Office of Human Research
Page Title

SOP No.: 602   SUBJECT RECRUITMENT PRACTICES

Author:    Office of Human Research

Effective Date:  October 1, 2007

Supercedes document dated:              N/A

Last Reviewed on:     N/A                                 

Results of Review:               N/A

This SOP pertains to:  the development, review, approval and implementation of materials and practices used for recruiting prospective participants who may subsequently be enrolled in FDA-regulated human subject research within Thomas Jefferson University.

Responsibility for executing this SOP:  Investigator and Designated Research Personnel

Approved By:

 

J. Bruce Smith, MD

 

Associate Vice President for Research

 

(signature on file at OHR)

Approved By:

 

Steven E. McKenzie, MD, Ph.D.

 

Vice President for Research

 

(signature on file at OHR)

 

1. PURPOSE

This procedure describes the steps for conducting participant recruitment for FDA-regulated human subject research within Thomas Jefferson University.

2. GENERAL INSTRUCTIONS

  1. The Institutional Review Board (IRB) is responsible for reviewing the methods, language and materials in all applicable media that Investigators propose to use to recruit their participants.
  2. Investigators are responsible for the content of all participant recruitment materials and ensuring that those materials have been properly reviewed by the IRB.
  3. Investigators are responsible for consulting with the IRB to ensure that all regulatory requirements have been taken into consideration in the development of these materials.
  4. Investigators and all other participating Investigators are responsible for overseeing participant recruitment and screening efforts for individual clinical research studies.

3. SPECIFIC PROCEDURES

3.1 Reviewing and Approving Recruitment Materials

  1. No claims (explicit or implicit) should be made in the recruitment materials that the investigational product is safe or effective for the purpose(s) under investigation, or that the investigational product is equivalent or superior to currently marketed products.
  2. Recruitment materials should not use terms such as "new treatment" or "new medication" or "new drug" that may confuse the prospective participant into thinking that the product is approved for that use.
  3. All materials should clearly state that the product is investigational or an alternative term that is understandable to the participant population.
  4. Recruitment materials also should not be misleading in any way, nor coercive to vulnerable populations, such as by overemphasizing monetary payments or making promises about the certainty of treatment success.
  5. The amount of monetary compensation needs to be carefully determined so as to not be coercive, thus enabling the prospective participant to make an informed decision about participating in the study.
  6. Only language appropriate for the target population will be used in recruitment advertisements intended for that population.
  7. FDA guidance permits the following information to be provided in participant recruitment materials:
    • Name and address of the Investigator and/or study facility
    • Purpose of the study and summary of eligibility criteria
    • Expected duration of the study
    • Straightforward and truthful description of benefits to participants
    • Location of the study and who to contact for information
  8. The Investigator should have draft recruitment literature, telephone scripts and the text of materials to be audio taped or videotaped evaluated by the IRB for regulatory compliance.
  9. All recruitment materials will be submitted to the IRB for review and approval prior to use.
  10. Subjects will be recruited in an unbiased manner, irrespective of race, religion, sexual orientation, or economic status; unless a specific inclusion or exclusion is dictated in the clinical protocol and approved by the IRB.
  11. To ensure unbiased selection of participants, screening logs should be maintained by the site for each study (Reference SOP 603, Subject Screening and Enrollment).
  12. Special issues regarding the recruitment and enrollment of vulnerable populations will be submitted to and reviewed by the IRB.
  13. No publishing and distributing or other use of any recruitment materials may occur until the materials have been approved by the IRB.
  14. Copies of all recruitment materials and their approvals must be maintained in the appropriate section of the Regulatory Master File.
  15. In conducting investigator-initiated trials, the Investigator is responsible to ensure the above is being conducted for each participating site.

3.2 Developing and Implementing the Recruitment Plan

  1. The following are important elements of a recruitment plan:
  2. The Investigator is responsible for following all institution policies on recruitment and identifying the target population for potential study participants based on specific inclusion/exclusion criteria for a study.
  3. The Investigator should establish a recruitment timeline and identify sources of potential participants.
  4. The Investigator should determine appropriate recruitment methods (e.g., video/radio ads, letters, community talks, newspaper articles, patient support groups, Internet) based on these assessments.
  5. The Investigator should monitor the progress and assess the results of the recruitment strategy, and develop appropriate alternative strategies, if necessary, if participant enrollment is less than optimal.

4. APPLICABLE REGULATIONS AND GUIDELINES

21 CFR 50.20

General requirements for informed consent

21 CFR 56.109

IRB review of research

21 CFR 312.60

General responsibilities of investigators

21 CFR 312.62

Investigator recordkeeping and record retention

FDA Information Sheets, October 1998

Screening Tests Prior to Study Enrollment and Recruiting Study Subjects

May 1997

International Conference on Harmonisation; Good Clinical Practice:  Consolidated Guideline

5. REFERENCES TO OTHER APPLICABLE SOPs

GA-102

Responsibilities of the Research Team

SS-201

Assessing Protocol Feasibility

SS-204

Protocol Start-Up

PM-303

Regulatory Files and Subject Records

SM-401

Informed Consent Development and Implementation

SM-403

Subject Management While on Study

6. ATTACHMENTS

A. Guidelines for Recruitment and Advertising

7. DEFINITIONS AND GLOSSARY

The following definitions from the International Conference on Harmonisation, Good Clinical Practice: Consolidated Guideline apply to this SOP.

Informed Consent: A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject’s decision to participate. Informed consent is documented by means of a written, signed, and dated informed consent form.

Subject/Trial Subject: An individual who participates in a clinical trial, either as a recipient of the investigational product(s) or as a control.

Vulnerable Subjects: Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate. Examples are members of a group with a hierarchical structure, such as medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention. Other vulnerable subjects include patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons, patients in emergency situations, ethnic minority groups, homeless persons, nomads, refugees, minors, and those incapable of giving consent.

 

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