GOG 152 IRB APPLICATION by 1yG682

VIEWS: 4 PAGES: 25

									                                                                       Protocol No.
                                                                       Receipt Date



                                              Institutional Review Board (IRB)
                                     REQUEST FOR APPROVAL OF INVESTIGATION
                                        INVOLVING USE OF HUMAN SUBJECTS
Medical Center and federal policies require review of each protocol by the Medical Center's IRB with respect to the:
1) Rights and welfare of subjects; 2) adequacy of methods used to secure informed consent; and 3) risk and potential benefits
of the research to the subject. Read instructions carefully and then type and complete each item. If an item is not applicable,
indicate this by "NA". Obtain required signatures. Completed application and required attachments must be submitted as a
PDF file via email to submit2IRB@med.cornell.edu. Files too large to send via regular email should be sent via the WCMC
File transfer system at http://transfer.med.cornell.edu.


1.    Principal Investigator                                                                            Degree

2.    Academic Title                                                                                Telephone

3.    Email                                                                                                 Fax

4.    Department                                                              Division

5.    Mailing Address                                                                                            Room

6.    Research Coordinator                                                Telephone / Email

7.           New Protocol                    Prior Protocol Number:

8.    Project title (if applicable, use same title as externally-funded research):

      Purpose of Project (one or two sentences):
9.



10.   Expected dates of study                                                 to
      Expected duration of study for individual subjects (days/months)

11.   Source of funds (agency, institutional, or industry sponsor)

12.   Proposal:            will not be submitted      will be submitted            has been submitted       to funding agency (date):

13.   Proposal (Grant) Title                                                             Proposal (Grant)
      (If different from project title)                                                  Coeus Number

14.   If project will be funded to another investigator, give Principal Investigator’s name and grant title


15.   Co-investigators:
                     Name                               Degree                         Department                         Telephone #
A.
B.
C.
D.
E.
F.

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  .

16.   Student Research:           No                Yes, complete the items below

       List Student Name(s):




      Indicate the role of the student(s) and who will supervise the student(s):




17.   Where will study be conducted? (be specific)




18. Required Summary: Please create a brief descriptive summary of this study (200 words or less), in Layman Terms (8th
grade language), that would be useful as a public awareness mechanism.




                             SECTION A. NON TECHNICAL RESEARCH PLAN

State concisely the design, aims and specific objectives of the research, and the procedures to be used to accomplish
these aims in language that can be understood by a non-scientist. Since the Board includes lay persons, avoid or
explain highly technical language. Describe what will happen to subjects and what they will be expected to do. State specific
interventions which would not be performed except for the purposes of this study. Do not include the technical summary
from the NIH grant or sponsor’s protocol in lieu of the non-technical research plan. Use continuation pages if necessary.

A1. Study Design (for example, hypothesis, research question, standard and experimental procedures, special or unusual
    equipment of procedures):




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A2. Rationale and justification for the study (for example, historical background, investigator’s personal experience,
pertinent medical literature):




A3. Primary study endpoint:




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A4. Primary objective:




A5. Secondary objectives:




A6. Inclusion/Exclusion criteria:




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A7. Treatment plan: (include amount and frequency of samples of blood and other bodily fluids in chart below)

      Bodily Fluid         Amount            Frequency             Total
      Blood

      Urine

      Other_________




A8. Statistical considerations (e.g. justification for sample size or “n”):




A9. Relative importance/value of the trial, considering “standard” therapy and published/competing trials:




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                                           SECTION B. SUBJECT POPULATION

B1.     Number being enrolled:         Male:                      Female:                Age Range                   to

B2.     Type:                 Inpatients              Patient Controls                        Patient Minors (up to 18 years)

                              Outpatients             Normal Volunteers                       Volunteer Minors (up to 18 years)

B3.     Special Groups (check applicable boxes):

                Minors*                                                   Prisoners*

                Fetuses*                                                  Students and/or employees

                Pregnant Women*                                           Derived materials or data

                Special racial or ethnic group (specify):                 Mentally/cognitively impaired (e.g. mentally ill, mentally
                                                                          retarded, emotionally disturbed, senile dementia)

* These special groups require additional protections under the law – see applicable sections at the end of this application.


B4.     Rationale for use of special groups, or subjects whose ability to give voluntary informed consent may be in question:




B5.     Subject's state of physical health. Indicate if seriously or terminally ill.




B6.     Indicate a) how subjects are initially identified (medical records, physician referral, canvassing, classes, etc.; be specific),
        b) and/or recruited (bedside or clinic interview, ads, telephone, letter, etc.; be specific). Note: For HIPAA purposes, please
        specify if the patients whose medical records or appointment records (logs) are being reviewed for recruitment purposes
        are patients of the Principal Investigator or Co-investigators. If not, then a HIPAA waiver is necessary.




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B7.     Will WCMC General Clinical Research Center be                          Yes                      No
        used?
                                                                               Pediatric Unit           and/or Adult Unit




B8.     Will subjects receive any inducements before, or rewards or compensation during or after study?

             No           Yes,     How much and in what form? (Cash, taxi fares, medical care, meals, gifts, etc.):




                                                SECTION C. HUMAN TISSUE

1. Is human tissue from patients at this institution (WCMC) being used in this study (for definition of human tissue and surgical
waste, see Human Tissue Section & Request Form at http://www.med.cornell.edu/research/for_pol/ins_rev_boa.html).
          No, proceed to Section D

           Yes, complete the Human Tissue Section & Request Form. Submit completed form, a copy of the IRB protocol
           application, and a copy of the consent form (if applicable) to: submit2pathology@med.cornell.edu for
           departmental approval.




                                                        SECTION D. RISKS
The purpose of this section is to determine if subjects will be placed "at risk" – (i.e., exposed to the possibility of physical,
psychological, sociological, or other harm as a consequence of any activity proposed in the research project)

RISK CLASSIFICATION: What is the overall risk classification of the research: (select the classification that applies)
                                        No more than minimal risk                     Greater than minimal risk

NOTE: according to HHS/FDA regulations, no more than minimal risk means: “The probability and magnitude of harm or
      discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily
      life or during the performance of routine physical or psychological examinations or tests.”




DOES THE RESEARCH PLANNED IN THIS PROJECT INVOLVE:                                                                                Yes     No

D1.      Any surgical procedure. If yes, complete question D16

D2.      Administration of drugs, chemical or biological agents; if yes, complete section H.

D3.      Use of radioisotopes or other sources of ionizing radiation (e.g., x-ray machine, etc.). If yes, complete section F


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D4.      Major changes in diet or exercise. If yes, explain in detail:




D5.      Administration of physical stimuli other than auditory and visual stimuli associated with normal classroom situation.
         If yes, explain in detail:




D6.      Deprivation of physiologic requirements such as nutrition or sleep, manipulation of psychological
         and/or social variables (e.g., sensory deprivation social isolation, psychological stresses, deceptions, etc.)
         If yes, explain in detail:




D7.      Use of new medical devices as defined by FDA regulations: If yes, complete Section G.


D8.      Use of deceptive techniques without the knowledge of subject



D9.      Possible invasion of privacy of subject or family, including use of personal or medical information. If yes, explain in
         detail:




D10.     Any probing of information which might be considered personal or sensitive


D11.     Presentation to the subject of any materials which they might find to be offensive, threatening or degrading.
         If yes, explain in detail:




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The following section will request information related to the precautions which will be taken to minimize risks to subjects.

D12.    Please describe the Data Safety Monitoring Plan (DSMP) in detail: see box below for help




            A DSMP is a prospectively defined strategy to assess the assumptions made in the protocol design while the study is in progress. Its
            main purpose is to ensure the safety of participants in human research studies and the validity and integrity of research data collection.

            Depending on the nature, size, complexity and risk of the study, the level of monitoring can vary from investigator oversight, to an
            Independent Monitor (IM) to a Data Safety Monitoring Board (DSMB) for more complex and high risk trials.
            Key elements to be included in a DSMP are:
                    Assessment of risk and monitoring level
                    Safety contact: Who is responsible?
                    Safety monitoring: Who will do it? How often?
                    Informed consent process; consistency with protocol
                    Data collection process
                    Adverse Events Monitoring: Anticipated and Unanticipated
                     – Description of anticipated adverse events
                     – Grading and attribution method
                     – Reporting of unanticipated adverse events
                     – Plans for periodic reporting
        Impact on termination of subjects from the study and study closure

D13.    Will an Independent Monitor be used?
            Yes, external (Please identify and provide credentials)

            Yes, internal

            No

D14.    Will an external Data Safety Monitoring Board (DSMB) be used for the assessment of the safety data?
          Yes – Provide a copy of the membership information, including name of employee, academic affiliation, and relationship to sponsor

            No – But an internal DSMB is needed.
            No – And an internal DSMB is not needed. Please complete the remaining sections.

D15.    Is the protocol an NIH-funded Phase I, II or III Clinical Trial?
            Yes – Provide a copy of the NIH-approved Data Safety Monitoring Plan (DSMP) and proceed to Section E
            No – Please complete the remaining sections




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D16.     Describe risks of study agent(s) and/or device(s) in detail. Assess their seriousness and incidence of complications or
         adverse events when known. Include animal data if trials in humans have not been performed.




D17.     List all study procedures and identify risk (see key below for examples and attach additional sheets as necessary)
         Procedures being done                                                           Risk level for subject (mark appropriate column)
                                                                                             Minimal             Moderate              High




        LEVEL OF MONITORING
        Minimal/Low/Moderate       Appropriate category if all identified procedures are checked in the Minimal/Low and/or Moderate Risk
        Levels of Monitoring       sections above

                                   Examples of Minimal risk: Quality of Life Questionnaire, Electrocardiogram (ECG), CT/MRI scan, DEXA
                                   scan, Venipuncture/ Intravenous catheter, Observation, Psychological testing

                                   Examples of Moderate risk: Endoscopy, Use of pharmaceutical agents under study

        High Level of Monitoring   Appropriate category if any of the identified procedures are checked in the High Risk section above and/or if
                                   any of the items below are applicable (mark all that apply)
                                   Phase I/II protocol with substantial subject risk, blinded or multi-center study
                                   Phase III randomized or comparative clinical investigation (Note: Phase III trials require a DSMB)
                                   Pilot clinical study
                                   Investigational Device(s)
                                   Investigator-initiated IND(s)
                                   Vulnerable population

                                   Example of High risk: Gene transfer, Use of investigational pharmaceutical agent(s), Research-associated
                                   high risk clinical procedure (e.g., dialysis, bronchoalveolar lavage, studies done under sedation)




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D18.    Describe adverse events that may cause termination/dropout of a subject




D19.    Describe interim and complete stopping rules for the study (if applicable)




D20.    Describe other alternative and accepted procedures or methods of diagnosis and treatment, if any, that were considered
        and why they will not be used.




D21.    Assess potential benefits to subjects and to society which may accrue as a result of this research. Analyze risk-benefit
        ratio, and why benefits to be gained outweigh and risks:




                                 SECTION E. CONFIDENTIALITY OF DATA
What specific safeguards will be employed to protect confidentiality of data, e.g., coding or removal of identifiers as soon as
possible, limitation of access to data, use of locked file cabinets, protection of computer-based data systems, etc.? Will data
which identify individual subjects be published or in any way disclosed to third parties other than project personnel? (Please
include that the IRB and Federal oversight agencies may have access to the data.) If so, explain here, and incorporate in
consent form:




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E2.      Will subjects have access to their research records while they are enrolled in the study? The HIPAA authorization form
         should contain the same information as in this section.
            Yes (skip to Question E3)
            No – answer all questions below
a) Please explain in detail the basis of your request for the temporary suspension of subjects’ rights to access their research
records while they are enrolled in the study. (Example: This is a double-blind study and the subjects will not have access to
information about the arm of the study to which they were assigned.)




b) List the specific sections of the research record or specific information subjects will not have access to while participating in
the study. [Example (1): You will not have access to the information relating to the arm of the study to which you are assigned.
Example (2): You will not have access to genetic test results that have no clinical significance.]




c) At what specific point in time will the suspension be lifted? [Example (1): Access to the information will be reinstated when the
blinds are lifted and the primary investigator knows the arm of the study to which the subject was assigned. Example (2): When
the genetic testing becomes clinically significant and subject wants to view there research records.]


NOTE: If you check ‘no’, you must also add a paragraph in the IRB consent form explaining the following:
1. While enrolled in this research study there is a temporary suspension to access the research record.
2. The specific sections of the research record or specific information they temporarily will not have access to as listed
above.
3. The reasons for the suspension.
4. The specific point in time the suspension will be lifted.

E3.     Will any data, tissue, and/or blood sample(s) be collected/stored for use in future research? The HIPAA authorization
        form should contain the same information as in this section.
           No (skip to Section F)

            Yes (answer all questions below)

If Yes, will the data, tissue, and/or blood sample(s) be stored/sent? (check all that apply)

            Weill Cornell Medical College (WCMC Research Repository/Database)

            An outside agency, sponsor, or individual (Repository/database maintained by an outside entity)
Note: If the information or specimens will be given to an outside agency, sponsor, or individual, then you must also add a
paragraph to the IRB consent form stating the following:
    "You may agree to allow your data, tissue, and/or blood sample(s) to be used for future research either within or outside
    WCMC-NYPH. If information goes to an outside entity then the privacy rule may not apply."
**This sentence must be located in the IRB consent form before the subject is asked to make a choice about the use of
data, tissue, and/or blood samples for use in future research.




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                      SECTION F. ADDITIONAL REGULATORY INFORMATION

F1. USE OF RADIATION PRODUCING EQUIPMENT AND RADIOACTIVE MATERIALS

a.) Will diagnostic ionizing radiation (radionuclides, radiography, fluoroscopy, computed tomography) and/or radiation
    therapy be used in the course of this study?

    _____ Yes        _____ No

b) If radionuclides are to be used the following items must be completed:

       1.) Name of radionuclides licensee:__________________________________________

            # of License:______________ Date Issued:___________ Does license cover human use? _____ Yes _____ No

       2.) Radionuclide(s) to be administered:_______________________________________

       3.) Chemical form(s)         __________________________________________________

       4.) Activity administered per procedure (in millicuries) for each radionuclide: (Use separate sheet for each type of
           examination.) _________________________________________________________________________

             ____________________________________________________________________________________ .

       5.) How many studies of each type will be performed per patient :___________________________

       6.) Will any complementary non-radioactive drugs be administered as part of the radionuclide study?

            _____ No _____Yes, name of drug(s) and dose schedule(s): ________________________________

       7.) Dosimetry*:

            Major Organ dose:__________rad         Total body dose: _____________rad

            Gonadal dose:   Female ___________rad Male________________rad

            Other: _______________________________________________________________________

            Source of dosimetry data: ________________________________________________________

c) If radiography, fluoroscopy or computed tomography are to be used the following items must be completed:

       1) Type of examination                            Body Region exposed

            ______________        Radiography            ___________________________________________

            ______________        Fluoroscopy            ___________________________________________

            ______________        Computed               ___________________________________________

       2) Dosimetry*: Include entrance skin dose, gonadal dose, critical organ doses, e.g., lens of eye, bone marrow.
                                                                                                            .

       3) How many times will each examination be done?

d) If research involves radiation therapy detailed description of methodology and dosimetry should be provided on a separate
   page.
   Referral for assistance with dosimetry calculations may be obtained by calling Radiation Safety at 746-6964.




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F2. RECOMBINANT DNA AND/OR GENE TRANSFER
    Does this project involve the use of recombinant DNA and/or gene therapy? If so, Institutional Biosafety Committee
    (IBC) approval must be obtained. [Note: Recombinant DNA studies that are exempt from RAC review under Appendix
    M, are not exempt from local IBC review]

         _____Yes           _____No

     Not sure if IBC approval is required? Contact 212-746-6201

     Need help filing an IBC application?
     Forms are available on the Intranet at: http://intranet.med.cornell.edu/research/ibc.html or call 212-821-0628

F3. CONFLICT OF INTEREST

     Do any investigators and/or co-investigators, or members of their families, have a Financial Interest in a business or
     outside entity, or an Intellectual Property interest, that relates to this project?

         _____Yes           _____ No

     A copy of the WCMC Study Specific Financial Disclosure Form for each investigator and/or co-investigator involved with
     this study must be attached to this application.
     The form may be found at: http://med.cornell.edu/research/for_pol/ins_rev_boa.html

     If you answered yes above, have you included a disclosure of the conflict of interest in the informed consent document?

         _____Yes           _____ No; please explain why you believe that disclosure to potential subjects is not necessary or
                                     not appropriate.

     Conflicts of interest exist when investigators or the institution have financial interests that may compromise or present the
     appearance of compromising an individual’s, group’s, or institution’s judgment in conducting, reviewing, or reporting
     research. These relationships vary from those with negligible potential to those with great potential to influence judgment,
     and not all relationships represent true conflicts of interest. A fully informed consent is one in which all related financial
     interests are disclosed.




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                                          SECTION G. MEDICAL DEVICES
NOTE: If this study involves an FDA regulated device, please submit any communications from the FDA regarding IDE,
or humanitarian use applications related to this submission.

Will any medical devices be used during the study?

           No, proceed to Section H

           Yes If this study involves the experimental use of medical and surgical diagnostic therapeutic devices of unproven
                safety and efficacy, the investigator must determine the applicability of the Investigational Device Exemption
                federal regulations to the study, and must complete the following:

G1. FDA IDE#: ___________
    Please provide copies of any relevant FDA correspondence related to this IDE

G2. Name of device: ___________________________________________________________________________________


G3. Sponsor of device: _________________________________________________________________________________


G4. Will device be custom-built? _____Yes              _____No

G5.    Does the study involve a           "significant risk" device (see below), or a           "non-significant risk device

       Significant risk device means an investigational device that:
          (a) Is intended as an implant and presents a potential for serious risk to the health, safety, or welfare of a subject;
           (b) Is purported or represented to be for use in supporting or sustaining human life and presents a potential for
              serious risk to the health, safety, or welfare of a subject.
           (c) Is for a use of substantial importance in diagnosing, curing, mitigating, or treating disease or otherwise preventing
               impairment of human health and presents a potential for serious risk to the health, safety, or welfare of a subject;
           (d) Otherwise presents a potential for serious risk to the health, safety or welfare of a subject.

G6. Non-Significant Risk Device (Complete, if applicable)

         Is this a previously "banned" device      _____Yes        _____No

G7.   Significant Risk Device (Complete, if applicable)

         a) Does sponsor intend to apply for IDE?        _____Yes        _____No

         b) Have you signed an agreement with sponsor to participate in the study?          _____Yes       _____No

         c) Submit on continuation page the investigational plan of sponsor and reports to prior investigations.




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                       SECTION H. USE OF DRUGS OR BIOLOGICAL AGENTS
NOTE: If this study involves an FDA regulated drug, please submit any communications from the FDA regarding IND, or
humanitarian use applications related to this submission.
The Joint Commission on Accreditation of Healthcare Organizations (JCAHO) requires that the administration of
investigational drugs to patients cared for within a health care organization be under the central control of the hospital
pharmacy department.

All IRB-approved protocols that involve the administration of FDA-approved medications and/or investigational medications
MUST utilize the Investigational Pharmacy to dispense the medications specified in the research protocol. Prior to submission
of a new IRB application, investigators must make arrangements with the Investigational Pharmacy and must have Section H
signed by an authorized member of the Department of Pharmacy. This will ensure that all medications are accounted for and
that studies budget properly for the utilization of the Investigational Pharmacy. Please complete the Use of Drugs or
Biological Agents Form. Submit completed form, a copy of the IRB protocol application, and a copy of the consent
form (if applicable) to: submit2rx@med.cornell.edu for departmental approval




Note: A copy of this form must be placed in the patient’s medical chart along with a copy of the signed and dated
      informed consent.




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                     SECTION I – SPECIAL POPULATIONS OF RESEARCH SUBJECTS
                                                   PEDIATRIC SUBJECTS

Please check the category below that best represents the degree of risk and benefit to which the children in this study will be
exposed. Note: more than one category may be indicated, such as when a protocol involves both a study group and a
control; in that case, please specify the group to which the category applies.
The federal regulations divide research into different risk categories: research that is not greater than minimal risk to
the participant and research that is greater than minimal risk. Under the regulations, minimal risk means that the
probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than
those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or
tests.
CHECK ONE OF THE FOLLOWING BELOW:
1. ____The proposed research is not greater than minimal risk, as defined above. (45 CFR 46.404)

2. ____The proposed research poses a greater than minimal risk with the potential for direct benefit. (45 CFR 46.405)
        The risk must be justified by the benefit. Please explain:




         The risk/benefit assessment must be at least as favorable as that presented by alternative approaches. Please explain:




3. ____The proposed research is greater than minimal risk with no prospect for direct benefit to individuals, but is likely
        to yield generalizable knowledge about the subjects’ disorder or condition. (45 CFR 46.406) (Answer below)
        NOTE: If your research is in this category, consent of both parents is required unless one parent is deceased,
        unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for and custody
        of the child.

         This research is approvable if:




         The risk represents a minor increase over minimal risk. Please justify:




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         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. Please
         justify:




4. ____ Research involving minors that does not fit within the above categories but which presents an opportunity to
         understand, prevent, or alleviate a serious problem affecting the health or welfare of children, is approvable only with
         approval of the Secretary of HHS, after consultation with a panel of experts. (45 CFR 46.407) If this category
         applies, please consult the IRB office at 212-821-0577.




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                                                        Assent of Minors

The federal regulations require that adequate provision be made for soliciting the assent of children when, in the judgment of
the IRB the children are capable of providing assent, taking into consideration the ages, maturity, and psychological state of the
children involved. Generally, the assent of a child could be sought when the child is seven years of age or older, on an assent
form that is written in language understandable to a child in the age group involved.


                                   PREGNANT WOMEN, FETUSES AND NEONATES

The federal regulations divide research into different risk categories: research that is not greater than minimal risk to the
participant and research that is greater than minimal risk. Under the regulations, minimal risk means that the probability
and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily
encountered in daily life or during the performance of routine physical or psychological examinations or tests.

5. PREGNANT WOMEN AND FETUSES

     (a) When appropriate, have studies been done on animals and non-pregnant individuals? _____ Yes _____ No

         If yes, please explain briefly the nature and findings of these previous studies:




     (b) Does the research pose a greater than minimal risk to the woman or fetus? _____ Yes        ______ No

         If yes, please check the appropriate category and justify:

         _____ The risk to the fetus is caused solely by interventions/procedures that hold out the prospect of direct benefit for
         the woman or fetus. Justification:




         _____ There is no prospect of direct benefit to either the woman or the fetus, but the risk to the fetus is not greater
         than minimal and the purpose of the research is the development of important biomedical knowledge that cannot be
         obtained by any other means. Justification:




To be approvable, the risk must be the least possible for achieving the objectives of the research. Please justify:




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If the research holds out the prospect of direct benefit to the woman and/or the fetus, or if the research presents no more than
minimal risk, consent of the woman must be obtained.

If the research holds out the prospect of direct benefit solely to the fetus, the consent of the woman and the father of the
fetus must be obtained, unless the father is unavailable, incompetent, incapacitated, or if the pregnancy resulted from incest or
rape.

The PI must agree that no inducements, monetary or otherwise, will be offered to terminate a pregnancy.
_____ PI agrees     _____ PI does not agree.

The PI must agree that individuals engaged in the research will have no part in any decisions as to the timing, method, or
procedures used to terminate a pregnancy.
_____ PI agrees     _____ PI does not agree

The PI must agree that individuals engaged in the research will have no part in determining the viability of a neonate.
_____ PI agrees     _____ PI does not agree


6. NEONATES

         For the purpose of human subject protection regulations, newborns are considered neonates until they are determined
         to be viable. The regulations applicable to pediatric subjects would then apply. This section applies to neonates of
         uncertain viability and nonviable neonates.

         When appropriate, have preclinical and clinical studies been conducted and have they provided data for assessing
         potential risks to neonates: ____ Yes        ____ No

         The PI must agree that individuals engaged in the research will have no part in determining the viability of the
         neonate. ______ PI agrees          ______ PI does not agree

(a) Neonates of uncertain viability.
        To be approved, either:

         The research must hold out the prospect of enhancing the probability of survival of the neonate to the point of
         viability and any risk is the least possible for achieving that objective. Please justify:




          OR

         The purpose of the research is the development of important biomedical knowledge which cannot be obtained by
         other means and there will be no added risk to the neonate resulting from the research. Please justify:




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Consent of either parent of the neonate of uncertain viability is required, or, if neither is able to consent, of the legally
authorized representative of either parent. Consent of the father or his representative is not required if the pregnancy resulted
from rape or incest.

(b) Nonviable neonates. After delivery, nonviable neonates may not be involved in research unless,

         ______      Vital functions of the neonate will not be artificially maintained,
         ______      The research will not terminate the heartbeat or respiration of the neonate,
         ______      There will be no added risk to the neonate resulting from the research, and
         ______      The purpose of the research is the development of important biomedical knowledge that cannot be obtained
                      by other means.
Consent of both parents of the nonviable neonate is required, unless either parent is unable to consent due to unavailability,
incompetence or incapacity. The consent of the father is not needed if the pregnancy resulted from rape or incest. Consent of
a legally authorized representative of either or both parents is not adequate.




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                                                          PRISONERS

Because prisoners may be under constraints because of their incarceration which could affect their ability to make a truly
voluntary and uncoerced decision about whether or not to participate as subjects in research, the federal regulations provide
additional safeguards for the protection of prisoners as human subjects in research.

The federal regulations divide research into different risk categories: research that is not greater than minimal risk to the
participant and research that is greater than minimal risk. Under the regulations, minimal risk means that the probability
and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily
encountered in daily life or during the performance of routine physical or psychological examinations or tests.

The IRB can only approve research that falls into one of the following categories and which has been approved by the
Secretary of HHS after consultation with a panel of experts.

 Please check the one that applies and justify the research:

____     Cause and Effect: Study of the possible causes, effects, and processes of incarceration and of criminal behavior and
         presents no more than a minimal risk.




_____    Institutional Structures: Study of prisons as institutional structures or of prisoners as incarcerated persons, provided it
         causes no more than a minimal risk.




______ Conditions Affecting Prisoners as a Class: Research on conditions particularly affecting prisoners as a class (e.g.
         vaccine trials and other research on hepatitis which is more prevalent in prisons; research on social and psychological
         problems such as alcoholism, drug addiction and sexual assaults.




Revised 01/16/2008                                                                                               Page 22 of 25
                                        SECTION J. INFORMED CONSENT
Informed consent is necessary for all research involving human subjects and must be documented in some manner. The
investigator may determine which method would best serve the interest of the subject population, but the Board reserves the right
to require alternative or more stringent means of securing consent. Use of subjects unable to give personal consent for reasons of
age, mental state, legal or other such status, requires that consent or assent be secured from parents or a legally authorized
representative.
If a legally authorized representative will be used, please provide justification (in J1 below) to conduct research on a subject
unable to consent for him or herself.

 J1.    Describe procedures used to obtain informed consent (and minor assent, if applicable), including how and where informed
        consent (and assent, if applicable) will be obtained.




 J2.    Will you obtain written consent?             Yes           No
          NOTE: Always required when there is a definite physical, social, or psychological risk to the subject. Document must
          embody all of the basic elements of informed consent. These are contained in the template IRB Consent Form.


 J3.    Will you obtain only oral consent?           Yes           No
          NOTE: Oral consent may be sufficient in the case of studies that present no more than minimal risk to the subject. Subject
          must be informed of applicable basic elements of consent. No signed document is necessary on the part of the subject.
          However, a sample written copy of the information to be imparted to the subject must be submitted and approved by the
          Board. This method of obtaining consent is approved ONLY for no more than minimal risk studies.

        Sample documentation is attached:            Yes           No


 J4.    Will you use a standard hospital consent form?           Yes          No
         NOTE: Special written research consent form is not required for use of unidentified surgical waste tissues, or autopsy
         specimens including specimens from Special Subject Populations (i.e. fetuses, minors, pregnant women, prisoners or the
         mentally disabled), provided that the Tissue Submission policy has been followed and completed satisfactorily and
         appropriate approval from the Department of Pathology has been obtained. The standard hospital form, which clearly
         permits use of the tissue or fluid for research MUST BE ATTACHED (Form #45350 for surgery, or Form #41160 for
         autopsy specimens).




 Revised 01/16/2008                                                                                            Page 23 of 25
PRINT:
PI Name ___________________________________      Protocol Title________________________________________________________________ __

                                                SECTION K. SIGNATURES
1. I certify that the above information concerning procedures to be taken for protection of human subjects is correct. I will
   seek and obtain prior approval for any modification of this protocol and will report promptly to the Institutional Review
   Board any unexpected or otherwise significant adverse effects encountered in the course of the study.


                Investigator Name                                       Signature                                Date


   This proposal has been reviewed and approved for submission to the Committee on Human Rights in Research



           Department Chairperson Name                                  Signature                                Date



2. Are subjects covered under this research protocol administratively the responsibility of another department?
               No              Yes, approval is required, please obtain signature below.

      a)    Department Name:


             Department Chairperson Name                                Signature                                Date


      b)    Department Name:


             Department Chairperson Name                                Signature                                Date

3. Will your research involve the use of human tissue(s)?
               No              Yes, approval is necessary by the Chairperson of the Department of Pathology


   Human Tissue IRB Compliance Leader                                   Signature                                Date

4. Does this protocol make use of Perioperative Services (which includes the OR, Endoscopy, IVF, Genetics, Anesthesia,
   Gastrointestinal, Bronchoscopy and Pulmonary Function)?
               No              Yes, please obtain the signature of the Administrative Director of Perioperative Services


                 Marjorie Guglin, RN
                Admin Director Name                                     Signature                                Date


  The International Committee of Medical Journal Editors (ICMJE) has established a requirement
  that all clinical trials be entered in a public registry before the onset of patient enrollment as a
  condition of consideration for publication. Additional information may be found at:
  http://clinicaltrials.gov/ and at http://www.icmje.org/clin_trialup.htm

  Please contact the Protocol Registration System ("PRS") administrator by e-mail at:
  ICR@med.cornell.edu to set up a PRS user account to register new and ongoing clinical trials.
  The e-mail should contain the PI’s full name, department, phone number and e-mail address.


Revised 01/16/2008                                                                                               Page 24 of 25
                                            Attachments


Please attach the following for the IRB to review your research:

        Original Request for Approval of Investigation Involving Use of Human Subjects (IRB
         Protocol), including the consent form (and assent form, if applicable).

        Sponsor’s protocol
        Investigator’s brochure
        Data collection sheets
        Study Specific Financial Disclosure Form for each investigator
        NIH grant application (if applicable)
        HIPAA research forms
        Any recruitment notices or advertisements
        Any survey instruments, psychological tests, interview forms, or scripts
        Any communication from the FDA regarding IND, IDE, or Humanitarian Use applications related
         to this submission
        Research Billing Analysis Form




Revised 01/16/2008                                                                    Page 25 of 25

								
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