Attitudes toward Genetic Research Review: Results from a Survey of Human Genetics Researchers

Abstract

Background: Researchers often relate personal experiences of difficulties and challenges with Institutional Review Board (IRB) review of their human genetic research protocols. However, there have been no studies that document the range and frequency of these concerns among researchers conducting human genetic/genomic studies. Methods: An online anonymous survey was used to collect information from human genetic researchers regarding views about IRB review of genetic protocols. Logistic regression was used to test specific hypotheses. Results from the national online survey of 351 human genomic researchers are summarized in this report. Results: Issues involving considerable discussion with IRBs included reconsent of subjects (51%), protection of participants’ personal information (39%) and return of results to participants (34%). Over half of the participants had experienced one or more negative consequences of the IRB review process and approximately 25% had experienced one or more positive consequences. Respondents who had served on an IRB were about 80% more likely to report positive consequences of IRB review than their colleagues who had never served on an IRB (p = 0.03). Survey responses were mixed on the need for reconsent before data sharing and risks related to participant reidentification from genomic data. Conclusion: The results from this study provide important perspectives of researchers regarding genetic research review and show lack of consensus on key research ethics issues in genomic research.

Researcher and Institutional Review Board Chair Perspectives on Incidental Findings in Genomic Research

“…Findings from this study provide evidence regarding current viewpoints of researchers in which a plan for disclosure of IRRs may be contingent on the genotyping method, medical significance of the specific finding, the participant preferences, and viewpoints of IRB chairs on need for guidance for disclosure of GIFs from genetic research studies. This evidence builds on the findings from Edwards et al (2011) in which return of results was not a common finding. Edwards et al also noted that those researchers who had served on IRBs were more likely to report positive consequences of IRB review.…”

“…When researchers were asked what they would do in response to hypothetical situations involving unexpected findings in genetic research, most stated they would disclose IFs, with their decisions governed by quality of information, adherence to rules, and research participant welfare (Meacham et al, 2010). However, only about one-third of researchers who were surveyed about IRB challenges regarding human genetic research identified return of IRRs to participants as an important issue (Edwards et al, 2011).…”

Researchers’ opinions towards the communication of results of biobank research: a survey study

“…Opinions were more divided concerning such an obligation if a participant asked for results or if the researcher felt the participant might be interested. 8,9 The similarity of findings in studies from different countries suggests that researchers share common views. On the other hand, differences in opinions were found between Spanish and US researchers, 8 warranting caution in generalization of study results.…”

“…However, only few studies addressed their opinion on this issue. [8][9][10][11] We surveyed researchers involved in biobanks to study their opinions towards an obligation to return research results to participants and related issues such as ownership of blood samples, privacy, therapeutic relation, costs and implications for participants. …”

Scientists’ perspectives on consent in the context of biobanking research

“…[9][10][11][12][13] The ethical and legal appropriateness of different consent models is one of the most divisive topics with the absence of a consensus among academic scholars, 6 research policies, 14 and public opinion data. 15 While the bulk of research studies focus on capturing the perceptions of the general public and patients on research ethics issues related to biobanking, [16][17][18] only a few have focused on understanding the views of scientists who may manage biobanks [19][20][21][22][23][24][25] and even fewer concentrate on scientists' perceptions of informed consent. 26,27 It is important to capture the opinions of scientists as they run biobanks and are the end users of biorepository samples and information and thus have first-hand knowledge on biobank functions.…”