In order to protect the rights, well-being, and personal privacy of individuals, to ensure a favorable climate for the conduct of scientific inquiry, and to protect the interests of the University of Washington, the policy and procedures described below have been established for the conduct of research involving human subjects.
The following general principles apply equally to all research involving human beings, whether carried out solely with University resources or with the assistance of outside funds. The University assumes responsibility for communicating and explaining these principles to University personnel, and for providing procedural guidelines to effect their observance.
| A. | The University of Washington and the individual members of its faculty,
staff, and student body recognize their responsibility for protection of the rights and
welfare of human subjects, and for upholding the ethical principles of respect, beneficence,
and justice in the conduct of research with human research subjects. |
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| B. | Appropriate professional attention and facilities shall be provided to insure the
safety and well-being of human subjects. No subject in a research activity shall be
exposed to unreasonable risk to health or well-being. |
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| C. | Research involving children (persons under 18 years of age), other legal
incompetents, and persons unable to give informed consent may be approved if there is
no risk or suffering for the individual subject. On the other hand, research involving
a child, another legal incompetent, or a person unable to give informed consent should
not be approved if there would be a significant risk or suffering without the
possibility of benefit to the individual subject. [Title 45, Code of Federal Regulations,
Part 46, Subpart D, shall be followed for research involving
children.] |
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| D. | The confidentiality of information received from subjects in experiments or
respondents to questionnaires shall be fully protected, both during and after the
conduct of a research activity, within the limits of the law. |
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| E. | Before a subject participates in research involving risk or substantial stress or
discomfort, this shall be carefully explained; the investigator shall be satisfied that
the explanation has been understood by the subject; and the consent of the subject,
shall be obtained. The elements of informed consent are established by the federal
government and by the University. |
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| F. | A request by any subject for withdrawal from a research activity shall be honored
promptly without penalty or without loss of benefits to which the subject is otherwise
entitled, within the limits of the research. |
Precedent and practice have established the principle that certain types of research that might be called "human subjects research" do not require review for the protection of human subjects. The following types of activity do not require such review:
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Human subjects research exempted from federal regulations for the protection of human subjects (Title 45, Code of Federal Regulations, Part 46.101 (b), see Section 8 of this part) may be approved by the relevant department chair, 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 chair, 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 Section 2 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 prior to the initiation of any use of human subjects in the proposed research.
It shall be the responsibility of the relevant department chair, 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 1 above. If the decision is affirmative on both points, the form should be signed and forwarded to the Office of Grants and Contract Services, Human Subjects Division. If the relevant department chair, 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 1 above, the investigator should be so advised and asked to complete Form UW 13-11 for submission to the Human Subjects Review Committee. Student research should be approved by the faculty sponsor before requesting the approval of the department chair, director, or dean.
The relevant department chair, 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 must be submitted to the Human Subjects Review Committee for approval.
It is the obligation of each investigator to bring to the attention of the relevant department chair, director, or dean any proposed research involving the use of human subjects not covered by Sections 2 and 3 above and hence requiring approval by a Human Subjects Review Committee (Institutional Review Board). Form UW 13-11 is to be used for this purpose. Approval for the protection of human subjects in such research must be obtained prior to the initiation of any use of human subjects in the proposed research.
It shall be the responsibility of the relevant department chair, director, or dean to review the proposed research to determine that the investigators are qualified to conduct the research. If the decision is affirmative on this point, the form should be signed and forwarded to the Office of Grants and Contract Services, Human Subjects Division, for referral to the appropriate Human Subjects Review Committee (Institutional Review Board). If the relevant department chair, director, or dean determines that the investigator is not qualified to conduct the proposed research, the investigator should be so advised.
Student research should be approved by the faculty sponsor before
requesting approval by the department chair, director, or dean.
| A. | Human Subjects Review Committees, and subcommittees thereof, shall be
established in accord with federal requirements for Institutional Review Boards. The
subcommittee may approve only certain kinds of research involving no more than minimal risk,
as prescribed in the procedures and criteria for expedited review in Title 45, Code of
Federal Regulations, Part 46.110 (see Section 9 of this part). |
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| B. | It shall be the responsibility of the Human Subjects Review Committees, and of
subcommittees thereof, 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 1 above. |
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| C. | The Human Subjects Committees, and subcommittees thereof, may require modifications in
the proposed procedures as a condition of approval. |
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| D. | Human Subjects Review Committees, or a subcommittee thereof, may grant approval for
a period of one year commencing with the anticipated beginning date of the
research. |
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| E. | When research procedures are modified during the course of the research in any way
that may affect the rights and welfare of human subjects in the research, 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. |
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| F. | Research that continues beyond the period of approval by a Human Subjects Review Committee, or by a subcommittee thereof, must be reapproved for an additional period. Investigators requesting the renewal of approval should use Form HS SR-1 for this purpose. |
If a subcommittee of a Human Subjects Review Committee makes a decision that the investigator believes to be unduly restrictive on the proposed research, the investigator may appeal, in writing, for review by the appropriate Human Subjects Review Committee.
If a Human Subjects Review Committee makes a decision that the investigator believes to be unduly restrictive on the proposed research, the investigator should first discuss the matter with the chair of the relevant Human Subjects Review Committee, taking care to explain the reasons for believing that the proposed procedures are in compliance with University policy and with federal regulations. If the issue cannot be satisfactorily resolved by negotiation, the investigator may appeal the decision of the committee, in writing, to the Vice Provost for Research.
Upon receipt of an appeal the Vice Provost for Research shall convene an ad hoc committee constituted so as to fulfill the federal requirements pertaining to Institutional Review Boards, and with a majority of the members being past but not current members of Human Subject Review Committees at the University of Washington. This ad hoc committee shall consider the appeal and issue a recommendation within no more than 60 days from receipt of the appeal by the Vice Provost for Research. The ad hoc committee shall give the investigator an opportunity to present orally, or in writing, or both, the reasoning underlying the appeal. Upon completion of the review, the ad hoc committee shall communicate its decision in writing to the Vice Provost for Research, giving the reasoning for the decision. A copy of the decision of the ad hoc committee shall be given to the investigator. The decision of the ad hoc committee shall be treated as a decision of a University of Washington Human Subjects Review Committee (Institutional Review Board duly approved by OPRR prior to convening as an IRB appeals board).
The Research Advisory Board shall have general oversight responsibility for University policy on the protection of human subjects and shall consider policy changes that may be required to comply with federal regulations, to ensure fairness to investigators, or to protect more adequately the rights and welfare of human subjects in research. When appropriate, such policy changes should be recommended by the Board to the Vice Provost for Research.
Research activities in which the only involvement of human subjects will be in one or more of the following categories:
| A. | Research conducted in established or commonly accepted educational
settings, involving normal educational practices, such as: |
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| 1) | Research on regular and special educational instructional strategies;
or |
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| 2) | Research on the effectiveness of or the comparison among instructional techniques,
curricula, or classroom management methods. |
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| B. | Research involving the use of educational tests, (cognitive, diagnostic,
aptitude, achievement), if information taken from these sources is recorded in such a
manner that subjects cannot be identified, directly or through identifiers linked to the
subjects. |
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| C. | Research involving survey or interview procedures, except where all of
the following conditions exist: |
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| 1) | Responses are recorded in such a manner that the human subjects can be identified,
directly or through identifiers linked to the subjects; |
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| 2) | The subject's responses, if they became known outside the research, could reasonably
place the subject at risk of criminal or civil liability or be damaging to the subject's
financial standing or employability; and |
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| 3) | The research deals with sensitive aspects of the subject's own behavior, such as
illegal conduct, drug use, sexual behavior, or use of alcohol. All research involving
survey or interview procedures is exempt, without exception, when the respondents are
elected or appointed public officials or candidates for public office. |
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| D. | Research involving the observation (including observation by participants)
of public behavior, except where all of the following conditions exist: |
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| 1) | Observations are recorded in such a manner that the human subjects can be identified,
directly or through identifiers linked to the subjects; |
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| 2) | The observations recorded about the individual, if they became known outside the
research, could reasonably place the subject at risk of criminal or civil liability or
be damaging to the subject's financial standing or employability; and |
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| 3) | The research deals with sensitive aspects of the subject's own behavior such as
illegal conduct, drug use, sexual behavior, or use of alcohol. |
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| E. | Research involving the collection or study of existing data, documents,
records, pathological specimens, or diagnostic specimens, if these sources are publicly
available or if the information is recorded by the investigator in such a manner that
subjects cannot be identified, directly or through identifiers linked to the
subject. |
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| F. | Unless specifically required by statute (and except to the extent
specified in Section 1), research and demonstration projects which are conducted
by or subject to the approval of the Department of Health and Human Services, which are
designed to study, evaluate, or otherwise examine: |
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| 1) | Programs under the Social Security Act, or other public benefit or service
programs; |
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| 2) | Procedures for obtaining benefits or services under those programs; |
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| 3) | Possible changes in or alternatives to those programs or procedures; or |
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| 4) | Possible changes in methods or levels of payment for benefits or services under those programs. | ||
Research activities involving "no more than minimal risk" and in which the only involvement of human subjects will be in one or more of the following categories:
| A. | Collection of: hair and nail clippings, in a nondisfiguring manner;
deciduous teeth; and permanent teeth if patient care indicates a need for
extraction. |
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| B. | Collection of excreta and external secretions including sweat, uncannulated saliva,
placenta removal at delivery, and amniotic fluid at the time of rupture of the membrane
prior to or during labor. |
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| C. | Recording of data from subjects 18 years of age or
older using non-invasive procedures routinely employed in
clinical practice. This includes the use of physical sensors
that are applied either to the surface of the body or at a
distance and do not involve input of matter or significant
amounts of energy into the subject or an invasion of the
subject's privacy. It also includes such procedures as weighing,
testing sensory acuity, electrocardiography, electroencephalography,
thermography, detection of naturally occurring radioactivity,
diagnostic echography, and electroretinography. It does not include
exposure to electromagnetic radiation outside the visible range
(for example, X–rays, microwaves). |
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| D. | Collection of blood samples by venipuncture, in amounts not
exceeding 450 milliliters in an eight-week period and no more
often than two times per week, from subjects 18 years of
age or older and who are in good health and not pregnant. |
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| E. | Collection of both supra- and subgingival dental plaque and
calculus provided the procedure is not more invasive than routine
prophylactic scaling of the teeth and the process is accomplished
in accordance with accepted prophylactic techniques. |
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| F. | Voice recordings made for research purposes such as
investigations of speech defects. |
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| G. | Moderate exercise by healthy volunteers. |
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| H. | The study of existing data, documents, records, pathological
specimens, or diagnostic specimens. |
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| I. | Research on individual or group behavior or characteristics of
individuals such as studies of perception, cognition, game theory, or
test development, where the investigator does not manipulate subjects'
behavior and the research will not involve stress to
subjects. |
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| J. | Research on drugs or devices for which an investigational new drug exemption or an investigational device exemption is not required. |
June 7, 1972; November 20, 1975; June 15, 1976; October 1, 1982; September 12, 1990; June 8, 2005.
For related information, see: