Human Subjects Research Program

The Human Subjects Research Program at Brookhaven National Laboratory (BNL) encompasses all research involving human subjects performed at or in conjunction with BNL. Human subjects research includes a wide variety of activities such as in vivo and in vitro studies, research on medical records, collection of data through surveys or observation, research using pathological specimens, discarded tissue, secretions and genetic material and use of investigational drugs or devices.

The Standards Based Management System (SBMS) for Human Subjects  Research is a step by step guide for Principal Investigators conducting research with human subjects.   Instructions for submitting protocols are detailed on the SBMS and the applications forms are found below.  

The Institutional Official (IO) for Human Subjects Research is the Signatory Official legally authorized to represent BNL to assure protections for human subjects as specified in the FederalWide Assurance (.doc) between Brookhaven Science Associates, LLC (BSA) and the Department of Health and Human Services (DHHS). 

The Quality Assurance (QA) Physician provides assurance that throughout any clinical research activity at BNL subject safety receives the highest priority. The QA Physician chairs the Clinical Research Quality Assurance and Credentialing Committees. The QA physician also serves as a resource to Principal Investigators for designing the safest clinical approach to a protocol.

The Office of Research Administration (ORA) provides administrative support for the BNL Human Subjects Research Program.  The ORA and QA Physician report directly to the IO.

The Institutional Review Board (IRB) for BNL is the State University at Stony Brook (SB) Committee on Research Involving Humans Subjects (CORIHS).  

Prior to submission to CORIHS, all protocols must be reviewed and approved by the Life Sciences Quality Assurance Committee, the Assistant Laboratory Director for Life Sciences and the Radioactive Drug Research Committee (if applicable).  All submissions are processed through the ORA. 

All protocols, except those sponsored by pharmaceutical companies, must also be reviewed by the General Advisory Committee (GAC) of the General Clinical Research Center (GCRC) at Stony Brook. 

All personnel working with human subjects at BNL must be credentialed by the Credentialing Committee.  Forms and instructions are available on the Credentialing Committee website.

All personnel listed on a human subjects protocol must take, at a minimum, CITI and HIPAA training.  Links to these training courses are available at BNL Training.

Human Subjects Research at Stony Brook

The function of the CORIHS  is to assure that  risks to research subjects are minimized and that risks are reasonable in relation to the anticipated benefits and to protect the rights and welfare of research subjects in accordance with the following:

• Department of Health and Human Services Policy for the Protection of Human Subjects 45 CFR 46
• Food and Drug Administration Policy for the Protection of Human Subjects 21 CFR 50
• Food and Drug Administration Policy for the Protection of Human Subjects 21 CFR 56
• Department of Energy Protection of Human Subjects 10CFR745
• Department of Energy Order on the Protection of Human Subjects O443.1A
• Department of Energy Policy on the Protection of Human Subjects P443.1A
• The Belmont Report

Please review the the CORIHS Policies and Procedures.

All CORIHS forms are available and processed through  IRBNet.  Please follow the submission directions available through this link. 

All  experimental radioactive drugs used in human subjects research must meet the standards established by the Food and Drug Administration as authorized by 21 CFR Part 36.1.  The BNL Radioactive Drug Research Committee (RDRC) is responsible for such compliance. 

The following forms may be downloaded by clicking on the document.  Always download the form since they are updated often.  Please forward the completed forms to the ORA both electronically and signed hard copy.  

Please note: for non-BNL Principal Investigators, the Responsible Physician for the study must be a BNL employee.

• Request for Human Subjects Research Review
• Research Protocol
• Consent Form
• Consent Form Glossary
• CORIHS Adverse Event Reporting Form
• Exempt Application

Above  are the only official versions  of the submission forms.  Always check and use the  most current version of the form for submission.

Please use the Investigator Checklist  to ensure all required steps are completed prior to submission to the ORA.

Related Information

• United States Department of Energy Protection of Human Subjects Program
• United States Department of Health & Human Services/Office of Human Research Protections
• United States Department of Energy Former Worker Program
• United States Department of Energy Human Subjects Protection Resource Book

Contact Information

Darcy Mallon
Phone: (631) 344-3362
Fax: (631) 344-3220
Email: mallon@bnl.gov

Address:
Brookhaven National Laboratory
Building 490
PO Box 5000
Upton, NY 11973-5000
Attn: Darcy Mallon

Last Modified: November 7, 2007

One of ten national laboratories overseen and primarily funded by the Office of Science of the U.S. Department of Energy (DOE), Brookhaven National Laboratory conducts research in the physical, biomedical, and environmental sciences, as well as in energy technologies and national security. Brookhaven Lab also builds and operates major scientific facilities available to university, industry and government researchers. Brookhaven is operated and managed for DOE’s Office of Science by Brookhaven Science Associates, a limited-liability company founded by Stony Brook University, the largest academic user of Laboratory facilities, and Battelle, a nonprofit, applied science and technology organization.

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