Once the pool of potential participants for a research study is identified, the investigator must decide how to approach those individuals to see if they are interested in participating in the study.
Recruitment procedures must demonstrate “respect” for potential participants, the first principle of the Belmont Report. Recruitment procedures must ensure voluntary participation in research and must also protect potential participants’ privacy and confidentiality. Participants should not feel coerced into participating in research, nor must they fear the loss of some benefit to which they are otherwise entitled if they choose not to participate.
In deciding how to approach potential research participants, investigators should also consider the additional risks associated with individuals who may be vulnerable to coercion or undue influence, such as children, prisoners or adults with impaired decision-making capacity. A person in authority, such as a teacher recruiting students or a physician recruiting patients, should take special precautions to ensure that an individual’s decision to participate in research is not based on subtle pressures such as grades, monetary reward, or fear of loss of benefits, such as medical treatment. The UW-Madison IRBs have developed specific guidelines on the recruitment of relatives, employees and students. See, IRB Review of Participant Recruitment, below.
Recruitment materials, including print, audio and video materials, must accurately present the purposes of the research and the research procedures involved and should contain no coercive language or coercive incentives for participation. For example, if the study involves comparing an investigational drug to a placebo, the advertisement should not mention the study drug only. Rather, it should indicate that some subjects in the study will receive a placebo, or describe the purpose of the study as comparing the investigational drug to a placebo.
Payments or incentives for participation in research should not be offered as a means of coercive persuasion, but instead as recognition of the participant’s investment of time, loss of wages, or other inconvenience incurred as a result of participation.
Investigators should describe in their initial review applications the recruitment methods and materials they plan to use. Samples of all advertisements, such as brochures, flyers, newspaper ads, radio and television announcements, audio tapes, video tapes, URLs, bulletin board tear-offs, posters and letters to potential participants, along with an explanation of other methods of recruiting subjects, must be submitted to the IRB.
If the recruitment materials are not ready at the time of the initial application, investigators may submit the material as an amendment to an already approved project. Requests for approval of recruitment materials following initial IRB review of the protocol should allow sufficient time for any necessary revisions prior to publication. Advertisements, press releases, etc., may qualify for expedited review.
Investigators proposing to recruit their students, employees or patients or other participants who may be vulnerable to coercion or undue influence in the recruitment process should justify in the protocol the necessity for the inclusion of these participants and describe the precautions that will be used to prevent coercion in the recruitment of these individuals.
Investigators must disclose to the IRB any payments or other incentives that will be offered to participants as well as any payments or incentives offered to investigators or research staff by the research sponsor.
The IRBs will consider the following when reviewing recruitment methods and materials:
The IRB will also review a recruiting plan to make sure that it complies with HIPAA (Health Insurance Portability and Accountability Act), FERPA (Family Educational Rights and Privacy Act) and institutional requirements.
In addition, plans to recruit certain populations, such as students and employees, receive added scrutiny by the IRB to assure that these individuals’ decisions to participate in a study are truly voluntary. In most cases, UW-Madison IRBs do not allow direct recruitment of participants by someone in a status relationship with those individuals (e.g., supervisor/employee, faculty member/student). The investigator may contact the IRB for strategies for indirect recruitment.
See, Recruitment of Participants with Status Relationships (Relatives, Employees and Students) Guidance posted on the UW-Madison Step by Step Instructions for Protocol Submission webpage: http://www.grad.wisc.edu/research/hrpp/submissioninstructions.html.
Recruitment materials inform potential participants of a research activity and provide them with an opportunity to contact the researcher. Any material aimed at recruiting participants into a study (including audio or video tapes) must be reviewed and approved by the IRB prior to being used. Approved copies of recruitment materials are maintained in the IRB’s files.
Advertising for research subjects is not, in and of itself, an objectionable practice. When advertising is to be used, however, the IRBs will review the information contained in the advertisement, as well as the mode of its communication, to determine whether the procedure for recruiting subjects affords adequate protection. IRB review is necessary to ensure that the information is not misleading to subjects, especially when a study will involve vulnerable participants.
Recruitment materials that the IRBs generally review, among others, include:
The IRBs generally do not review:
Content of Advertisements
The IRBs will consider the following factors when reviewing a recruitment advertisement:
Advertisements should not pressure readers into participating. Advertisements should include the word "research." Investigators should avoid phrases such as "help needed" or "subjects wanted." The recommended wording is "you are invited" or "participants invited." Extravagant attention-getting devices such as extremely large, bold typefaces and dollar signs may be prohibited.
Placement of Advertisement
For each advertisement, the IRB will also want to know:
FDA has issued guidance on IRB review of recruitment materials. See, FDA Information Sheets, Recruiting Study Subjects (1998 Update).
Financial incentives for participation in research may be allowed in low risk, non-therapeutic studies as long as the amount in not coercive. However, financial incentives are not allowed for participation in therapeutic research studies, although IRBs allow reimbursement to participants in all research studies for research related expenses such as the cost of transportation and parking and loss of wages. Compensation should not be excessive relative to the nature of the project.
If participants will be paid for their time/effort, it is recommended that the wording "Compensation Available" be used in recruitment materials, rather than specifying a specific amount. Statements of payment should not be in larger type than the rest of the ad.
The UW Madison IRBs recommend that compensation not be withheld contingent on the participant's completion of the study. In most cases involving continued participation, compensation should be given on a reasonable prorated basis to avoid the impression that the investigator is coercing the participant to continue in a study or is punishing the participant for non-compliance.
Information regarding how to process payments to research participants is posted on UW-Madison’s Step by Step Instructions for Protocol Submission webpage, see Step 7: http://www.grad.wisc.edu/research/hrpp/submissioninstructions.html
UW-Madison policy prohibits payments from the University or a research sponsor to an investigator if such payments are conditioned upon a particular research result or are linked to successful research outcomes.
Payments for participant enrollment or for the referral of patients to clinical studies are only permitted when such payments: