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THE COMMITTEE ON HUMAN RESEARCH

USCF SUBJECT RECRUITMENT GUIDELINES - (June 2003, Revised March 2008)

•  Ethical Concerns
•  Principles
•  Acceptable Methods
•  Who May Recruit
•  Documents Needing Review
•  Special Cases:
   •Keeping Information About Refusers
   •Sponsor’s Role
   •Recruiting Students and Staff
   •Recruitment in Classrooms
   •Telephone Scripts
   •Incentives and Referral Fees
   •Videos

Ethical Concerns

The researcher and the CHR must consider the following ethical questions when evaluating a recruitment strategy:

• Respect for privacy: Does the recruitment strategy respect an individual’s reasonable expectations for privacy? Will patients be upset when they learn researchers not involved in their care have read their medical records without permission?
• Lack of pressure: Is the study introduced in a way that allows subjects ample time to consider, with no undue pressure because of timing of the request, who makes the request, how the request is made, or the offering of excessive inducements? Will patients be put in a situation where they may hesitate to say “no” to their own physician? How will pressure be minimized?
• Unbiased presentation: Is all information accurate, balanced, and free of misleading emphases that make the study excessively attractive? Is the information as complete as is appropriate for each stage of recruitment?
• The “Therapeutic Misconception:” Patients tend to believe a clinical trial—or anything proposed by health care providers—will benefit them, even if they’re told there is no assured benefit. Does the recruitment strategy work to counteract this misconception?
• Conflicting concerns:
  • Subjects may prefer that someone involved in their care contact them about research, but they may find it hard to say “no” to a care provider.
  • Clinicians may find their clinical judgment in conflict with a desire to enroll patients in their research.
    

Principles

• Use of medical records: Access to medical records and identifiable health information by people not directly involved in a patient’s care should be avoided.
• Use of Protected Health Information: The amount of identifiable information gathered and the number of people who have access to identifiable information must be minimized.
• Contact: Prospective research subjects should be contacted by people directly involved in their care, not by unknown researchers.
• Exceptions: Exceptions to these principles may be granted where necessary. The CHR application must explain why exceptions are necessary; approval is not automatic.

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Acceptable Methods

The following methods of recruiting subjects have been used in studies being conducted at UCSF 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 method of recruitment should be discussed within the CHR application and noted on the HIPAA Supplement.

1. Clinics maintain a separate CHR-approved recruitment protocol that asks patients if they will agree ahead of time to be contacted for research. See sample Consent Form to be contacted for future research. Investigators contact patients about particular studies in accord with their signed consent.



2. Study investigators enter recruitment information into the UCSF Seeking Clinical Trials Volunteers website or another website similarly managed. Subjects then contact the study investigators. See Frequently Asked Questions (FAQs) and Letter from the Committee on Human Research for more information.



3. Advertisements, notices, and/or media are used to recruit subjects. The CHR 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. See Advertisements, Notices, And/Or Media Format Guidelines for more information.



4. Study investigators provide their colleagues with a "Dear Patient" letter describing the study. This letter can be signed by the treating physicians and would inform the patients how to contact the study investigators. The study investigators are prohibited from having access to patient names, addresses, or phone numbers; patients must initiate contact. See 8.b below for additional options.



5. Study investigators send a CHR-approved letter to colleagues asking for referrals of eligible patients interested in the study. The study investigators may provide the referring physicians a CHR-approved information sheet about the study to give to the patients. If interested, the patient will contact the PI. Or, with documented permission from the patient (e.g., note in medical record indicates primary care provider spoke with patient who agreed to be contacted), the PI may be allowed to contact patients about enrollment.



6. 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 (see discussion of ethical concerns above).



7. Study investigators recruit potential subjects who are unknown to them. Examples include snowball sampling, use of social networks, direct approach to unknown people in public situations, and random dialing.
   



8. Study investigators request a Waiver of Consent/Authorization for recruitment purposes. In all cases the waiver must be justified in the CHR application and the Supplement: Request for Waiver of Consent/ Authorization must be completed. Waivers are granted in three primary situations:
   
   
   1. 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.
      
      
   2. 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.

   3. 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.
   
   
   
   4. Large-scale epidemiological studies and other population-based studies may need to identify subjects through registries, medical records in multiple institutions, or other sources. The researchers may need to contact prospective subjects directly rather than through professionals involved in the prospective subjects’ health care. This approach involves a greater invasion of privacy than other methods, because researchers without approval from patients gather significant private health information about the patients, and then contact the patients directly. Because this approach is an exception to the CHR’s usual policies, the application must explain in detail why it is impossible to do the study unless the CHR (1) waives authorization/consent to obtain subjects’ identities and (2) allows researchers to contact subjects directly.

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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 CHR (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 (1) health care professionals actually involved in the care or (2) administrative or research staff working with the professionals involved in the care.

Documents Needing Review

The following types of recruitment documents must be submitted as part of the initial application for CHR review. Any additions or changes to these documents must be submitted as formal modifications of the study:

• Letters to Subjects: All letters to subjects or their representatives, regardless of who signs the letters, including the PI, a primary care provider, or an organization the subject has joined.
• Advertisements: All advertisements in all media, including flyers, posters, newspaper ads, radio or television announcements, and informational videos. TV or video materials should be submitted as tapes or DVDs.
• Scripts: All scripts or guides that will be used for in-person or telephone recruitment interviews.
• Web Postings or Pages: Submit printouts of postings or pages used for direct recruitment. Informational descriptions posted on websites that have policies insuring that study descriptions are accurate and balanced (e.g. clinical trial sites maintained by the UCSF Comprehensive Cancer Center and Office of Research) need not be submitted for review.

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Special Cases

Keeping Information About Refusers: In general, no identifiable information may be kept about prospective subjects unless they consent to even this limited participation in the research. The protocol should describe how this consent will be obtained. With CHR approval, non-identifying information about refusers may be collected. See PHI: List of 18 Identifiers and Definition of PHI for a list of items that identify subjects. If the research cannot be done if refusers’ consent to record basic information is required, the CHR will consider waiving consent.

Sponsor’s Role:

• In general, UCSF does not permit its researchers to provide subject contact information to sponsors. Sponsors may not directly contact prospective subjects based on information from UCSF researchers.
• If the sponsor plans a national or local advertising campaign to recruit subjects, all materials must be submitted for CHR review, including any scripts or guides used when prospective subjects call the sponsor’s representatives.

Recruiting Researchers’ Students and Staff: Researchers should not directly ask their students or staff to be research subjects, as it may be hard to refuse such a request. The CHR prefers that researchers post flyers and allow volunteers to initiate contact about the study. No pressure should be applied to encourage participation.

Recruitment in Classrooms: Potential participation in research must be presented as a voluntary option. Participation cannot be tied to grades. It must be clear that there will be no stigmatization of students who decline to participate. If class time will taken for research participation, alternative activities should be provided for those who decline (especially in pre-college levels).

Telephone Scripts: In telephone surveys, the initial recruitment call sometimes leads directly into the consent process. In such studies, the script should include, at least, the names of the persons responsible for the study, reference to UCSF, a description of the types of questions that will be asked, an estimate of the time it will take to complete the interview, and the direct question of whether or not a person wishes to participate. The interviewers also should have available an investigator's telephone number in case the prospective subjects have questions about the study that the interviewer cannot answer, and the CHR phone number if there are questions about a research subject’s rights.

Incentives and Referral Fees: Per-patient incentive payments or referral fees, whether paid for each referral or each enrollment, are not allowed. Such payments may encourage recruiters to put inappropriate pressure on prospective subjects and are illegal in California. Lump-sum payments not tied to the number of patients referred or enrolled may be allowed in particular studies. Investigators should include all information about incentives and/or referral fees in the recruitment section of the protocol.

Videos: Videos used in subject recruitment must be reviewed and approved by the CHR, just like other recruitment tools. Investigators should obtain CHR approval for a concept or script before making a major investment in video production. When a video has been prepared in advance by a sponsor it should be submitted for review. If the video is not approved, the CHR may allow the study to proceed as long as the video is not used by the local investigator and the local investigator does not accept referrals from any advertising campaign that uses the video.