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Guidance & FAQs

Recruitment & Subject Contact

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.

Bonus payments and incentives for research related activities

Bonuses to University of Minnesota personnel for recruitment are NOT permitted based on University of Minnesota Regents Policy.

See Gifts Received and Given by Regents and University Officials and the Code of Conduct.

Suggested Methods for Subject Contact

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.

How to explain intrusive methods to the IRB

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.

More Information

IRB Advertising Guidelines

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.

Click here for more details on IRB Advertising Guidelines

What requires review and approval

The IRB review policy includes, but is not limited to:

  • Newspaper ads,
  • Radio or television announcements
  • bulletin board tear-offs
  • posters
  • health fair materials about the study
  • computer bulletin boards or internet advertising
  • 800 number ads
  • disease databases (PDQ) - if the researcher has any control over the content
  • talk show appearance media kits
  • press releases designed to promote a study and encourage participation
What doesn't require review
  • Ads in professional journals targeted at referring physicians
  • Flyers to referring agencies that are not to be seen by patients
IRB Advertisement Review Considerations
  1. It can not be misleading. It can not make promises of safety or efficacy; benefits or financial rewards must be reasonably stated. (Outsized fonts emphasizing money are discouraged.)
  2. No claims should be made, explicitly or implicitly that the research is superior to any current practice.
  3. It must be quite clear that it is for research or for an investigation.
  4. It should give the name of a primary contact and a method of making contact.
  5. It may give some brief eligibility criteria such as disease, condition, or age limits.
  6. It may give brief procedural information such as the location of the research, duration of participation, mode of administration and name of the test article.

The IRB will also consider placement of any advertising. For each advertisement, the IRB wishes to know:

  1. the name or type of the media (e.g., the San Francisco Times)
  2. The targeted audience of the selected media.
  3. Whether the medium selected is primarily designed to target a specific group. (e.g., specific ethnic or cultural group, gays, adolescents, etc.)

Advertising Resources

FDA Advertising Guidance