Parts of the following information were adapted from
the UW Human Subjects Division Website: http://www.washington.edu/research/hsd/.
The primary purpose of the UW Institutional Review Board (IRB) and its review process is to assure that the safety, rights, and welfare of human research participants are protected.
The IRB has the authority to specifically determine:
The IRB also has the authority to take the following actions related to human subjects research:
"Human Subjects Research" is a systematic investigation involving human subjects that is designed to develop or contribute to generalizable knowledge.
Clinical trials are biomedical or behavioral research studies in which the safety or therapeutic effect of an intervention, pharmacokinetics, or the effectiveness of a diagnostic procedure is being evaluated in human beings.
If you are a faculty or staff member, or a student at the University of Washington, and your research involves the use of human subjects (either directly or through records or other data such as specimens or autopsy materials), your research requires UW IRB review.
The UW IRB reviews the majority of human subjects research conducted by UW researchers.
However, there are exceptions:
All clinical trials conducted by UW researchers are reviewed by one of the following Institutional Review Boards (IRBs):
At the same time you submit your research to the UW IRB for approval, you may need to be in touch with the UW Clinical Research Budget & Billing (CRBB) office if your clinical research study includes items, tests, or services provided by HMC, SCCA, UWMC, or UWP. If you have any funding or support from any entity outside of UW, you must be in touch with the UW Office of Sponsored Programs (OSP) so they may negotiate the appropriate terms. Lastly, all clinical research must be registered at ClinicalTrials.gov before any research subjects are enrolled in your study.
To help you determine whether your study must be reviewed by CRBB, and what kind of review is required, please refer to the Clinical Trials Policy Review and Reporting Requirements Decision Tree.
Clinical Research Budget and Billing (CRBB)
UW Medicine at South Lake Union
Administrative Bldg, 3rd Floor
815 Mercer St.
Seattle, WA 98109-4714
The Office of Sponsored Programs, a unit in the Office of Research at the University of Washington, supports and advises the entire academic community in securing external support for sponsored projects and collaborations.
OSP reviews, negotiates, approves, and provides administrative oversight related to proposals and establishment of awards on behalf of the University of Washington in accordance with all applicable policies, and regulations.
Office of Sponsored Programs (OSP)
UW Tower, 17th Floor
4333 Brooklyn Ave NE
Seattle, WA 98195-9472
The UW Clinical Trials Administrator (Arna Elezovic, 206-543-0639, firstname.lastname@example.org) facilitates the initial and results registrations with ClinicalTrials.gov for UW researchers.
UW researchers are responsible for registering their trials prior to enrolling human subjects and should use the web based data entry system called the Protocol Registration System (PRS).
Access to the PRS system is at: https://register.clinicaltrials.gov/, but requires a user name and password. Please contact HSD's Clinical Trials Administrator if you need a new account in PRS, forgot your current user name or password, need to transfer your study from one owner to another, or have any other questions.
The steps for registering a clinical trial with ClinicalTrials.gov are outlined in the following document: ClinicalTrials.gov - Instructions for Registering Your Trials.
There are three types of research, and each receives a different level of review.
Research that involves the review of medical records, retrospective or prospective, and does not involve collecting any other information from or about the research subjects, is typically referred to as "Medical Records Review."
In most cases involving the prospective review of the subjects' Protected Health Information (PHI), researchers will need to obtain written consent and HIPAA authorization to review subjects' records. A waiver of consent and HIPAA authorization is generally applicable for retrospective reviews.
There are two tools that will assist researchers who do case reports by providing a written description of policies and procedures. A case report is information collected and presented on one or more individuals to highlight an interesting experience, observation, treatment, presentation, relationship, or outcome. It typically (but not always) results from a retrospective review of the individual's record. This is different from a case study, which typically involves a prospective intervention or prospective collection of specimens or data that is not part of standard service or care.
Researchers can use this one-page decision tree to self-identify any HIPAA and IRB requirements that apply to a specific case report. It also provides brief information on how to fulfill those requirements, and a definition of "case report".
The primary IRB issue is whether the case report meets the definition of research provided in federal human subjects regulations. If it does not, then IRB review is not required. Researchers can answer the three short questions on this form to self-determine whether IRB review of a specific case report is required. The form should be completed and kept with the researcher's other records about the case report. It does not need to be submitted to the Human Subjects Division in most cases.
Investigators applying to do any genetics research involving human subjects should be prepared to demonstrate to the Institutional Review Board that:
Investigators conducting genetic research sponsored by the Department of Health and Human Services (DHHS) should consider the protections provided by the Genetic Information Non-Discrimination Act (GINA) when developing their consent processes. For more information, see http://www.hhs.gov/ohrp/humansubjects/guidance/gina.html.
Research using biological specimens is not always considered Human Subjects Research.
The Use of Non-Identifiable Specimens/Data Review Determination Form is intended to help researchers determine whether human subjects are involved in research that consists of obtaining private information (data) and/or biological specimens, according to federal, state, and UW definitions.
Most federal agencies have adopted a single, consistent, definition of human subject (45 CFR 46. 102(f)). Under this definition, a human subject is a living individual about whom an investigator conducting research obtains data through intervention or interaction with the individual, or by identifiable private information. It is UW IRB policy to apply this definition to all research regardless of the source of any funding that is supporting the research.
The Food and Drug Administration (FDA), however, includes individuals that have investigational drugs, devices or controls used on their specimen, even if the specimen is unidentified. The UW IRB therefore applies this definition to only FDA-regulated research involving investigational drugs and devices.
Researchers are required to obtain the informed consent of all participants in human subjects research prior to enrolling those individuals in a study. The individual's consent must be voluntary and based upon adequate knowledge of the purpose, risks, and potential benefits of a research study. All potential participants should also be informed of their right to abstain from participation or to withdraw consent to participate at any time without reprisal. After ensuring that a person has understood the information, the researcher should then obtain the person's consent, preferably in writing. If consent cannot be obtained in writing, the non-written consent must be formally documented and witnessed.
In cases where individuals are unable to provide consent, either because they are minors or because they are physically or mentally incapable of making informed decisions, researchers are required to obtain "assent" or agreement to participate in a study from the individual. No individual should be enrolled in a study if they do not want to participate, even in cases where their legal guardian consents to their participation. When possible, an assent form should be used to document an individual's assent.
The IRB may waive the requirement to obtain a subject's consent for a limited class of research. Waivers are sometimes deemed appropriate for research activities carried out in emergency situations in which the subject may benefit from an investigational device or drug, but the subject's medical condition and the unavailability of legally authorized representatives of the subjects preclude the possibility of obtaining his or her informed consent.
Click here for information about consent forms on the UW IRB website and to access the consent form sample template.
A policy and procedure was implemented on 12/2/2010 to address significant financial interests in research, as defined by UW Policy GIM 10, and other possible types of research conflicts of interest. The policy and procedure are posted on the HSD website, as a document entitled "Researcher Conflict of Interest."
The policy statement is:
"Researchers are required to disclose to the IRB any potential conflict of interest with respect to a human subjects research activity, including any significant financial interest. A significant financial interest of any member of the research team shall be disclosed to the subjects through the consent process, unless consent is not required (exempt research) or has been waived by the IRB. For research that uses a consent form, the disclosure requirement is fulfilled by the Financial Interest section of the consent form (for all consent forms approved after December 31, 2010)."
The requirements of a Significant Financial Interest (SFI) Management Plan from the UW Office of Research shall be incorporated into the research before the IRB can grant full unconditional approval or HSD can grant exempt status for the research. The IRB or HSD may impose additional requirements to mitigate or manage financial or other potential conflict of interest if it feels that the researcher's plans and the SFI Management Plan are not sufficient. This policy applies to all human subjects research activities, regardless of level of IRB review, type of research, or source of funding.
Purpose: The purpose of the new section is to implement the new policy about significant financial interest (see above).
Description: A new section called "Financial Interest" has been added to the UW Consent Form Template. It is required when any member of the research team has a significant financial interest, as defined by UW Policy GIM 10. If no one has a significant financial interest, the section may be omitted. The consent form must disclose the existence of a significant financial interest but not the monetary value of the financial interest. The consent template provides short descriptive language to use for specific types of financial interest.
New research: All consent forms approved after December 31, 2010 must have this new section, if applicable.
Existing research: The Financial Interest section must be added to the already-approved consent forms of ongoing research, if applicable. This may be done at any time (such as when a Modification is being submitted for another purpose) but will be required at the time of the next Status Report if the issue has not already been addressed. In some cases, the IRB may contact the research team and require the consent form revision before the next Status Report. Though this revision will generally not require re-consenting of already-enrolled subjects who are still actively participating in a study, the IRB will use its judgment to determine whether the financial interest information should be communicated to such subjects.
Anonymity and confidentiality are not the same.