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.
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:
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.
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.
Research Participant Information
Click here if you are interested in participating in a research study or just want to learn more about this research.
Last Modified: January 3, 2013