Ethics review of public health studies

Without any need to go historically back to the Nazi human experimentation or the Tuskegee Syphilis Study or so to justify the need for research ethics, now it is a standard practice that all public health (and other) studies involving humans or human biological materials shall be conducted as per accepted ethical principles. To ensure the ethical soundness of such studies, it is a requirement that study protocols undergo a rigorous ethics review by research ethics committees (RECs) or institutional review boards (IRBs).

 But what part of the research protocols shall undergo review by RECs or IRBs? Some researchers are not happy when RECs or IRBs review parts of the protocol other than the ethics statement section. Shall RECs or IRBs review only the ethics statement of public health research protocols?

RECs or IRBs shall review a protocol in its entirety, not just the ethics statement section. Anything from research problem identification to the design of the study methodology and to the data analysis, interpretation and reporting of findings could raise ethical issues. It is, therefore, crucial that public health research protocols be reviewed in their entirety (from title to annexes). Generally, review of a public health research protocol shall address the following: 1) scientific review, 2) conflict of interest review and 3) ethics review.

The three types of reviews are briefly discussed below.

 Scientific review. Scientific review is required to ensure the scientific soundness of the proposed study. This includes reviewing whether the study has a clear research question and objectives, whether it is going to generate new knowledge, whether the methodology is appropriate and so on.  A study that is not scientifically sound cannot be ethical. For example, a study that is not likely to come up with new knowledge, and that is likely to “reinvent the wheel”, unnecessarily bothers study participants and unnecessarily wastes meager resources and is hence unethical.

 Conflict of interest review. This is required to ensure that parties that are directly or indirectly involved in the research do not have a vested interest that influences the researchers. Such influences may included, for example, influence of a funding agency on how the research is to be conducted, whether results should be published, where and when to publish the findings and cherry-picking of findings for publication. A review of review articles on the health effects of passive smoking published between 1980 and 1995 by Barnes and Bero^[1] has found out that review articles published by tobacco industry-affiliated authors had about 88 times higher odds of concluding that passive smoking has no health effect compared to authors who are non tobacco-industry affiliated, which shows the influence of funding agencies on authors. Hence, conducting public health studies which have a conflict of interest is unethical and hence RECs or IRBs shall ensure that proposed studies are free from such conflicts of interest.

Ethics review. This is required to ensure that the proposed study be conducted in accordance with the three basic principles, viz. respect for persons, beneficence and justice.^[2]  A study that violates any of these basic principles is unethical.

To conclude, ethics review of public health research protocols shall not be restricted only to the ethics statement section of the protocols. It should rather review the protocols in their entirety and make sure that planned studies are scientifically sound, free from conflict of interest and comply with the basic ethical principles of studies involving humans or human biological materials. 

  

Reference

1.      Barnes DE, Bero LA. Why Review Articles on the Health Effects of Passive Smoking Reach Different Conclusions. JAMA. 1998;279(19):1566-70.

2.      Council for International Organizations of Medical Sciences (CIOMS). International Ethical Guidelines for Biomedical Research Involving Human Subjects. Geneva; 2002.