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Washington State University

HRPP policies & procedures manual

100: Authority and purpose

1. Purpose

The purpose of this policy is to:

  • State the institutional authority under which the Human Research Protection Program and the Institutional Review Board (IRB) is established and empowered.
  • Define the purpose of the IRB.
  • State the ethical principles governing investigators, Office of Research Assurances (ORA) staff and the IRB to ensure that the rights and welfare of human participants are protected.
  • State the authority and jurisdiction of the IRB.
  • Define the independence of the IRB.
  • Define the relationship of the IRB to other University committees, University officials and other institutions.

2. Policy

2.1 Mission

The IRB is charged with a twofold mission:

  1. to determine and certify that all research reviewed by the IRB conforms to the regulations and policies set forth by DHHS, the FDA, Washington State regulations and University policies regarding the health, welfare, safety, rights, and privileges of human participants; and
  2. to assist investigators in conducting ethical research that complies with the DHHS, FDA, Washington State regulations and University policies in a way that permits accomplishment of the research activity.

2.2 Statement of institutional authority

The Washington State University Institutional Review Board (WSU IRB) is a presidential committee. The institutional official (IO) for the IRB is the vice president for research. The Institutional Official (IO) signs the WSU Federalwide Assurance (FWA) with the U.S. DHHS which, among other requirements, assures that all human subject research will comply with 21 CFR (FDA Good Clinical Practice) and 45 CFR Part 46 (DHHS Protection of Human Subjects). The WSU IRB is registered with the Office of Human Research Protections and the Food and Drug Administration.

2.3 Purpose of the IRB

The WSU IRB is an administrative body established to protect the rights and welfare of human participants in research activities conducted under the auspices of WSU. The WSU IRB also assists researchers in conducting safe and ethically sound research involving human participants.

2.4 Governing principles and ethical obligations

The organization, IRB members, IRB staff, investigators, and research staff are expected to understand, adhere and apply their obligation to protect the rights and welfare of human subjects research participants. All individuals involved are guided by the ethical principles regarding all research involving humans as participants as set forth in the report of the National Commission for the Protections of Human Subjects of Biomedical and Behavioral Research, entitled: Ethical Principles and Guidelines for the Protections of Human Subjects of Research (the Belmont Report). These principles are defined in the Belmont Report as follows:

  • Beneficence — The sum of the benefits to the subject and the importance of the knowledge to be gained to outweigh the risks to the subjects as to warrant a decision to allow the subject to accept these risks.
  • Autonomy — Legally effective informed consent is obtained, unless the requirements for waiver of informed consent are met by adequate and appropriate methods in accordance with the provisions of applicable regulations.
  • Justice — The selection of subjects is equitable and is representative of the group that will benefit from the research.

The IRB’s duty is to inform and assist investigators and advisors with ethical and procedural issues related to the use of human participants in research in order to facilitate compliance with university policies and procedures, federal regulations, and state law.

The principal investigator’s duty is to carry out all protections concerning human participants, as required by good clinical practice, WSU policy, and by state and federal regulations. When the protocol is designed and carried out by a student, the designated faculty advisor must submit the IRB application as the principal investigator (PI), and the responsibility of ensuring the protections of human participants ultimately rests on the PI. The faculty advisor serving as the PI has an obligation to consider carefully whether an individual (student or staff) is qualified to adequately safeguard the rights and welfare of human participants.

2.5 Authority and jurisdiction

Scope of authority defined:

The WSU IRB has the authority to certify exempt projects; approve and review all non-exempt (expedited and full board) human subject research (prior to and after approval); and require amendments to, suspend, or disapprove all research activities that fall within its jurisdiction, as specified by both the federal regulations, state regulations and Institutional policy.

The IRB has the authority to ensure that research conducted under its jurisdiction is designed and conducted in a manner that protects the rights, welfare and privacy of human participants in research.  Specifically:

  • The IRB may disapprove, modify, or approve studies based upon consideration of human participant protection aspects.
  • The IRB reviews, and has the authority to approve, require modification in, or disapprove all research activities that fall within its jurisdiction.
  • The IRB has the authority to conduct continuing review as it deems necessary to protect the rights and welfare and privacy of human participants in research, including requiring progress reports from investigators and reviewing the conduct of the study.
  • The IRB may suspend or terminate approval of a study not being conducted in accordance with the IRB’s requirements or that has been associated with unexpected serious harm to research participants.
  • The WSU IRB has the authority to conduct post approval reviews on any applications for any reason. Review may consist of a review of documents and/or review of the activities to determine whether the research is being conducted in accordance with the IRB’s requirements and the approved application.
  • The IRB has the authority to observe or have a third party observe the informed consent process and/or audit the progress of any study in its jurisdiction as it deems necessary to protect the rights and welfare of human participants in research.

2.6 Independence of the IRB

The IRB is independent and does not answer to individuals, departments, or units that rely on the IRB for the review of their research. The IRB is the final authority for all decisions regarding the protection and welfare of human participants in research. Institutional officials and administrators may not approve the research if it has not been approved by the IRB.

Inappropriate attempts to influence the IRB process, individual IRB members, or IRB staff will be reported to the IO. The IO will respond to any inappropriate attempt to influence the IRB process and has the authority to limit or remove an investigator’s privilege to conduct research.

3. Specific policies

3.1 Externally funded research

If the study is part of an application to a sponsoring agency, the IRB must review the protocol concerning human participants before or when the grant or contract application is processed, and/or prior to release of grant funds.

Contracts or other funding agreements: If an IRB application indicates that a study has a contract or other funding agreement, the contract is subject to review.

3.2 Review of research by officials and other committees

Even though the IRB application may be approved, the PI must also apply to other appropriate committees that require approval: the Institutional Biosafety Committee (IBC), the Institutional Animal Care and Use Committee (IACUC), and the Radiation Safety Committee.

Biosafety: Research involving the direct and deliberate transfer of biologically derived products (as listed below) into human participants must receive approval from the IBC. The IRB may grant final approval of study, but the approval letter will state that the research cannot commence until approval of the IBC. The investigator is responsible for providing the IRB with the IBC approval before the start of the study. The following is a list of biologically derived products and is not all-inclusive:

  • Human gene therapy even if the recombinant DNA is produced elsewhere
  • Modification of the germ line genes of animals (transgenic)
  • Recombinant DNA
  • Experimentation using carcinogenic (known or suspected) or highly toxic compounds
  • Experimentation using BL2 or BL3 infectious microorganisms

Radiation Safety Committee:  Research involving exposing human participants to radiation through x-rays or radionuclides, for which the participants would otherwise not have been exposed, must receive approval from the Radiation Safety Committee or approval from the Radiation Safety Officer (RSO).

3.3 Cooperative research

In the conduct of cooperative research projects, each institution is responsible for safeguarding the rights and welfare of human participants and for complying with any applicable regulations. Federal regulations [45 CFR 46.114 & 21 CFR 56.114] allow for cooperative research projects which involve more than one institution. To avoid duplication of review efforts by IRBs, WSU can choose to conduct joint reviews, accept the review of another qualified IRB, or make other arrangements to establish oversight responsibilities.

The WSU IRB will determine whether or not a cooperating institution is engaged in human subjects research and how the review of the research will be conducted. This determination is made by the ORA director, in consultation with the IRB chair, based on the outside institution’s role and whether that role meets any of the criteria for “engaged in research” as defined in the OHRP Guidance of October 2008.

3.4 Use of policies and procedures

The ORA staff and the IRB must maintain and follow all written policies and procedures consistent with federal regulations, good clinical practices, and biomedical ethics when reviewing proposed research.

3.5 Serving as IRB of record for other institutions

The WSU IRB will enter inter-institutional agreements with other IRBs.

3.6 Multiple IRB approvals needed [to conduct research at other sites]

Often, a researcher conducting research at another site may need approval from that site’s IRB. If the site does not have an agreement with the WSU IRB, the WSU researcher must secure approval from both the WSU IRB, and the other site’s IRB. The researcher must notify the WSU IRB of their submission for review to another site’s IRB. This information must be included on the WSU IRB submission form.

3.7 Accepting review of another IRB

The WSU IRB does not accept the review of another IRB unless that IRB has an FWA and a written cooperative or inter-institutional agreement is in effect between WSU and the external IRB.

4. Applicable regulations and guidelines

21 CFR 56.108, 56.109, 56.113
45 CFR 46.108, 45 CFR 160 &164
Belmont Report

5. Forms

None

6. Procedures to employ implement this policy & assignment of responsibility

WhoTask
IO, ORA director,
chairpersons of
IRBs, IRB
members, IRB
coordinator
Ensure compliance with federal regulations, policies and procedures to
guarantee the protection of human participants in research

Report to the vice president for research any inappropriate attempts to influence
the IRB process.
IO, ORA directorInvestigate and act on reports of inappropriate attempts to influence the
IRB process.
ORA directorEvaluate on an ongoing basis the IRB program for adherence and
compliance with federal, state, and local policy and regulations.
Evaluate (at least yearly) the IRB workload regarding timely and
thorough review. Is a designated signatory for the IRB.
IRB coordinatorEnsure communications between IRB and any additional IRBs where
approval is sought. All copies of correspondence with investigator will
be sent to additional IRBs. Copies of correspondence between
additional IRBs and investigator will be requested.