Guidance on Recruitment of Research Subject

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Under Federal regulations, the IRB must review and approve recruitment of subjects to ensure that the methods to be used are not coercive and that the confidentiality and privacy of potential subjects are protected in the research study. Every protocol must include a recruitment section that clearly describes:

• How potential subjects will be identified
• How and by whom subjects will be approached about participation
• When consent is obtained in relation to the start of the study procedures
• Whether third parties (calling centers/centralized screening centers) will assist with recruitment of subjects

Selecting appropriate recruitment methods depends upon how the potential subject was initially identified. Potential subjects can be identified in several ways. Below are guidelines to consider when developing recruitment methods for different research studies. All recruitment letters must be submitted for IRB review and approval.

1. SUBJECTS IDENTIFIED THROUGH PRIVATE MEDICAL INFORMATION

At times, recruitment efforts may target individuals known to have a specific medical condition. Medical records, patient registries, clinical databases and referrals from treating physicians can be useful resources to identify potential subjects. When using this method of recruitment it is essential to take precautions in ensuring patient privacy.  When investigators do not have a professional relationship with the subjects they investigator should not make the first contact with potential subjects. The active participation by the patient's primary/specialist health care provider in the recruitment process is the preferred method of contact. This will ensure that consideration is given to the appropriateness of an individual patient's participation in the research prior to recruitment and that the patient's privacy is respected by the researchers.

• The primary/specialist health care provider, usually a physician, who is known to the potential subject and has first hand knowledge of the patient's medical history must (1) give approval for his/her patient to be contacted for research purposes, (2) initially introduce the study to the patient AND (3) obtain the patient's permission to be contacted by study staff.
• The primary/specialist health care provider can introduce the study and obtain the patient's permission to be contacted by study staff either (1) verbally during the course of providing medical care OR (2) through the use of a recruitment letter (refer to guidelines for use of recruitment letters below).

Use of Recruitment Letters

Recruitment letters are frequently prepared by the study staff but must be signed by the patient's physician/investigator, but not the investigator alone. In some cases, it may be appropriate for a physician representative on behalf of an entire practice/clinic staff to sign the letter rather than the potential subject's primary/specialist physician. It is never appropriate for recruitment letters to come from study staff, such as research assistants or data managers.

In the letter, the primary/specialist physician should indicate that one of his/her medical colleagues is conducting a research study. The letter should explain the purpose of the research, and provide a brief description of the nature and extent of involvement, e.g., duration of participation and study procedures.

Potential subjects must be allowed to "opt in", depending upon the nature of the research. When the research involves sensitive or personal information, such as illegal behavior, drug or alcohol use, mental illness, sexual behavior or other sensitive issues, the IRB may require more stringent "opt in" procedure be followed when recruiting subjects.

• OPT IN Procedure: The recruitment letter should include a telephone number to call or a postcard to return if the subject is interested in learning more about and/or participating in the study. The investigator may not contact subjects who have not called or returned a postcard indicating interest in learning more about the study.
  
  In either case, care should be taken to ensure that letters are properly addressed to avoid delivery to an incorrect party, and return postcards must not contain information regarding the patient's medical condition, medication or diagnosis.

Since Investigators are not authorized to contact potential research subjects identified in reviews preparatory to research unless they are directly responsible for care of the potential subject and entitled to PHI as a result of that duty.

If the investigator intends to recruit potential subjects with which the investigator has no professional relationship, the following procedures are prescribed:

• Obtain permission of the patient’s physician other healthcare provider known to the patient, and

• Provide IRB-approved study information (brief) to the patient’s physician or other healthcare provider known to the patient, and

• Healthcare Provider/physician or their agent provides the patient with an introduction to the study and the name of the investigator (staff member), to contact if the prospective subject is interested in the research.

Investigator’s who have previously obtained full consent and authorization to contact a research subject as a result of a previously approved research project, may contact his or her former research subjects provided that the subject agreed to be contacted for information on future research conducted by the same principal investigator or co-investigator (s).

2. RECRUITMENT OF SUBJECTS FROM AMONG THE INVESTIGATOR'S OWN PATIENTS

When recruiting potential subjects from among their own patients, investigators must consider the possibility that their patients may feel obligated to participate because they are being asked by their treating physician. For the investigator, maintaining a dual role as investigator and treating physician may create subtle conflicts and ethical tension, while for the patient/subject it may create some uncertainty. Investigators should reinforce with their patients that participation is voluntary, that they do not have to participate, and the decision not to participate will not affect their care, now or in the future. Any plans to minimize the possibility that patients will feel obligated to participate, e.g., initially contacting patients about the research in writing and allowing patients to make further inquiries if they are interested, etc. should be outlined in the protocol.  

3. ADVERTISING

The text of all direct advertising for research subjects, i.e., advertising that is intended to be seen or heard by prospective subjects, must be reviewed and approved by the IRB prior to distribution, posting, publication, or broadcasting. Direct advertising includes, but is not limited to newspaper, radio, TV, bulletin boards and the internet. Please refer to the NYU SoM Guidelines for Advertisements.

Unlike potential subjects identified through private medical information, those responding to advertisements have initiated the first contact and therefore, have implicitly given their permission to be contacted by study staff.

4. RECRUITMENT OF EMPLOYEES/STUDENTS IN INVESTIGATOR'S DEPARTMENT

Studies of volunteers who are directly supervised by the investigator(s) or who are the investigator's students should be avoided and will usually be disapproved by the IRB. In this setting, there are confidentiality problems and issues of coercion or obligation (either real or perceived) which are best avoided entirely. It is acceptable to advertise for volunteers in approved areas in the investigator's department or within the hospital (following hospital guidelines) and allow individuals in the department who are not directly supervised by the investigator(s) to participate in research studies.

5. ALTERNATIVE RECRUITMENT APPROACHES

The guidelines listed above may not be applicable to every situation that arises in the research process. Carefully justified alternative approaches will be considered on a case-by-case basis. The IRB Office staff will offer guidance to investigators upon request.