General Lab Information

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.

  • 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 443.1D. 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.
  • 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 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 Central Department of Energy Institutional Review Board (CDOEIRB).
  • All submissions by the PIs are routed to the CDOEIRB office for review in coordination with the BNL ORA Director.
  • All personnel listed on a human subjects protocol must take Human Subjects Research training.

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

Definitions

  • Conflict of Interest: A situation where an employee's private interests, typically financial or economic, conflict with their public duties and responsibilities, potentially compromising their integrity and objectivity in performing their official roles.
  • Human subjects are defined by DHHS regulations at 45 CFR 46 as “a living individual about whom an investigator (whether professional or student) conducting research: 1) obtains information or biospecimens through intervention or interaction with the individual and uses, studies, or analyzes the information or biospecimens; or 2) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
  • Identifiable Private Information: Private information for which the identify of the subject is or may readily be ascertained by the investigator or associated with the information. All subject personally identifiable information must be maintained in according to DOE guidance.
  • 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." Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program that is considered research for other purposes. For purposes of this part, the following activities are deemed not to be research:
    1. Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.
    2. Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).
    3. Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.
    4. Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.

Related Information

Contact

Office of Research Administration
Brookhaven National Laboratory
Building 120 – P.O. Box 5000
Upton, NY 11973-5000

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