Human Research Protection Program

The Human Research Protection Program (HRPP) 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 and through IRBNet.   Policies and procedures for the HRPP can be found in the HRPP Manual.  Policies and procedures for the Clinical Research Center can be found in the CRC Policies and Procedures Manual.

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 Office of Research Administration (ORA) provides administrative support for the BNL Human Subjects Research Program and reports 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.  Once a protocol has been approved, the Clinical Research Center Quality Assurance Committee ensures the safety of human subjects as they participate in research protocols at BNL by evaluating the environment of care provided for research subjects, the safety and security of the research environment, the quality, content and completeness of the subject record entries and the level of subject satisfaction.

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 361.1.  The BNL Radioactive Drug Research Committee (RDRC) is responsible for such compliance. 

All submissions are processed through the ORA. 

All licensed medical professionals 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.  Complete the Personnel Addition Form to add personnel to a protocol.

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 O443.1B
• 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 subject personally identifiable information must be maintained in according to DOE guidance.

FORMS

The following forms may be downloaded by clicking on the document.  Always download the form since they are updated often. 

• Data Safety Monitoring Plan (DSMP)
• RDRC Application
• Consent Form
• Consent Form Glossary
• Exempt Application
• Personnel Addition Form

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 Points to Consider and the Investigator Checklist  to ensure all required steps are completed prior to submission to the ORA.

Research Participant Information

Click here if you are interested in participating in a research study or just want to learn more about this research.

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: January 3, 2013
Please forward all questions about this site to: Darcy Mallon

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 the Research Foundation for the State University of New York on behalf of Stony Brook University, the largest academic user of Laboratory facilities, and Battelle, a nonprofit, applied science and technology organization.

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