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.

Research is defined by DHHS regulations at 45 CFR 46 as "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

Human subjects are defined by DHHS regulations at 45 CFR 46 as “a living individual about whom an investigator (whether professional or student) conducts research and obtains: data through intervention or interaction with the individual; or identifiable private information.

It is DOE policy that any DOE-funded or DOE laboratory-managed or conducted research involving intentional modification of an individual’s or a group of individuals’ environment, for example through installation of devices in homes and/or through introduction of gases/chemicals to trace airflow in occupied residential, commercial, or public settings, be managed as human subjects research and thus subject to the requirements of DOE Order 443.1B.  Such projects must be reviewed and approved by the Central DOE Institutional Review Board (IRB), a DOE laboratory IRB, or (if conducted by a university) a university IRB with an approved Federalwide Assurance of compliance, prior to the initiation of the research and after consultation with the appropriate Human Subjects Protection (HSP) program manager.  See the FAQs for additional guidance.

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. 

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).  

All submissions are processed through the ORA. 

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 O443.1B
  • 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. 

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.

ORA Submission Date CORIHS Submission Date CORIHS Meeting Date
10/06/14 10/20/14 11/06/14A
10/20/14 11/03/14 11/20/14B
11/03/14 11/17/14 12/11/14A
11/17/14 12/01/14 12/18/14B
10/08/14 12/13/14 01/08/15A
12/22/14 01/06/15 01/22/15B
01/05/15 01/20/15 02/12/15A
01/20/15 02/10/15 02/26/15B
02/08/15 02/23/15 03/12/15A
02/22/15 03/10/15 03/26/15B
03/08/15 03/23/15 04/09/15A
03/22/15 04/06/15 04/23/15B
04/06/15 04/20/15 05/14/15A
04/27/15 05/12/15 05/28/15B
05/11/15 05/26/15 06/11/15A
05/25/15 06/08/15 06/25/15B
06/08/15 06/22/15 07/09/15A
06/22/15 07/07/15 07/23/15B
07/06/15 07/20/15 08/13/15A
07/27/15 08/10/15 08/27/15B
08/10/15 08/24/15 09/10/15A
08/24/15 09/08/15 09/24/15B
09/08/15 09/21/15 10/08/15A
09/21/15 10/05/15 10/22/15B
10/05/15 10/19/15 11/05/15A
10/19/15 11/02/15 11/19/15B
11/02/15 11/16/15 12/03/15A
11/16/15 11/30/15 12/17/15B

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

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Contact Information

Darcy Mallon
Phone: (631) 344-3362
Fax: (631) 344-5854
Email: mallon@bnl.gov

Address:
Brookhaven National Laboratory
Building 120
PO Box 5000
Upton, NY 11973-5000
Attn: Darcy Mallon

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Last Modified: October 27, 2014
Please forward all questions about this site to: Darcy Mallon