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?

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?

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?

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?

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.

Avoid giving access to medical records and identifiable health information to people not directly involved in a patient’s care.

Minimize the amount of protected health information (PHI)/identifiable information gathered and the number of people who have access to identifiable information.

Clinics, departments or other groups asks patients if they will agree ahead of time to be contacted for research. Investigators contact patients about particular studies in accord with their signed consent.

To keep patients informed of potential research opportunities, many departments maintain lists of current studies on their websites or other public websites, such as the NCI's cancer clinical trial listing. Making your study available to the public in this fashion is optional.

Based on FDA guidance, you do not need to submit the website text to the IRB if the it only provides basic trial information, such as: 

• the title,
• purpose of the study,
• protocol summary,
• basic eligibility criteria, 
• study site location(s) and
• how to contact the site for further information. 

If the listing contains additional descriptive information about the study, submit the text of the website so the IRB may assure that the description does not promise or imply a certainty of cure or other benefit beyond what is contained in the protocol and the informed consent document.

ClinicalTrials.gov and UCSF Clinical Trials Finder: If your UCSF study is open and listed on ClinicalTrials.gov, it will automatically be pulled into the UCSF Clinical Trials website. This new tool lets potential participants search for active studies at UCSF and contact the study team. Study information is extracted at least weekly from ClinicalTrials.gov, so please keep information about your study current on ClinicalTrials.gov and and respond promptly to potential participants.

Please note that the IRB does not need to review submissions to ClinicalTrials.gov, but you must provide the IRB with the clinical trial identifier (NCT#).

Reminder: IRB submission and approval is still required for other types of advertisements, including web-based recruitment materials.

The IRB must first approve the text of these items. Subjects who respond to these will contact the study investigators. See advertising guidelines for more information. Note: No HIPAA-regulated PHI is used in this recruitment strategy.

This letter is signed by the treating physician(s) and informs 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. The IRB has created a sample recruitment letter. See 8.b below for additional options.

In all cases, the waiver must be justified in the "Waiver of Consent/Authorization for Recruitment Purposes" section of the application. Waivers are granted in four primary situations:

a. Minimal risk, no-subject-contact studies: 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.

b. Review of charts before recruitment: 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. 

c. Direct approach by someone not involved in the patient’s care: 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.

d. Large-scale epidemiological studies and other population-based studies: These types of 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 IRB’s usual policies, the application must explain in detail why it is impossible to do the study unless the IRB 1) waives authorization/consent to obtain subjects’ identities and 2) allows researchers to contact subjects directly.

Submit 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. The IRB has created a sample recruitment letter. You do no need to submit "Dear Doctor" letters for review.

Submit all advertisements in all media, including flyers, posters, newspaper ads, radio or television announcements, and informational videos. Ensure the ads meet the advertising guidelines.

Note: TV ads or videos used in subject recruitment must be reviewed and approved by the IRB, just like other recruitment tools. Investigators should obtain IRB 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 (as a DVD or disc). If the video is not approved, the IRB 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.

CTSI’s Consultation Service, the Participant Recruit Program (PRP), facilitates cohort identification to communicate with potentially eligible patients via MyChart or direct mail. This PRP service is the only way that UCSF allows the use of MyChart for research recruitment. 

For more information, please see our MyChart page.

In general, no identifiable information may be kept about prospective subjects unless they consent to even this limited participation in the research. The IRB Application should describe how this consent will be obtained. With IRB approval, non-identifying information about refusers may be collected. See the PHI definition and list of 18 identifiers for a description of items that identify subjects. If the research cannot be done if refusers’ consent to record basic information is required, the IRB will consider waiving consent.

• 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 IRB review, including any scripts or guides used when prospective subjects call the sponsor’s representatives.

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

Investigators/Key Study Personnel cannot be listed as an Investigator or Key Study Personnel and also participate as a research participant.

Investigators should not enroll themselves in their own research studies due to multiple concerns, such as privacy, data quality/scientific validity, consent, and payment issues. This guidance does not affect faculty, investigators, or Key Study Personnel (KSPs) from deciding to participate in the research studies of other investigators.

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 be taken for research participation, alternative activities should be provided for those who decline (especially in pre-college levels).

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. Include all information about incentives and/or referral fees in the recruitment section of the protocol.

The Break the Glass alert is a layer of privacy for various UCSF patients. The notice is placed on charts for a range of reasons. These patients may include high profile patients or faculty that require additional privacy protection.

Proceeding to screen patients with the break the glass alert is acceptable under the following conditions:

For example: IRB #18-00000 recruitment screening.