General Recruitment PoliciesRecruitment plans for research projects should be designed to fully encompass racial, ethnic, and gender diversity. Efforts to identify and recruit potential human research subjects should be designed to respect personal rights to privacy and confidentiality. Everything possible should be done to avoid coercion of subjects in their recruitment for research study participation. Recruitment of vulnerable subjects should be done with respect to the regulations at 45 CFR 46, Subparts B, C or D, as appropriate. Show
Recruitment methods will be evaluated to ensure compliance with federal regulations as well as HIPAA Privacy rules. All print, video, and audio advertisements used to solicit prospective research subjects (‘directed advertising’) must be reviewed and approved by the IRB prior to dissemination. The IRB prohibits cold-calling of potential research subjects. "Cold-calling" is the practice of investigators or research staff, unknown to the potential research subject, initiating contact with the potential subject based on their prior knowledge of private information. To avoid a cold-calling scenario, the research study should be introduced to the potential research subject by an individual who, by virtue of his/her position, would normally have access to the potential subject’s confidential information (e.g., the personal physician of the potential subject or a member of the clinic or practice staff). If the potential research subject indicates an interest in study participation, s/he should be instructed to either (a) contact the investigators directly or (b) permit the individual who initiated this contact to share with the research team the person’s interest in study participation so that the researchers can subsequently contact the potential subject and provide more information about the study. The individual who initially introduced the study to the potential subject should document this permission in his/her records. As per the HIPAA privacy regulations, a health care provider may not share individually identifiable health information with research investigators without the written authorization of the patient. Hence, whenever there is the possibility that the potential subject’s health information and identity will be shared with members of the research team, a valid HIPAA authorization may be required from the potential subject. There are exceptions, however. For example, when a UPMC clinician refers a potential subject to a UPMC researcher a written HIPAA authorization is not required. The referring UPMC clinician must document in the clinical record the potential subject’s permission for his/her contact information to be shared with the UPMC researcher. More discussion of this, with model HIPAA authorizations for sharing health information is available in the IRB HIPAA Guidance Web page. Examples of acceptable methods of contacting and/or recruiting potential research subjects include:
Directed AdvertisingDirected advertising includes, but is not limited to, newspaper, radio, TV, Internet ads, audio/video tapes, bulletin boards, posters, and flyers that are intended for prospective subjects. The following are not considered to be 'direct advertising' and do not require prospective IRB review:
Examples of clinical trial listing services that do not need IRB review and approval include the National Institutes of Health (NIH) ClinicalTrial.gov website, the NIH National Cancer Institute’s cancer clinical trials listing (Physician Data Query [PDQ]), FDA Clinical Trials, and the government-sponsored AIDS Clinical Trials Information Service (ACTIS). When information posted on a clinical trial website goes beyond directory listings, such information is considered part of the recruitment and informed consent process and requires IRB review and approval. Examples of information which would exceed basic listing information include descriptions of clinical trial risks and potential benefits or solicitation of identifiable information (e.g., name and contact information). Submission of Advertisements Directed at Potential Research SubjectsAdvertisements directed at potential research subjects should be reviewed at the time of initial IRB review of the protocol. Advertisements directed at potential research subjects not reviewed at the time of initial IRB review must be submitted as a modification and reviewed in an expedited manner by the IRB.
Approval CriteriaThe following criteria must be met in order to gain IRB approval:
The advertisement should generally be limited to the information that potential subjects need to determine their eligibility and interest in the research. When appropriately worded, the following items may be included in advertisements, but are not required:
Investigator NotificationsInvestigators will be notified in writing of IRB approval of advertisements directed at potential research subjects. The written notification of IRB approval of the research will include a statement that the advertisement was approved by the IRB. In addition, the correspondence will specify that any substantive modification of the advertisement requires re-approval by the IRB prior to dissemination. What kinds of persons and organizations are affected by Hipaa's requirements?What kinds of persons and organizations are affected by HIPAA's requirements? Health care providers, health plans, and health information clearinghouses, their business associates, and the workers for those organizations.
How the principle of beneficence can be applied to a study employing human subjects?Terms in this set (29) Which of the following is an example of how the principle of beneficence can be applied to a study employing human subjects? Determining that the study has a maximization of benefits and a minimization of risks.
Which of the following is true with respect to the IRB chair time commitments?Which of the following is true with respect to IRB chair time commitments? The IRB chair's time commitment includes the IRB meetings, but may also include other activities such as expedited reviews and non-compliance issues.
Which example of research with prisoners would be allowable under the regulations?Which example of research with prisoners would be allowable under the regulations? Examining age at first arrest as a predictor of adult criminal history. Examining age at first arrest is the correct answer.
|