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Sandra M. Stevens Hunt
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From: OR-IRB-HRP <firstname.lastname@example.org> On Behalf Of Office of Research Human Research Protections/Institutional Review Board
Sent: Thursday, April 11, 2019 9:33 AM
Subject: [Human Research Protections] NIH Releases Protocol Template for Behavioral and Social Sciences Research Involving Humans
NIH Releases Protocol Template for
Behavioral and Social Sciences Research Involving Humans
On April 1 2019, the NIH Office of Science Policy launched a new protocol template for Behavioral and Social Sciences Research.
The aim of the protocol template is help behavioral and social science researchers prepare research protocols for human studies measuring social or behavioral outcomes, or testing a behavioral or social science-based intervention.
There are important benefits for using the new behavioral and social sciences research template:
§The template is an effective resource for communicating the science, methods, and operations of a clinical trial, allowing for standardization of procedures and guiding replication studies.
§Consistent use of the template will reduce the chance for inaccuracies in study procedures that could potentially result in null or spurious findings.
§It fosters training and accountability of study staff and allows for efficient review by peers and oversight bodies.
§It assists investigators who are less familiar with the information and level of detail expected in a clinical protocol and fully adheres to the International Conference on Harmonisation (ICH) E6 Good Clinical Practice guidelines.
§Using the template through the e-Protocol Writing Tool allows users to seamlessly send and edit protocol information directly to clinicaltrials.gov.
While the template is a suggested format for clinical trials that are testing a behavioral or social intervention or manipulation, it can be an effective tool to help anticipate decision-points and potential challenges before a study launches, which can help avoid delays down the road.
§NIH e-Protocol Writing Tool Portal: https://e-protocol.od.nih.gov/#/home
§NIH Clinical Trial E-Protocol Tool and Template Documents: https://osp.od.nih.gov/clinical-research/clinical-trials/
Use of the template is encouraged, but it is not mandatory.
Questions about the new protocol template can be sent to the NIH Office of Science Policy at: SciencePolicy@od.nih.gov
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