302. Recruitment Materials and Combined Recruitment/Consent Materials
Updated Oct. 4, 2019
The purpose of recruitment materials is to let members of the sample population know a research study is available, to invite them to consider participation, and to give them enough information to decide if they may be interested in participating in the research or wish to obtain additional information about the research.
Minimum Recommended Content for Recruitment Materials
Recruitment materials should be written in lay language, limited to the information needed by prospective subjects to determine their eligibility and interest, and free from coercive or influential statement. Coercion or influence may arise indirectly through promises of beneficial outcomes or use of disproportionate incentives.
Recruitment materials must be consistent with the information in the IRB or exempt application.
Recruitment materials, including verbiage and graphics, must conform to commonly accepted standards of “good taste,” by using graphics and verbiage that the general public would find non-offensive.
Recruitment materials must include the following information:
- Name and contact information for the researcher who is conducting the research;
- Name of the institution or facility conducting the research;
- A clear statement that a proposed activity is research;
- Statement of the purpose of the research or condition under study (i.e., why the activity is being done);
- A summary of the eligibility criteria;
- A brief list of benefits to subjects (if any);
- The time and other commitments required of participants;
- Where the research activity will take place;
- Person or office to contact to obtain more information about or to sign up for the study.
Additional Required Content for Combination Recruitment/Consent Materials
For minimal risk research with no or limited contact between recruits and the researchers (e.g., online, telephone, or mail surveys), the recruitment document might serve to both invite and inform recipients about the research (i.e., be used as a combination recruitment and consent document).
When recruitment materials will serve the dual purpose of inviting and informing participants, additional information may be warranted ( as applicable to the proposed research):
- Description of any reasonably foreseeable risks or discomforts to participants;
- Description of the extent, if any, to which confidentiality of records identifying the subject will be maintained; and
- Specification that participation is voluntary, and that neither refusal to participate nor discontinuing participation (regardless of when the participant chooses to withdraw) will invoke any penalty or loss of benefits to which the participant is otherwise entitled;
- Name and contact information for a person to call for questions about the research; and
- Name and contact information for a person or entity unassociated with the research for individuals to make a complaint or report a problem about the research.
Recruitment materials may not
- State or imply a certain favorable outcome or other benefits beyond those outlined in the IRB application and consent materials;
- Include exculpatory language (see IRB policy definitions).
- Emphasize payment or incentives for participation;
- Promise “free treatment,” “free testing (or medications),” “free counseling” when the reality is that subjects will not be charged for taking part in the study;
- Use terms such as “new treatment,” “new medication,” or “new drug” without clarifying that the “new” treatment, program, or test article is investigational;
- Make claims or imply that the experimental drug, device, intervention, or program is safe or effective for the purposes under investigation;
- Make claims or imply that the experimental drug, device, intervention, or program is comparable or superior to any other drug, device, intervention, or program;
- Make claims, either explicitly or implicitly, about the drug, biologic, or device under investigation that are inconsistent with FDA labeling;
- Include misleading or inaccurate information; or
- Allow compensation for participation in a trial offered by a sponsor to include a coupon good for a discount on the purchase price of the product once it has been approved for marketing.
Submitting Recruitment Materials for IRB Review
- Recruitment materials must be included among the documents submitted for IRB review.
- Print advertisements such as letters, handouts, flyers and web pages must be in final format.
- Advertisements using media other than print, such as radio or television, may be submitted as scripts, scripts with representative proposed graphics, or story boards must be in final format.
Modifications to Recruitment Materials
For exempt research, including research that is exempt under the University’s IRB Flexibility Policy (i.e., Flex-Exempt), minor changes or additions to recruitment materials do not require prior IRB approval
For all non-exempt research, modifications to recruitment materials must submitted as protocol amendments for prior IRB review and approval before use.
IRB Review and Approval of Recruitment Materials
The IRB reviews recruitment materials with consideration for the sample population, recruitment settings, study methods and procedures; and to determine the following:
- Content (prose and graphics) is appropriate for the sample population.
- Content is consistent with the information in the IRB application and consent documents.
- Materials contain the applicable, recommended content.
- Materials do not contain unacceptable content.
- Materials are free from bias, and do not coerce or unduly influence potential participants.
- Materials do not overly emphasize incentives or compensation.
- Materials appropriately reference extra or course credit, and alternatives when applicable.
- Materials conform to accepted standards of “good taste.”
For some research studies, to ensure that the recruitment materials accurately represent the research study, the IRB may assess whether or not inconveniences and discomforts of participation, such as time commitment and restrictions on diet or other activities, should be mentioned in the recruitment materials.
IRB approval notices confirm approval of recruitment materials.