News

GCP Training Required for NIH-Sponsored Clinical Trials

December 16, 2016

The National Institutes of Heath (NIH) policy on Good Clinical Practice (GCP) training takes effect January 1, 2017

This policy establishes the expectation that all NIH-funded investigators and staff who are involved in the conduct, oversight, or management of clinical trials should be trained in Good Clinical Practice (GCP), consistent with principles of the International Conference on Harmonisation (ICH) E6 (R2).

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NIH Single IRB Requirement Postponed

December 16, 2016

The National Institutes of Health (NIH) is extending the effective date of the NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research from May 25, 2017, to September 25, 2017.

A copy of the NIH Policy was published in the Federal Register on June 21, 2016 (81 FR 40325). See https://www.gpo.gov/fdsys/pkg/FR-2016-06-21/pdf/2016-14513.pdf 

Guidance and Frequently Asked Questions to assist in the implementation of the policy will soon be available at http://osp.od.nih.gov/office-clinical-research-and-bioethics-policy/clinicalresearch-policy/models...

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Undergraduate Research and Course Projects

December 5, 2016

Undergraduate students at Harvard are encouraged to become deeply involved in the research life of the University. There is a vast array of opportunities for students at all experience levels to participate in academic inquiry, from research assistantships to independent projects. Frequently, these research projects involve interactions with and/or identifiable data about human beings as participants.  While some undergraduate research activities that involve human participants require approval by the Institutional Review Board (IRB; the federally mandated committee that...

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