedure presents experiences to subject that are reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social, or educational situations: iii. Explain why the intervention or procedure is likely to yield generalizable knowledge about the subjects’ disorder or condition, which is of vital importance for the understanding or amelioration of the subjects’ disorder or condition: iv. Explain how adequate provisions are made for soliciting the assent of the children and the permission (parental/guardian informed consent) of their parents or guardians: d. Category 4 (§46.407): Research not otherwise approvable under one of the above categories, which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children. The Secretary of HHS must approve, after consultation with a panel of experts following publication and public comment. 2 Rev. 06/05 i. Explain why the proposed research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health or welfare of children: ii. Explain how adequate provisions are made for soliciting the assent of the children and the permission of their parents or guardians: NOTE. When research is covered by categories §46.406 and §46.407, the informed consent must be obtained from both parents unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child. 2. Cognitively Impaired. Respond to the following: a. Explain the procedures proposed for evaluating the mental status of prospective subjects to determine whether they are capable of consenting and/or soliciting their assent. b. Is it reasonable to expect that during the course of the study, subjects may lose their capacity to consent or their ability to withdraw (e.g. research involving administration of or withdrawal from psychotropic agents)? No. Yes. Explain what provisions have been made to protect the subject’s rights (e.g. power of attorney, consenting a caregiver as well as the subjects, etc.). c. Explain how persons authorized to give legally valid consent on behalf of any individual(s) judged incapable of consenting on their own behalf will be identified and adequately informed of their roles and obligations for protecting the subject? d. Explain if and how the subject’s physician or another health care provider will be consulted before any individual is invited to participate in the research. e. Explain how, in your opinion, the research is or is not likely to interfere with ongoing therapy or regimens and how the research entails no significant risks, tangible or intangible, or if the research presents some probability of harm, how there is at least a greater probability of direct benefit to the subject. 3. Students as Subjects. a. Explain how the possibility of coercion or undue influence is minimized when informed consent is being sought: b. Explain what genuinely equivalent alternatives are available for students who wish not to participate: B. List specific eligibility requirements for subjects, including those criteria which would exclude otherwise acceptable subjects (e.g. inclusion/exclusion criteria). C. State the number of subjects to be recruited both locally and nationally (if a multi-center study). List total as a single number, rather than a range. 3 Rev. 06/05 SECTION IV: RECRUITMENT A. Will health information be accessed in order to identify and/or to determine eligibility of potential research subjects, which could include the records of the PI and co-investigators? Yes. Complete and submit the Recruitment Checklist. (Skip # 1 and # 2 below) No. Complete ONLY 1. and 2. below. 1. Describe how potential subjects will be initially identified (include specific source, e.g. databases, medical records, advertisements, newsletters, self-referral, physician referral, from clinics, etc.): 2. Describe how potential subjects who are identified will be contacted (e.g. letter, phone call, face-to-face) and who will be contacting them (e.g. their physician, research coordinator, nurse, etc.). Include a copy of all information to be shared with or intended to be seen by potential subjects. Note: If your study includes recruitment incentives, explain such arrangements in Section X. SECTION V: STUDY PROCEDURES List all methods by which information or data about or from subjects will be obtained, including any drugs or devices to be used on human subjects and all procedures/interventions that are being performed that would not otherwise be performed outside of the research study [e.g. an investigational drug, a blood draw that is taken purely for research (not treatment purposes) or a standardized survey that is being completed solely for the purposes of this research]. SECTION VI: POTENTIAL RISKS State the potential risks – for example, physical, psychological, social, legal, loss of confidentiality or other – connected with the proposed procedures. SECTION VII: PROTECTION PROCEDURES 1. Describe procedures for protecting against, or minimizing, the potential risks described in Section VI, including using procedures that are already being performed on subjects for diagnostic, treatment, or standard purposes, when appropriate. 2. Explain provisions to protect privacy interests of subjects. This refers to how access to subjects will be controlled (e.g. time, place, etc. of research procedures). 3. Is this a multi-center study? No. Continue to the next section. Yes. Is IUPUI/Clarian the lead site? No. Continue to the next section Yes. Describe how you will manage communication and information from other sites such that all participants are protected. 4 Rev. 06/05 SECTION VIII: DATA SAFETY MONITORING PLAN For all research that is greater than minimal risk (i.e. requires full IRB review), a Data Safety Monitoring Plan must be developed. This is a plan to assure the research includes a system for appropriate oversight and monitoring of the conduct of the study to ensure the safety of subjects and the validity and integrity of the data. N/A. The research is minimal risk (i.e. expedited study) The DSMP is contained in the protocol. State where in the protocol the description is located: NOTE: Ensure that all points outlined below are addressed in the description in the protocol. If any points are not addressed, within the protocol, they should be addressed below. If neither of the above two options apply, complete the questions below: 1. Who will be responsible for the data and safety monitoring? (Examples include: a DSMC or DSMB, medical monitor, investigator, independent physician) Clarify if this individual or committee is independent from the sponsor and/or investigator. 2. What will be monitored. (Examples include: data quality, subject recruitment, accrual, and retention, outcome and adverse event data, assessment of scientific reports or therapeutic development, results of related studies that impact subject safety, procedures designed to protect the privacy of subjects) 3. What are the procedures for analysis and interpretation of data, the actions to be taken upon specific events or endpoints, the procedures for communication from the data monitor to the IRB and site, and other reporting mechanisms? 4. What is the frequency of monitoring? (The appropriate frequency of data and safety monitoring will be dependent on the nature and progress of the research; however, monitoring must be performed on a regular basis (e.g, at least annually). 5. What information will be reported to the IRB? (Minimally, the IRB requires the following information at the time of continuing review: 1) frequency and date(s) of monitoring; 2) summary of cumulative adverse events; 3) assessment of external factors (i.e. scientific reports, therapeutic developments, results of related studies) that impacted the safety of subjects; 4) summary of subject privacy and research data confidentiality outcomes; and 5) any changes to the risk-benefit ratio. SECTION IX: CONFIDENTIALITY & SAFEGUARDS A. Check the items below to explain how confidentiality and privacy of data collected for the purpose of the research study will be protected. Keep in mind that all members of the research team should only gather or share the minimum amount of PHI needed for the study. (See the HIPAA Glossary for more details regarding the Minimum Necessary rule.) 1. Data Source (Please check all that apply) a. Treatment or Test Results, Medical and/or Dental Records, etc.: Paper Film Electronic (e.g. CareWeb or Regenstrief Medical Record System, VA CPRS (VA medical record system), patient care database, etc.) b. Interviews (Phone or Face-to-Face) c. Survey or Questionnaire Paper Electronic d. Video e. Audio f. Photographs g. Other (Please describe): 2. Data Recording / Collection Method (Please check all that apply) a. Computer: 5 Rev. 06/05 Laptop Hard Drive Local Shared Drive Web-based CDs, Floppy Disks, etc. Other (Please describe): b. PDA (Personal Digital Assistant) c. Paper (e.g. Notes, Case Report Form, etc.) d. Video e. Audio f. Other (Please describe): Please describe how you will safeguard data for all the Data Recording / Collection Methods described in VIII.A.2. by completing #3, #4 and #5 below. Please check all that apply. 3. Secure Storage a. Who will have access to the individually identifiable information/data? Principal Investigator Research Coordinator Co-Investigators Governmental Agencies Research Sponsor, Monitor, Other Research Organizations Other (Please describe – e.g. BioStats, outside multicenter collaborators, or other colleagues not listed on the Summary Safeguard Statement, etc.): b Please describe the measures you are taking to safeguard the information/data: Locking cabinets and doors Information is located in an area with limited public access Computers and/or files will be password-protected PDAs and removable media (such as CDs, diskettes, etc…) will kept in a secure location Regular back-ups of electronic data. NOTE: All electronic data should be backed up on a regular basis. Describe any other measures you are using to safeguard the data: 4. Secure Disposal a. How long will you retain the data before discarding? Minimum of 3 years for non-health data Minimum of 7 years for health data, per Indiana State law Per sponsor requirements Indefinitely Other (Please describe): b. How will you discard the data? Paper will be shredded Delete files from or destroy diskettes and CDs* Permanently delete data from computers and PDAs* Other (Please describe) 1. Sharing Data For this purpose, sharing may include releasing, transmitting or providing access to research and health data within the research team, outside the university, to research sponsors, etc. You must use reasonable safeguards when sharing any form of research data, health or non-health. *See the IUPUI/Clarian SOP for Subject Privacy and Confidentiality and the HIPAA Glossary for more details.) a. Will you share data in any of the following formats? Non-Health Data only. De-identified Data. Limited Data Set. (NOTE: A Data Use Agreement may be required) Identifiable Data (i.e. includes patient identifiers, names, initials, Subject ID numbers, etc. - Please answer items 1. and 2. below.) 1. Indicate which secure method(s) of transmission will be used? Check all that apply: Secured web site Encrypted email US Postal Service or other trackable courier services (not campus mail) Fax in a secured area Shared drive with password protection 6 Rev. 06/05 Personal delivery by authorized research personnel Private telephone conversation to authorized personnel Other: (describe) 2. Will you share identifiable health data with anyone not listed on the Summary Safeguard Statement or the Authorization? 1. No – Proceed to Section IX. 2. Yes – These people must be added to the summary safeguard statement and the authorization form: Data will not be shared – Please explain: SECTION X: STUDY BENEFITS A. What, if any, benefit is to be gained by the SUBJECT? B. What information may accrue to SCIENCE or SOCIETY, in general, as a result of this work? SECTION XI: PAYMENT FOR PARTICIPATION A. Will subjects be paid for participation in the study (e.g. monetary, free services, gifts, course credit, including extra credit)? No. Proceed to Section XI. Yes. Complete items B., C., and D. below. B. Explain the payment arrangements (e.g. amount and timing of payment and the proposed method of disbursement), including reimbursement of expenses. Note: Payments must accrue and not be contingent upon completion of the study. However, a small payment (bonus) for completion of the study may be approved by the IRB if it is found to not be persuasive for the subjects to remain in the study. C. Justify the proposed payment arrangements described in section B. (e.g., how this proposed payment arrangement is not considered to be coercive). D. Explain if there will be any partial payment if the subject withdraws prior to completion of the study (e.g. prorated). Note: This payment may be paid at the end of the subject’s participation or at the end of the study. SECTION XII: RISK-BENEFIT RATIO Describe how risks to subjects are reasonable in relation to anticipated benefits. SECTION XIII: INFORMED CONSENT A. I WILL be obtaining informed consent from all subjects. I am NOT requesting any waivers, exceptions or alterations to the informed consent document or process. 1. When (in what timeframe) and where (what setting) will consent take place? Indicate any waiting period between informing the subject and obtaining consent. 7 Rev. 06/05 2. Who will be responsible for obtaining initial and ongoing consent? When this responsibility is delegated to someone other than the PI, explain how the individual(s) will be prepared to obtain informed consent for the research activity. 3. Explain how subjects’ privacy will be protected during the consent process. This refers to how access to subjects will be controlled (e.g. time, place, etc. of consent procedures). 4. Explain what additional safeguards are in place to protect the rights and welfare of subjects likely vulnerable to coercion and undue influence. B. I am requesting a complete waiver of the informed consent process (e.g. no informed consent document). Note: If you are requesting an exception to the requirements of informed consent for an emergency use of an FDA-regulated study, please complete item E. below). For the IRB to grant a complete waiver of informed consent, all of the following criteria must be met: 1. The research involves no more than minimal risk to the subject. Please explain: 2. The waiver will not adversely affect the rights and welfare of the subjects. Please explain: 3. The research could not be practicably carried out without the waiver of informed consent. Please explain: 4. Whenever appropriate, subjects will be provided with additional pertinent information after participation. Please explain: 5. The research is NOT FDA-regulated (i.e. The activity is NOT an experiment or does NOT involve one or more of the following test articles: foods or dietary supplements that bear a nutrient content claim or a health claim, infant formulas, food and color additives, drugs for human use, medical devices for human use, biological products for human use, electronic products. Additionally, NONE of the following can be true:, the research involves using the test article with one or more participants, the research is being done as part of an IND or IDE submission, the data may be submitted to the FDA, or the data may be held for inspection by the FDA). 6. ONLY COMPLETE FOR RESEARCH AND DEMONSTRATION PROJECTS CONDUCTED BY OR SUBJECT TO THE APPROVAL OF STATE OR LOCAL GOVERNMENT OFFICIALS. In order for the IRB to approve a waiver of informed consent for a research or demonstration project, conducted by or subject to the approval of state or local government officials, it must NOT be FDA-regulated and be designed such that it studies, evaluates, or otherwise examines one of the following (check all that apply): public benefit or service programs; procedures for obtaining benefits or services under those programs; possible changes in or alternatives to those programs or procedures; or possible changes in methods or levels of payment for benefits or services under those programs. C. I am requesting a waiver of written documentation of informed consent (e.g. you will be explaining the elements of the study, but will not be obtaining the subject’s signature). NOTE: You must submit a written statement regarding the research, which must be provided to subjects upon their request. 8 Rev. 06/05 For the IRB to grant a waiver of written documentation of informed consent, EITHER of the following criteria must be met: 1. 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, and the research is not FDA-regulated. Each subject will be asked whether the subject wants documentation linking the subject with the research and the subject’s wishes will govern. Please explain: OR 2. 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 Please explain: D. I am requesting modification to the required elements for informed consent. Check all of the required elements below that you are requesting to modify or omit from the informed consent document: Statement that the study involves research Disclosure of appropriate alternative procedures Explanation of the purposes of the research or courses of treatment Expected duration of subject participation Statement describing the extent to which Description of procedures to be followed confidentiality of records identifying subjects will be maintained Identification of any procedures that are experimental Explanation regarding any compensation Description of any reasonably foreseeable risks Explanation of available medical treatments if or discomforts to subjects injury occurs Description of benefits (to subjects or others) Contact information for questions about the that may reasonably be expected from the research, research-related injury, or subject rights research Statement that participation is voluntary For the IRB to grant modification to the required elements for informed consent, all of the following criteria must be met 1. Explain how this research involves no more than minimal risk to the subject. 2. Explain how the waiver will not adversely affect the rights and welfare of the subjects. 3. Explain how the research could not be practically carried out without waiver of informed consent. 4. Explain how, if appropriate, subjects will be informed of pertinent results at the conclusion of the study. 5. The research is NOT FDA-regulated (i.e. The activity is NOT an experiment or does NOT involve one or more of the following test articles: foods or dietary supplements that bear a nutrient content claim or a health claim, infant formulas, food and color additives, drugs for human use, medical devices for human use, biological products for human use, electronic products. Additionally, NONE of the following can be true:, the research involves using the test article with one or more participants, the research is being done as part of an IND or IDE submission, the data may be submitted to the FDA, or the data may be held for inspection by the FDA). 9 Rev. 06/05 E. ONLY COMPLETE FOR RESEARCH INVOLVING PLANNED EMERGENCY USE OF AN AGENT: I am requesting an exception from the general requirements for informed consent AND my research is subject to FDA regulations. For the IRB to grant an exception to the requirements for informed consent, all of the following criteria must be met: 1. The human subject is confronted by a life-threatening situation necessitating the use of the test article. Please explain: 2. Informed consent cannot be obtained from the subject because of an inability to communicate with, or obtain legally effective consent from, the subject. Please explain: 3. Time is not sufficient to obtain consent from the subject’s legal representative. Please explain: 4. There is available no alternative method of approved or generally recognized therapy that provides an equal or greater likelihood of saving the life of the subject. Please explain: SECTION XIV: AUTHORIZATION FOR THE USE/DISCLOSURE OF PROTECTED HEALTH INFORMATION N/A (HIPAA does not apply based on your responses to Section I.B., I.C., and I.D. above) Check here if this is an approved study that was granted a waiver of informed consent prior to April 14, 2003. A request for a waiver of authorization is not necessary. If you answered “yes” to Section I.C. and I.D. above (you will be utilizing, accessing, collecting, or generating identifiable health information as part of the study), answer item A. or B. below: A. If you are obtaining written informed consent: 1. Will an Authorization for the Release of Health Information for Research be obtained from every subject at the time of enrollment/consent? No. Explain rationale and complete item B. below to request a waiver of Authorization. Yes. Provide a copy of the Authorization for review. 2. Will health information be accessed prior to obtaining the informed consent (e.g. for recruitment or screening purposes)? No. Yes. You must complete Section IV. of this summary safeguard statement and attach a recruitment checklist. B. If you are requesting a waiver of informed consent or written informed consent or you checked “no” to A.1. above: 1. Is a waiver of authorization requested? No. Explain rationale. Yes. Complete the following three questions below: [NOTE: If a waiver of authorization is approved by the IRB, it is the responsibility of the principal investigator to track all disclosures of health information for a period of six years (see the Use and Disclosure of Health information for Research Purposes SOP for additional information)]. 1. Explain how this research involves no more than minimal risk of loss of privacy to the subject. a. Describe the plan for protecting the identifiers from improper use and disclosure. 10 Rev. 06/05 b. Describe the plan to destroy the identifiers at the earliest opportunity that is appropriate for the research study. Identifiers may only be maintained following completion of a study if there is a legitimate reason for maintaining the data (e.g required by law, etc.). c. Provide written assurances that the identifiable health information will not be re-used or disclosed to any other person or entity, except as required by law, for authorized oversight of the project or for other permitted research purposes. 2. Explain how the research could not be practicably conducted without waiver of authorization or an alteration to the authorization form. 3. Explain how the research could not be practicably conducted without access to and use of the individually identifiable health information. SECTION XV: USE OF CANCER PATIENTS Will this study specifically enroll cancer patients (e.g. is the study focused on cancer treatment or care or does the study include a control group of cancer patients)? No. Yes. You must first obtain approval from the Scientific Review Committee (SRC) prior to submitting to the IRB. Please include that approval with your IRB study submission. Call 317/274-0934 for additional information. Check here if this study is a retrospective chart review involving cancer patients; SRC approval is NOT necessary. SECTION XVI: INFECTIOUS AGENTS/RADIATION Does the research involve any of the following materials or agents: A. infectious materials (pathogens, live vaccines, retroviral vectors, etc.)? No Yes B. other potentially infectious material (blood, urine, biological samples, etc.) No Yes C. radiation / radioactivity (e.g. x-rays, nuclear medical scans) in addition to what is used for standard clinical treatment? No Yes Note: Investigators are not required to submit studies to the IRB prior to submitting it to Radiation Safety if radiation beyond standard of care is involved. Concurrent IRB and radiation safety review is permissible. At Methodist, nothing further is required (as the Research Review committee includes a radiation review, after study submission). If any of these agents are used, see additional requirements under Other Reviews in the IRB Instruction Packet. SECTION XVII: FEDERAL FUNDING A. Has a proposal for funding been submitted to or is this study funded by a federal agency (e.g. DHHS, NIH, VA, CDC, etc.)? No. Proceed to Section XVII. Yes. Has a copy of the proposal already been submitted with another IRB study? No. Provide one copy of the entire funding proposal (or DHHS-approved protocol if not part of the funding proposal)or explain why one is not needed (e.g. the investigator is not the direct recipient of the grant money [federal pass- thru]): Yes. List the IRB study number with which the proposal was originally submitted: B. Is this study a DHHS multicenter clinical trial that includes a DHHS -approved sample informed consent? No. Yes. Provide a copy of the DHHS-approved sample consent document. Note: If this is a federally-funded study, you will be required to track the race and ethnicity of subjects enrolled. This is reported to the IRB at the time of continuing review. 11 Rev. 06/05 SECTION XVIII: GENE THERAPY A. Does this study involve the use of non-cancer-related gene therapy? No. Yes. Has the proposal been submitted to the GCRC Advisory Committee? [NOTE: It is a requirement of the School of Medicine for all non-cancer related gene therapy studies to be reviewed by the GCRC Advisory Committee. Additionally, it is the GCRC’s requirement that approval be granted from them prior to IRB submission.] No. You must submit to the GCRC Advisory Committee before you can submit to the IRB. Please call 317/278-3446 for more information. Yes. Include a copy of that approval with this study submission. B. Does this study involve the use of cancer-related gene therapy? No. Yes. Has the proposal been submitted to the Scientific Review Committee (SRC)? [NOTE: It is a requirement of the School of Medicine for all cancer-related gene therapy studies to be reviewed by the Scientific Review Committee (SRC). Additionally, it is the SRC’s requirement that approval be granted from them prior to IRB submission.] No. You must submit to the SRC before you can submit to the IRB. Please call 317/274- 0934 for more information. Yes. Include a copy of that approval with this study submission. SECTION XIX: FINANCIAL CONFLICT OF INTEREST A. Do any of the investigators listed under Section XXI. of this document have a financial conflict of interest associated with the conduct of this study? (Required financial disclosures include: (1) an equity interest that exceeds $10,000 or represents more than a 5% ownership interest in any one enterprise or entity (equity in a privately held entity for which the value is not known will be treated as above the 5% threshold), when aggregated for the Academic Appointee or Staff Member and his or her Family Members; (2) salary, royalties, or other payments expected to exceed $10,000, when aggregated for the Academic Appointee or Staff Members and his or her Family Members over the twelve month period.; (3) compensation to the Academic Appointee or Staff Member and his or her Family Members of any amount that could be higher for a favorable outcome than for an unfavorable outcome, such as compensation that is explicitly greater for a favorable result or compensation to the investigator in the form of an equity interest in the sponsor of a covered study or in the form of compensation tied to sales of the product, such as a royalty interest; (4) proprietary or other financial interest by the Academic Appointee or Staff Member and his or her Family Members in the product to be used in clinical trials including, but not limited to, a patent, trademark, copyright or licensing agreement; and (5) fiduciary, director, board, or executive position of the Academic Appointee or Staff Member and his or her Family Members in any enterprise or entity regardless of whether the position is compensated). No Yes. List names of individuals with such financial interest: Please refer to the SOP on Conflict of Interest Reporting to the IRB at: http://www.iupui.edu/~respoly/human-sop/human-sop- index.htm for additional information. SECTION XX: INVESTIGATIONAL DRUGS/DEVICES N/A. No investigational drugs or devices used in this study. INVESTIGATIONAL DRUGS A. Name of Drug Sponsor: Name of Drug: IND Number*: 1. Either submit documentation from the FDA or sponsor verifying the IND number or if the IND number is included in the sponsor’s protocol or investigator’s brochure, check here: . 2. Does the investigator, IU or Clarian hold the IND? No Yes. Before approval can be granted, the investigator must meet with a member of the Clinical Trials Program (CTP) staff to discuss the additional responsibilities as a sponsor of an IND. Please contact CTP at 317/278-3858 and submit documentation from them verifying this discussion has taken place. This requirement does not apply at Clarian/Methodist. 3. Will services of the Investigational Drug Services (IDS) be used? Yes No. The investigator must demonstrate understanding of the handling and control of investigational test articles by reviewing the Investigational Drug Accountability SOP. Check here to confirm this has been done. 12 Rev. 06/05 B. Study Phase: I I/II II II/III III III/IV IV C. If this study involves the investigational use of a marketed drug or biologic, and in the opinion of the investigator does not require submission of an IND, six conditions must be met (e.g. responses to conditions listed below must be “yes” for an IND to not be required). Please respond to the following conditions: No Yes The study is not intended to be reported to FDA in support of a new indication for use or to support any other significant change in the labeling for the drug. The study is not intended to support a significant change in the advertising for the product. The study does not involve a route of administration or dosage level, use in a subject population, or other factor that significantly increases the risks (or decreases the acceptability of the risks) associated with the use of the drug product. The study is conducted in compliance with the requirements for IRB review (21 CFR 56) and informed consent (21 CFR 50). The study is conducted in compliance with the requirement concerning the promotion and sale of drugs (21 CFR 312.7). The study does not intend to invoke (21 CFR 50.24). INVESTIGATIONAL DEVICES D. Name of Device Manufacturer: Name of Device: IDE Number*: 1. Either submit documentation from the FDA or sponsor verifying the IDE number or if the IDE number is included in the sponsor’s protocol or device manual, check here: . 2. Does the investigator, IU or Clarian hold the IDE? No Yes. Before approval can be granted, the investigator must meet with a member of the Clinical Trials Program (CTP) staff to discuss the additional responsibilities as a sponsor of an IDE. Please contact CTP at 317/278-3858 and submit documentation from them verifying this discussion has taken place. This requirement does not apply at Clarian/Methodist. 3. The investigator must demonstrate understanding of the handling and control of investigational test articles by reviewing the Investigational Device Accountability SOP. Check here to confirm this has been done. E. The IRB is required to determine whether or not the device is significant risk. To help in this determination, please provide the sponsor’s documentation on the risk assessment and the rationale used in making the risk determination. Please provide the investigator’s assessment of the device risk below: Significant Risk Nonsignificant Risk Risk assessment and rationale for above risk determination: SECTION XXI: INVESTIGATORS List the principal investigator and any co-investigators* and their respective departments. (If there are multiple investigators, please indicate only one person as the principal investigator; others should be designated as co-investigators). * For purposes of completing this section, the definition of a co-investigator is 1) someone who is playing a role in the design, conduct, or reporting of the research, including persons obtaining consent; or 2) someone who is making independent decisions about the inclusion or exclusion of participants in the study. These co-investigators are further delineated in Part B and C based on whether they are directly interacting or intervening with subjects. Those co-investigators that are directly interacting or intervening with subjects (listed in Part B) must pass the human subjects protection test. Persons listed in section B. must provide the IRB with documentation of their agreement to participate in the research. This can be accomplished by either having each individual provide his/her signature next to his/her name below on the copy of this document submitted to the IRB or by having each individual submit a memo (or email) to the IRB reflecting agreement to participate in this specific protocol. 13 Rev. 06/05 Note that individuals listed in sections A. and B. below are required to pass the IUPUI/Clarian human subjects test requirement unless special circumstances apply. For more information, refer to http://www.iupui.edu/%7Eresgrad/Human%20Subjects/human- menu.htm. A. Principal Investigator: Department B. Co-investigators: (Please include the respective department) List those directly interacting or intervening with subjects (including persons obtaining consent): Note: All investigators in this category must pass the online human subjects protection test and submit a memo/e-mail (or sign next to their name below) to acknowledge their participation in this study. Name Department C. List other co-investigators who are not directly interacting or intervening with subjects: D. If this study is a collaboration with investigators at unaffiliated institutions, and our IRB is providing the review and approval for their role in the study, list all such co-investigators,* their respective institutions, and specify their role and what procedures they will be performing: Name of Co-investigator Institution Role Procedures performed 14 Rev. 06/05
"IUPUI AND CLARIAN INSTITUTIONAL REVIEW BOARDS "