Reference:USA FDA INFORMATION SHEET - Recruiting Study Subjects, Guidance for Institutional Review Boards and Clinical Investigators Jan-1998 -
From GxPlex
| Document information | |
|---|---|
| Reference | USA FDA INFORMATION SHEET -
Recruiting Study Subjects, Guidance for Institutional Review Boards and Clinical Investigators Jan-1998 |
| Validity area | USA |
| Scope(s) | HM |
| Document name | FDA INFORMATION SHEET -
Recruiting Study Subjects, Guidance for Institutional Review Boards and Clinical Investigators |
| Version / Revision | Jan-1998 |
| Status | Current |
| Document type | Official recommendation |
| Language(s) | EN |
| Description | INFORMATION SHEET
Recruiting Study Subjects Guidance for Institutional Review Boards and Clinical Investigators |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Module | Module 3 — Unit 3.2.1 |
| Scope | HM |
| Document part | - |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Ethics committee, FDA, Requirements, Safety |
Content
FDA requires that an Institutional Review Board (IRB) review and have authority to approve, requiremodifications in, or disapprove all research activities covered by the IRB regulations [21 CFR56.109(a)]. An IRB is required to ensure that appropriate safeguards exist to protect the rights andwelfare of research subjects [21 CFR 56.107(a) and 56.111]. In fulfilling these responsibilities, an IRBis expected to review all the research documents and activities that bear directly on the rights andwelfare of the subjects of proposed research. The protocol, the consent document and, for studiesconducted under the Investigational New Drug (IND) regulations, the investigator's brochure areexamples of documents that the IRB should review. The IRB should also review the methods andmaterial that investigators propose to use to recruit subjects.
A. Media Advertising: […] When direct advertising is to be used, the IRB should review the information contained in theadvertisement and the mode of its communication, to determine that the procedure for recruitingsubjects is not coercive and does not state or imply a certainty of favorable outcome or otherbenefits beyond what is outlined in the consent document and the protocol. [....] B. Receptionist Scripts […]
