The Handling of Minimal Risk Research by Ethics Review Boards

by Ben Lockhart

All Human research in the academia must be approved by an Ethics Review Board before data collection can begin. In Canada Ethics review boards are called Research Ethics Boards and follow the Guidelines of the Tri- Council Policy Statement. In the United States, Ethics Review Boards are called Institutional Review Boards and follow the guidelines as put out by the Belmont Report. Minimal risk research is defined in Canada as, “that where potential subjects can reasonably be expected to regard the probability and magnitude of possible harms implied by participation in the research to be no greater than those encountered by the subject in those aspects of his or her everyday life that relate to the research” it is at this time that the research can be regarded as within the range of minimal risk.” (TCPS,2009). While in the United States the code of federal regulations defines Minimal Risk Research as the probability and magnitude of harm or discomfort anticipated in the research not being greater in and of themselves that ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests (Code of Federal Regulations, 2009). The requiring of review of minimal risk research has brought about a fair bit of controversy (Ceci &Bruck, (2009). The purpose of this study was to determine what the attitudes of researchers were toward Ethics Review Boards and the effect of Ethics Review Boards on Minimal risk Research. Participants were researchers at universities in the States of Alaska, Alabama, Arkansas and California engaged in minimal risk research. 1, 5oo invitations were sent out of which only 114 responded.

In your view, is it acceptable to go ahead with a minimal risk research project without getting Ethics Review Board approval? The mean disagreement value for this statement was 5.72. The statement “How prevalent do you think conducting minimal risk research without Ethics Review Board approval is?” had a agreement value of 3.42. The findings support that some research is being conducted without approval, for it this was not happening then the mean should be closer to 7. Ninety eight percent of respondents reported that their Ethics Review Board required review of minimal risk research. Thirty-seven percent felt that their productivity had been limited by their Ethics Review Board, while fifteen percent reported that they had chosen not to carry out studies due to revisions required by the Ethics Review Board. It was reported that delays by an Ethics Review Board had caused eighteen percent of respondents to miss important deadlines and twelve-percent reported having a protocol approved by one board but denied by another. In respect to limiting productivity thirty-one percent of respondents reported that Ethics Review Boards had limited their productivity. Negative experiences with an Ethics Review Board were congruent with their attitudes toward Ethics Review Boards. Researchers who had reported that Ethics Review Boards limited their productivity were less satisfied with the ethical oversight of minimal risk research. Also researchers who reported that their productivity had been limited by their Ethical Review Boards showed stronger agreement for going ahead with a minimal risk research project without getting approval. Researchers that reported having chosen not to carry out a research project showed more acceptance for going ahead with a research project without getting Ethics Review Board approval. Researchers who have missed important project deadlines due to Ethics Review Boards reported that the current process of oversight results in reduced productivity. All tests were independent samples t-tests. The level of significance used was .01. In respect to the tables only the questions that are significant were used. Because 9 t-tests were used the family wise error rate was beyond alpha, specifically was .08. It was calculated using this formula 1(1-.01) to the power of 9.

The limitations of this study are that it only looked at four states. It is also limited due to the response rate of 10 percent.Future research should attempt to get all provinces of Canada and all states off the United States to get a better understanding of researcher’s attitudes. In respect to Universities requiring research that has already been approved by Ethics Review Board be approved by their own board. Future investigations could focus on this practice. Future research could investigate the phenomenon of going solo.