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. 2023 Feb-Apr;18(1-2):58-68.
doi: 10.1177/15562646221138450. Epub 2022 Dec 7.

Protecting the Vulnerable and Including the Under-Represented: IRB Practices and Attitudes

Luke Gelinas  1 , David H Strauss  2 , Ying Chen  3 , Hayat R Ahmed  4 , Aaron Kirby  5 , Phoebe Friesen  6 , Barbara E Bierer  7
Affiliations

Protecting the Vulnerable and Including the Under-Represented: IRB Practices and Attitudes

Luke Gelinas et al. J Empir Res Hum Res Ethics. 2023 Feb-Apr.

Abstract

Since their inception, Institutional Review Boards (IRBs) have been charged with protecting the vulnerable in research. More recently, attention has turned to whether IRBs also have a role to play in ensuring representative study samples and promoting the inclusion of historically under-represented groups. These two aims-protecting the vulnerable and including the under-represented-can pull in different directions, given the potential for overlap between the vulnerable and the under-represented. We conducted a pilot, online national survey of IRB Chairs to gauge attitudes and practices with regard to protecting the vulnerable and including the under-represented in research. We found that IRBs extend the concept of vulnerability to different groups across various contexts, are confident that they effectively protect vulnerable individuals in research, and believe that IRBs have a role to play in ensuring representative samples and the inclusion of under-represented groups.

Keywords: IRB; ethics; inclusion; research; survey; vulnerable.

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Figures

Figure 1
Figure 1
Does your IRB routinely consider any of the following groups to be “vulnerable”?
Figure 2
Figure 2
IRB effectiveness in protection and promoting inclusion
Figure 3
Figure 3
In your personal view, should IRBs seek to ensure inclusion of study populations that reflect the demographics of the condition being studied?
Figure 4
Figure 4
Does your IRB routinely seek to ensure inclusion of study populations that reflect the demographics of the condition being studied?
Figure 5
Figure 5
Categories of Demographic Data Collected at the Time of Continuing Review (n=322)
See this image and copyright information in PMC

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References

    1. Assembly WMA General. 1996. WMA Declaration of Helsinki—Ethical Principles for Medical Research Involving Human Subjects. World Medical Association, Somerset West, South Africa.
    1. Bayer Antony, and Tadd Win. 2000. Unjustified exclusion of elderly people from studies submitted to research ethics committee for approval: descriptive study. Bmj 321 (7267):992–993. - PMC - PubMed
    1. Baylis Françoise, and Kaposy Chris. 2010. Wanted: Inclusive Guidelines for Research Involving Pregnant Women. Journal of Obstetrics and Gynaecology Canada 32 (5):473–476. doi: 10.1016/S1701-2163(16)34502-9. - DOI - PubMed
    1. Beauchamp Tom L. 2008. “The Belmont Report.” In The Oxford Textbook of Clinical Research Ethics, edited by Emanuel Ezekiel J., 149–55. Oxford University Press.
    1. Berry, Sandra H, Dmitry Khodyakov, David Matthew Grant, Alexandra Mendoza-Graf, Elizabeth Bromley, Gina Karimi, Levitan Barbara A, Karin Liu, and Sydne J Newberry. 2019. Profile of Institutional Review Board Characteristics Prior to the 2019 Implementation of the Revised Common Rule: RAND.

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