No Risk Research (Exemptions) - Human Subjects Review Committees - Minimal risk review (Expedited)
Full Committee Review - Emergency Review - Approval in Principle - Modifying an approved application - Continuing review
Back to Contents
Certain research activities are exempted from Federal regulations for the protection of human subjects (Title 45, Code of Federal Regulations, Part 46.101(b), see also section II.C.1.-6.). Research falling into one or more the these categories may be approved by the relevant department chairperson, director, or dean, with the following exception: if subjects are to provide sensitive information that entails more than minimal risks for persons other than themselves, such research should be submitted for review by a Human Subjects Review Committee, or by a Subcommittee thereof, even though such research may be exempt from Federal regulations.
It is the obligation of each investigator to bring to the attention of the relevant department chairperson, director, or dean any proposed research involving the use of human subjects that is eligible for departmental approval (but not excluded by the provisions of II.C., above), using a "Certification of Exemption" application (Form HS EX-1) for this purpose. Approval for the protection of human subjects in such research must be obtained before approaching or initiating the use of human subjects in the proposed research.
It is the responsibility of the relevant department chairperson, director, or dean to review the proposed research to determine (a) whether the proposed research is eligible for departmental approval, and (b) whether the proposed research will be conducted in accord with the general principles described in Section I.A., above. If the decision is affirmative on both points, the form should be signed and a copy forwarded to the Human Subjects Division, Office of Sponsored Programs. If the relevant department chairperson, director, or dean determines that the proposed research is not eligible for departmental approval, or that the proposed research will not be conducted in accord with the general principles described in Section I.A., above, the investigator should be so advised and required to complete Form UW 13-11 for submission to the Human Subjects Review Committee.
Students should document the approval of their faculty sponsors before requesting the approval of the department chairperson, director, or dean.
The relevant department chairperson, director, or dean may grant approval for the research for a specified period not to exceed five years. If the procedures of the research are to be modified during the course of the research in a way that may affect the rights and welfare of human subjects in the research, such modifications must be approved prior to their implementation. If the modifications are such that the research is no longer eligible for departmental approval, the modified research protocol must be submitted to a Human Subjects Review Committee for approval. Each grant or contract proposal must be covered by a separate Certification of Exemption. A copy of each new Certification of Exemption must be forwarded to the Human Subjects Division.
Training and assistance is available to department chairpersons, directors or deans responsible for the review of research falling into the exempt categories from the Human Subjects Division.
The University of Washington supports at least two Human Subjects Review Committees, each duly constituted to comply with Federal regulations pertaining to an Institutional Review Board. At least one of the Human Subjects Review Committees is constituted to review the use of human subjects in biomedical research, and at least one is constituted to review the use of human subjects in social and behavioral research.
In accord with Federal regulations, a majority of the members of the Human Subjects Review Committee must be present to constitute a quorum, and one of those present must be a member whose primary concerns are in nonscientific areas.
Each Human Subjects Review Committee is composed of nine members, one of whom is a staff coordinator, and least one of whom is "not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution." Each of these is a voting member and eligible to serve on Subcommittees of that Human Subjects Review Committee. The number of members of a Human Subjects Review Committee may be expanded or contracted to be suitable for the workload of the Committee, provided each Committee has at least five members and otherwise fulfills Federal requirements.
If a Human Subjects Review Committee regularly reviews research that involves a vulnerable category of subjects, it will include one or more individuals who are primarily concerned with the welfare of these subjects.
Alternate members of a Human Subjects Review Committee may be named to ensure a quorum at any regularly scheduled meeting of the Committee. Alternates are selected from a roster of previous members of the Committees.
If a Committee member finds it necessary to be absent from one or more Committee meetings, that member should notify the Human Subjects Division to that effect so that an alternate member can serve in place of the absent member.
If a Committee or Subcommittee member has an interest in an application to be reviewed by the Committee, the member may not vote on that application. His or her vote may not be included in the count to constitute a quorum.
The Vice-Provost for Research appoints all members of Human Subjects Review Committees and Subcommittees.
It is the responsibility of the Human Subjects Review Committees, and of their Subcommittees to review proposed research involving the use of human subjects to determine (a) whether the proposed research will be conducted in accord with Federal regulations for the protection of human subjects, and (b) whether the proposed research will be conducted in accord with the general principles described in Section I above.
The Human Subjects Committees and Subcommittees may require modifications in the proposed procedures as a condition of approval.
Human Subjects Review Committees or Subcommittees may grant approval for a period of no more than one year commencing with the date the Committee or Subcommittee approves the application and commensurate with the level of risk posed by the research.
When research procedures are modified during the course of the research in any way that may affect the safety, rights, and welfare of human subjects in the research (changes in study procedures, recruitment procedures, or follow-up, for example), approval for such modifications must be obtained before the modifications are implemented. Other changes (e.g. change in funding source or investigators) must be reported to the Human Subjects Review Committee.
Research that is planned to continue beyond the period of approval by a Human Subjects Review Committee or by a Subcommittee must be re-approved for an additional period before the current period of approval expires. The continued period of approval may be up to one year, commensurate with the level of risk. Researchers are responsible for keeping track of the period of approval and requesting continuing review in a timely manner. Investigators requesting the renewal of approval should use Form HS SR-1 for this purpose. As a courtesy, the Human Subjects Division will send out reminders to researchers about two months before the period of approval is about to expire.
All researchers intending to involve human subjects in their research must complete and send the UW Human Subjects Review Committee application form to a University-level committee or subcommittee. The form is designed to be self-explanatory. If assistance is required, questions may be addressed to the staff of the Human Subjects Division, at 543-0098. All required materials (e.g., consent forms, questionnaires, debriefing statement, advertisement, grant or contract proposal) should accompany the application form submitted to the Human Subjects Division. The omission of any required document may result in a delay in the review. All copies must be typed. At least one copy should include the original inked signatures of the investigator, the investigator's chairperson, and the investigator's faculty sponsor, if appropriate.
The application form is available as a Word for Windowstm template. Copies may be obtained by sending a blank diskette to the Human Subjects Division. The form is also available from the Human Subjects Division's web page.
Minimal risk ("expedited") review is intended to provide a review for projects that involve a minimal amount of risk, equivalent to what would be encountered in daily life. Human Subjects Review Committee subcommittees charged with minimal risk review may approve a proposal (possibly contingent upon procedural changes) or may refer a proposal for full Committee review. A subcommittee may not disapprove a proposal. Subcommittees consist of one or more members of the Human Subjects Review Committees.
Minimal risk review is usually more rapid than full review. However, if a proposal is submitted for minimal risk review but is found to require full review, the process may actually be slower. Therefore, investigators should submit a proposal for minimal risk review only after carefully considering whether or not the proposed study meets the criteria for minimal risk review, as explained below.
From the viewpoint of the investigator the procedures for minimal risk and full review are the same. The application form must be completed and submitted together with any supplementary documents. The Human Subjects Division staff will pre-view the application form to determine if it eligible for minimal risk review.
If the Human Subjects Division staff determines that the proposed research is eligible for Subcommittee review, staff will refer that application to a specific Subcommittee of the appropriate Human Subjects Review Committee. Staff may refer an application to a Subcommittee if the criteria for minimal risk review appear to be met even if the researcher did not request minimal risk review.
Modifications or amendments to approved activities may also be eligible for minimal risk review. If a Human Subjects Review Coordinator determines that a modification is "risk-relevant" (see below) but entails only minimal risks, such a modification shall be referred to a specific Subcommittee of the appropriate Committee.
After review, each Subcommittee member classifies the application (or modification) in one of the following ways:
If any Subcommittee member recommends referral to the full Committee, it is referred. If both recommend approval as is, the application will be approved.
Subcommittees are not authorized to disapprove an application. If a Subcommittee member believes that an application should be disapproved, the member will refer the application to the full Committee.
A full Human Subjects Review Committee reviews all activities involving the use of human subjects that do not meet the criteria for exemption or minimal risk review. When an application is received at the Human Subjects Division, it is screened for completeness. If information is missing from the application, or if material is missing, the investigator will be contacted and requested to supply the missing information. Applications are assigned to Committee review on a "first come, first served" basis. A week before the scheduled meeting of the appropriate committee (bio-medical or behavioral), applications are assigned to members for review and a copy of each application is mailed to each member. Committees meet every two weeks.
Each application on the Committee agenda is assigned to a primary reviewer who is responsible for summarizing the application for the Committee and for making a recommendation for action.
Joint Review: In the event that joint review by a biomedical Committee and a social and behavioral Committee is appropriate for a given application, one of the two Committees is designated the primary Committee. The chair or staff coordinator of the primary Committee is responsible for specifying how the joint review can best be accomplished in each instance, for coordinating the joint decision of the two Committees, and for communicating the decision to the investigator.
Criteria for Approval: The criteria for decisions on Human Subjects Applications are as specified in the Federal regulations, supplemented by University of Washington policy as stated in the University Handbook and Human Subjects Manual, and by applicable laws of the United States and the State of Washington.
Scientific Merit: If an application involves more than minimal risks to subjects, the Human Subjects Review Committees must balance risks against their judgment of the scientific merit of the proposed research and, hence, of the likely benefits of the research. Otherwise, the scientific merit of the proposed research is not relevant to the task of the Human Subjects Review Committees.
Legal Advice: When the expertise of the Attorney General's Division is required or desired, the Manager of the Human Subjects Division will request such assistance.
Meeting Attendance: Investigators with applications pending before a Committee may, with the approval of the relevant Committee chair, attend that portion of the Committee meeting set aside by the Chair for the investigator's appearance. However, the Committee may continue discussion of the application in the investigator's absence, and the investigator is not to be present when the vote on the application is taken.
Committee Determinations: The Committee may approve an application as submitted, approve an application conditional on specified modifications or conditional on specified assurances that certain assumptions are correct, disapprove an application, or defer a decision until additional information or revisions have been submitted. The decision on each application will be made by a majority vote of the members present.
If an application is approved as submitted, the Committee Chairperson will sign the application, the consent documents will be stamped "approved," and the approved application and accompanying material will be returned to the investigator.
If an application is conditionally approved, the Committee will send the investigator a letter detailing the Committee's concerns. The investigator should respond to the concerns as soon as possible for prompt approval. A Subcommittee of the Human Subjects Review Committee may review the response. If the response meets the Committee's concerns and recommendations, the Subcommittee is authorized to present the application to the Committee Chair for signature. If the Subcommittee believes the response is non-responsive or raises additional concerns, it may refer the response back to the full Committee for reconsideration.
If review is deferred, the investigator will be sent a letter outlining the reasons the Committee was unable to come to a decision about the application and requesting additional information to help the Committee in its reconsideration. The reconsideration will be scheduled at the next available meeting of the Committee after the Human Subjects Division has received the investigator's response. The investigator may appear before the Committee at that time. Following reconsideration, the Committee may approve the application contingent on clarifications and revisions, continue to defer a decision pending additional information, or may deny approval.
If approval is denied, the Committee will send a letter to the investigator explaining why the reason the application could not be approved. The investigator will be informed of the right to appeal the decision at that time (see section I.C, , above).
In the unusual event of serious concerns about the protection of human subjects that are not clearly covered by federal law, state law or university policy, a Human Subjects Review Committee may nevertheless require modifications in the investigator's procedure, or the Committee may defer a decision pending clarification of the relevant regulations, or the Committee may decline to approve the application. In such instances, the relevant Committee chair may report the nature of the problem in writing to the Vice-Provost for Research with the suggestion that consideration should be given to a clarification or re-formulation of University of Washington policy to provide clear criteria for similar instances in the future.
Approval is granted for a period of no longer than one year and commensurate with the level of risk posed by the research, and is valid only as long as procedures approved by the Committee are followed.
Investigators requesting emergency one-time use of an investigational drug or device should call the Human Subjects Division for information. The U.S. Food and Drug Administration (FDA) allows only one use of an investigational article on an emergency basis without prior review and approval from the Human Subjects Review Committee. The Human Subjects Division staff will facilitate consultation with a Committee chair or appropriate member, and will prepare documentation to obtain the release of the drug or device. The researcher is responsible for complying with all federal regulations regarding the emergency use of test articles (including the requirement to obtain consent from the subject or his or her legally authorized representative) and for reporting back to the Human Subjects Review Committee within five working days. If researchers anticipate additional situations in which the test article might be used, they should prepare a complete Human Subjects Review Committee application for submission to the Committee.
There are two circumstances in which the Human Subjects Review Committees may grant approval required by a funding agency without having reviewed all of the study procedures and consent documents. One is if study procedures are to be developed during the course of the research, but human subjects approval is required by the sponsoring agency. The other is if the involvement of human subjects depends on the outcomes of work with animal subjects. The Principal Investigator may request an "approval in principle" in a cover letter accompanying a completed Form UW 13-11. The Human Subjects Review Committee may then grant approval without having reviewed the as yet undeveloped recruitment, consent, and intervention materials. However, if the proposal is funded, the Principal Investigator must submit such materials for approval, accompanied by a completed Form UW 13-11, at least 60 days before recruiting human subjects into the study, or into any pilot studies or pre-tests. Approval in principle is granted to satisfy funding agency requirements and for the convenience of investigators.
Investigators may wish to modify, or amend, their approved applications. Modifications may be approved if they are within the scope of what the Committee originally authorized. For example, if a researcher wishes to add a population to an existing study, but not alter the study procedures or purpose, a modification request is usually appropriate. Likewise, modifying a procedure without changing the study's purpose or study population may also be appropriate. If, however, the researcher wishes to add a population and revise study procedures, he or she will need to submit a new application for human subjects approval. A modification form is available for investigators who wish to request approval of amendments or modifications (see the Forms Section of this Manual).
There are three types of modifications:
Investigators may seek several sources of funding for one research activity. It is not necessary to submit a complete new Human Subjects Review Committee application to accompany each new grant or contract proposal. All proposals for the same activity may be listed on one application. Should investigators seek additional funding for the activity after initial approval has been granted, they should request, in writing, that the new proposal be added to the existing approval. This is appropriate only in cases in which the new proposal describes what has already been described in the approved application. The investigator must send four copies of a completed form or of a signed memorandum requesting that the proposal for funding be added. The memorandum should include the following information:
The investigator should enclose one copy of the cover page and narrative portion of the proposal with the four copies of the form or memorandum.
Research activities are approved for no longer than a period of one year and may be approved for a shorter period of time commensurate with the level of risk posed by the activity. Investigators are responsible for seeking continuing review before the approval period expires. Should the approval period expire, the research should cease until re-approval has been granted.
If researchers propose minor changes which do not affect risks to subjects, they should submit one signed original and three (3) copies of the Status Report. Examples of minor changes include: addition, deletion, or change in title, departmental affiliation, telephone number of investigators; minor change in size of specimen to be taken; deletion of a questionnaire or of items from a questionnaire; addition of study sites. If there are questions about what constitutes a minor change, call the Human Subjects Division for advice.
If changes in the activity are proposed that may pose significant risks to subjects, investigators must submit nine copies of a new Human Subjects Review Committee application form and of the signed Status Report for review. Such changes may include but are not limited to: changes in drugs or medications; addition of a vulnerable subject population, addition of audio or visual recordings; changes in radiation exposure; substantive changes in or additions to questionnaires or interviews; additions of or changes in invasive procedures (e.g., addition of biopsy, change in route of administration of a drug. If there are questions about what constitutes a major change, call the Human Subjects Division for advice.
To close out an application, complete the Status Report and return one signed copy of the form. This will terminate approval. No research activity with human subjects may be conducted after the approval has been terminated.
As a courtesy to investigators, the Human Subjects Division will send a notice and the Status Report form to investigators about two months before the end of the approval period. An investigator who does not receive such a reminder should contact the Human Subjects Division as soon as possible to request a copy of the Status Report.
If the activity involves exposing subjects to radiation, Radiation Safety Committee approvals must also be renewed.
Renewal applications are assigned to a Committee member who shall serve as the primary reviewer. A full Committee or Subcommittee reviews renewal applications, depending the level at which they were initially reviewed, unless the research has changed in such a way as to require a different level of review.