The following methods of recruiting subjects have been used in studies being conducted at the University of Colorado Denver and its affiliated institutions. Depending on circumstances, any of these methods may be in compliance with both the federal Common Rule (45 CFR 46) and the federal HIPAA Privacy Rule (45 CFR 164), but there also may be ethical and practical problems with any of the methods. The methods of recruitment must be outlined in the COMIRB application, and all materials distributed to potential research participants must also be approved by the COMIRB prior to us
- Investigators maintain a separate database that asks research participants if they will agree ahead of time to be contacted for research in the future. Investigators contact patients about particular studies in accord with their signed consent.
Study investigators enter recruitment information on the School of Medicine list of University of Colorado Denver Clinical Trials web page or a similarly managed website. Subjects then contact the study investigators.
- Advertisements, notices, and/or media are used to recruit subjects. The COMIRB must first approve the text of these. Subjects who respond to these will contact the study investigators. Note: No HIPAA-regulated Protected Health Information is used in this recruitment strategy.
- Study investigators provide their colleagues with a "Dear Patient" letter describing the study. This letter can be signed by the study investigators and would inform the patients how to contact them.
Study investigators send a COMIRB-approved letter to colleagues asking for referrals of eligible patients interested in the study. The study investigators may provide the referring physicians a COMIRB-approved information sheet about the study to give to the patients. If interested, the patient will contact the PI.
Study investigators who are also clinicians providing direct care recruit their own patients directly. Nurses or staff working with the investigators also may approach the patients. This respects privacy but also raises ethical concerns because of the difficulty of saying no and the therapeutic misconception .
Study investigators recruit potential participants who are unknown to them. Examples include snowball sampling, use of social networks, direct approach to unknown people in public situations.
- Study investigators request a Waiver of Consent/Authorization for recruitment purposes. In all cases, the waiver must be justified in the "Waiver of Consent/Authorization for Recruitment Purposes" section of the COMIRB application. Waivers are granted in three primary situations:
In minimal risk studies in which subjects will be not be contacted (e.g., many chart review studies) researchers request a complete waiver of consent/authorization. The application must explain why the study cannot be done without the waiver.
- If the study requires researchers to review charts to identify prospective subjects who will then be contacted and asked to be in the study, the justification for the waiver to review charts must show why the study cannot be done without the waiver. The waiver covers collecting only the minimum amount of information needed to make contact; consent is obtained before additional information is gathered. The CHR’s usual policy is that patients identified through chart review should be approached by someone already involved in their care. "Already involved in their care" includes health care professionals directly involved in their care as well as administrative and research staff working with the health care professionals.
- In some circumstances it may be necessary for members of the research team who are not involved in the patient’s care to make the approach, either in person or by phone or letter. The application should explain why the study cannot be done unless the researchers approach subjects directly. Direct approach by someone not involved in the patient’s care is an exception to the usual policy but may be approved in exceptional circumstances such as emergency care research.
Who may Recruit
Individuals initiating contact (in person or by phone) with potential subjects must have basic knowledge about the study (so they can answer questions) and training in the voluntary nature of research participation. They also should be prepared to provide prospective subjects with
- a researcher’s name and phone number (for questions about the study) and
- the phone number of the COMIRB (for questions about a research subject’s rights).
For purposes of recruitment, people are considered "involved in the patient’s care" (and therefore eligible to review HIPAA-protected information without an authorization or waiver) if they are:
- health care professionals actually involved in the care or
- research staff working with the professionals involved in the care.