CHAPTER FIVE: 5200
RESEARCH
POLICIES
July 2003
5200
INVESTIGATIONS INVOLVING HUMAN SUBJECTS
PREAMBLE:
This section outlines the considerations, legal and ethical, that need to be
taken into account in any research that involves human subjects. It was original
to the 1979
Handbook and was revised in July of 1995, and again in July 2003, to reflect
changes in applicable federal law. For further information, contact the Research
Office (208-885-6651). [rev. 7-03]
CONTENTS:
A. General
Policy
B. “Subject
at Risk”
C. Direct or
Indirect Participation
D. Human
Assurances Committee
E. Responsibilities of the Human Assurances Committee
F. Informed
Consent
G.
Responsibilities of Departmental Administrators
H.
Responsibilities of Principal Investigators [ed. 7-06]
A. GENERAL
POLICY.
UI complies with the policy of the U.S. Department of Health and Human Services
(HHS) concerning the protection of human subjects in all activities in which
human subjects may be at risk. In the execution of this policy, UI is guided by
the ethical principles promulgated in the “Declaration of Helsinki.”
Nonetheless, these principles are never held to or construed so as to supersede
any local, state, or federal law. It is also understood that, in respect to any
activities supported in part or in full by grants from or contracts with HHS,
the Helsinki principles and UI policies are never held to, or construed so as
to, supersede any HHS policies or regulations.
B. “SUBJECT
AT RISK.”
The term, “subject at risk,” refers to any person who may be exposed to the
possibility of physical, psychological, sociological, or any other harm as a
consequence of his or her participation as a subject in any activity that goes
beyond or falls short of the application of those established and accepted
methods necessary to meet the subject’s needs.
C. DIRECT OR INDIRECT PARTICIPATION. A subject’s participation may be either
direct or indirect. Direct participation implies an immediate or proximate
physical or psychological involvement of the subject in an activity; for
example, application of an experimental vaccine or of a procedure designed to
test the subject’s response to experimental therapy. Indirect participation
involves use of a subject’s body fluids, tissues, or other physical materials,
or of any personal information obtained from the subject, for any therapeutic or
diagnostic purposes. Indirect participation also includes use of tissues, body
fluids, or other physical materials from spontaneously aborted fetuses and
deceased subjects. The fact that a subject’s participation may be indirect,
however, does not in any way diminish the fundamental responsibility of UI
investigators to protect adequately the rights and sensibilities of a human
subject, or, in the case of a deceased subject, the subject’s next of kin.
D. HUMAN
ASSURANCES COMMITTEE (HAC).
D-1. The HAC, which functions as a committee of the Research Council, has the
responsibility of ensuring that, for each activity planned or conducted: (a) the
rights and welfare of human subjects are adequately protected; (b) the risks to
the subjects are outweighed by the potential benefits, either to the subject
directly or to scientific understanding in general; and (c) the informed consent
of all subjects is obtained through methods that are both adequate and proper.
[NOTE: The responsibilities of HAC are elaborated in E; see also
1640.54.]
D-2.
The members of the HAC represent a variety of disciplines, such as law,
medicine, sociology, psychology, soil sciences, and zoology, and include one
non-UI member who serves as community representative. This diversity brings to
the review process a wide range of perspectives and ensures that each proposed
project in which there may be human subjects at risk will be reviewed not only
in terms of UI policies on human protection, but also in terms of applicable
law, standards of professional conduct and practice, the ethical principles of
the Helsinki declaration, and the consensus of responsible contemporary
community opinion.
D-3.
A quorum for HAC meetings shall be a majority of the total membership. When any
proposal for the investigational use of a new drug is being reviewed, at least
two members who are licensed to administer drugs in the state of Idaho and at
least one member not so licensed will be consulted. Any HAC member who has a
professional responsibility for, or involvement in, any proposed activity is
disqualified from participating in any review of that activity, except that he
or she may provide information or explanation to HAC.
D-4. HAC will meet as frequently as required to review new and continuing research
proposals involving human subjects, but not less than one time per year.
E.
RESPONSIBILITIES OF THE HUMAN ASSURANCES COMMITTEE.
E-1. HAC was established to review all projects and activities that involve human
subjects.
E-2. To increase efficiency and to ensure that all such projects are in compliance
with UI and HHS regulations, HAC members should familiarize themselves with the
regulations described herein.
a.
HAC members are selected by the vice president for research and graduate studies
to represent UI and community interests and to encompass a broad base of
interest.
b.
The vice president for research and graduate studies [see
5100 B-8] is a member
of HAC.
c.
The HAC chair or designated representative will receive and preliminarily review
proposals submitted by investigators. If any information is lacking, or if other
requirements of this policy have not been sufficiently met, HAC will request
additional information.
d.
The HAC chair or designated representative will forward a copy of the complete
protocol and attachments to selected members of HAC, chosen on the basis of
their special competence, for detailed review. (“Protocol” is used in this
policy in its sense as “the plan of a scientific experiment or treatment.”) The
chair may also use consultants in an advisory capacity who are not HAC members.
These consultants may or may not be UI employees.
e.
As part of the detailed review, HAC or its consultants may request additional
information about the proposed activity. These requests should be transmitted by
the HAC chair to the investigators.
f.
At the next regular meeting of HAC, or one called for this specific purpose, the
protocol will be presented by HAC members or consultants chosen to carry out
this function to the committee for review. The principal investigator of the
proposed activity must be present to give additional information. HAC will
discuss the human protection issues raised and will decide by two-thirds vote or
more: (1) to approve the proposal; (2) to approve the proposal with
restrictions; or (3) to defer approval pending changes in the protocol.
Otherwise, the proposal is disapproved. If the proposal qualifies for
“expedited” review according to federal guidelines, the HAC chair will review
the proposal, either alone or in consultation with one or more members of the
HAC committee. In case of “expedited review”, written approval will be sent to
the investigator as indication of approval or disapproval of the project
according to Federal Code Title 45, Part 46.101.
g.
Minutes must be taken of HAC meetings and copies distributed to members.
h.
HAC will send its decision in writing to the principal investigator, who in turn
will inform the appropriate department members.
i.
Adverse decisions of HAC concerning any proposed activity may be appealed by the
principal investigator through his or her departmental administrator to the vice
president for research and graduate studies. Adverse decisions or restrictions
imposed by HAC, however, can be reversed or modified only by a two-thirds
majority of HAC.
j.
HAC must receive all reports, annual reviews, and proposed changes in protocols
from investigators. It must receive and transmit to the investigators all
requests for additional information. HAC will ensure that projects are reviewed
at least annually.
k.
Once an activity is underway, the HAC chair must receive in writing from the
investigator notification of any change or proposed change in the protocol, any
emergent problems or potential problems, or any injury or harm suffered by a
subject as a consequence of his or her involvement in the activity.
l.
HAC will notify HHS of emergent problems that might affect the rights, safety,
or welfare of human subjects involved in any activities covered by these
procedures as reported by either the departmental administrator or HAC.
m.
HAC will receive and consider complaints or questions from staff members or
subjects that are referred to HAC by the vice president for research and
graduate studies, departmental administrators, or principal investigators.
n.
HAC must ensure that the safeguards specified in public law are followed to
maintain the confidentiality and security of all information obtained from human
subjects. HAC should familiarize itself with the provisions concerning
confidentiality published in the Federal Register of June 18, 1991. HAC
should also familiarize itself through legal counsel with those statutes and
common-law precedents that may bear on these decisions. The provisions of this
policy may not be construed in any manner or sense that would abrogate,
supersede, or moderate more restrictive applicable law or legal precedents.
[ed. 7-03]
o.
HAC will be provided legal counsel by the university counsel.
F. INFORMED
CONSENT.
F-1. Whenever any research activity involves human subjects, it is mandatory that the
investigator, or his or her duly certified representative, obtain the informed
consent of any and all such subjects. The informed-consent procedures and
documents employed for this purpose should not contain exculpatory language
through which the subject is made to waive, or to appear to waive, any of his or
her legal rights, or to release UI or its representatives from any liability for
negligence.
F-2. It is the policy of UI that any consent given by a subject is “informed consent”
only if the disclosure by the investigator, or his or her duly certified
representative, to the subject contains all of the following elements:
a.
An explanation of the procedures that are to be used, including the
identification of those that are experimental, in language and in a way
comprehensible by any layman.
b.
A fair disclosure of any potential risk or discomforts attending or potentially
stemming from the subject’s participation in, or premature withdrawal from, the
activity without prejudice.
c.
A fair description of the sought-for benefits to the subject directly, or to
scientific understanding in general.
d.
A full disclosure of any extant alternative procedures that would or might be
advantageous to the subject.
e.
An offer to answer any inquiries concerning the procedure, its potential or
possible effects, and its risks, and a description of the proper and most
expeditious means for making such inquiries and obtaining a response.
f.
A clear statement to the effect that the subject is free to withdraw his or her
consent and to terminate participation in the project or activity at any time,
for any reason, without notice.
F-3.
A subject’s informed consent will not be sought or obtained in a coercive or
manipulative manner. Informed consent will be obtained in one of two ways:
a.
The subject, or authorized representative, may be asked to sign a
written-consent document that embodies the six elements described above.
b.
The subject, or authorized representative, may be asked to sign a document
indicating that the subject has had the six basic elements of consent explained
orally, that he or she understands this oral description, and that, in awareness
thereof, the subject agrees to participate in the activity described. If such a
“short form” is used, however, it must be countersigned by an auditor-witness to
the oral presentation and to the signature of either the subject or the
subject’s representative. Whenever an oral presentation is to be given to the
subject in lieu of written disclosure, a written summary of the information to
be orally transmitted should be prepared and submitted to HAC for prior review
and approval.
F-4. Regardless of which of the above approved methods of consent is used, a full and
complete oral explanation must be given, including, where applicable, a full
reading to the subject of the consent document.
F-5. There may be cases in which the use of either of these procedures for obtaining
informed consent may be considered inappropriate by UI’s investigator, either
because the potential risks to human subjects may seem minimal or because the
use of either procedure would adversely affect the experimental design or
preclude the possibility of obtaining legitimate or reliable results.
Modification to the two approved informed-consent procedures can be suggested.
However, any modification must be approved, before implementation, by HAC. This
approval must be recorded in the minutes of the HAC and the minutes must be
signed by the chair. No such modifications will be approved by the HAC unless
and until the HAC determines:
a.
that the risk to any human subject is in fact minimal, justifying a less full
disclosure in the informed-consent procedures than would normally be required;
or
b.
that the use of either of the prescribed procedures for obtaining informed
consent would in fact invalidate objectives of considerable immediate
consequence and that the use of any reasonable alternative means for attaining
these objectives would be less advantageous to the subject.
F-6.
In no case, however, shall an investigator propose, or HAC approve, an
informed-consent procedure in which any possible or potential risk is knowingly
or purposely minimized, misrepresented, or otherwise distorted.
F-7. Copies of the informed-consent documents will be submitted to HAC as part of the
application for approval. The executed forms will be kept by the principal
investigator. Storage of informed-consent documents and any other material that
contains names, or other identifying characteristics of subjects, will be in
locked files in the safety deposit box in Business and Accounting Services. The
identity of subjects in research must be protected as specified in public law. [ed. 7-03]
G.
RESPONSIBILITIES OF DEPARTMENTAL ADMINISTRATORS.
G-1.
To ensure maximum protection of human subjects and to ensure compliance with UI
and HHS regulations, departmental administrators must follow the procedures
outlined herein. These procedures may be amended to cover new activities at UI
and collaborating institutions and to comply with changes in applicable federal
regulations.
G-2. Departmental administrators must familiarize themselves with these and all
regulations pertaining to the use of human subjects, because the administrators
will serve as intermediaries between principal investigators in their respective
departments and HAC. The departmental administrator may be the principal
investigator of a proposed activity that involves human subjects. In either
case, departmental administrators must be aware of their responsibilities in
studies performed in part or in full by members of their department.
Departmental administrators must:
a.
Review all proposals involving human subjects that are submitted by department
members (this should be done as early in the planning stage as possible) and
ensure that the studies meet requirements for protection of human subjects. If
such protection is not adequate, they must suggest ways to bring the proposed
studies into compliance.
b.
Forward two copies of the approved proposal to the HAC chair. A grant or
contract application to HHS may serve this purpose. Allow for a minimum of one
week between submission to HAC and HAC review.
c.
As required, obtain additional information from the principal investigator
concerning proposals under review by HAC.
d.
Appear before HAC for review of the proposed activity. The principal
investigator may also be asked to appear by HAC or the departmental
administrator.
e.
After approval and initiation of the project or activity, report in writing to
the HAC chair any proposed change in the protocol, any emergent or potential
problems, or any physical or psychological harm or injury suffered by a subject
as a consequence of involvement in the activity.
f.
Provide information to HAC as requested to ensure periodic review of activities
directed by department members. They must further ensure that a report covering
the project’s effects concerning human subjects is submitted annually, upon
completion of the project, or more frequently if requested by HAC.
H.
RESPONSIBILITIES OF PRINCIPAL INVESTIGATORS. To ensure maximum protection of human subjects and to ensure compliance with UI
and HHS regulations, principal investigators must follow the procedures outlined
herein. These procedures may be amended to cover new activities at UI or
collaborating institutions and to comply with new federal regulations.
H-1. Write a detailed protocol for the proposed activity. Grant or contract
applications submitted to HHS are acceptable. This protocol should contain a
completed “Human Subjects Form,” copies of informed-consent documents to be
used, and a complete explanation of how informed consent will be obtained. These
forms are available from departmental administrators. Examples of
informed-consent documents are on file with HAC. Informed-consent documents
should be designed to cover the specific study. Principal investigators should
solicit the assistance of HAC in the development of such documents.
H-2.
For each proposed activity, the investigator should inform his or her staff and
all prospective subjects, if these are available, of UI’s concern for the
subjects’ welfare, of the regulations governing the use of human subjects, and
of UI’s policy on the protection of human subjects, as filed with HHS. Copies of
the regulations and policy should be made available to staff or prospective
subjects upon request.
H-3.
Two copies of the complete protocol are to be forwarded to the departmental
administrator.
H-4. The principal investigator must provide additional information concerning the
protocol to the departmental administrator on request. The investigator may be
asked to appear with the departmental administrator before HAC, to present a
full explanation of risks and protection for human subjects, describe the
procedure to be used to achieve informed consent, and answer questions.
H-5.
Following HAC approval and the initiation of the activity, the principal
investigator must notify the departmental administrator, for forwarding to HAC,
of any proposed change that will or may affect human subjects. There should be
no change in studies with human subjects until HAC has reviewed and approved the
change. Changes that must be made in emergencies should be made at the
discretion of the principal investigator. Consultation should be had with the
departmental administrator, the vice president for research and graduate
studies, and/or the HAC chair if this is possible. Changes in protocol must be
reported in writing to the HAC chair as soon as possible.
H-6. The principal investigator must notify the departmental administrator of any
injury or harm, physical or psychological, suffered by a subject because of
participation in the study or of any emergent or potential problems.
H-7. Periodic review of the protocol is essential. The principal investigator must
submit a full report concerning human subjects at least annually and upon
completion of the project. This report must be given to the departmental
administrator who will forward it to HAC. HAC at its discretion may request more
frequent reports.
H-8. The principal investigator must make provisions for the safe retention of
complete records of human subjects for at least three years following the
completion of the project or activity. This period may be extended for certain
studies at the discretion of HAC.
H-9.
Investigators must follow the safeguards specified in public law to ensure the
confidentiality and security of all information obtained from human subjects.
Questionnaires, inventories, interview schedules, and other data-gathering
procedures must be carefully designed to ensure that only information relevant
to the project will be obtained. When body tissues, fluids, or other similar
materials are brought to UI from a hospital or physician’s office, only a code
or hospital number should be used, not the patient’s name. The principal
investigator would then have access to the patient only through the referring
physician or hospital. If subjects’ names are submitted to UI, they should be
stored in the safety deposit box in Business and Accounting Services. Under no
circumstances should subjects’ names be maintained in the investigator’s files.
Master codes and ciphers must be kept in secure places, distinctly separate from
encoded and enciphered data. The shipment, delivery, and transfer of all data,
printouts, and files between offices and institutions may require careful
controls. Computer-to-computer transmission of identifiable data is forbidden
without the express consent of HAC. Provisions should also be made for the
destruction of all edited, obsolete, or depleted data on punched cards, tapes,
discs, and other records. The investigator should notify HAC before this action.
HAC may also determine a future date for destruction of all stored primary data
pertaining to a project or activity. Particularly relevant to the decision of
HAC are those rights of the subject that are defined by law. [ed. 7-03]
H-10.
In collaborative activities with other institutions, the investigator must give
supportive evidence that rights of human subjects are being adequately protected
in any activity performed in those institutions.
H-11. The investigator should inform his or her staff and prospective subjects that
complaints or questions concerning any activity in which they are involved can
be sent in writing to the investigator, to the departmental administrator, and
to the vice president for research and graduate studies. The staff and subjects
should be informed that they may go directly to HAC if they are not satisfied
with the disposition of the matter. The investigator should inform the subject
or staff member of the most expeditious manner in which the matter might be
brought to the consideration of HAC.
H-12. When research involving human consumption of alcohol is contemplated, it is the
responsibility of the applicant to obtain a copy of the “University of Idaho
Guidelines on the Administration of Ethyl Alcohol in Human Experimentation.”
Each item in the guidelines must be addressed in the protocol before
submitting it to the institutional review board (HAC). In addition, all
investigators should obtain a copy of the “Recommended Council Guidelines on
Ethyl Alcohol Administration in Human Experimentation” of the National Institute
on Alcohol Abuse and Alcoholism (NIAAA) available from the UI Research Office.
The NIAAA-recommended guidelines will be used by the institutional review board
(HAC) in evaluating the protocol.
