IRB prior approval is required for all matters that are relevant to the recruitment and retention of research participants. This includes the methods and materials of recruitment, and the amounts, schedules and details of all recruitment-related payment arrangements including incentives, compensation or other inducements paid or provided to participants, investigators, organizations or to those referring research participants. After study approval, no changes may be made to recruitment methods, materials or payment arrangements unless these changes are approved by the IRB through the amendment process.
Such recruitment-related information must be fully disclosed by investigators in applications to the IRB and shall be reviewed by the IRB pursuant to policies for study or amendment approval. Applications must describe the methods by which potential subjects will be identified, contacted and recruited. Copies of all advertising or other recruitment materials or tools (with a description of how they will be used) must be submitted for IRB review and approval.
This requirement for IRB approval extends to the mode of recruitment communications and to advertisements or other recruitment materials that include (but are not limited to) tapes or other broadcast media for television, radio or internet (website) postings, advertisements, flyers, posters, brochures, newspaper advertisements, e-mail solicitations , telephone scripts, correspondence to subjects or other cooperating individuals such as referring physicians or facilities, and press releases intended to facilitate recruitment of subjects. This also includes any sponsor-provided advertisements. These materials should be submitted in their final form by the Principal Investigator to the HSRO for IRB approval with the initial application for the study; and any subsequent changes to approved materials, or any new materials, must be approved by the IRB before these changes or additions are implemented.
Internet (website) or other postings providing basic information about studies but without the intent to recruit, or without information about recruitment do not require IRB approval. Investigators may submit such materials to the IRB for its determination as to whether IRB approval is required
Unless the IRB approves otherwise (such as for materials provided within multi-site trials), only documents or other advertising or recruitment materials bearing the HSRO approval stamp may be used in the conduct of research. Recruitment materials that cannot show the HSRO approval stamp, such as e-mail solicitations, internet websites and broadcasted material must mention that the study has been approved by the UM IRB unless the IRB approves otherwise (such as for websites managed by external sites). Advertisements approved by the IRB must subsequently be submitted to the UM Public Relations Office for their endorsement as to form, content, and publication method.
The requirement for IRB approval extends also to recruitment methods including screening procedures. Such methods may include (but are not limited to):
- Maintaining a separate IRB-approved recruitment protocol: this is done to develop a database of potential participants (preparatory to research) who may be contacted by investigators about participation in IRB-approved studies in accord with their signed consent. In this method, IRB approval is required for participants/patients to provide consent to subsequently be contacted for future research studies.
- Direct recruitment of participants unknown to investigators: Examples include random digit dialing, approaching people in public settings, snowball sampling and the use of social networks.
- Utilizing clinical trial or other websites to post research study information.
- Providing colleagues with an IRB-approved Introduction letter and/or a letter to be distributed to individuals/patients describing the study and contact information and asking them to briefly inform potential participants about the study. NOTE – Potential participants may initiate contact and/or sign an authorization to use or disclose (release) identifying health information. Otherwise, study investigators may not have access to participant/patient information. (This authorization must be placed in the patient’s medical record indicating permission from the patient to be contacted for the study).
Note: For such recruitment, a partial waiver of HIPAA authorization must be requested from the IRB. This authorization does not constitute the required informed consent
- Approaching the investigator’s own patients, students, employees. IRB review of this method must be conducted with awareness that there may be ethical concerns if individuals have (or are perceived to have) difficulty saying no to an authority figure. Section 23.7 of these policies defines these individuals as potentially vulnerable and, where appropriate, provides special protections against undue influence or coercion. Medical record review is subject to HIPAA regulations. Additional regulations regarding student records are defined in the Family Educational and Rights Privacy Act (FERPA).
- Requesting a Waiver of Consent/HIPAA Authorization, if applicable for recruitment purposes. Waivers may be granted one or more of the following circumstances applies:
- The study is of minimal risk and subjects will be not be contacted. In many chart review studies, for example, investigators may request and justify a complete waiver of consent/HIPAA authorization
- A chart review is required to identify prospective subjects who will then be contacted and asked to participate in the study. In this case, investigators may request a partial HIPAA waiver with explanation why the study cannot be done without the waiver. With this partial waiver, only the minimum information needed to make contact may be collected and informed consent/HIPAA authorization must be obtained from participants before additional information is accessed.
- Identifying potential participants through registries, medical records in multiple institutions or other sources. This method, often used in large-scale epidemiological or other population-based studies, is of concern since investigators may gather health information before directly contacting potential participants. Applications for IRB approval must justify in detail why the study requires that the IRB grant a partial waiver of HIPAA authorization to obtain subjects' identities and why the IRB should allow investigators to contact subjects directly to gather the required written informed consent and HIPAA authorization and then to proceed with information gathering and/or the research protocol.