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. For the purpose of this part, the following activities are deemed not to be research:
- Scholarly and journalistic that focus directly on the specific individuals about whom the information is collected.
- Public health surveillance activities conducted, supported, requested, ordered, required, or authorized by a public health authority.
- Criminal justice investigations.
- Authorized operational activities in support of intelligence, homeland security, defense, or other national defense missions.
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 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.
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 443.1C. 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 are processed through the ORA.
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:
All subject personally identifiable information must be maintained in according to DOE guidance.
The following form may be downloaded by clicking on the document.
The above form is the only official version of the Exempt Application. Always download to ensure using the most current version of the form.