Institutional Review Board Requirements Research Articles

Obtaining informed consent: observations from community research with refugee and impoverished youth

This paper presents challenges facing researchers in applying basic ethical principles while conducting research with youth in a developing country context. A discussion of the cultural and social challenges to...

Practice-based Research Network Studies and Institutional Review Boards: Two New Issues

Practice-based research network (PBRN) study investigators must interface with multiple Institutional Review Boards (IRBs), many of which are unfamiliar with PBRN research. To present 2 IRB-related issues that have not appeared in the literature but occurred during the course of a large 5-year PBRN study involving 32 sites dispersed around the United States. Our study required IRB approval from a total of 19 local, hospital, academic center, and professional organization-based IRBs that reviewed a protocol of postpartum depression screening and follow-up completed in English or Spanish. Initial approval of the protocol and consent forms proceeded with only the usual barriers of submitting 19 different forms, and no protocol amendments were required. However, 2 unanticipated IRB issues provided significant additional work for the study team and the local practice sites. First, several IRBs required staff to repeat human subjects training every 1 to 2 years, resulting in 92 practicing physicians, residents, and members of the nursing staff spending time completing the exact same human subjects' training at least twice during the course of this study. Second, 17 of the 19 IRBs required that the patient be given consent forms that were newly stamped and dated each year, requiring the central site to reprint and replace consent forms yearly. Because not all IRBs returned the newly stamped and dated forms in a timely fashion, study enrollment with valid consent forms was interrupted in 4 sites for periods of 2 to 13 weeks. IRB requirements not directly responsive to federal regulations can add significant costs, frustrations, and burdens to PBRN studies. Non-federally mandated IRB requirements should be based on an identified need with evidence to support the solution.

The IRB Is Key

In his response to a letter on his Perspective “ Homo experimentalis evolves” ([1][1]) (31 October 2008, p. [672][2]), J. A. List replies that the economic research he conducted did not require informed consent by the unwitting participants because the study yielded interesting results and did no harm. The response concludes, “Those cases in which there are minimal benefits of informed consent but large costs are prime candidates for relaxation of informed consent.” There are certainly grounds for dispensing with informed consent in social sciences research, and Institutional Review Boards (IRBs) have guidelines for doing so. However, there are no general rules that cover every instance, and the investigator does not have the authority to make the decision about when the guidelines apply. Instead, exemptions are granted by IRBs only on a case-by-case basis. In this case, the appropriate question is, did List submit his research protocol to his supervising IRB and request an exemption? The decision to dispense with informed consent is not the author's. 1. 1.[↵][3]1. J. A. List , Science 321, 207 (2008). [OpenUrl][4][Abstract/FREE Full Text][5] # Response {#article-title-2} As my letter suggests, Institutional Review Boards (IRBs) are a necessary condition and serve an invaluable role; I wrote, “Local Research Ethics Committees and Institutional Review Boards in the United States serve an important role in monitoring such activities.” All of my research has IRB approval, and I suspect from W. R. Lovallo's concerns that he and I agree on all aspects of subject approval. In my own research, I have been even more stringent than IRB requirements—I do not deceive subjects and always ensure that they are better off due to my experiment. These conditions are certainly not a constraint in all, or even many, IRBs that I am aware of. On another note, some researchers do not have Local Research Ethics Committees and Institutional Review Boards. Outside the United States, researchers in the social sciences must rely largely on their own moral principles. I view my letter as also speaking to these scholars and letting them know that strict standards need to be followed. [1]: #ref-1 [2]: /lookup/doi/10.1126/science.322.5902.672a [3]: #xref-ref-1-1 View reference 1. in text [4]: {openurl}?query=rft.jtitle%253DScience%26rft.stitle%253DScience%26rft.aulast%253DList%26rft.auinit1%253DJ.%2BA.%26rft.volume%253D321%26rft.issue%253D5886%26rft.spage%253D207%26rft.epage%253D208%26rft.atitle%253DECONOMICS%253A%2BHomo%2Bexperimentalis%2BEvolves%26rft_id%253Dinfo%253Adoi%252F10.1126%252Fscience.1156716%26rft_id%253Dinfo%253Apmid%252F18621657%26rft.genre%253Darticle%26rft_val_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Ajournal%26ctx_ver%253DZ39.88-2004%26url_ver%253DZ39.88-2004%26url_ctx_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Actx [5]: /lookup/ijlink/YTozOntzOjQ6InBhdGgiO3M6MTQ6Ii9sb29rdXAvaWpsaW5rIjtzOjU6InF1ZXJ5IjthOjQ6e3M6ODoibGlua1R5cGUiO3M6NDoiQUJTVCI7czoxMToiam91cm5hbENvZGUiO3M6Mzoic2NpIjtzOjU6InJlc2lkIjtzOjEyOiIzMjEvNTg4Ni8yMDciO3M6NDoiYXRvbSI7czoyNDoiL3NjaS8zMjMvNTkxNS83MTMuMi5hdG9tIjt9czo4OiJmcmFnbWVudCI7czowOiIiO30=

Enrichment of C-Terminal Fragments in TAR DNA-Binding Protein-43 Cytoplasmic Inclusions in Brain but not in Spinal Cord of Frontotemporal Lobar Degeneration and Amyotrophic Lateral Sclerosis

TAR DNA-binding protein (TDP-43) has been recently described as a major pathological protein in both frontotemporal dementia with ubiquitin-positive inclusions (FTLD-U) and amyotrophic lateral sclerosis. However, little is known about the relative abundance and distribution of different pathological TDP-43 species, which include hyperphosphorylated, ubiquitinated, and N-terminally cleaved TDP-43. Here, we developed novel N-terminal (N-t) and C-terminal (C-t)-specific TDP-43 antibodies and performed biochemical and immunohistochemical studies to analyze cortical, hippocampal, and spinal cord tissue from frontotemporal dementia with ubiquitin-positive inclusions and amyotrophic lateral sclerosis cases. C-t-specific TDP-43 antibodies revealed similar abundance, morphology, and distribution of dystrophic neurites and neuronal cytoplasmic inclusions in cortex and hippocampus compared with previously described pan-TDP-43 antibodies. By contrast, N-t-specific TDP-43 antibodies only detected a small subset of these lesions. Biochemical studies confirmed the presence of C-t TDP-43 fragments but not extreme N-t fragments. Surprisingly, immunohistochemical analysis of inclusions in spinal cord motor neurons in both diseases showed that they are N-t and C-t positive. TDP-43 inclusions in Alzheimer's disease brains also were examined, and similar enrichment in C-t TDP-43 fragments was observed in cortex and hippocampus. These results show that the composition of the inclusions in brain versus spinal cord tissues differ, with an increased representation of C-t TDP-43 fragments in cortical and hippocampal regions. Therefore, regionally different pathogenic processes may underlie the development of abnormal TDP-43 proteinopathies.

Clinician Educators??? Experiences with Institutional Review Boards: Results of a National Survey

To explore clinician educators' perceptions and experiences in obtaining institutional review board (IRB) approval to conduct medical education research (MER). Institutional members of the Clerkship Directors in Internal Medicine (CDIM; n = 110) were surveyed in 2006. The survey included questions about familiarity with and clarity of IRB policies, satisfaction with review of education research protocols, and how MER might be facilitated. Of 83 respondents (response rate 76%), 50 had submitted a MER protocol to an IRB. Nearly all were deemed exempt (74/154) or minimal risk (71/154). No protocols were rejected or not approved. Nearly a fourth of respondents were unfamiliar with specific IRB policies directly applicable to MER. Among those respondents who had some familiarity with the IRB policies specified, 47% to 52% considered the IRB policies clear. Eighteen of 30 (60%) respondents with recent experience in multiinstitutional MER agreed there were notable differences in the expectations of various institutional IRBs; only two reported that multiple IRB reviews resulted in improvements to the protocol. Half (37/73) indicated they would be more likely to conduct MER if they had a better understanding of the IRB's role and requirements in MER. Sixty-six of 73 (90%) agreed they would benefit from a national consensus statement regarding the IRB's role in MER. A high percentage of clinician educators in CDIM are conducting IRB-approved MER. They report several challenges with working with IRBs, and they agree that IRBs and clinician educators would benefit from a national consensus on the IRB's role in MER.

Promoting Ethical Conduct in the Publication of Research

Promoting Ethical Conduct in the Publication of Research

Effect of Prior Authorization of Second-Generation Antipsychotic Agents on Pharmacy Utilization and Reimbursements

Effect of Prior Authorization of Second-Generation Antipsychotic Agents on Pharmacy Utilization and Reimbursements

Recruitment and Retention of Stroke Survivors: The CAReS Experience

Recruiting participants with chronic disabling conditions into research studies is a complex process, involving consideration of the rigors of Institutional Review Board requirements, complexities of the recruiting site and sensitivity to the needs of elderly participants. Retaining such participants is achieved by careful recruitment that ensures that participants match the established criteria, understand the study, and are committed to long-term participation-as well as by minimizing the burden as much as possible on the participants and making them feel an important part of a worthwhile effort throughout the duration of the study. This article reviews the recruitment process and reports strategies used in recruiting and retaining elderly subjects for the CAReS Research Study, an interdisciplinary, randomized intervention research study for stroke survivors and their spousal caregivers. Implications for occupational therapy are addressed.

Impact of IRB Requirements on a Multicenter Survey of Prophylactic Mastectomy Outcomes

This study assesses the variability in requirements among six institutional review boards (IRBs) and the resulting protocol variations for a multicenter mailed survey. We utilized a cross-sectional mailed survey to gather information on long-term psychosocial outcomes of prophylactic mastectomy among women at six health maintenance organizations, all of which are part of the Cancer Research Network. In the context of this collaborative study, we characterized the impact of the different sites' IRB review processes on the study protocol and participation. IRB review resulted in site differences in physician consent prior to participant contact, invitation letter content and signatories, and incentive type. The review process required two to eight modifications beyond the initial application and resulted in unanticipated delays and costs. Site-to-site variability in IRB requirements may adversely impact scientific rigor and delay implementation of collaborative studies, especially when not considered in project planning. IRB review is an essential aspect of research but one that can present substantial challenges for multicenter studies.