Click here to see RSA brochure

Click here to see Research Subject's Bill of Rights

Watch a brief video describing an overnight visit (Click here for an English version; Click here for a Spanish version)

Watch a brief video describing an outpatient (not overnight) visit (Click here for an Englsih version; Click here for a Spanish Version)

Click here to watch a brief video describing Metabolism and Nutrition procedures (English version)

Click here to watch a brief video describing DEXA procedures (English version)

Introduction   
To provide greater safeguards for participants in clinical research studies carried out by the CRC, the National Center for Research Resource (NCRR) has stipulated that each CRC program have a Research Subject Advocate (RSA) program. The RSA program provides oversight for the protection of human subjects at the MGH, MIT, and CNY CRCs. This program is supported through the NIH grant to the CRC and is directly responsible to the PI of the grant, Dr. Peter L. Slavin. Enrico Cagliero, MD is the Director of the RSA.

The responsibilities of the program have been specified by the NCRR, and include:

• Administration of informed consent
  
• Ensuring that the research carried out on the CRC is in compliance with the IRB and GAC approved protocols
  
• Review adverse event reporting
  
• Evaluating and assisting in data and safety monitoring and ensuring that Data Safety Monitoring Plans and Data and Safety Monitoring Boards are fully implemented
  
• Monitoring required education for the protection of human subjects
  
  

Why is the CRC RSA program important to you?           top
The RSA is available to ensure protocol implementation and compliance with the NIH and IRB regulatory guidelines for human safety monitoring. For RSA assistance, please contact Enrico Cagliero, MD at 617-726-7702.

RSA Brochure

Data and Safety Monitoring Plan (DSMP)
and Data and Safety Monitoring Board (DSMB)        top

All CRC protocols are required by the NIH to have a Data and Safety Monitoring Plan (DSMP). CRC protocol applications will include a DSMP, described in Turbo and will complete a DSMP worksheet. Please see links below for further details:

DSMP/DSMB Guidelines
DSMP Worksheet

CRC Sample DSMB Charter

Regulatory Links for Investigators           top

• NIH Policy and Guidelines on The Inclusion of Children as Participants in Research Involving Human Subjects:
  
• Guidance for Industry – Guidance for Human Somatic Cell Therapy and Gene Therapy:
  
• Reporting forms for AE and SAE for INDs & IDEs. Additionally, Safety Alerts for Drugs, Biologics, Devices, and Dietary Supplements:
  
• NIH web site about Certificates of Confidentiality:
  
• Partners IRB:
  
• The Food and Drug Administration (FDA):
  
• National Center for Research Resources (NCRR):
  
• National Institutes of Health (NIH):
  
• Office of Research Integrity:
  
• HIPAA - Office of the Secretary; Standards for Privacy of Individually Identifiable Health Information; Proposed Rule [HIPAA; 45 CFR Parts 160 and 164]:
  
• NIH guidelines on inclusion of women and minorities as subjects in clinical research (August 2, 2000):

Genetics  top

• Gene Therapy Patient Tracking System – Final Document June 27, 2002:
  
• Guidance for Industry – Supplemental Guidance on Testing for Replication Competent Retrovirus in Retroviral Vector Based Gene Therapy Products and During Follow-up of Patients in Clinical Trials Using Retroviral Vectors:
  
• Partners Guidelines for Genetic Research:
  
• Massachusetts - Chapter 254 of the Acts of 2000 – An Act Relative to Insurance and Genetic Testing and Privacy Protection:

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