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Human Studies Committee

The charge of the HSC is to safeguard the individual  rights and welfare of human subjects of research and ensure that clinical research is conducted according to federal, State, and institutional policies and regulations.

Click here to access the HSC 2014 Schedule

For HSC Protocol Submission forms, please go to IRBNet.
 

Policies
Adverse Events and Unanticipated Problems Reporting Policy
IRB Fee Policy
Noncompliance Policy
PI and HSC Jurisdiction Policy - January 2013
Protocol Exception and Reporting of Protocol Violations Policy - January 2013

Training in Human Subjects Research
Personnel Requirements (Updated 2/25/2014)
 

Contact Info:

         HSC@meei.harvard.edu

         Human Studies Committee (HSC) 
         Fariba Houman
         Director, Human Research Protections Program
         (617) 573-3446
         Fariba_Houman@meei.harvard.edu


EXTERNAL RESOURCES

Guidance for Industry - Investigational New Drug Applications (INDs)
Harvard Committee on Microbiological Safety (COMS)
PRIM&R - Public Responsibility in Medicine and Research

FDA

FDA
Good Clinical Practice in FDA-Regulated Clinical Trials
Guidance for Institutional Review Boards (IRBs), Clinical Investigators and Sponsors

NIH
Inclusion of Children Policy Implementation

Office of Human Research Protections, Health and Human Services
OHRP
OHRP Policy & Guidance
The Belmont Report
Federal Policy for the Protection of Human Subjects 'Common Rule'

Guidance on Certificates on Confidentiality
HIPAA
The Nuremberg Code

 

 

 

 

Page updated 4/10/2014.