Appendix H2 Guidelines for Critically Appraising the Ethical Aspects of a Study
- Was the study approved and monitored by an Institutional Review Board, Research Ethics Board, or other similar ethics review committee?
- Were study participants subjected to any physical harm, discomfort, or psychological distress? Did the researchers take appropriate steps to remove or prevent harm?
- Did the benefits to participants outweigh any potential risks or actual discomfort they experienced? Did the benefits to society outweigh the costs to participants?
- Was any type of coercion or undue influence used to recruit participants? Did they have the right to refuse to participate or to withdraw without penalty?
- Were participants deceived in any way? Were they fully aware of participating in a study, and did they understand the purpose and nature of the research?
- Were appropriate informed consent procedures used with participants? If not, was there a justifiable rationale?
- Were adequate steps taken to safeguard participants’ privacy? How was confidentiality maintained? Was a Certificate of Confidentiality obtained—and, if not, should one have been obtained?
- Were vulnerable groups involved in the research? If yes, were special precautions instituted because of their vulnerable status?
- Were groups omitted from the inquiry without a justifiable rationale, such as women (or men), or minorities?
