Recruitment of Subjects
Recruitment is the dialogue that takes place between an investigator and a potential subject prior to the initiation of the consent process. In some ways, recruitment is the introduction to the consent process. Recruitment may take the form of a flyer, a newspaper advertisement, etc., or a verbal exchange between an investigator and a potential subject. Investigators who are responsible for both the primary care of a subject/client and wish to consider enrolling the subject/client in a research project should carefully differentiate for the subject/client the alternatives and options of participation in the research without undue prejudice or pressure. Respect for potential subjects begins with recruitment procedures that ensure the voluntary participation of the subject. Potential subjects should not feel coerced into participating in research, nor must they fear the loss of some benefit to which they are otherwise entitled if they choose not to participate. A person in authority, such as a teacher recruiting students or a physician recruiting subjects, should take special precautions to ensure that a potential subject's decision to participate in research is not based on subtle pressures such as grades, monetary reward, or fear of loss of benefits, such as medical treatment.
Investigators proposing to recruit their students, employees or patients as research subjects should justify in the protocol the necessity for the inclusion of the dependent subject. In addition, the IRB will closely scrutinize the precautions in place to prevent the appearance of coercion in the recruitment of subjects. The investigator may contact the IRB for strategies for indirect recruitment.
All recruitment materials are required to have IRB review and approval prior to implementation. Prior to use, each recruitment tool should have an approval and expiration date on the original tool. Audio and video tools may be excepted from this requirement. When recruiting subjects from another institution with an IRB, investigators are required to gain IRB approval from that institution. In institutions without an IRB, investigators are required to obtain a letter of agreement indicating the research can be conducted at the site and the agency or institution will review, abide by and comply with the procedures approved by the UVA IRB.
A recruitment tool informs potential subjects of a research activity and provides them with an opportunity to contact the researcher. A recruitment tool may include, but is not limited to, post-cards, flyers, advertisements, press releases, brochures, and postings on the Internet. The following information should be included:
- name and contact information of the clinical investigator and/or research facility (letterhead is acceptable).
- the condition under study and/or the purpose of the research.
- in summary form, the criteria that will be used to determine eligibility for the study.
- time or other commitments required.
- the location of the research and the person or office to contact for further information.
- in drug or device studies, no claim should be made as to the superiority, safety or effectiveness of the drug or device. Proprietary names of study products may not be used.
- do not provide excessive monetary or other incentives that could be interpreted as inappropriate or coercive.
- are consistent with protocol.
Due to contractual obligations, recruitment tools should not include any proprietary identifiers, contain therapeutic or outcome claims or mention the corporate sponsor by name.
The IRB considers the following in its review of advertisements:
For additional information see : Advertising
- that no claims are made, either explicitly or implicitly, that the drug, biologic, device or investigational intervention is safe or effective for the purposes under investigation; or that the test article is known to be equivalent or superior to any other drug, biologic or device.
- that the advertising does not use terms such as “new therapy”, "new treatment", "new medication" or "new drug" without explaining that the test article or intervention is investigational; a phrase such as "receive new treatments" leads study subjects to believe that they will be receiving newly improved products of proven worth.
- that advertisements do not advertise "free medical treatment" when the intent is only to say that subject will not be charged for taking part in the investigation.
- placebo-controlled studies: the advertisements do not lead perspective subjects to believe that everyone who enrolls in the study will receive the investigational treatment.
- studies with multiple intervention arms, that subjects will be assigned randomly (or by another appropriate method) to one of the interventions (or standard, or no intervention if trial is the approved study design
- that advertisements do not emphasize the payment to subjects, if any, by such means as large or bold type.
- When advertisements are taped for broadcast, the IRB may review and approve the wording of the advertisement prior to taping and will review the final audio/video tape when completed.
Recruitment of Children
The ethical requirement of respect for persons, as outlined in the Belmont Report, applies to children as well as adults. Children, however, are in a dependent relationship to adults and easily manipulated in an academic or clinical setting. A child's dependent relationship entitles them to extra protections and are thus considered a "vulnerable subject population". Investigators should take every precaution to insure that a child's decision to participate in research is both voluntary and free from coercion. A child's refusal to participate should not be met with a negative response or punishment.
The IRB strongly recommends that investigators address the following when submitting applications that include the recruitment of children:
- Investigators should acknowledge and create a mechanism for addressing and minimizing the coercion implicit in requests to participate from parents, teachers, or other adult authorities.
- Investigators should make provisions to minimize the fear of ridicule, social pressure, or peer pressure to participate.
- Incentives or rewards for participation may be used but should not be so valuable, within the value system of the parent or the child, as to sway the child's legitimate reluctance to participate.
Permission of the School
School officials and/or teachers do not have the authority to give consent for the participation of children in research. Only a parent or guardian may allow a child, with the child's assent, to participate in research. The IRB requires submission of proof of approval of the school district prior to allowing investigators to contact, recruit, or enroll children into a study. Investigators should contact school district officials regarding the appropriate procedures for obtaining permission to conduct the research in individual schools.
The No Child Left Behind Act of 2001(Public Law 107-110) amended the Protection of Pupil Rights Amendment (PPRA), which concerns surveys of students, in two ways:
- First, it added an eighth category to the categories of protected information in surveys of children that were already covered by PPRA.
- Second, it gave parents new rights with regard to the surveying of students who are children, the collection, disclosure, or use of information from students for marketing purposes, and certain non-emergency medical examinations.
PPRA, as amended, has two sets of requirements for surveys:
- Requirements that apply to "protected information" surveys that are funded in whole or in part by the U.S. Department of Education.
- Requirements that apply to "protected information" surveys that are funded by sources other than the U.S. Department of Education and that are administered or distributed by education institutions that receive funds from any Department of Education program (i.e. public elementary and secondary schools and some private schools).
PPRA lists 8 categories of protected information for survey responses:
- political affiliations of student or student's parent;
- mental or psychological problems of student or student's family;
- sex behavior or attitudes;
- illegal, anti-social, self-incriminating or demeaning behavior;
- critical appraisals of others with whom students have close family relationships;
- legally recognized privileged or analogous relationships;
- religious practices, affiliations or beliefs of student or student's parent;
PPRA has implications for IRBs in applying the Common Rule criteria for waiving informed consent ( in section 116(d) of the Common Rule). Specifically the second IRB criterion: "research does not adversely affect the rights and welfare of subjects" is impacted because of the "rights" that PPRA gives parents.
Practical Implications in Applying the Common Rule Waiver Requirement pertaining to rights and welfare:
First Set of Requirements: US Department of Education Funded Protected Information Surveys
If the answer is yes to the three questions, PPRA affords parents the right to provide written informed consent.
- Does the research involve "protected information" surveys?
- Are the surveys U.S. Department of Education- funded in whole or part?
- Are the surveys "required"?
Payment for Recruitment
Finder's fees and other financial incentives paid by a sponsor or by an investigator to others related to the recruitment of research subjects are prohibited.
Payments should never go directly to investigators, key personnel or subjects without first going through the University.
No one may receive any incentive for the purpose of encouraging individuals to participate in research.
All payment by sponsors for research conducted under the auspices of the University of Virginia must be made directly to the University of Virginia and will be managed by the University.
*Taken from UVa IRB-HSR Research Guidance*