Marshall University

Huntington, WV

  

SUBJECT:  Recruitment and Selection of Human Subjects

 

PURPOSE:  To provide guidance in the recruitment, selection, and payment of human subjects.

 

POLICY:  To ensure that human subjects are recruited, selected, and, in certain cases, receive payment for their participation in research activities without being subjected to coercion or undue influence.  Human subjects are given sufficient information about the research and its risks and benefits to reach an informed decision as to whether they will voluntarily participate.  Adequate precautions are taken to safeguard their privacy and the confidentiality of the their information.  Human subjects are informed of the extent to which confidentiality of research records will be maintained.  The decision by human subjects not to participate may not jeopardize their ability to receive care, if applicable. 

 

SCOPE:  This policy covers all human subjects involved in research activities approved by the IRB.

 

RESPONSIBILITY: 

 

Principal Investigator is responsible for ensuring that human subjects are recruited, selected, and receive payment as deemed appropriate, in an environment free from coercion or undue influence.  It is also his/her responsibility to ensure that the informed consent has sufficient information about the research and that the informed consent is written at a reading level the subject can understand.  The risks and benefits are explained sufficiently for the human subject to reach an informed decision as to whether they will voluntarily participate.  The investigator is responsible for explaining the subject’s rights including his privacy and confidentiality.

 

IRB Chairperson, Members, and Alternates are responsible for ensuring that the rights and welfare of research subjects are protected.   They are responsible for ensuring recruitment, selection, and payment of human subjects are performed equitability, in a manner free from coercion, and undue influence.  The IRB is responsible for ensuring the informed consent contains information sufficient for the subject to assess risks and benefits and the consent is written at the subject’s level of understanding.

 

PROCEDURE:

 

Advertisements and Recruitment Incentives. 

The IRB reviews advertisements, recruitment, and payment incentives associated with the research to ensure they are consistent with prohibitions on coercion and undue influence.  The advertisement to recruit subjects must be limited to the information the prospective subjects need to determine their eligibility and interest.  When appropriately worded, the following items may be included:

 

(1)   The name and address of the clinical investigator and research facility.

(2)   The condition under study and the purpose of the research.

(3)   In summary form, the criteria that will be used to determine eligibility for the study.

(4)   The time or other commitment required of the subjects.

(5)   The location of the research and the person or office to contact for further information.

(6)   A clear statement that this is research and not treatment.

 

      When reviewing advertisements, the IRB is required to review:

• The information contained in the advertisement

• The mode of its communication

• The final copy of printed advertisements

• The final audio/video tape taped advertisements

The IRB reviews advertising to assure that advertisements do not:

• State or imply a certainty of favorable outcome or other benefits beyond what is outlined in the consent document and the protocol.

• Make claims, either explicitly or implicitly, that the drug, biologic or device is safe or effective for the purposes under investigation.

• Make claims, either explicitly or implicitly, that the test article is known to be equivalent or superior to any other drug, biologic or device.

• Use terms such as "new treatment," "new medication" or "new drug" without explaining that the test article is investigational.

• Promise "free medical treatment" when the intent is only to say participants will not be charged for taking part in the investigation.

• Include exculpatory language.

• Emphasize the payment or the amount to be paid, by such means as larger or bold type.

 

The IRB evaluates the recruitment procedures to assure that informed consent is given freely and to avoid coercion or undue influence.  They evaluate from what population the subjects will be drawn, what incentives are being offered, and the conditions under which the offer will be made. 

 

Recruitment Procedure:

 

The IRB requires a copy of all forms of advertisements to be submitted for review and approval prior to publication.  This is one of the requirements for a protocol submission.  A good way to avoid any possibility of coercion and to promote voluntary participation is to place flyers, posters, and brochures in public places and to advertise in newspapers and other local publications.  The recruitment material should include the following:

(1)     investigator name and address

(2)     purpose of the research

(3)     eligibility criteria for participation in research study

(4)     an accurate description of the benefits for the subject

(5)     time required and any other commitments required of the subject

(6)     location of research

(7)     contact person for further information

 

The investigator must receive approval from the IRB before he/she reviews medical charts, logbooks, or databases for potential subject.  The investigator may request information concerning the number of cases that may fit the study criteria in order for the investigator to determine if he can obtain a sample size large enough to support the research study.  Investigators are not to requests names from persons having access to records or databases in order for the PI to contact the potential subjects.  These subjects, if contacted, could perceive this action as an invasion of privacy and a breach of subject confidentiality.

 

An investigator may recruit his own patients, but if he plans recruiting another physician’s patients, he should request the assistance of that physician to introduce the research protocol.  The investigator can prepare an informational letter explaining the protocol and the potential subject’s physician can deliver this letter.  The letter should include the following:

(1)    explain the research study

(2)    tell who is conducting the study

(3)    what the study is designed to investigate

(4)    why the potential subject is being asked to participate (medical diagnosis, age, sex, etc.)

(5)    whom to contact if interested in learning more about the study

(6)    ask permission for the investigator to contact the subject directly

The personal physician would contact the investigator to give him the names of interested subjects.  The IRB requires a draft of the above stated letter with the other required application materials.

 

Subject Selection.  The IRB considers subject selection criteria in its review of research to ensure that the criteria are appropriate to the purposes of the research, the setting in which the research occurs, and the fair (equitable) distribution of the burdens, risks and benefits of the research.  The IRB evaluates the potential benefits, burdens, and risks of the research.  They also evaluate any inclusion or exclusion criteria, any scientific and ethical justification for including vulnerable populations such as children, prisoner, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons as well as the scientific and ethical justification for excluding classes of persons who might otherwise benefit from the research.

 

At continuing reviews, the IRB considers whether recruitment methods, enrollment procedures, and selection criteria fairly distribute the burdens, risks and benefits of research by evaluating the number of subjects, gender (male/female), children, minority status, and vulnerable subjects entered into the study. 

 

Payment to Research Subjects.  The IRB reviews any proposed payments to research subjects associated with the research.  Payments to research subjects may not be of such an amount as to result in coercion or undue influence on the subject’s decision to participate.  Payments may not be provided to subjects on a schedule that results in coercion or undue influence on the subject’s decision to continue participation.  For example, payment may not be withheld as a condition of the subject completing the research.  If the subject withdraws early, payment must be prorated to reflect the time and inconvenience of the subjects participation up to that point.  Applications must include the amount and schedule of all payments.

 

Payment may be permitted, with prior approval of the IRB, in the following circumstances:

 

(1)   No direct subject benefit and the standard of practice locally is to pay participants in this situation. 

(2)   Others being paid.  In multi-institution studies, where subjects at a collaborating institution are to be paid for the same participation in the same study at the same rate proposed.

(3)   Comparable situations.  In other comparable situations in which, in the opinion of the IRB, payment of subject volunteers is appropriate.

(4)  The participant will incur transportation expenses that would have been incurred in the normal course of receiving treatment and will not be reimbursed by another mechanism.

 

Payments to participants must meet the following criteria:

 

(1)   Credit for payment must accrue as the study progresses and not be contingent upon the participant completing the entire study. 

(2)  Any amount paid as a bonus for completion must be reasonable and not so large as to unduly induce participants to stay in the study when they would otherwise have withdrawn.

(3)  All information concerning payment, including the amount and schedule of payments, must be set forth in the consent document.

(4)  The entire payment may not be contingent upon completion of the entire study.

(5)  Compensation for participation in a trial offered by a sponsor may not include a coupon good for a discount on the purchase price of the product once it has been approved for marketing.

 

Investigators who wish to pay research subjects must indicate in their proposal the justification for such payment with reference to the criteria listed and, in addition, must:

 

(1)   Substantiate that proposed payments are reasonable and commensurate with the expected contributions of the subject;

(2)   State the terms of the subject participation agreement and the amount of payment in the informed consent form; and

(3)   Substantiate that subject payments are fair and appropriate, and that they do not constitute (or appear to constitute) undue pressure on the veteran subject to volunteer for the research study.

 

The IRB reviews all proposals involving the payment of subjects (in excess of reimbursement for travel) in the light of these guidelines.  The research office ensures that such payments to subjects are made from appropriate funds.

 

Payments in exchange for referrals of potential participants ("finder's fees") are prohibited.  Also payments to the organization or research staff designed to accelerate recruitment that were tied to the rate or timing of enrollment ("bonus payments") are prohibited.

 

For VA research, participants cannot be paid to participate in research when the research was integrated with a patient's medical care and when it made no special demands on the patient beyond those of usual medical care.  For VA participants payment is limited to situations allowed by the VA.

 

Compensation for Injury.  The IRB ensures that subjects are provided with accurate information about the availability of compensation and treatment for injury occurring in the research that it reviews.   However, this requirement does not apply to (1) treatment for injuries due to non-compliance by a subject with study procedures; or (2) research conducted for Marshall University under a contract with an individual or other academic institution.

 

Compensation to PIs, physicians and other health care providers for identifying and /or enrolling subjects is considered “fee splitting” and must not occur. 

 

Indemnity and Liability Provisions.  Execution of an indemnity or liability agreement with an industry-sponsor or external collaborator requires the express approval of the Marshall University General Counsel, and is rarely permitted.

 

Compliance with All Applicable State and Local Law.   All human subject research conducted at Marshall University or by the University’s employees or agents or otherwise under the auspices of the VA must comply with applicable state and local laws.  The IRB shall familiarize themselves with the requirements of all applicable state and local laws pertinent to the conduct of human subject research and shall ensure that the research it approves complies fully with all such requirements.  IRB SOPs should reference applicable state and local law. 

 

Voluntary Participation Statement.  It is particularly important that subjects understand and have complete confidence that failure to participate will not jeopardize any University-provided care.  Informed consent information must contain clear statements of the following:

 

(1)   Participation in the research is voluntary.

(2)   Refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled.

(3)   The subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

 

Human subjects will be notified of significant new findings in generally within three (3) months of the release of the new findings by the research study coordinator.

 

FOLLOW-UP RESPONSIBILITY:  Director, Office of Research Integrity

 

REFERENCES:  38 CFR 16

                              45 CFR 46

 

 

 

Revised 5-1-2007