A study has an observation component in a Twelve Step Program. For the purposes of this case study, you can presume that the activity meets the definitions of “research” and “human subjects.” What kind of safeguards should the investigator put into place to ensure the ethical conduct of this kind of observation?
– Director of research integrity at a university


One approach would be to do “community consultation” with members of the 12 Step group in advance of the actual observation and to share with them the research plan and to get their input about what kinds of safeguards they would want to put into place to feel comfortable participating in the research.  The researcher could speak to the safeguards that will be put into place to maintain the privacy of the subjects and the confidentiality of the data collected.  Safeguards could include recording the information about the participants in such a way that they cannot be linked to the data collected. An IRB could also waive of the requirement for subjects to sign the consent form that would link subjects to participation the study.

In the spirit of getting buy-in ahead of time, the researcher could reach out to the 12 Step group and ask the group for ideas about what to do if some attendees do not choose to participate.  For example, would group members be willing to attend a different meeting or could the attendees break out into groups for that particular session.  From my experience working, the community consultation allows the prospective subjects to weigh in on what is important to them, informed the IRB review process and may have helped with recruitment process.  A process that engages the group of perspective participants before the research begins may in the end save time and is consistent with the ethical principle of respect for persons.


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