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Ethics in Clinical Research

In reading clinical research, one thing a practitioner may not think to consider is the human subject ethics of the project they are reviewing. Yet this is an important part of the research, and it is supposed to be reported. What you would look for would be a statement that the participants in the research gave their informed consent, and that the project was approved by an institutional review board (IRB, or a different name in other countries).

In the United States, human subject research is regulated under 45CFR46, which is also known as the Common Rule. This lays out how humans may be used as research participants and it lays out the requirement for research review by an IRB. The IRB must have at least 5 members, one of whom is a public member and one without scientific expertise. The IRB looks at the risks and rewards of a given project and only approves that research if in their opinion the benefits outweigh the risks. The actual function of an IRB is covered under a different set of federal regulations, 21CFR56. Basic requirements are that risks are minimized and are reasonable, selection of subjects in equitable, informed consent will be sought, safety is monitored, privacy is protected and vulnerable populations are protected (such as children, prisoners, pregnant women, etc.).

Informed consent is spelled out as well. A consent form must have the following elements: (1) A statement that the study involves research, (2) benefits, (3) reasonable risks, (4) disclosure of alternate procedures, (5) a statement related to confidentiality of records, (6) contact information for questions, (7) a statement that participation is voluntary and can be withdrawn without penalty, (8) A statement related to whether compensation is available; other elements can be required under certain circumstances.

For the reader, you would need to look only to see that somewhere in the methods section of the paper, the author states that their project was approved by an IRB and that participants freely gave their consent. If this is not stated, it does not mean it was not done, but reporting requirements for clinical research do suggest this be made overt and explicit.

 

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