Recruitment of Human Subjects
The following information and samples are provided to help researchers develop recruitment materials customized to the design of the individual research project.
Sample subject recruitment advertising
60-second radio scripts
Sample A
Ever get cold sores? Developing cold sore sensations may include tingling or burning around the lips. If you feel a cold sore developing, please listen. You might be qualified for a research study of an investigational medication for cold sores. Call toll free: 1 (888) 99-STUDY. That's 1 (888) 99-STUDY. You must have experienced at least two cold sores within the past year and be over 18. Qualified participants will be compensated and will receive topical study medication. If you feel a cold sore developing, please call Viral Study Associates as soon as possible: 1 (888) 99-STUDY. This is a toll free number: 1 (888) 99-STUDY.Sample B
Do you get cold sores? You know, fever blisters? Listen carefully, you might be qualified for a research study of an investigational medication for cold sores. If you qualify, you'll receive topical study medication, and you will be compensated. Call toll free: 1 (888) 99-STUDY. That's 1 (888) 99-STUDY. Volunteers must have experienced at least two cold sores within the past year and be over 18. To find out if you qualify, please call Viral Study Associates as soon as possible: 1 (888) 9-9-S-T-U-D-Y. This number is toll free. Do you get cold sores? Call 1 (888) 99-STUDY.
Guidelines for subject recruitment advertising
It is the policy of Western 麻豆传媒应用 University that all research involving human subjects will be reviewed by the IRB. As part of the review process, the IRB reviews all research documents and activities that bear directly on the rights and welfare of the subjects of the proposed research. These include the protocol, research instruments, consent documents and methods that investigators propose to recruit subjects. The involvement of human subjects in research is not permitted until the IRB has reviewed and approved the research protocol. This means that no contact with subjects, including recruitment and obtaining consent, can be initiated until the research has been approved, although researchers may contact organizations from which subjects will be recruited.
Direct advertising (i.e., advertising that is intended to be seen or heard by prospective subjects) includes, but is not limited to, newspapers, radio, television, bulletin boards and the internet. Not included are professional communications between health professionals and bona fide media news stories. Direct advertising for study subjects is considered to be the start of the informed consent and subject selection processes. Advertisements must be reviewed and approved by the IRB as part of the package for initial review. When the investigator(s) decide at a later date to advertise for subjects, the advertising is considered an amendment to the ongoing study. The IRB reviews the advertising to assure that it is not unduly coercive and does not promise a certainty of cure beyond what is outlined in the consent documents and the protocol. This is especially critical when a study may involve subjects who are likely to be vulnerable to undue influence.
When direct advertising is to be used, the IRB will review the information contained in the advertisement and its mode of communication. This is to ensure that the procedure for recruiting subjects is not coercive and does not state or imply a certainty of favorable outcome or other benefits beyond what is outlined in the consent documents and the protocol. The IRB will review the final copy of printed advertisements to evaluate the relative size of type used and other visual effects. When advertisements are to be taped for broadcast, the IRB must review the final audio/video tape. The IRB may review and approve the wording of the advertisement prior to taping to preclude re-taping because of inappropriate wording.
No claims should be made, either explicitly or implicitly, that the experimental procedure is safe or effective for the purposes under investigation, or is known to be equivalent or superior to any other procedure. Advertising for recruitment into studies should not use terms such as "new treatment" or "new procedure" without explaining that the procedure is investigational. Advertisements should not promise "free treatment" when the intent is only to say subjects will not be charged for taking part in the investigation. Advertisements may state that subjects will be paid but should not emphasize the payment or the amount to be paid.
Any advertisement to recruit subjects should be limited to the information the prospective subjects need to determine their eligibility and interest. When appropriately worded, the following items should be included in all advertisements:
- The name and address of the investigators and research facility.
- 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.
- A brief list of potential benefits, if any, to the participant, to society, or to the discipline.
- The time or other commitment required of the subjects.
- The location of the research and the person or office to contact for further information.