IRB Chairs' Perspectives on Genomics Research Involving Stored Biological Materials
Ethical Concerns and Proposed Solutions
Bibliographic Data
| ID | 12807403 |
|---|---|
| Authors | Leslie E Wolf (0000-0002-4660-8383, University of California, San Francisco, corresponding author), Joseph A Catania (0000-0003-0527-9867, University of California, San Francisco), M Margaret Dolcini (University of California, San Francisco), Lance M Pollack (0000-0001-7140-2582, University of California, San Francisco), Bernard Lo (0000-0001-6210-9667, University of California, San Francisco) |
| Year | 2008 |
| Volume | 3 |
| Issue | 4 |
| Pages | 99-111 |
| Publication date | 2008-12-01 |
| Open Access | Yes |
| Type | ARTICLE |
| Venue | Journal of Empirical Research on Human Research Ethics (JOURNAL) |
| Journal identifiers | ISSN: 1556-2646 • E-ISSN: 1556-2654 |
| Publisher | SAGE Publishing (PUBLISHER • US) |
| DOI | 10.1525/jer.2008.3.4.99 |
| PMID | 19385758 |
| OpenAlex | W2028807476 |
| Language | EN |
| Citations received | 5 |
| References cited | 11 |
WE EVALUATED 55 IRB CHAIRS' perspectives on ethical issues in a hypothetical study involving mental health-related genomics research using stored specimens to identify potential barriers and solutions to such research. Most Chairs identified the ethical issues of consent and confidentially as important. The majority of Chairs expressed concern about using materials in new research, especially concerning a mental health condition, that was not discussed in the original consent. Few Chairs considered permissible strategies, such as deidentification and waiver of consent, which could allow the proposed research to go forward without consent. Chairs who reviewed more protocols and had attended conferences on human subjects protection identified more of the salient ethical issues in the scenario. Our study could not determine whether Chairs were not familiar with the strategies of de-identification and waiver of consent, or believed that they did not adequately protect participants who had provided specimens for research. Thus, our findings suggest that investigators and IRBs should consider future use of specimens and obtain appropriate consent before collection of specimens. Furthermore, our findings suggest that IRBs can improve review of genomics research involving stored specimens by redesigning forms to prompt IRB members to consider some strategies, such as de-identification and Certificates of Confidentiality, that are recommended for this type of research and by sending members to conferences on human subjects protections and research ethics
Alternative medicine · Biobank · Bioinformatics · Biorepository · Confidentiality · Engineering ethics · Ethical issues · Human research · Identification (biology · Informed consent · Medical education · Mental health · Pathology · Political science · Psychiatry · Research ethics · Waiver · Biomedical Ethics and Regulation · Engineering · Ethics in Clinical Research · Law · Medicine · Psychology · Race, Genetics, and Society
| Citations per year | 0.29 |
|---|---|
| Citation span | 2009 - 2014 (6) |
| Highly cited | No |