VETERANS ADMINISTRATION MEDICAL CENTER

Miami, Florida

Guidelines for Subject Recruitment in Research Studies

At the recommendation of the Human Studies Subcommittee, the Research and Development Committee has implemented the following guidelines for investigators who may wish to recruit subjects for approved research studies by the posting of public notices:

1.	Before requesting permission for the posting of such notices, the principal investigator must first attempt to recruit subjects by referral from physicians or other involved health professionals. The principal investigator should send memoranda to the appropriate services (through their service chiefs) describing the study and the eligibility requirements for participants and requesting cooperation in the recruitment of subjects. If the response to this solicitation is considered inadequate after one month or more has elapsed, the principal investigator may seek the approval of the Chairman of the Human Studies Subcommittee for the use of posters, or newspaper, by documenting in writing the needs of the study for participants and unsuccessful attempts to recruit subjects by referral through health professionals.

2.	Approval for the use of posters will be guided by the following criteria:

a.	All statements made on posters will coincide completely with the approved informed consent for the specific study with regard to inducements, benefits, risks, etc.

b.	The content will conform to the standards of the Department of the Health & Human Services (HHS),. Those include:

(1)	the name and address of the clinical investigator;
(2)	the purpose of the research and, in summary form, the eligibility criteria that will be used to admit subjects into the study;
(3)	a straightforward and truthful description of the benefits (e.g., payments or free treatment) to the subject from participation in the study; and
(4)	the location of the research and the person to contact for further information.

c.	All posters will be professionally lettered by the Medical Media Service or other sources and be dignified as to design and content. Handwritten posters will not be approved. Lettering will be of uniform size throughout.

e.	Posters will be placed only in clinical areas, e.g., the waiting rooms of the services involved, and not in public areas such as the Canteen, hallways, etc.

f.	The permission and advice of Building Management Service must be obtained as to the proper means of affixing and maintaining posters.

g.	The number of posters for each study will be limited to a reasonable amount, not to exceed 15.

h.	It will be the responsibility of the investigator to remove posters as soon as possible after completion of the intake phase of the study.

1.	It will be the responsibility of the Chairman, Human Studies Subcommittee, to approve all posters before they are placed. His recommendation will be forwarded to the Chief of Staff for concurrence.

j.	If a poster is not approved, the investigator shall have the right to appeal this decision to the Research and Development Committee at its next regularly scheduled meeting. The Committee’s decision will be final in all instances.

3.	Approval for the use of newspaper ads will be guided by the following criteria:

a.	All statements made in the newspaper will coincide completely with the approved informed consent for the specific study with regard to inducements, benefits, risks, etc.

b.	The content will conform to the standards of the HHS. Those include:

(1)	the name and address of the clinical investigator;
(2)	the purpose of the research and, in summary form, the eligibility criteria that will be used to admit subjects into the study;
(3)	a straightforward and truthful description of the benefits (e.g., payments or free treatment) to the subject from participation in the study; and
(4)	the location of the research and the person to contact for further information.

c.	Lettering will be of uniform size throughout.

5.	Paying Subjects money for Participation in Research:

(1)	Under no circumstances is it ethical for house staff to be paid for referring/recruiting volunteers.

(2)	Payment, when made, must be prorated for each visit, not contingent upon completing the entire study.

(3)	It is acceptable for a subject to be paid for participation in a study where the procedures are not directly related to his medical condition. If the subject is being treated for the disease being studied then he should not be induced to participate by monetaiy payment (See exception, Circular 10-88-7 - If non-VA subjects are being paid for their participation and requirements are the same, compensation should not be withheld from VA subjects.)

(4)	The portion of the Informed Consent dealing with monetary payment is
to go under the Benefits Section. (See HIHS, FDA P.83 - “Payment to Research Subjects for Participation in Studies is Considered a Benefit”)

The Committee felt the guiding principle for all research must be that benefits, other than monetary, always outweigh the risks.