University of Virginia Library

POLICY OF THE UNIVERSITY OF VIRGINIA FOR THE PROTECTION
OF HUMAN SUBJECTS

The following resolution was adopted:

• RESOLVED by The Rector and Visitors of the University of Virginia that the following is adopted as the official policy with respect to the Policy of the University of Virginia for the Protection of Human Subjects:

PURPOSE

The Policy of the University of Virginia for the Protection of Human Subjects is to assure that in the plans and conduct of sponsored projects and activities that include human subjects:

The rights and welfare of subjects are adequately protected.

The risks to subjects are outweighed by potential benefits.

The informed consent of subjects will be obtained by methods that are adequate and appropriate.

IMPLEMENTING GUIDELINES

REVIEW COMMITTEES: COMPOSITION AND FUNCTIONS

The complexity of the University of Virginia requires that there be two review committees, with a separate chairman for each, responsible for protecting human subjects who may be "at risk"[1] in research, training, demonstrations or other University activities. Both committees are responsible to the Vice President and Provost of the University.

All applications which include human subjects who may be "at risk," whether in research, training, demonstrations or other, and originate in the Medical Center will be reviewed by the Clinical Research Committee, which is appointed by the Dean of the Medical School. The committee is composed of ten members from varying backgrounds to assure complete and adequate review. Most of the members will be engaged in private practice as well as research. (See Appendix A, "Current Membership and Qualifications of the Clinical Research Committee.")

All applications which include human subjects who may be "at risk," whether in research, training, demonstrations, or other, and originate in the University outside the Medical Center will be reviewed by the Human Subjects Committee, which is appointed by the Vice President and Provost. This committee is composed of at least six members with representation from the Schools of Education, Engineering and Law and the Departments of Psychology and Sociology and Anthropology. (See Appendix B, "Current Membership and Qualifications of the Human Subjects Committee.")

The Chairman of each committee will serve as ex officio member of the other. The Human Subjects Committee member from the School of Law may serve as consultant to the Clinical Research Committee, upon request. Conversely, applications to the Human Subjects Committee which have medical implications will be referred to the Clinical Research Committee for review and approval. A committee reviewing a project which involves the use of experimental new drugs will include a quorum including not less than two persons licensed to administer drugs, and one who is not so licensed.

No individual shall participate in the review of the research activities in which he is involved, except to provide information to the committee. A committee member will absent himself during the discussion of and voting on his own application.

The chairman of either committee shall be responsible for determining the need for and obtaining expert advice whenever necessary for the competent review of an application. The source and nature of such advice shall be reported to the Vice President and Provost, along with the committee's decision. Similarly, the review committee shall inform each investigator of the need for and suggest sources of expert advice or consultation during the conduct of the investigation. This information will form a part of the committee's decision report.

A majority of the committee members constitute a quorum, a majority of which may pass on an application. The result of such vote, along with appropriate attachments, shall be reported immediately to the Office of Sponsored Programs and to the Vice President and Provost.

INITIAL AND CONTINUING REVIEW PROCEDURES BY THE COMMITTEES[2]

TIMING OF REVIEW

The committee will meet as often as the need arises. Research described in applications and contract proposals shall, whenever possible, be given institutional review and approval prior to submittal to the sponsor.

There may be occasions when a second review by the committee will be required before the research project is initiated. Also, the committee shall require the project or program director to report for review any emergent problems or proposed procedural changes which might affect the status of the research with regard to the committee's review criteria. No such changes, except those necessary to eliminate apparent immediate hazards, will be allowed without prior approval of the committee.

Prior to submittal of a grant application to the committee, the principal investigator should discuss his application with his department head during its preparation, and submit it to the review committee before the application is sent to the sponsor. The proposal or application should be appropriately marked in the spaces provided or, when missing, the following statement should be typed on the lower or right-hand margin of the page bearing the name of the institutional official signing the application or proposal for the institution:

HUMAN SUBJECTS---REVIEWED AND APPROVED ON (date). (This date should be no more than 90 days prior to the submittal date and must not be more than 12 months prior to the proposed starting date).

If it is necessary to delay the review, the proposal should be appropriately marked in the spaces provided on the forms or, if missing, the following statement should be typed in the lower or right-hand margin of the page bearing the name of the institutional official authorized to sign or execute applications or proposals for the institution:

HUMAN SUBJECTS---REVIEW PENDING ON (date). (This date should be at least one month earlier than the proposed starting date of the project to avoid possible conflict with the award date).

Pending reviews will be completed as much in advance of the stated pending review date as is practicable. If the final action is disapproval, or is approval contingent on substantive changes in the proposal, the Director of the Office of Sponsored Programs will be asked to so notify the operating agency and, where appropriate, will formally withdraw the application from further consideration by that agency.

ADEQUATE PROTECTION OF THE RIGHTS
AND WELFARE OF SUBJECTS

The committee will carefully examine the research plan from each investigator to arrive at an independent determination of the possible hazards involved. In particular, the committee will be alert to the possibility that the principal investigator may unintentionally introduce unnecessary or unacceptable hazards or fail to provide adequate safeguards. The committee will consider the research plan as a whole in order to determine that the normally minor and acceptable risks are not aggravated by the design of the plan. The committee must be assured by the investigators that proper precautions will be taken to deal with emergencies that may develop even in the course of routine procedures.

OBTAINING INFORMED CONSENT

The committee will assist in the development of a proper and appropriate investigation consent form. The guidelines for the wording of such forms, for the methods by which patients or subjects are to be informed in a valid manner, and for the limitations and exceptions to the rule that all subjects or their guardians must be informed and be given written consent, are derived from those issued on August 24, 1966, by FDA commissioner J. P. Goddard (Title 21, Part 130.37, as published in the Federal Register of August 30, 1966). The basic guideline has been expanded, however, to include not only the use of new drugs but all other investigative procedures as well.

Consent will be obtained whenever possible from the subject himself. Whenever the subject is not legally or physically capable of giving informed consent because of age, medical incapacity or inability to communicate, or when the attending professional investigator believes that the giving of full information would be contrary to the best interest of the subject, a review committee may consider the validity of consent of the next of kin, legal guardians or other responsible third parties who represent the subject's interest. The committee will determine if the consent, whether secured in writing or orally, or implicit in the voluntary participation in a well advertised activity, is adequate in the light of risks to the subject and the circumstances of the research. The committee will also determine if the information to be given to the subject or responsible third parties, orally or in writing, is a fair explanation of the procedures, the possible benefits, and the attendant hazards.

RELATIVE WEIGHTS OF RISKS VERSUS BENEFITS

Even though informed consent has been obtained or can be anticipated, the committee will carefully consider the relative weights of the risks and benefits of the procedures to the subjects.

NOTIFYING THE PROJECT DIRECTOR OF THE
COMMITTEE'S DECISION

When the committee's overall recommendation concerning a research project is favorable, it will prescribe restrictions or conditions under which research may be conducted, define areas of possible pertinent changes in the research plans which should be brought to the investigator's attention, and determine the nature and frequency of interim review procedures to insure continued acceptable conduct of the research. Unfavorable recommendations concerning the proposed research project cannot be removed except by the committee. Under no circumstances shall proposed research or proposed changes in research plans not approved by the research committee be implemented with sponsor funds. In the event of unfavorable recommendations, the investigator proposing the research will be informed of the reasons for any adverse actions taken by the committee.

PROCEDURE FOR PROCESSING A TYPICAL
GRANT APPLICATION

The application should be discussed by the principal investigator with his department head during its preparation and subsequently submitted to the review committee before or as soon as possible after submittal to the sponsor.

The committee chairman will study each application, seek clarification and obtain expert advice or consultation as needed, and schedule it for committee consideration. Each application will be discussed carefully and unhurriedly, and the final decision and recommendation will be communicated in detail to the principal investigator. Disapproval of an application may be appealed to a full meeting of both committees and the Vice President and Provost, with the investigator appearing in person with his department head and other expert consultants to support his appeal. The final decision will be by written ballot with the Vice President and Provost voting. Confirming disapproval at this point precludes further appeal.

If the investigator agrees to the committee decision report and this is properly signed, he is free to begin his investigation when funded. If he disagrees, he may request a re-hearing for modification of the conditions of the committee decision. When all is in agreement, the Vice President and Provost will be so notified. The Director of the Office of Sponsored Programs will not authorize an expenditure from sponsor funds until all questions concerning research protocol involving human subjects have been appropriately settled.

SELF-SURVEILLANCE AND REPORTING

Each investigator and each department head in signing the committee decision report affirm their respective pledges: the investigator (1) to follow faithfully the protocol spelled out in his application (with amendments, if any are recommended by the committee), (2) to report promptly any departure from protocol or untoward occurrences to his department head, and (3) to modify or terminate his investigation at the decision of the department head or committee; the department head, (1) to share in the responsibility for the conduct of the investigation, (2) to consult with the review committee regarding any significant departure from protocol or the occurrence of any untoward developments, specifically, permanent disability or death, and (3) to respond to the annual request for reports of work in progress, correcting any deficiencies of supervision as they become obvious. The committee reserves the right to terminate the experiment at any time if by majority vote it decides that the risks of further experimentation are prohibitive. In the event of such an occurrence, the Director of the Office of Sponsored Programs will so notify the sponsoring agency.

CONTINUING REVIEW OF RESEARCH

The committee shall require the project or program director to report to the committee for review any emergent problems or proposed procedural changes which may affect the status of the research with regard to the committee's review criteria. No such changes except those necessary to eliminate apparent immediate hazards will be made without prior approval by the committee. The committee shall carry out interim reviews of the conduct of all research projects at appropriate intervals.

RECORDS AND REPORTS

The formal records of the committee are as follows: (1) Minutes of Meetings - A copy will be furnished to each committee member and the Vice President and Provost. The Minutes will identify each application by title, intended sponsor, identifying number (if shown), project period, and principal investigator(s), with appropriate source and substance of any expert advice made part of the review, and will record any pertinent discussion, tabulated vote, and the final decision on each application. Also, the committee decision reports will be recorded as soon as possible. (2) Committee Decision Report - Three copies are to be completed for each application. This form includes the date of the meeting, the number of members present, the title, the identifying number, principal investigator(s), the majority decision, any suggestions concerning possible need for expert advice and consultation or utilization of special professional assistance or facilities, specific recommendations of methods to be used in obtaining informed consent, the requirement that all departures from protocol, untoward developments, etc. be reported to the department head, the request that the department head periodically review this investigation as part of work and progress in his department, and the signatures of the committee chairman, the principal investigator(s) and the department head. (3) Annual Reports - The committee will request a statement of satisfactory progress in January from each department head under whom a principal investigator has begun or continued a previously approved investigation during the previous year. These reports are to be kept in the committee files, and a summary will be sent to the Vice President and Provost for his records.

FACILITIES AVAILABLE TO PROTECT THE HEALTH
AND SAFETY OF HUMAN SUBJECTS

At the University of Virginia Medical Center there are extensive facilities and personnel available to protect the health and safety of human subjects, particularly those who require emergency care. The University of Virginia Medical Center is registered by the American College of Surgeons, the American Medical Association, and the American Hospital Association and is fully accredited by the Joint Commission on Accreditation of Hospitals. All internships and residencies are approved by the Council on Medical Education and Hospitals of the American Medical Association.

VOICING OF COMPLAINTS AND CONCERNS
BY HUMAN SUBJECTS

Human subjects who wish to voice complaints or concerns about their involvement in a particular research, training, demonstration or other activity may do so to the committee which first approved the activity. In the event that the human subject is not satisfied, further administrative review is available. Appeal from the review of the Clinical Research Committee is to the Dean of the School of Medicine, then the Vice President and Provost, and finally the President of the University. Appeal from the review of the Human Subjects Committee is to the Vice President and Provost and then the President.