Genetics researchers’ and IRB professionals’ attitudes toward genetic research review: a comparative analysis

Abstract

Purpose Genetic research involving human participants can pose challenging questions related to ethical and regulatory standards for research oversight. However, few empirical studies describe how genetic researchers and institutional review board (IRB) professionals conceptualize ethical issues in genetic research or where common ground might exist. Methods Parallel online surveys collected information from human genetic researchers (n = 351) and IRB professionals (n = 208) regarding their views about human participant oversight for genetic protocols. Results A range of opinions were observed within groups on most issues. In both groups, a minority thought it likely that people would be harmed by participation in genetic research or identified from coded genetic data. A majority of both groups agreed that reconsent should be required for four of the six scenarios presented. Statistically significant differences were observed between groups on some issues, with more genetic researcher respondents trusting the confidentiality of coded data, fewer expecting harms from reidentification, and fewer considering reconsent necessary in certain scenarios. Conclusions The range of views observed within and between IRB and genetic researcher groups highlights the complexity and unsettled nature of many ethical issues in genome research. Our findings also identify areas where researcher and IRB views diverge and areas of common ground.

Controversies among Cancer Registry Participants, Genomic Researchers, and Institutional Review Boards about Returning Participants’ Genomic Results

“…The purpose of the survey was to document the range and frequency of occurrence of concerns and expectations regarding participating in human research studies, including genomic studies, and to compare these findings to our previous surveys of IRB professionals and genetic researchers from the GRRIP study that was conducted in 2009 [5,6,8]. Detailed methods for this study, including the survey instrument, have been published previously [14].…”

“…Details on the GRRIP study and the development of the surveys have been described previously [5,6,9]. Briefly, parallel online surveys were used to anonymously collect information from human genetic researchers (n = 351) and IRB professionals (n = 208) regarding their views about human participant oversight of genetic protocols, and participants were allowed to skip questions they did not wish to answer.…”

“…Our initial work measured the opinions and practices of human genetic researchers and IRB leaders regarding ROR, reconsent, data sharing, identifiability, and potential for harm [5] in the context of genomic research. The Genetics Research Review Issues Project (GRRIP), which queried both IRB professionals and genetic researchers using qualitative and quantitative methods, discovered that these groups did not agree with each other on many of these issues, including ROR, likelihood of identification from coded genomic data, and potential for harm if identified [5].…”

“…The Genetics Research Review Issues Project (GRRIP), which queried both IRB professionals and genetic researchers using qualitative and quantitative methods, discovered that these groups did not agree with each other on many of these issues, including ROR, likelihood of identification from coded genomic data, and potential for harm if identified [5]. There was also a lack of consensus within the groups on a number of issues, including several scenarios around ROR [5][6][7][8][9].…”

“…The Genetics Research Review Issues Project (GRRIP), which queried both IRB professionals and genetic researchers using qualitative and quantitative methods, discovered that these groups did not agree with each other on many of these issues, including ROR, likelihood of identification from coded genomic data, and potential for harm if identified [5]. There was also a lack of consensus within the groups on a number of issues, including several scenarios around ROR [5][6][7][8][9]. These findings are consistent with previous results, including studies showing that although most researchers would return a clinically significant result, there was no consensus as to what constituted an appropriate threshold [10][11][12].…”