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When contacting potential research subjects to solicit their participation in a project, one must consider the risks and ethical aspects of the contact, as well as those of the research for which subjects are sought.
The most common risks of contacting a potential subject are related to intrusiveness and violations of privacy; when the potential subject reached is a vulnerable individual (child, woman, or prisoner), additional risks may be present. When the selection of an individual to contact involves privileged records or sensitive information, there may also be a risk of breach in confidentiality.
Bonuses to University of Minnesota personnel for recruitment are NOT permitted based on University of Minnesota Regents Policy.
Non-intrusive techniques such as a letter involve the least amount of risk to the subject.
Before any potentially intrusive contact is made, a positive response (such as a return call or postcard) is required
If sensitive information or private records are involved – the initial contact is made by someone with legitimate access to the information (and, in the case of medical patients, to said patients).
When a research subject is asked to identify additional potential subjects (e.g. relatives or people sharing a socioeconomic or behavioral feature, sometimes referred to as "snowball" technique). It is recommended that the current research subject deliver the invitation materials to the prospective participant and have that individual then contact the investigator to initiate the screening, information and consent dialogue.
There may be circumstances in which the "cleanest" approach is for some reason impracticable, and in which the risk of intrusiveness may be low. In such circumstances, a researcher may propose a contact technique that minimizes the risk and that gives a genuine opportunity to avoid it, but that does not depend on a positive response from the candidate before proceeding.
Researchers planning to solicit research participants by contacting people in their homes must assess and minimize these risks for the specific study and the specific recruitment technique planned.
The investigator must specifically explain why such an approach is necessary, and how the least intrusive/risky method consistent with successful research has been identified and chosen (noting that "impracticable" is a much higher standard than is "inconvenient"). This information is asked for in the IRB application forms.
The IRB will then decide if the merit of the research, the potential benefit to subjects, the risks of the study per se and the risks of the contact are in such balance as to allow approval of the research.
Research proposals employing intrusive means of contacting potential subjects without their prior consent may be deferred by the IRB or returned by administrative staff if they do not include a specific explanation of the perceived need for such methods.
Adapted from work by Dale Hammerschmidt M.D.
The IRB defines advertising as "any outreach effort designed to encourage potential subjects to contact the investigator's site requesting information."
It views advertisements as an extension of the consent process and subject selection process. Therefore, the IRB must review all means of recruiting subjects to participate in a research study, including advertisements prior to publication.
The IRB review policy includes, but is not limited to:
The IRB will also consider placement of any advertising. For each advertisement, the IRB wishes to know: