On This Page
- What is an IRB?
- What is the Purpose of IRB Review?
- Does My Study Require IRB Review?
- What is the IRB Review Process?
- What are the IRB's Criteria of Review and Conditions of Approval?
- What is Scientific Review Committee (SRC) Review?
- Do You Have More Questions Regarding Human Subjects Regulations or Review?
What is an IRB?
An Institutional Review Board (IRB) is tasked with reviewing research involving human subjects in order to protect the safety, rights, and welfare of research participants.
Today at Fred Hutch, four IRBs review biomedical and behavioral research involving human subjects. The IRBs review research submitted by Fred Hutch investigators and by investigators from the other Cancer Consortium institutions (University of Washington and Seattle Children’s) in certain contexts. The IRBs also may review participating sites outside the Cancer Consortium, generally in the context of regulatory single IRB requirements.
Fred Hutch IRBs review and approve research in accordance with U.S. Department of Health and Human Services regulations at 45 CFR 46. In addition, for studies involving products regulated by the U.S. Food and Drug Administration, the Fred Hutch IRBs comply with the requirements set forth in 21 CFR 50, 21 CFR 56, 21 CFR 312, and 21 CFR 812.
History of the IRB
Scientific research has produced substantial social and health benefits while also posing some troubling ethical questions at times. Some dates important in the development of institutional review boards, or IRBs, include the following:
- In August 1947, during the Nuremburg War Crime Trials at the conclusion of World War II, the Nuremburg Code was drafted as a set of standards for judging those involved in reported abuses of human research subjects. It became the prototype for later efforts to ensure the protection of human subjects in research.
- On July 12, 1974, the National Research Act established IRBs to review biomedical and behavioral research involving human subjects.
- In March 1983, federal regulations detailing the basic U.S. Department of Health and Human Services policy for the protection of human research subjects were adopted.
- On August 19, 1991, the 1983 regulations were updated. Known as Title 45, Public Welfare, Part 46, the current regulations provide comprehensively detailed information about the duties and responsibilities of IRBs.
The Fred Hutch IRB
Fred Hutch IRB meetings are held four times per month. See the Meeting Schedule webpage for the IRB meeting schedule.
While Fred Hutch does not provide copies of the IRB membership rosters, the Fred Hutch IRB rosters are on file with OHRP. If you require documentation of this, please see the below IRB roster letter.
The Institutional Review Office (IRO) administers all activities requiring IRB review, as well as activities Exempt from IRB review and determinations of Not Human Research. The IRO reports to the Fred Hutch VP & Chief Compliance Officer.
What is the Purpose of IRB Review?
The purpose of IRB review is to ensure that research studies comply with applicable regulations (federal, state and local), meet commonly accepted ethical standards, follow institutional policies, and adequately protect the rights and welfare of research participants.
Does My Study Require IRB Review?
To determine if your study requires IRB review, your study must meet the definition of both “research” and “human subjects”. These questions must be assessed in the order below:
1) Is the Activity Research?
Research is defined by HHS as “A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge”.
See Is It Research? for more information.
2) Does the Research Involve Human Subjects?
A human subject is defined by HHS as “A living individual about whom an investigator (whether professional or student) conducting research: (1) obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (2) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.”
In addition, the term "human subject" is not limited to activities involving the intact human, but also extends to activities involving the use of human embryos, fetuses, organs, tissues, body fluids, or graphic, written or recorded information.
See Not Human Research Determinations for more information or the IRB policy Determining when Activities are Research or Human Research.
If you have answered yes to both of the questions above, your study requires IRB review.
NOTE: Per institutional policy, most research defined as “Not Human Research” requires administrative review by the IRO (rather than IRB review). Review the Not Human Research Determinations page for the exceptions.
What is the IRB Review Process?
For all IRB submissions, study teams will submit the applicable SmartForm(s) and requested documents through Hutch IRB. For more information see Submissions to the IRB.
Once a submission is considered to be review ready (meaning the submission has been assessed by the IRO and any staff-requested clarifications have been made), it will be sent to the IRB for review. Refer to the Turnaround Times webpage for more information on general turnaround time expectations.
IRB chairs determine review status (for example, exempt, minimal risk or full). However, review status is subject to change. For studies that are reviewed by a convened IRB, the Fred Hutch IRB meets four times per month. Refer to the Meeting Schedule webpage for the IRB meeting schedule.
Following IRB review, you will be provided with a written decision via Hutch IRB indicating the determination: Approval, Modifications Required to Secure Approval, Deferral, or Disapproval. Review HRP-103 - Investigator Manual for more details about these decisions.
Activities cannot be implemented until the IRB has issued approval and all required modifications have been confirmed complete. Additionally, if required, implementation steps in OnCore must also be completed.
What are the IRB’s Criteria of Review and Conditions of Approval?
Fred Hutch IRBs approve research based on the determination that the following requirements have been satisfied:
- Risks to subjects are minimized by using procedures that are consistent with sound research design and do not expose subjects to unnecessary risk, and, whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.
- Risks to subjects are reasonable in relation to anticipated benefits, if any, and the importance of knowledge reasonably expected to result.
- Selection of subjects is equitable.
- Informed consent will be sought from each prospective subject or the subject's legally authorized representative, in accordance with, and to the extent required by, 46 CFR 46.116.
- Informed consent will be appropriately documented or appropriately waived.
- Where appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
- Where appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
- When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.
- Institutional policies and procedures have been met.
What is Scientific Review Committee (SRC) Review?
Cancer-related interventional research must undergo scientific review, regardless of funding source, as mandated by the National Cancer Institute. This second-stage review ensures studies are assessed for scientific merit and integration of the research effort with regard to competing protocols and Cancer Consortium research priorities. See the Cancer Consortium Scientific Review Committee webpage for more information.
If your study requires SRC review, SRC approval must first by obtained before submitting to the IRB for review.
Do You Have More Questions Regarding Human Subjects Regulations or Review?
Please direct questions or concerns about human subjects regulations, FDA regulations on investigational new drugs or devices, emergency treatment acknowledgements, or other policies and procedures involving human subjects to IRO@fredhutch.org.