For Institutional Officials

This section is meant to be a resource for each organization’s Institutional Official (IO) for Human Subjects Research.

  • The IO is responsible for ensuring that the Human Subjects Protection Program (HSPP) functions effectively and that the institution provides the resources and support necessary to comply with all requirements applicable to research involving human subjects. The IO represents the institution, as named in the Federalwide Assurance (FWA)
  • The Institutional Official (IO) is the individual who is legally authorized to act for the institution and, on behalf of the institution, obligates the institution to the Terms of the Assurance.
  • The IO should be an individual of sufficient rank who has the authority to ensure that all obligations of the HSPP are carried out effectively and efficiently. The IO should be at a level of responsibility sufficient to allow authorization of necessary administrative or legal action should that be required. OHRP recommends that the IO not be the chair or member of any IRB designated under the FWA.
  • The IO should take training in the protection of human research subjects, prior to or immediately upon assuming the role as IO. Such training is offered online through CITI.
  • In addition to familiarizing him/herself to the Federal requirements for conducting human subjects research, it will be critical that any IO from a DOE/NNSA laboratory become familiar with the DOE-specific requirements.  Institutional Officials from organizations conducting collaborative research with DOE and/or the DOE/NNSA national laboratories should also be familiar with the DOE-specific requirements.

General administrative obligations of the IO:

  • Designating one or more Institutional Review Boards (IRBs) that will review research covered by the institution's FWA;
  • Providing sufficient resources, space, and staff to support the IRB's review and record keeping duties;
  • Providing training and educational opportunities for the IRB and investigators;
  • "Setting the tone" by promoting an institutional culture of respect and conscience, so that the ethical conduct of human subjects research is supported at the highest levels of the organization;
  • Ensuring effective institution-wide communication and guidance on human subjects research;
  • Ensuring that investigators fulfill their responsibilities;
  • Encouraging that all staff engaged in the conduct or oversight of human subject research participate in education activities;
  • Serving as a knowledgeable point of contact for OHRP and other federal agencies, or delegating this responsibility to another appropriate individual.

What the IO cannot do:

  • Approve research that has been disapproved (or not yet approved) by the IRB.

Some responsibilities that may be delegated by the IO to a designee:

The IO may delegate the performance of certain oversight and operational duties to one or more individuals. 

  • Appointing IRB members. Suspending or terminating the IRB membership of any individual for whom it has been determined that he/she is not fulfilling membership responsibilities and or obligations;
  • Appointing the IRB chair or co-chairs. Suspending or terminating the appointment of any chair or co-chair who not is fulfilling his/her responsibilities and or obligations;
  • Performing periodic evaluation of the performance of the IRB chairs and co-chairs and administrative staff;
  • Managing and administering funds. Ensuring that adequate personnel, space and other resources are allocated to the HSPP;
  • Reviewing and signing memoranda of understanding and cooperative agreements between the institution and other organizations, including those that establish reliance on IRBs of record for collaborative research (e.g., IRB Authorization Agreements, Individual Investigator Agreements);
  • Being the point of contact for correspondence addressing human subjects research with the OHRP, FDA and other agencies as applicable, including reports to federal agencies;
  • Ensuring that IRB members and investigators are knowledgeable to conduct research in accordance with ethical standards and all applicable regulations;
  • Developing and implementing an educational plan for IRB members, staff and investigators;
  • Ensuring that IRB members and investigators are knowledgeable to conduct research in accordance with ethical standards and all applicable regulations;
  • Performing periodic evaluation of the performance of the IRB members and administrative staff;
  • Recruiting qualified members to include expert, non-scientific and unaffiliated representation on the IRB;
  • Reviewing and approving Standard Operating Procedures (SOPs) for the IRB and HRPP;
  • Overseeing daily operations of the IRB and HRPP in accordance with the SOPs.

Responsibilities that should not be delegated by the IO to a designee:

  • Signatory authority for the FWA;
  • Completing recommended Assurance training for the IO;
  • Ensuring that the IRB functions independently and that its chair or chairs and members have direct access to the IO for appeal if they experience undue influence or if they have concerns about the function of the IRB;
  • Ensuring that adequate resources, including funds, space, and personnel are provided to support the operation of the HRPP.

Other Responsibilities Specific to the DOE IO:

  • Oversees and monitors Departmental implementation of the requirements of DOE Order 443.1C, 10 CFR Part 745, and 45 CFR Part 46 (Other Subparts), as well as related Executive Orders, Presidential Memoranda, and other Presidential directives and international requirements, as applicable, in consultation with the NNSA, as appropriate.
  • Reports to the Secretary of Energy for purposes of this function and determines what constitutes Departmental HSR, in consultation with the NNSA.
  • Allocates resources for the DOE HSPP.
  • Assures policies are in place that require that the research review process be independent and free of coercion and undue influence.
  • Implements a process to receive and act on complaints and allegations regarding the DOE HSPP.
  • Oversees the Central DOE IRBs and formally appoints all members of the Central DOE IRBs.
  • Must approve classified research to be conducted at DOE sites/laboratories after IRB approval and prior to initiation.
  • Must concur on all requests for partial or full exemptions from the requirements of DOE Order 443.1C.
  • Approves and rescinds authorization agreements with other DOE and outside institutions for IRB review.