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SampleIRBChecklist.pdf
Appendix e iRB Checklist for Scientific Reviewers
1
University of Pittsburgh IRB Checklist for Scientific Reviewers
Revised May 2008
OSIRIS Section TRIAGE Yes No NA
T 3.0 Is risk level noted by investigators consistent with risks the study poses to subjects?
COVER SHEET Yes No NA
CS 9.0 If not already listed, does this study require an IND or IDE?
OBJECTIVE, AIMS, BACKGROUND AND SIGNIFICANCE Yes No NA
1.4 Is the research design adequate to yield scientifically sound data?
RESEARCH DESIGN AND METHODS Yes No NA
2.1 Is the duration of the study drug intervention limited appropriately to that which is mini- mally necessary to evaluate efficacy?
2.18 Is there a statistical justification for the sample size?
2.18 Is the proposed statistical treatment of the data appropriate for the design of the study?
2.3.1 Is a placebo being used where an effective treatment exists?
2.6 Are the study procedures and study visits clearly outlined and described?
2.6 Are all procedures described clearly defined as either research related or completed as part of the subject’s clinical care? (regardless of study participation)
HUMAN SUBJECTS Yes No NA
3.0 Is the study population appropriate for the goals of the study? (consider both the nature and size of the sample)
3.5–3.11 Are adequate safeguards in place to protect any subject that would be categorized as vulnerable as defined by Subparts B, C and D? 46.111 (b)
3.13 Are the criteria for inclusion of subjects appropriate?
3.14 Are the criteria for exclusion of subjects appropriate?
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2 Appendix E IRB Checklist for Scientific Reviewers
RECRUITMENT Yes No NA
4.4 Are methods of subject recruitment equitable, taking into consideration the nature and setting in which the research is being conducted? (46.111 (a) (3))
4.4 Are the methods of recruitment legal, ethical and free from coercion or undue influence?
INFORMED CONSENT DOCUMENT—REQUIRED ELEMENTS Yes No NA
4.9 Is there a clear statement that the study involves research?
4.9 Is there a clear statement of the purpose of the study?
4.9 Is the expected duration of the subject’s participation included?
4.9 Is there a description of procedures to be following during subject’s participation?
4.9 Are procedures which are experimental identified?
4.9 Is there a complete and clear description of the potential risks (i.e., is quantitative information on the expected frequency of the listed side effects provided)?
4.9 Are the potential benefits to the subjects (if any) clearly described? If there are no benefits, is this clearly stated?
4.9 If applicable, have all alternative treatments or courses of treatment that might be advan- tageous to the subject been satisfactorily described?
4.9 Is there a statement describing the extent to which the confidentiality of subjects’ records will be maintained?
4.9 For research that is more than minimal risk, is there an explanation of whether compensa- tion for injury will be provided?
4.9 Is there an explanation of whom to contact for questions about the research, research subject’s rights, and in the event of a research-related injury?
4.9 For research that is more than minimal risk, is there a statement regarding treatment that is available if an injury were to occur as a result of the research?
4.9 Is there a statement that participation in the research study is voluntary?
4.9 Is there a statement that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled?
4.9 Is there a statement that the subject may discontinue participation at any time without penalty of loss of benefits to which the subject is otherwise entitled?
4.9 Does the consent form contain exculpatory language?
INFORMED CONSENT DOCUMENT—ADDITIONAL ELEMENTS Yes No NA
4.9 Is there a statement that the treatment or procedure may involve risks to the subject (or em- bryo or fetus, if the subject is or may become pregnant) which is currently unforeseeable?
4.9 Is there a statement that indicates the anticipated circumstances under which the sub- ject’s participation may be terminated by the investigator without regard to the subject’s consent?
4.9 If subjects are expected to bear any additional costs for participation, are the costs identified?
4.9 Are the consequences of a subject’s decision to withdraw from the research and proce- dures for orderly termination of participation included?
4.9 Is there a statement that significant new findings developed during the course of the research which may relate to the subject’s willingness to continue participation will be provided to subjects?
4.9 Is the approximate number of subjects involved in the study included?
INFORMED CONSENT PROCESS Yes No NA
4.12 Is sufficient information provided about the informed consent process that will take place (including who will conduct the consent interview, whether there will be a waiting period between informing the prospective participant and obtaining consent and steps that will be taken to minimize the possibility of coercion or undue influence)?
4.12 Will informed consent be sought from each prospective subject or the subject’s legally authorized representative to the extent required by §46.116? (46.111 (a) (4))
4.12 Will informed consent be appropriately documented in accordance with and to the extent required by §46.117? (46.111 (a) (5))
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IRB Checklist for Scientific Reviewers 3
POTENTIAL RISKS AND BENEFITS Yes No NA
5.1–5.5 Are the risks to subjects reasonable in relation to the anticipated benefits, if any? (46.111 (a) (2))
5.1–5.5 Are risks and benefits in the protocol consistent with risks/benefits in the consent?
5.12 Are the potential benefits to the subject and/or society clearly described and outweigh the risks being incurred? (46.111 (a) (2))
5.13 Does the research plan have adequate provision for monitoring the data collected to ensure the safety of the subjects? (46.111 (a) (6))
5.2.2 Are the risks to the subject minimized by using procedures that are consistent with sound research design and, whenever appropriate, by using procedures already being per- formed on the subjects for diagnostic or treatment purposes? (46.111 (a) (1))
5.4 Have appropriate statements regarding reproductive risks and birth control been in- cluded?
5.8 Are there adequate provisions to protect the privacy of subjects and to maintain the confi- dentiality of data? (46.111 (a) (7))
COSTS AND PAYMENTS Yes No NA
6.0 Are the financial obligations of the subject, the sponsor and the institution clearly de- scribed?
6.1 Are costs/availability of the experimental drug/device following study completion ad- dressed?
6.1 Is there a clear description distinguishing between the costs related to research proce- dures versus clinical care procedures (done regardless of study participation)?
6.2 Do all payments seem sufficient yet not large enough to be coercive?
QUALIFICATIONS AND SOURCE(S) OF SUPPORT/REFERENCES Yes No NA
7.1 Do the principal investigator and co-investigators have the appropriate academic/clinical credentials and experience for this study?
7.2 Were appropriate references cited in the research protocol to support the research design and the risks and benefits of the study?
Used with permission from the University of Pittsburgh's Institutional Review Board.
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