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HRPP Policy - Recruitment of human subjects
About This Policy
- Effective date:
- Last updated:
- Policy Contact:
IU Human Subjects Office
A criterion for approval of research is that selection of subjects is fair and equitable. The IRB evaluates this criterion by considering both the selection criteria and proposed plans for recruitment of subjects for each research study. Recruitment represents the beginning of the consent process; as such, all recruitment methods and materials must meet ethical guidelines and must be reviewed and approved by the IRB before recruitment begins.
The IRB must ensure that recruitment methods and materials, including payment amount and timing of disbursement to subjects, are not coercive, misleading, or unduly influential. If the circumstances of the research could give rise to any level of undue influence (e.g., payment for subjects' participation, instructors recruiting their own students, supervisors recruiting their direct reports, health care professionals recruiting their own patients), the study team must provide appropriate safeguards and/or assurances that the decision to participate will not affect the relationship.
Recruitment materials directed to potential subjects must be reviewed and approved by the IRB prior to use to ensure they are not unduly influential or misleading. Materials directed to other audiences (e.g., materials given to health care providers, teachers, or schools who will facilitate recruitment of subjects; news articles not intended for recruitment of subjects; financial page information for investors) and listings on clinical trial websites which provide basic information limited to title, purpose, study summary, basic eligibility criteria, locations, and contact information do not need to be reviewed by the IRB.
Recruitment materials must include information prospective subjects need to determine their eligibility and interest. Materials should be written in a language understandable to the subjects, and may not:
- Emphasize the payment or payment amount by such means as larger or bold type
- Include exculpatory language
- State or imply certain favorable outcomes or other benefits beyond what is outlined in the informed consent document and the protocol
- Claim that an investigational drug, biological product, or device 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, biological product, or device
- Use terms such as "new treatment" or "new drug" without explaining that the test article is investigational
- Promise free medical treatment when the intent is only to say that subjects will not be charged for taking part in the study
- Include a coupon or other incentive from the sponsor for a discount on the purchase price of the test article once it has been approved for marketing.
Recruitment methods are described and justified in the IRB application, including:
- identification of potential subjects
- plans for contacting potential subjects
- payment arrangements for subjects' participation
- potential undue influence
Recruitment materials directed to potential subjects are attached to the IRB application.
For FDA-regulated research, the IRB must review and approve the final versions of any printed, audio, or video advertisements; however, the IRB may review and approve the wording prior to taping or final design.
Individuals found to be in violation of this policy may be subject to sanctions relating to their participation in research with human subjects, up to and including permanent suspension or debarment from engaging in research with human subjects at Indiana University.Back to top
IU HRPP Policies
Related Policy Documents
IU HRPP Guidance
Related Guidance Documents
- AAHRPP Standards
- Element II.3.C
- Element III.1.E
- 45 CFR 46.111
- FDA Guidance: Recruiting Study Subjects Information Sheet, Guidance for Institutional Review Boards and Clinical Investigations
- IU Policy on Drawings, Games, and Prizes
- OHRP Guidance: Clinical Trial Website: When is IRB review required and what should IRBs consider with reviewing?
clinical trial A research study in which one or more human subjects are prospectively assigned to one more interventions (which may include placebo or other control) to evaluate the effects of the interventions on biomedical or behavioral health-related outcomes.
device (medical device) As regulated by the FDA, an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is: 1) recognized in the National Formulary, or the United States Pharmacopeia, or any supplement to them; 2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals; or 3) intended to affect the structure or any function of the body of man or other animals, and; which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes. See FDA Guidance for Industry and FDA Staff on Classification of Products as Drugs or Devices and Additional Product Classification Issues.
drug As regulated by the FDA, A) articles recognized in the official United States Pharmacopoeia, official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and B) rticles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and D) articles intended for use as a component of any articles specified in clause (A), (B), or (C). See FDA Guidance for Industry and FDA Staff on Classification of Products as Drugs or Devices and Additional Product Classification Issues.
informed consent An ongoing process by which a subject (or his/her legal representative) voluntarily confirms his or her willingness to participate in a particular research project in accordance with the IU HRPP Policy on Informed Consent.
investigational biologic, drug, device, or test article A drug or device that is the object of a clinical investigation.
recruitment Initial identification and contact with potential subjects, which may include both direct interactions with individuals and/or accessing identifiable data or specimens for the purpose of determining whether an individual or their data or specimen may participate or be included in a study.
research A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge (Synonymous with clinical investigation For research subject to FDA regulations, any experiment that involves a test article and one or more human subjects, and that either must meet the requirements for prior submission to the FDA under §505(i), §507(d), or §520(g) of the Food, Drug & Cosmetic Act, or need not meet the requirements for prior submission to the FDA under these sections of the act, but the results of which are intended to be later submitted to, or held for inspection by, the FDA as part of an application for a research or marketing permit. The term does not include experiments that must meet the provisions of part 58 regarding nonclinical laboratory studies (21 CFR 50.3(c)).) The following activities are deemed not to be research under this definition: Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information that focus directly on the individuals about whom the information is collected; Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters); Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for the activities authorized by law or court order solely for criminal justice or criminal investigative purposes; Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.
sponsor An individual, company, institution, or organization that takes responsibility for the initiation, management, and/or financing of research.
test article Any drug for human use, biological product for human use, medical device for human use, human food additive, color additive, electronic product, or any other article subject to regulation under the Food, Drug, and Cosmetic Act or under §351 or §§354-360F of the Public Health Service Act.Back to top