If a subject's involvement in a research study could potentially harm them and the consent form is their only link to the research, which approach is most effective?

In circumstances where a subject's involvement in research might pose potential harm, and the consent form serves as their only link to the study, obtaining a waiver of documentation of informed consent can be an effective approach. This waiver allows researchers to forgo the traditional requirement of collecting written consent under specific conditions, typically when the research presents minimal risk to subjects or when the research could not practicably be carried out without the waiver.

This approach is beneficial because it protects the identity of participants and minimizes the risks associated with linking their personal information to their participation in the study. By not requiring a signed consent form, researchers can safeguard the subjects against potential harm that might arise if the consent form were to be misplaced or accessed by unauthorized individuals.

In this context, using other methods, such as coding responses or obtaining a Certificate of Confidentiality, may also provide layers of protection; however, they do not directly address the concern related to the consent form being the only link to the research. Signing the consent form under an assumed name may complicate the informed consent process and does not fully mitigate the risks involved. Thus, obtaining a waiver of documentation of informed consent offers a streamlined and effective means to ensure the protection of participants while still facilitating essential research activities.