Which of the following elements should not be included on a recruitment poster:
This guidance document defines the standards and parameters for utilization of advertisements and other recruitment materials in research studies. The main purpose of such materials is to inform and invite potential subjects to participate in a research study. Advertisements and recruitment materials targeting research participants should be thought of as the beginning of the informed consent process. These materials should be limited to the information prospective subjects need to determine their eligibility and interest. Show
Advertisements and Recruitment MaterialsPrior to posting and/or distribution, the IRB must approve the final content of any and all advertisements and recruitment materials for studies that are conducted under the purview of the IRB. This includes but is not limited to recruitment via flyers, telephone (verbal guide), SONA, email, social media, and internet*. This information should be submitted to the IRB with the initial application or project revision. The IRB reviews the material to assure that it is accurate, not coercive or unduly optimistic, and not creating undue influence on the subject to participate; this includes but is not limited to: a) Statements implying a certainty of favorable outcome or other benefits beyond what is outlined in the consent document and protocol b) Claims, either explicit or implicit, that the activity, intervention, drug, biologic or device is safe or effective for the purposes under investigation c) Claims, either explicit or implicit, that the activity, intervention, or test article is known to be equivalent or superior to any other drug, biologic or device d) Use of terms like “new test,” “new treatment,” “new method,” or “new drug” without explaining that it is investigational e) Promises of “free tests,” or “free treatment” when, in actuality, the participants will just not be charged for taking part in the investigation f) Emphasis on compensation (e.g., bold type, larger font, etc.) g) Inclusion of exculpatory language Recruitment materials mustinclude: a) Title of the study b) Name of the PI c) Clear statement that this is research or a study d) Contact information for interested individuals When appropriately worded, the following items may be included: a) Condition being studied and/or the purpose of the research b) Primary criteria that will be used to determine eligibility for the study. Consideration should be given to whether the method of recruitment and the presentation of eligibility criteria could result in additional risk. For example: email: "We are contacting you because you attended a support group for..." vs. email: "Researchers would like to learn more about people who...". c) Time or other commitment required of the subjects d) Location of the research e) Potential direct or societal benefits Recruitment materials and compensation plans cannot include: a) coupons or discounts on the purchase price of the study product, if marketed Once approved by the IRB, recruitment materials cannot be manipulated or altered without review and approval. For exempt and FLEX studies there are certain exceptions to this policy. Please see the project revision guidance for more information. *Recruitment using social media ads that are size limited (e.g Facebook, Twitter, etc.) must be linked to a page or document that contains all required recruitment elements. Examples Recruitment Email Recruitment Flyer with Pull-tags Recruitment Business Cards Bad Flyer Sample Good Flyer Sample Guidance Version Date: January 19, 2018 All materials aimed at recruiting participants into a research study (including the final copy of printed advertisements, scripts, audio or video tapes, or web sites) must be reviewed and approved by the IRB prior to use (HRP-315). You will be asked to include a description of your recruitment methods in either the protocol or the local addendum to the sponsor’s protocol.
Required Elements
For additional guidance on recruitment materials, refer to HRP-315 WORKSHEET Advertisements (Recruitment Materials) Recommended Elements
Elements That Are Not Allowed*
*Contact the IRB with any requests to include disallowed elements that may be appropriate within specific contexts of research. Types of Recruitment MaterialsTeaser AdvertisementsFor online recruitment, projects may use teaser ads placed on social media sites such as where character length is limited:
Social MediaSocial media can be defined as any online and mobile resource that provides a forum for generating, sharing, or discussing ideas and content; variably grouped as online communities (e.g., patient support groups, population-specific dating services); social networking (e.g., Facebook; Twitter); professional networking (e.g. LinkedIn); content production and sharing (e.g., YouTube, Tumblr, blogs); location-based services (e.g. Tinder, Grindr); and others. Ensure that proposed social media recruitment strategies respect all relevant ethical norms, including:
What is the difference between Groups and Pages in Facebook?Pages are open forums that can be created by companies, celebrities, and brands. These are public and although only administrators of Pages can post to the account, people with personal Facebook profiles can comment on any posts or pictures. The comment feature cannot be disabled, but comments can be removed/hidden by the administrator. Groups can be more private than Pages because the administrator has an option to choose the privacy setting. The comment feature can be managed in each group, as determined by the administrator.
Bulk E-MailThe IRB is responsible for the review and approval of the content of bulk e-mail intended to solicit participants for a research study. It does not oversee the sending of the bulk e-mail at Northwestern. Investigators should ensure they are in compliance with for the use of bulk e-mail at Northwestern and the steps for obtaining approval to send bulk e-mail through the enterprise Northwestern Bulk E-mail system. Press Releases & Interviews (Media Relations)Federal regulatory bodies view media relations material as a form of participant recruitment and an element of the informed consent process. Media relations material includes press releases, scripted broadcasts, non-scripted interviews or information distributed on the Internet. For more information on when to submit media relations materials and accompanying information to the IRB please see our dedicated Media Relations webpage. Recruiting Individuals Where No Treatment Relationship ExistsNMHC Health Care Professionals or Northwestern employed Researchers who are recruiting patients where no treatment relationship exists may recruit NMHC patients as follows:
Recruitment Materials That Do Not Require IRB Review per FDA Guidelines
Recruitment Strategies That Are Not Allowed
In which of the following studies would it not be appropriate to provide subjects with information?In which of the following studies would it NOT be appropriate to provide subjects with information about missing elements of consent: Your answer : A study in which subjects were assigned to study activities based on an undesirable or unflattering physical characteristic as assessed by members of the research team.
Which of the following is a requirement of an informed consent form quizlet?A general requirement for the informed consent form is that it may not include any exculpatory language. Exculpatory language is that which waives or appears to waive any of the subject's legal rights or releases or appears to release those conducting the research from liability for negligence.
What is the relationship between an institution and the institution's IRB?The relying institution must assure the IRB that conflicts have or can be managed or resolved. The reviewing IRB has the right to request additional information and to require additional management and opportunity to further review the case. Relying institution's policies govern COI.
Which of the following statements in a consent form is an example of exculpatory language quizlet?Which of the following statements in a consent form is an example of exculpatory language? I waive any possibility of compensation for injuries that I may receive as a result of participation in this research.
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