University of Washington Human Subjects Manual
III. Review Procedures
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
- No Risk Research (Exemptions): Departmental-level review
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.
- Human Subjects Review Committees
- General Information: Human Subjects Review Committees and Subcommittees
- Structure
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.
- Function
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.
- Human Subjects Review Committee Application form
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 review (Expedited)
- General information
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.
- Procedures
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:
- approve as submitted;
- approve with minor modifications or on condition that certain specified
assumptions about the investigator's procedures are correct; or
- refer to the full Committee (i.e., the application is not eligible for
"minimal risk" review).
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.
- Full Committee Review
- General information
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.
- Procedures
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.
- Emergency Review
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.
- Approval in Principle
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.
- Modifying an approved application
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).
- Types of modifications
There are three types of modifications:
- "Informational modifications" report changes that have no potential
implications for human subjects, e.g., the addition of a associate
investigator, a change in title or funding source, a reduction in the number
of subjects included, deletion of items from a questionnaire.
- "Minor procedural modifications" entail minor changes in the procedures
affecting human subjects but which do not significantly affect the risks to
human subjects, e.g., drawing a slightly different amount of blood, adding
non-sensitive questions to a questionnaire.
- "Risk-relevant procedural modifications" entail changes in the procedures
affecting human subjects which might affect the risks to human subjects,
e.g., adding a new feature to the treatment of subjects that might increase
risk, initiating the videotaping of subjects.
- Procedures
- "Informational modifications" may be recorded by Human Subjects Division
staff without approval from a Human Subjects Review Committee or
Subcommittee. Human Subjects Review Coordinators have the authority to
determine whether a modification is or is not to be treated as an
"informational modification."
- "Minor procedural modifications" which do not affect risks to subjects may
be approved by staff without review by a Committee or Subcommittee. Human
Subjects Review Coordinators have the authority to determine whether a
modification is or is not to be treated as a "minor procedural
modification."
- "Risk-relevant procedural modifications" are to be referred for Subcommittee
review if the procedural modification entails only a minimal risk to human
subjects. Human Subjects Review Coordinators have the authority to
determine whether a modification is appropriate for Subcommittee review.
Subcommittees will review such modifications in accord with the procedures
outlined above.
- "Risk-relevant procedural modifications" that entail more than minimal risk
shall be referred to the appropriate Human Subjects Review Committee for
review. Human Subjects Review Coordinators have the authority to determine
whether a modification is appropriate for Committee review. Committees
will review such modifications in accord with the procedures outlined
above.
- Adding Funding Sources
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 name of the principal investigator on the Human Subjects Review Committee application;
- the title and current number of the Human Subjects Review Committee application;
- the name of the principal investigator of the new proposal for funding;
- the title of the new proposal;
- the name of the agency to which the proposal is being submitted;
- the proposed dates of funding; and
- a statement describing any differences between the proposal and the approved
application or, if there are none, a statement to that effect. If there are
differences, the researcher must submit four copies of the revised consent
documents and any other revised or additional information (questionnaire,
data collection sheets, etc.)
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.
- Continuing review
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.
- Types of continuing review
- Renewal with minor or no changes
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.
- Renewal with major changes
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.
- Study termination
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.
- Procedures
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.
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Section IV: Informed Consent
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