The IRB chairs, IRB-designees and convened IRB shall conduct a systematic review of the study materials and shall consider the same principles and criteria in its deliberations of all new or continuing studies, no matter whether these fall into the exempt, expedited or convened IRB category, in accordance with 45 CFR 46 and 21 CFR 56. Among these criteria are:
1) Research Relevance.
2) Minimization of Risks. Both physical and non-physical risks to human subjects should be minimized to the extent possible by using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk. Whenever appropriate, studies should use procedures already being performed on the subjects for diagnostic or treatment purposes (45 CFR 46.111 and 21 CFR 56.111).
3) Reasonable Risk/Benefit Ratio. Both physical and non-physical risks to human subjects should be reasonable in relation to any anticipated benefits (the risk/benefit ratio) to subjects, and the importance of the knowledge that may reasonably be expected to result. The IRB should account for risks and benefits that may result from the research as distinguished from those that subjects would receive if not participating in the research. The IRB should not consider possible long-range effects of applying knowledge obtained in the research. The IRB should take into consideration the level of risk and the validity of the research design in determining the risk/benefit ratio (45 CFR 46.111 and 21 CFR 56.111).
4) Equitable Selection of Subjects. The IRB should take into account the research purposes and settings, special problems involving vulnerable populations (e.g. children, prisoners, pregnant women, persons with mental disabilities or impaired decision-making capacity and persons disadvantaged economically or educationally) in evaluating subject selection equities (45 CFR 46.111 and 21 CFR 56.111).
5) Quality Informed Consent Forms. These should contain all required elements, conform with regulations and ethical standards, be complete, accurate and comprehensible and provide potential subjects with an accurate and fair description of the risks or discomforts and the anticipated benefits.
6) Adequate Safety Monitoring and Provisions for Privacy and Confidentiality. The IRB should ensure that research plans make adequate provisions for data and safety-monitoring to protect the privacy of subjects and to maintain the confidentiality of individually-identifiable data (45 CFR 46.111 and 21 CFR 56.111).
7) Protection of Vulnerable Subjects. The IRB should ensure that adequate safeguards have been included in each study to protect the rights and welfare of vulnerable subjects (45 CFR 46.111 and 21 CFR 56.111).
8) Conflict of Interest. The IRB should ensure that steps are adequate to evaluate, manage, reduce or eliminate potential or real conflicts of interest.
9) Investigator's Educational Requirements and Certification. The IRB should ensure that the PI and all personnel engaged in the study have met current educational requirements for the protection of human research subjects as mandated by the University. The IRB should also determine that investigators are qualified through education, training and experience to conduct the research.
The assessment of risks and benefits requires that the IRB carefully and systematically review relevant data including putative alternate ways of obtaining the benefits sought in the research. In conducting its reviews, therefore, all IRB members should receive and review the study application and all supplemental documents (and for continuing reviews, a status report on the progress of the research) and other information (if applicable) including:
1) The number of subjects accrued or to be accrued
2) A summary of adverse events and any unanticipated problems involving risks to subjects or others and any withdrawal of subjects from the research or complaints about the research since the last IRB review
3) A summary of any relevant recent literature, interim findings, and amendments or modifications to the research since the last review
4) Any relevant multi-center trial reports
5) Any other relevant information, especially information about risks associated with the research
6) A copy of the proposed or current informed consent document and any newly proposed consent document
In assessing risks and benefits and the justifiability of research, the IRB shall follow the following five guidelines of the National Institutes of Health (http://ohsr.od.nih.gov/guidelines/Belmont.html):
1) Brutal or inhumane treatment of human subjects is never morally justified
2) Risks should be reduced to those necessary to achieve the research objective. It should be determined whether it is necessary to use human subjects at all and/or whether alternative procedures could reduce or eliminate risks
3) When research involves significant risk of serious impairment, the IRB should require written justification of the risk (looking usually to the likelihood of benefit to the subjects – or, in some rare cases, to the discernable voluntariness of the participation
4) When vulnerable populations are involved in research, the appropriateness of involving them should be demonstrated. Variables which should go into such judgments include the nature and degree of risk, the condition of the particular population involved, and the nature and level of the anticipated benefits
5) Relevant risks and benefits must be thoroughly defined in documents and procedures used in the informed consent process