The IRB considers recruitment of subjects to be all procedures that take place from the first contact with a potential subject to the point when they enroll in a study or return a completed survey. This includes follow-up contacts, or "nudges", used as reminders to complete mail, e-mail, or telephone surveys.
Following are policies regarding advertising that may be used, be it paper or oral, and the number of follow-up contacts that will be allowed. Any deviations to these policies must be submitted with justification for the need and are subject to review by the full committee.
A. Media Advertising:
Direct advertising for research subjects, i.e., advertising that is intended to be seen or heard by prospective subjects to solicit their participation in a study, is not in and of itself, an objectionable practice. Direct advertising includes, but is not necessarily limited to: newspaper, radio, bulletin boards, posters, and flyers that are intended for prospective subjects. Also included are “dear doctor” letters when soliciting for study subjects. Not included are: (1) news stories and (2) publicity intended for other audiences, such as financial page advertisements directed toward prospective investors.
The IRB considers direct advertising for study subjects to be the start of the informed consent and subject selection process. Advertisements should be reviewed and approved by the IRB as part of the package for initial review. When the investigator decides at a later date to advertise for subjects, the advertising requires an amendment to the ongoing study. If such advertisements are easily compared to the approved consent document, the IRB chair, or other designated IRB member, may review and approve the advertising document by expedited procedures. If the IRB reviewer has doubts, or other complicating issues are involved, the advertising will be reviewed at a convened meeting of the IRB.
The IRB reviews advertising to assure that it is not unduly coercive and does not promise a certainty of cure beyond what is outlined in the consent 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 the mode of its communication to determine 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 document 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 will review the final audio/video tape. The IRB may review and approve the wording of the advertisement prior to taping. The review of the final taped message prepared from IRB approved text may be accomplished through expedited procedures. The IRB cautions investigators to obtain IRB approval of message text prior to taping, in order to avoid having to re-tape because of a finding of inappropriate wording.
For clinical studies, no claims should be made, either explicitly or implicitly, that the drug, biologic 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, biologic or device. Such representation would not only be misleading to subjects but would also be a violation of federal regulations concerning the promotion of investigational drugs.
Advertising for recruitment into investigational drug, biologic or device studies should not use terms such as “new treatment,” “new medication” or “new drug” without explaining that the test article is investigational. A phrase such as “receive new treatments” leads study subjects to believe they will be receiving newly improved products of proven worth.
Advertisements should not promise "free medical 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 by such means as larger or bold type.
Generally, 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 may be included in advertisements. It should be noted, however, that the IRB does not require inclusion of all of the listed items.
- the name and address of the investigator and/or 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 participation benefits, if any (e.g., a no-cost health examination);
- the time or other commitment required of the subjects; and
- the location of the research and the person or office to contact for further information.
B. Receptionist Scripts:
Often, the first contact a prospective study subject makes is with a receptionist who follows a script to determine basic eligibility for the specific study. The IRB will assure the procedures followed adequately protect the rights and welfare of prospective subjects. In some cases, personal and sensitive information is gathered about the individual. The IRB should have assurance that the information will be appropriately handled. A simple statement such as "confidentiality will be maintained" does not adequately inform the IRB of the procedures that will be used.
Examples of issues that should be reviewed: What happens to personal information if the caller ends the interview or simply hangs up? Are the data gathered by a marketing company? If so, are names, etc. sold to others? Are names of non-eligibles maintained in case they would qualify for another study? Are paper copies of records shredded or are readable copies put out as trash? The acceptability of the procedures would depend on the sensitivity of the data gathered, including personal, medical and financial information.
The IRB will generally allow 5 contacts with potential subjects in mail, e-mail, or telephone surveys.
- Pre-contact postcard/letter
- Information sheet and survey
- Follow-up postcard/letter
- Second mailing of survey
- Telephone contact
After the telephone contact (actually speaking with a person, as opposed to leaving a message), any further contact would be with stipulations such as the caller verbally agrees to be re-contacted in a couple of weeks by a postcard reminder if the survey is not returned. The potential subject must explicitly agree to any further follow-up. For example, in the telephone contact, when the potential subject has agreed to have another survey sent, the researcher could ask: "Could we call you again in 2-3 weeks to remind you to return the survey?" or "Could we send you a card in 2-3 weeks to remind you to return the survey?" Anytime a referral to a more appropriate potential subject is made, then the recruitment procedure can go back to item one and start over.
All possible follow-up procedures must be approved by the IRB first. Procedures requested outside of this policy will be evaluated on a case by case basis.