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Human Research Protection ProgramThe 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. 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 Quality Assurance (QA) Physician provides assurance that throughout any clinical research activity at BNL subject safety receives the highest priority. The QA Physician chairs the Clinical Research Quality Assurance and Credentialing Committees. The QA physician also serves as a resource to Principal Investigators for designing the safest clinical approach to a protocol. The Office of Research Administration (ORA) provides administrative support for the BNL Human Subjects Research Program. The ORA and QA Physician report 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 regarding 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 protocols, except those sponsored by pharmaceutical companies, must also be reviewed by the General Advisory Committee (GAC) of the General Clinical Research Center (GCRC) at Stony Brook. All personnel 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. 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:
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. Please forward the completed forms to the ORA both electronically and signed hard copy.
Please note: for non-BNL Principal Investigators, the Responsible Physician for the study must be a BNL employee. 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.
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Contact Information
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Last Modified: January 19, 2010 |
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