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6 Improving the IRB Process
Pages 135-148

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From page 135...
... Guidance and recommendations focus on improving the IRB process through the efforts of IRB staff, members, and institutional officials. THE SCOPE OF FEDERAL REGULATORY AUTHORITY Since the 1970s, federal regulation of research involving human participants has been limited to two categories: (1)
From page 136...
... . More recent OHRP data indicate that 37 percent of research organizations with federalwide assurances "unchecked the box" (Association for the Accreditation of Human Research Protection Programs, 2013)
From page 137...
... reliance agreements and memoranda of understanding to protect local population concerns, (4) single IRBs of record for multisite studies, and (5)
From page 138...
... For example in personal spaces or blogs, where the data are in text form, the ethical questions pertain to the authors' or participants' expectations regarding whether the site is public or private; whether their personal network of connections contains sensitive information; and whether analysis, publication, redistribution, or dissemination of the content could harm participants in any way. Another example of shared ethical responsibility pertains to considerations in conducting research in which communities are the central topic of inquiries, and where ethical questions therefore relate to risks for both individuals and communities.
From page 139...
... This 4-year innovation and demonstration initiative was launched to add flexibility and reduce administrative burden for certain types of minimal risk research that are neither federally sponsored nor have sponsor or other contractual restrictions requiring adherence to federal regulations, do not contain FDA-regulated components, do not have prisoners as subjects, and do not include a Certificate of Confidentiality issued by the National Institutes of Health. Further, 2-year approval periods are granted, and a new exemption category was created for research involving the analysis of identifiable data where there is no direct interaction or intervention with human subjects.
From page 140...
... Collaborative and Sharing Mechanisms A variety of institutional and collaborative initiatives have streamlined IRB review when investigators at multiple institutions are involved. In instances when one IRB serves as the designated IRB and local stakeholders have concerns about specific populations, reliance agreements and memoranda of understanding can help assure them that the rights and protections of the local populations are covered, while investigators can avoid duplicative IRB review.
From page 141...
... , a name given to IRBs that have the same purpose as those described in the ANPRM as the "single IRB 6  In fact, the first detailed documentation of the burdens associated with multiple IRB review -- significantly titled We shall overcome: Multi-institutional review of a genetic counseling study -- was published by a team of social scientists who reported on their complex negotiations with multiple IRBs in getting an initial approval and periodic reapproval of their interview research, which was carried out at multiple genetics counseling clinics. They said, "At times, we found ourselves wandering through bureaucratic mazes that made us think we were re-enacting Franz Kafka's classic novel, The Trial, rather than engaging in social science research" (Kavanagh et al., 1979, p.
From page 142...
... IRB Shopping One concern is that sponsors and investigators engaged in the development and execution of a multisite study could "shop around" seeking a relatively permissive IRB: one that is likely to provide a "rubber stamp" approval of researcher or sponsor plans. Although IRB shopping is possible, it is no more likely to occur with a single IRB of record than it is in the current system, in which researchers may sometimes be able to choose among relevant IRBs.9 7  See the National Cancer Institute's Welcome to the Central IRB Initiative webpage at https://ncicirb.org [November 2013]
From page 143...
... The committee suggests deal ing with this possibility in much the same way as suggested for criticisms emanating from OHRP -- that is, hold the single IRB of record responsible for the errors it commits and hold the local institution responsible only for inadequate or negligent actions oc curring within the institution. Complexity in Incorporating Multiple IRBs into a Single System Many IRB and institutional Human Research Protection Program personnel have cautioned that converting to a single-IRB-of-record system is likely to be a complex task.
From page 144...
... [Dr.] O'Rourke, who supports the gradual phasing-in of single IRBs of record, cautions that, in their development, one should take care not to underestimate the time required to work out the details of starting up, the long-term costs of central IRB infrastructure, the confusion resulting from discrepancies in the institution-specific conventions for assigning of institutional and IRB review responsibility, and the critical role that trust and familiarity play in development and negotiation of IRB reliance relationships.
From page 145...
... Recommendation 6.3: In each institution in which research involving human participants is carried out, a system should be developed for the appeal of IRB decisions. CONCLUSION In closing, the committee has sought to inform the efforts of the federal government in revising the Common Rule that governs the protection of human participants in research within the context of social and behavioral sciences.
From page 146...
... The committee also aims to assist in developing best practices for implementing the new human research protections and assessing the effectiveness of the rules and their implementation. Thus, the committee recommends that research be conducted on the costs and benefits of regulating social and behavioral research for the research participants themselves, and for institutions, IRBs, investigators, and sponsors.
From page 147...
... :3-19. Association for the Accreditation of Human Research Protection Programs (2013)
From page 148...
... Institutional Review Blog. Secretary's Advisory Committee on Human Research Protections.


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