RECRUITMENT OF RESEARCH SUBJECTS
Federal regulations, the Human Research Committee must
review and approve methods used to recruit subjects to
ensure that the methods are not coercive and that the
confidentiality and privacy of potential subjects are
protected. Every protocol must include a recruitment section
that clearly describes:
potential subjects are identified
and by whom subjects are approached about participation
consent is obtained in relation to the start of the
third parties (calling centers/centralized screening
centers) will assist with recruitment of subjects for
appropriate recruitment methods depends upon how the potential
subject was initially identified. Potential subjects can
through private medical information about individuals
who are NOT patients of the investigator(s) (e.g., medical
records, clinical databases, patient registries or by
among the patients of the investigator(s),
advertisements in various media, and
among the employees/students of the investigator(s).
refer to the applicable section [I., II., III., or IV.
below] for a description of the appropriate procedures
for each recruitment method.
I. RECRUITMENT OF SUBJECTS IDENTIFIED THROUGH PRIVATE
Recruitment efforts frequently 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; however it is essential to take special
precautions to ensure that patient privacy is protected
and that the individual patient is appropriate to participate
in the research. It is not appropriate for investigators
to make the first contact with potential subjects identified
through their private health information. Rather, active
participation by the patient's primary/specialist health
care provider in the recruitment process ensures 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.
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).
For Use of Recruitment Letters
Although recruitment letters are frequently prepared by
the study staff, they must be signed by the patient's
physician, or the patient's physician and the 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 out"
or "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 HRC may require that the more stringent "opt
in" procedure be followed.
OPT OUT Procedure: The recruitment letter
should include a telephone number to call or a postcard
to return if the subject is not interested in participating
in the study. If no telephone call is received or postcard
returned, the subject may then be contacted by the investigator
to determine whether or not the subject is interested
in learning more about and/or participating in the study.
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
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
Recruitment letters must be submitted for review and approval
by the HRC.
II. RECRUITMENT OF SUBJECTS FROM AMONG THE INVESTIGATOR'S
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. Further, the Committee asks
researchers to describe any plans that are in place 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.
III. RECRUITMENT OF POTENTIAL SUBJECTS THROUGH 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 HRC 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 Partners Guidelines for
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.
IV. RECRUITMENT OF EMPLOYEES/STUDENTS IN INVESTIGATOR'S
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 Human Research
Committee. 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.
ALTERNATIVE RECRUITMENT APPROACHES
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 Human Research Office staff
will offer guidance to investigators upon request.
OTHER RECRUITMENT CONSIDERATIONS
of Harvard Medical School Students
the mutual protection of the student, investigator, and
the Medical School, any protocol in which Harvard Medical
School students are recruited must be submitted to the
Dean's Office for review and approval before activation.
and Rewards for Recruitment of Patients and Referral to
enrollment of patients into approved trials is desirable,
but care must be taken to ensure that the interests of
patients are not jeopardized during the recruitment process.
Cash payments or other financial or non-monetary incentives
to physicians for referral of patients, otherwise known
as "finder's fees", pose a conflict of interest
and are not permissible. Financial incentives to physician-investigators
to accelerate enrollment of their own patients in their
own clinical trials pose a similar conflict of interest
and are not acceptable. The HRC requires full disclosure
of any financial arrangements that may encourage physicians
to recruit patients for research participation that may
not be in the patient's best interests. In some special
circumstances, physicians who are not formally listed
on the protocol may be performing specific research-related
activities (such as conducting screening examinations
or tests, or participating in the consent process), but
solely in the role of service providers. These physicians
may be reasonably compensated for their time and effort.
Such arrangements should be clearly detailed and justified
in the research protocol.