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UMB HRP Components
The Human Research Protections Program is comprised of many UMB individuals, offices, boards, and committees. These components within UMB are all responsible for protecting the rights and welfare of subjects participating in Human Research.
The Senior Vice President and Chief Research and Academic Officer is designated as the Organizational Official.
The Institutional Official has the authority to take the following actions or delegate these authorities to a designee:
- Create the Human Research Protection Program budget.
- Allocate resources within the Human Research Protection Program budget.
- Appoint and remove IRB members and IRB chairs.
- Hire and fire research review staff.
- Determine what IRBs the organization will rely upon.
- Approve and rescind IRB authorization agreements.
- Place limitations or conditions on an investigator's or research staff's privilege to conduct Human Research.
- Create policies and procedures related to the Human Research Protection Program that are binding on the organization.
- Suspend or terminate IRB approval of research.
- Disapprove research approved by the IRB.
The individual identified by the Institutional Official as the point of contact with DHHS's Office for Human Research Protections (OHRP) and who exercises operational responsibility, on a day-to-day basis, for the institution's program for protecting human subjects.
All non-exempt Human Research must be reviewed by an IRB that has been designated by the Organizational Official.. The list and scope of review for IRBs designated by the Organization Official to be relied upon are listed in the IRB rosters available from the Human Research Protections Office (HRPO).
The IRBs relied upon by this organization have the authority to:
- Approve, require modifications to secure approval, and disapprove all Human Research overseen and conducted by the organization. All Human Research must be approved by an IRB designated by the Organizational Official. Officials of this organization may not approve Human Research that has not been approved by the IRB.
- Suspend or terminate approval of Human Research not being conducted in accordance with the IRB’s requirements or that has been associated with unexpected serious harm to subjects.
- Observe, or have a third party observe, the consent process and the conduct of the Human Research.
- Determine whether data may be used that was not collected in accordance with the IRB’s requirements.
- Evaluate financial interests of investigators and research staff and have the final authority to decide whether the financial interest and management plan, if any, allow the Human Research to be approved.
IRB member and IRB staff have the responsibility to follow Human Research Protection Program policies and procedures that apply to IRB members and staff.
The Human Research Protections Office is the coordinating office for the Human Research Protection Program.
Legal Counsel has the responsibility to:
- Provide advice upon request to the Organizational Official, IRB, and other individuals involved with the Human Research Protection Program.
- Determine whether someone is acting as an agent of the organization.
- Determine who meets the definition of “legally authorized representative” and “children” when Human Research is conducted in jurisdictions not covered by policies and procedures.
- Resolve conflicts among applicable laws.
IRB members, staff and investigators have access to the University Counsel for legal guidance and interpretation of local, State and Federal laws and regulations as they relate to research. Any HRPO Director may serve as the liaison between the IRB, the HRPO and University Counsel.
If the IRB panels need legal counsel independent of the organization, the Office of the Attorney General of the State of Maryland will be consulted.
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Studies involving an investigator or research staff member with a conflict of interest must be approved by the Conflict of Interest Officer or Advisory Committee before final IRB approval may be granted. The Conflict of Interest Officer will assure that all conflict of interest disclosures are reviewed in accordance with University policies and Federal regulations including, where appropriate, referral to the Conflict of Interest Advisory Committee and committees established in schools to advise their academic administrators. If the conflict of interest involves a VA study, then a VA representative will be a member of the Conflict of Interest Advisory committee.
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Deans and Department Chairs have the responsibility to:
- Oversee the review and conduct of Human Research in their department or school.
- Forward complaints and allegations regarding the Human Research Protection Program to the Organizational Official.
- Ensure that each Human Research study conducted in their department or school has adequate resources.
Investigators and research staff have the responsibility to:
- Follow the Human Research Protection Program requirements described in the Investigator Manual.
- Follow the Human Research Protection Program policies and procedures that apply to IRB members and staff.
- Comply with all determinations and additional requirements of the IRB, the IRB chair, and the Organizational Official.
These individuals are responsible for assessing a study's scientific merit, available resources (i.e., adequate number of qualified staff, adequate facilities, and availability of medical or psychological resources that human subjects may need as a consequence of the research), possible conflicts of interest, and study feasibility.
The goal of the University of Maryland's Environmental Health and Safety (EHS) Division is to protect university workers, university patients, university research subjects, the environment, and the community from exposure to hazardous materials while protecting the integrity of experimental materials. The EHS Division seeks to prevent exposure by assisting researchers in conducting risk assessments and providing guidance to university personnel on the practices, safety equipment and facilities under which hazardous materials can be safely manipulated.
In addition, the EHS Division is charged with ensuring that researchers and laboratories on campus are in compliance with University policies and all regulatory requirements for working with hazardous materials.
The Institutional Biosafety Committee (IBC) is a component within EHS.
- Any research activity involving the deliberate transfer of recombinant DNA or RNA, or DNA or RNA derived from recombinant DNA into one or more humans must be approved by the Institutional Biosafety Committee (IBC) before final IRB approval may be granted.
- Studies utilizing recombinant DNA or potentially infectious microorganisms in the course of their research, but not for direct and deliberate transfer into humans, may require approval from the IBC prior to final IRB approval and initiation of the experiment.
- Any research activity utilizing a "Select Agent" as defined in 42 CFR 73, 7 CFR 331, or 9 CFR 121 must be approved by the IBC before final IRB approval may be granted.
- Studies utilizing recombinant DNA or potentially infectious microorganisms in the course of their research, but not for direct and deliberate transfer into humans, may require approval from the IBC prior to initiation of the experiment; however, this approval is not required for final IRB approval.
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The Radiation Safety Committee (RSC) is a component within EHS.
Studies involving radiation exposure (from x-rays or radiopharmaceuticals) of human subjects from routine diagnostic or therapeutic procedures used in a supporting role and which the individual would otherwise not receive as a part of their medical care must be approved by the Radiation Safety Committee (RSC) before final IRB approval may be granted.
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For Veterans Administration (VA) research, the Research and Development Committee has the responsibility for oversight of the local research program as defined in VHA Handbook 1200.01. The Veterans Administration (VA) Research and Development Committee has delegated its responsibility to conduct scientific review to the IRB. The Research & Development Committee must review and approve all Veterans Administration research and must also review and approve all modifications including those related to biosafety or radiation safety.
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