ࡱ> sur 'bjbj 4N}c}cu/4 4 {  8dA<\}L[[[[[[[$g^a[[[v###d[#[##2dUTYU hpW.[i\T\.W&ada\TYaTYPv0T#D<[[<"\a4 A: Saint Louis University Institutional Review Board (IRB) GUIDELINES FOR RECRUITMENT OF SUBJECTS FOR RESEARCH Recruitment materials that are seen or heard by prospective subjects to solicit participation in a study are considered part of the consent process and must have IRB approval prior to their use.( Below are acceptable recruitment methods to solicit potential subjects for research projects. Please describe, using sufficient detail, one or more of these methods in the appropriate section of your IRB application. IRB approval is not required for i) communications intended to be seen or heard by health professionals (such as dear doctor letters that request referrals), ii) general news story information or iii) publicity intended for other audiences (such as potential investors). The Principal Investigator (PI) or co-investigator can recruit his/her own subjects where the investigator has the right to access that population. Two general principles define the right to access: 1) either the investigator knows or is affiliated with the subjects, (for example, a school principal can approach students from his/her own school, a physician can recruit his/her own patients, etc.) or 2) anyone in the general population would have access to the subjects (for example, the investigator can send a letter to individuals on a publicly available list. It is always important for the investigator to err on caution when deciding whether or not a list is publicly available. Investigators should call the IRB for assistance in this scenario). NOTE: When contacting subjects directly (e.g., via mailed letter or emailed message), the text should include a general statement regarding how the investigator obtained the subjects contact information (e.g., We are contacting members of the XXX Association regarding or You are receiving this questionnaire because you are a health care provider in the State of Missouri.). A. ACCEPTABLE RECRUITMENT METHODS Any of the following acceptable methods of recruitment, including the materials used should receive IRB review and approval prior to use. Direct advertising may be used for the purpose of recruiting prospective research subjects. These advertisements may appear in any of a variety of media outlets: newspapers, worldwide web, radio, television, bulletin boards, posters, etc. Investigators should submit copies of telephone scripts, planned news releases or public service announcements that ask for volunteers. Recruitment advertisements should include the following information as appropriate: Brief description of the study (i.e., purpose) That the study is research (clinical studies should not say it is for treatment) Age restrictions or other qualifications for eligibility Benefits (if any) Time commitment Compensation (if any is offered but without overemphasizing by such means as larger or bold type) Name and address of the investigator or center doing the research Location of the research and name of the person to contact for further information (it should be someone who is knowledgeable about the study, not just a general telephone operator) IRB protocol number and approval details (the IRB office will add this information in the footer at time of approval) Recruitment advertisements should NOT include the following: State or imply a certainty of favorable outcomes or other benefits beyond what is outlined in the consent document and the protocol Exculpatory language Promise of free treatment when the intent is only to say participants will not be charged for taking part in the investigation Claims, either explicitly or implicitly, about the drug, biologic, or device under investigation that are inconsistent with FDA labeling Use the terms such as new treatment, new medication or new drug without explaining that the article is investigational Information regarding compensation for participation in a trial offered by a sponsor to include a coupon good for a discount on the purchase price of the product once it has been approved for marketing. The PI can send a letter to colleagues, asking for referrals of eligible subjects who are interested in the study. Communications directed to colleagues would not require IRB approval, but this method of recruitment should be stated in the protocol. The PI also can ask physician colleagues to send out general Dear Patient letters describing the study. The PI may draft the letter with the treating physicians signature, but may not have access to the patient names or the mailing addresses. If the PI wants the letters to be individualized for the patients, the personalized information would have to be entered by the treating physician. For clinical studies, the treating physician must make the initial patient contact, not the researcher. If the patient is interested, then either the patient will contact the PI or, with the permission of the patient, the PI will be invited to talk with the patient about study participation. If you are planning to use a business, listserv, school, agency, etc. to recruit subjects, the IRB will need to see a letter from that organization giving the investigator permission to recruit. It is preferred that the recruitment materials come from the organization rather than directly from the researcher. Other methods may be acceptable. Please contact the IRB office ( HYPERLINK "mailto:irb@slu.edu" irb@slu.edu) for assistance if you are unsure whether the method will be appropriate. B. SUBMISSION OF RECRUITMENT MATERIALS Any marketing and communications material using the universitys name or logos (for press releases, paid advertising, study websites, etc.) should follow Saint Louis University standards. Please contact the department of University Marketing and Communications for assistance with the preparation and review of such research recruitment materials prior to IRB submission. Note that the IRB must approve the final version of the recruitment material before it is used. Newslink: If you are submitting an ad via Newslink, the IRB # and approval information should be provided to the editor with the request for posting. For guidelines on how to submit to Newslink, visit this website: /news/newslink/submission-guidelines.php For tips on how to prepare marketing and communication materials, visit  HYPERLINK "/marcom/additional-resources/index.php" /marcom/additional-resources/index.php or the SLU campus communicators website at:  HYPERLINK "http://www.slu.edu/pr/communicators/ad_archive.html" http://www.slu.edu/pr/communicators/ad_archive.html All other recruitment materials may be submitted directly to the IRB. Attach it to a HYPERLINK "/research/faculty-resources/research-integrity-safety/institutional-review-board-irb/irb_assets/form_change-in-protocol_for_information_only.doc"change-in-protocol / for information form (amendment in eIRB) unless it is a part of a new protocol submission. C. REVIEW AND APPROVAL OF RECRUITMENT MATERIALS The IRB will provide investigators with an IRB-approved version once the subject recruitment materials have been reviewed and approved by the IRB. This will include a stamp or footer with IRB approval information. The IRB stamp/footer should be visible on replicated copies when possible (such as flyers, materials for bulletin board posters, etc.). However, we recognize that not all materials can or will be duplicated with the IRB stamp/footer (e.g., glossy posters, newspaper ad, letters sent directly to participants, TV/radio scripts). (Once recruitment materials have received IRB approval, minor changes that do not alter the meaning or emphasis of the message do not require resubmission to the IRB. 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