Manual of Policies Procedures for Conducting Research with
Human Subjects
1.0
Introduction
The
1.1 The
During the post-World War II era, a number of ethical
codes dealing with treatment of human subjects were established, and among them
the Nuremberg Code (1947) was perhaps the most well known code developed to
deal with standards for medical experimentation with human
subjects. This was the first set of standards for
judging conduct with human subjects and served as a prototype of a variety of
later codes. Later, the National
Commission for the Protection of
Human Subjects in Biomedical and Behavioral Research used the Nuremberg
Code as the basis to expand consideration beyond medical human subject
experimentation to include broader ethical principles of research with human
subjects. The Commission's work resulted
in the Belmont Report (1978) that
established an ethical framework and basis by which specific rules guiding
research with human participants may be formulated and interpreted. These principles involve respect for persons,
beneficence/ nonmaleficence, and distributive justice
(Lederer & Grodin,
1994, p. 19). Both the Nuremberg Code
and the Belmont Principles[1] are
stated below, and a bibliography of various ethical codes is provided in
Appendix A.
The
1. The voluntary consent of the human subject is
absolutely essential.
2. The experiment should be such as to yield
fruitful results for the good of society, unprocurable by other methods or
means of study, and not random and unnecessary in nature.
3. The experiment should be so designed and
based on the results of animal experimentation and a knowledge of the natural
history of disease or other problem under study that the anticipated results
will justify the performance of the experiment.
4. The experiment should be so conducted as to
avoid all unnecessary physical and mental suffering and injury.
5. No experiment should be conducted where there
is an a priori reason to believe that
death or disabling injury will occur---except perhaps in those experiments
where experimental physicians also serve as subjects.
6. The degree of risk to be taken should never
exceed that determined by the humanitarian importance of the problem to be
solved by the experiment.
7. Proper preparations should be made and
adequate facilities provided to protect the experimental subject against even
remote possibilities of injury, disability, or death.
8. The experiment should be conducted only by
scientifically qualified persons. The
highest degree of skill and care should be required through all stages of the
experiment of those who conduct or engage in the experiment.
9. During the course of the experiment, the
human subject should be at liberty to bring the experiment to an end if he has
reached the physical or mental state where continuation of the experimentation
seems to him to be impossible.
10. During the course of the experiment, the
scientist in charge must be prepared to terminate the experiment at any stage
if he has probable cause to believe, in the exercise of good faith, superior
skill, and careful judgment required of him, that a continuation of the
experiment is likely to result in injury, disability, or death to the
experimental subject.
The
Three basic principles, in addition
to those generally accepted in our cultural tradition, are particularly relevant
to the ethics of research involving human subjects: respect for persons, beneficence,
and justice.
1. Respect for Persons
Respect for persons incorporates at
least two basic ethical tenets: (1) that
individuals should be treated as autonomous agents and (2) that persons with
diminished autonomy are entitled to protection.
The principle of respect for persons thus divides into two separate
moral requirements: the requirement to acknowledge
autonomy and the requirement to protect those with diminished autonomy.
To respect autonomy is to give
weight to autonomous persons' considered opinions and choices while refraining
from obstructing their actions unless they are clearly detrimental to
others. Respect for the immature and the
incapacitated may require protecting them as they mature or while they are
incapacitated.
In most cases of research involving
human subjects, respect for persons demands that subjects enter the research
voluntarily and on the basis of adequate information about the research situation
and possible consequences.
2. Beneficence
Persons are treated in an ethical
manner not only by respecting their decisions and protecting them from harm,
but also by making efforts to secure their well-being. Such treatment falls under the principle of
beneficence. Two general rules have been
formulated as complementary expressions of beneficent actions in this
sense: (1) do not harm and (2) maximize
possible benefits and minimize possible harms. Learning what will, in fact, benefit may
require exposing persons to risk. The
problem posed by these imperatives is to decide when it is justifiable to seek
certain benefits, despite the risks involved, and when the possible benefits
should be foregone because of the risks.
The obligations of beneficence
affect both individual investigators and society at large, because they extend
both to particular research projects and to the entire enterprise of
research. In the case of particular
projects, investigators and members of their institutions are obliged to give
forethought to the maximization of benefits and the reduction of risks that
might occur from the research investigation.
In the case of scientific research in general, members of the larger
society are obliged to recognize the longer term benefits and risks that may
result from the improvement of knowledge and from the development of novel
medical, psychotherapeutic, and social procedures.
3. Justice
Who ought to receive the benefits of
research and bear its burdens? This is a
question of justice---in the sense of "fairness in distribution" or
"what is deserved." An
injustice occurs when some benefit to which a person is entitled is denied
without good reason or when some burden is imposed unduly. The selection of research subjects needs to
be scrutinized in order to determine whether some groups (e.g., welfare
patients, particular racial and ethnic minorities, or persons confined to
institutions) are being systematically selected simply because of their easy
availability, their compromised position, or their manipulability, rather than
for reasons directly related to the problem being studied. Especially when research supported by public
funds leads to the development of therapeutic devices and procedures, justice
demands that such research should not unduly involve persons from groups
unlikely to be among the beneficiaries of subsequent applications of the
research.
1.2 Charge to the Human Subjects Committee
Thus, the Human Subjects Committee
at the
The members of the Human Subjects
Committee have prepared this Manual for distribution to the University
community. It provides detailed
information to support institutional initiatives for compliance with federal
regulations regarding protection of human subjects and to guide investigators
in procedures relevant to research protocols that include human subjects.
1.3 Criteria for Approval of Research
The Human Subjects Committee
approves research conducted with human subjects according to the regulation set
forth in 45 CFR 46.111. Research must
satisfy all of the following criteria in order to be approved.
"(1) Risks to
subjects are minimized: (i) By using procedures which are consistent with sound
research design and which do not unnecessarily expose subjects to risk, and (ii)
whenever appropriate, by using procedures already being performed on the
subjects for diagnostic or treatment purposes.
(2) Risks to
subjects are reasonable in relation to anticipated benefits, if any, to
subjects, and the importance of the knowledge that may reasonably be expected
to result. In evaluating risks and
benefits, the IRB (Institutional Review Board) should consider only those risks
and benefits that may result from the research (as distinguished from risks and
benefits of therapies subjects would receive even if not participating in the
research). The IRB should not consider
possible long-range effects of applying knowledge gained in the research (for
example, the possible effects of the research on public policy) as among those
research risks that fall within the purview of its responsibility.
(3) Selection of
subjects is equitable. In making this
assessment the IRB should take into account the purposes of the research and
the setting in which the research will be conducted.
(4) Informed
consent will be sought from each prospective subject or the subject's legally
authorized representative, in accordance with, and to the extent required by 45
CFR 46.116.
(5) Informed
consent will be appropriately documented, in accordance with, and to the extent
required by 45 CFR 46.117.
(6) Where
appropriate, the research plan makes adequate provision for monitoring the data
collected to insure the safety of subjects.
(7) Where
appropriate, there are adequate provisions to protect the privacy of subjects
and to maintain the confidentiality of data.
(b)
Where some or all of the subjects are likely to be vulnerable to coercion or
undue influence, such as persons with acute or severe physical or mental
illness, or persons who are economically or educationally disadvantaged,
appropriate safeguards have been included in the study to protect the rights
and welfare of these subjects" (Office for Protection from Research Risks,
1983, p. 8).
2.0 Distribution of Responsibility for the
Protection of Human Subjects[2]
The responsibility for protection of human subjects is
shared among several essential parties, including the principal and
co-principal investigators, department heads, Human Subjects Committee,
University administration, sponsoring agencies, and subjects themselves.
2.1 Principal and Co-principal Investigators
The primary responsibility for the day-to-day assurance
for protection of the rights and welfare of human subjects lies with the
individual responsible for the conduct of the research activity, (i. e., the principal investigator and/or co-principal
investigator). Specifically, the
investigator(s) is responsible for:
(1) careful research design;
(2) careful adherence to ethical codes and
applicable policies and procedures of the
(3) training and supervision of staff and
students participating in the research;
(4) providing information required and taking all
steps in initial and continuing review of research with human subjects;
(5) retaining required records;
(6) obtaining prior approval of Human
Subjects Committee for changes in research activity; and
(7) prompt reporting to the
Human Subjects Committee of unanticipated problems involving risks to subjects
or others.
2.2 Departmental Executive Officer
The executive officer of each
(1) assure that faculty, staff, and students are
kept informed of the
(2) assure that for any course offered by the
department in which participation of the registrants as human subjects is
expected, notification to this effect is given in the course description in
official University bulletins and course registration materials; and
(3) report promptly to the Human Subjects
Committee any unanticipated problems involving risks to subjects or others.
2.3 Human Subjects Committee
The Human Subjects Committee is responsible for:
(1) initial and continuing review of research
with human subjects;
(2) ascertaining acceptability of proposed
research in terms of institutional commitments, applicable law, and standards
of professional conduct and practice;
(3) documentation of such review in compliance
with applicable law, regulations, and policies; and
(4) provision of advice and counsel to
investigators engaged in research involving human subjects.
In addition, the Human Subjects Committee has
responsibilities for:
(5) providing assistance to University officials
in developing policy, procedures, information, and instructions concerning
human subject research;
(6) adjudication of differences
and review of problems arising in research involving human subjects;
(7) reporting to the appropriate institutional
officials unanticipated problems involving risks to subjects and others in work
funded by external agencies, including but not limited to federal agencies such
as HHS and PHS; and
(8) reporting to the appropriate institutional
officials any serious or continuing noncompliance by investigators with the
requirements and determinations of the Human Subjects Committee
2.4 Sponsoring Agencies
Sponsoring agencies usually accept responsibility for
evaluating research proposed for their support.
This evaluation is undertaken in addition to that provided locally. Investigators should be aware that sponsoring
agencies may impose additional conditions prior to or at the time of funding if
additional conditions are judged to be necessary for the protection of human
subjects. In addition, sponsoring
agencies may require that their funding for any project be terminated or
suspended if they find that the institution has materially failed to comply
with the terms of its regulations.
2.5 Subjects
Subjects who participate in research should:
(1) consider carefully the decision to
participate in research;
(2) ask questions freely;
(3) recognize that they are free to withdraw from
participation at any time;
(4) notify the investigator promptly of adverse
effects of participation;
(5) take unresolved complaints or concerns about
their participation in research to the executive officer of the department and,
if the matter remains unresolved, to the Dean of Faculty or to the Provost of
the University (see page iii in this
Manual).
3.0 Human Subjects Committee
The Human Subjects Research of the
3.1 Areas and Activities Covered by the Human
Subjects Committee
Any research undertaken at or under
the auspices of the
3.2 Human Subjects Committee Membership
The Human Subjects Committee shall
consist of at least seven persons (always an uneven number), including the
Chair, with varying professional, racial, ethnic, cultural, and gender
differences who are sensitive to community attitudes and knowledgeable about
professional conduct and regulations.
The Chair of the Human Subjects
Committee will serve at the request and be appointed by the Provost for a
period of four years and may be reappointed.
The Chair shall be a full-time faculty member at the
Human Subjects Committee members
will also serve at the request and be appointed by the Provost for a period of
overlapping four-year terms, so that when terms expire at least one-half of the
members shall have experience in Human Subjects Committee issues. At least one member of the Committee shall
have no affiliation with the University.
If a particular class or type of subject becomes the object of frequent
study, a person from this class or type whose primary concern on the Committee
shall be protecting the welfare of these subjects shall be added to the
committee. In the case where people who
are under the age of majority, i.e., children or adolescents, are a class or
type of subjects frequently studied, an advocate of one or both of these
classes will be selected to serve on the Committee on their behalf. Members of the committee will be informed
annually in writing of their appointment by the Provost.
Current members of the Human
Subjects Committee may be found in this Manual on page iv.
3.3 Meetings
Meetings of the Committee shall be
convened by the Chair or by, at least, any two members. For regular meetings, members shall have at
least seven (7) days' notice. Emergency
meetings may be convened if the conditions underlying the request warrant such
meeting; emergency meetings require at least 48 hours' notice. Two-thirds of the members of the full Human
Subjects Committee must be present in order to constitute a quorum and for the
meeting to be an official one. The Chair
will not vote, except in the case of a tie.
3.4 Changing Committee Regulations
The operating rules and regulations
of the Human Subjects Committee may be changed at a Committee meeting by a vote
of the majority of the Committee members present, based on a quorum of
two-thirds of the members present.
Operating rules and regulations shall be made to facilitate the
effective and efficient work of the Committee while maintaining compliance with
the rules and regulations set forth by federal statutes and regulations
relating to the protection of human subjects.
4.0 Proposals Submitted to the Human Subjects
Committee
4.1 Definition of Terms
The terms below are defined in the
context of PL93-348 and 45 CFR 46 (Revised March, 1983) and serve as a basis
for reviewing and determining the status of proposals submitted to the Human
Subjects Committee.
(1) Research: is a systematic investigation designed to
develop or contribute to generalizable
knowledge. Research includes the
concepts and processes of "trial" or "special observation,"
usually made under conditions determined by the investigator. Research aims to test a hypothesis, to
discover some unknown principle or effect, or to re-examine some known or
suggested truth. The term research
applies to systematic studies in which any substance or stimulus is
administered to a subject by any route.
It is intended to apply to studies which involve changes in physical or
psychological state or environment or major changes in diet and to the
pertinent methods for studying alterations in body functions and behavior under
such conditions. It is intended to apply
to the use of interviews, tests, observations, and inquiries designed to elicit
or obtain nonpublic information about individuals or groups.
Activities which meet this
definition constitute "research" for purposes of 45 CFR 46, whether
or not they are supported or funded under a program which is considered
research for other purposes. For
example, some "demonstration" and "service" programs may
include research activities. However,
the term research is not intended to apply to routine course development,
including evaluation of the effectiveness of such development, at the
(2) Human
subject: a living individual
about whom a researcher (whether a student or University faculty or staff
member, or someone outside the University using
Intervention includes both
physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the
subjects' environment that are performed for research purposes. Interaction includes communication or
interpersonal contact between investigator and subject. Private information includes
information about behavior that occurs in contexts in which an individual can
reasonably expect that no observation or recording is taking place and
information which has been provided for specific purposes by an individual and
which the individual can reasonably expect will not be made public (for
example, a medical record). Information
is individually identifiable if the identity of the subject is,
or may be, readily ascertained by the investigator or associated with the
information.
The definition of subject excludes
all accepted and established service relationships, such as the normal
relationship of patients to physicians, students to professors, and other
clients to professionals in which the patient, student, or client is receiving
aid or services consistent with accepted and established practice, and intended
only to meet his or her own personal needs.
The professional-client relationship has the welfare of the client as
the primary objective, whereas the investigator-subject relationship has the
discovery of new knowledge as its primary objective. This difference may not be fully understood
by the subject who is also a client, and can result in the investigator's gaining
consent without free decision---in part due to a trust based on a presumed role
which the investigator is not necessarily fulfilling at that time.
The normal employer-employee
relationship, in which legitimate services are rendered for salary, wages, or
remuneration in keeping with customary written or verbal contracts, is also
excluded from the definition of subject.
Payment of subjects does not alter their status as subjects.
If doubt exists as to whether the
procedures to be employed are within accepted and established practice or
whether the purpose is only for the personal needs of the client, the activity
should be considered to involve subjects whose rights and welfare are to be
protected in accord with this policy statement.
Similarly, if doubt exists as to whether the procedures are within the
normal limits of the employee's work scope, employees should be considered to
be participating as human subjects, and their rights and welfare must be
protected.
Of particular concern are the
following types of subjects:
(a)
children, including the newborn, and adolescents (i.
e., minors), because of their vulnerability,
diminished autonomy, and incomplete understanding;
(b) subjects with limited civil freedom, such as
prisoners, residents or clients of institutions for the mentally ill and
mentally retarded, and persons subject to military discipline; and
(c) pregnant women and the viable fetus, both in utero and ex utero. (The unborn should be considered subjects to
the extent that they have rights that can be exercised by their next of kin or
legally authorized representative.)
(3) Human
subject at risk: any individual
who may be exposed to the possibility of injury, including physical,
psychological, or social injury, as a consequence of participation as a subject
in any research, development, or related activity which departs from the
application of those established and accepted methods necessary to meet his
needs, or daily life, including the recognized risks inherent in a chosen
occupation or field of service.
(4) Minimal
risk: means that the risks of
harm anticipated in the proposed research are not greater than those risks
normally encountered in daily life or during the performance of routine
physical or psychological examinations or tests.
Certain risks are inherent in life
itself, at the time and in the places where life runs its course. Risks of daily life include the ordinary
risks of public or private living; those risks associated with admission to a
school or hospital; and the risk inherent in professional practice, as long as
these do not exceed the bounds of established and accepted procedures,
including innovative practices applied in the interest of the individual
patient, student, or client.
The fact that some types of research
do not involve risks beyond those experienced in daily life situations does not
mean that the investigator is any less responsible for his or her subjects.
(5) Responsible
project investigator: is a
qualified faculty member at or above the level of instructor or a qualified
staff member who will monitor the conduct of research involving human subjects.
(6) Children
and adolescents: refer to
persons who have not attained the legal age for consent to treatments or
procedures involved in research, under the applicable law of the jurisdiction
in which the research will be conducted.
(7) Legally
authorized representative, parent, guardian: Legally authorized representative is
an individual or other body authorized under applicable law to consent on
behalf of a prospective subject to the subject's participation in the
procedure(s) involved in the research. Parent
means a child's biological or adoptive parent.
Guardian means an individual who is authorized under applicable
state or local laws to consent on behalf of a child to general medical care.
(8) Assent: is a child's affirmative agreement to
participate in research. Assent should
not be construed in cases where a child simply fails to object and also does
not affirmatively agree to participate in a research study.
(9) Advocate: means an individual who has the background
and experience to act in, and agrees to act in, the best interests of the child
for the duration of the child's participation in the research and who is not
associated in any way (except in the role as advocate or member of the Human
Subjects Committee) with the research, the investigator(s), or the guardian
organization.
(10) Permission: means the agreement of parents(s) or guardian
to the participation of their child or ward in research.
(11) University
activity: means those projects
sponsored by the University itself, as well as projects carried out by
University faculty, staff, or students, using the facilities, personnel, or
records of the University.
4.2 Categories of Review Procedures:
All proposals that
concern research conducted with human subjects must be submitted to the Human
Subjects Committee for review. It is
the responsibility of the Committee, not the investigator or any other formal
or informal group of University faculty or staff otherwise constituted, to
determine the categorical status of proposed human subject research.
4.2a Expedited
Review of Proposals. In accordance
with the code of federal regulations, it is the policy of the Human Subjects Committee
to expedite review procedures for proposals that satisfy certain
conditions. These conditions are that
(1) there may be no more than minimal risk to the human subjects and the
proposed activities in the proposal must be among those on the list in Appendix
B or (2) if changes are made in previously approved research during the
period of one year or less for which approval is authorized by the Human
Subjects Committee, the changes must be forwarded to the Chair of the Committee
and determined to be minor. If neither
condition is satisfied in the proposal, then the full membership of the Human
Subjects Committee will review the proposal.
In sum, the Chair and/or members of the Human Subjects
Committee designated by the Chair will review each research proposal and either
approve it (i.e., determine that the proposal qualifies for expedited review and
complies in every way with federal regulations for the adequate protection of
human subjects) or refer it to the Human Subjects Committee
sitting-as-a-whole. If it is determined
that the proposal meets the qualifications for expedited review but is not in
full compliance with federal regulations and guidelines, it will be returned to
the principal investigator with an accompanying critique of the proposal
relative to the protocol and, specifically, treatment of human subjects and
specified modifications to be made to ensure the proposal's compliance with
federal regulations. In this case, the
proposal's approval will remain to be determined by the Committee pending
resubmission of the modified proposal to the Chair of the Committee. If it is determined that the proposal does
not satisfy either of the conditions for an expedited review, it will be
referred to the full Committee for review and discussion.
The Chair of the Human Subjects Committee will keep all
members of the Committee advised of research proposals that have been approved
under the expedited review procedure by providing a written summary of such
proposals at the formally scheduled operations meetings twice each semester,
four times per year.
4.2b Exempt
Status Review. The Human Subjects
Committee may find that some proposals are exempt from federal regulations for
full Committee review. As indicated in
45 CFR 46.101(b), research activities that involve the use of human subjects in
one or more of several categories are exempt from certain regulations; however,
they are not exempt from submission to the Human Subjects Committee. Appendix D describes the categories exempt
from the federal regulations developed to implement the amendments to the
Public Health Service Act, which is PL93-348, the National Research Act.
4.2c Full
Committee Review. Sitting as a
committee of the whole, the Human Subjects Committee will review proposals to
determine approval in the case where a proposal qualifies for neither the
expedited nor exempt category.
4.3 Guidelines for Preparing and Submitting a
Proposal
Principal investigators should submit two copies of the original proposal
(i.e., not a summary or synopsis) to the Chair of the Human Subjects
Committee. At minimum, all proposals
submitted to the Human Subjects Committee for review should follow the
guidelines listed below:
(1) The proposal should detail the purpose and
design of the proposed research and explicitly address how human subjects'
welfare and rights will be protected.
(2) Research proposals must be submitted to the
Committee for review and approval prior to beginning any collection of data
and/or submitting a proposal for grant support.
(3) In the case of a master's or doctoral
research study, the student should submit the full, approved dissertation
proposal to the Committee for human subjects review.
(4) If a faculty member's or student's proposed
research is initially approved by the Human Subjects Committee or Institutional
Review Board of another institution that governs the subjects or data, a copy
of the approval form should be submitted along with the full proposal to the
Human Subjects Committee at the University of Hartford.
(5) Prior to the collection of data,
investigators must inform subjects of their rights,voluntary
nature of their participation, any anticipated positive and negative
consequences of participating in a research project, and solicit their signed
consent to participate (see section 4.5 in this Manual). None of the subjects' legal rights may be
waived. Neither the project, the
University, the college, nor the researcher(s) may be waived from the
responsibility of providing informed consent.
(6) Submit two copies of the proposal, with a
completed Proposal Transmittal Form (Appendix E) attached to each, to the
Chair, Human Subjects Committee (see page v
in this Manual for address)
(7) Allow approximately 10-17 working days from
the date of receipt and when classes are in session for proposals to be
processed and response letters concerning the results of the review to be
issued to the principal investigator.
Investigators should take note that when the University is on an
official break and during the month of August, proposals will not be
reviewed. The last summer date for
submission of proposals is July 15 to ensure a completed review by August 1.
4.4 How to Submit Proposals to the Human Subjects
Committee:
4.4a Procedures
for Initiating Contact with the Human Subjects Committee. Contact with the Committee should be made
through the Chair, or any member if the Chair is away from campus for a lengthy
period of time. A researcher who is in
the process of developing a proposal may contact the Human Subjects Committee
Chair for assistance in understanding the role of the committee or in setting
up human subjects procedures. If any
problems arise in the consultation process, either the committee member or the
researcher may bring the problem to the full Committee.
Those who propose research projects involving human
subjects shall submit to the Committee, prior to (1) beginning any data
collection and/or (2) submitting a proposal for grant support, a research
proposal and completed Proposal Transmittal Form (Appendix E) that, combined,
detail all of the issues related to the welfare and rights of the subjects who
would be involved. If a master's or
doctoral research study is proposed involving human subjects, two copies of the
complete and approved dissertation proposal, with an appropriate draft Informed
Consent to Participate in a Research Study Form (Appendix C), shall be
submitted to the Human Subjects Committee.
The Chair of the Committee and/or designated member of
the Committee shall review each proposal to determine whether it meets the
conditions for an expedited review and, in effect, is or is not exempt from
review and full discussion by the Human Subjects Committee
sitting-as-a-whole. When the University
is officially in session, allow 10-17 working days from the date of receipt of
the proposal for review and written communication of results of the
review. Investigators should note that
proposal will not be reviewed when the University is not in official session or
during the month of August. Proposals
should be submitted by July 15 for review to be complete by
August 1.
When the Human Subjects Committee sitting as-a-whole
reviews a proposal, the principal investigator will provide copies of the
proposal and informed consent forms to each member of the Committee at least
five working days before the scheduled meeting.
In addition, the Committee may request the principal investigator to
meet with it for a discussion of the proposal before a decision is made. Such a request will be made at least 48 hours
in advance of the meeting. In order to
be approved, a project must receive a favorable vote of a majority of the
Committee members present at the meeting, with a necessary two-thirds quorum in
attendance. If the proposal is not
approved, the Chair will communicate in writing to the principal investigator
the full Committee's concerns.
4.4b Proposal
Transmittal Form. The Human Subjects
Committee seeks to improve its monitoring and record keeping role with regard
to treatment of human subjects in research studies at the
Proposals submitted without a Proposal
Transmittal Form will be returned to the principal investigator to complete and
attach to the proposal before resubmitting.
4.5 Informed Consent
In obtaining informed, voluntary consent from human
beings to participate as subjects in a research study, no implied or explicit
coercion shall be involved in their selection and request to participate. For example, an instructor in authority over
potential subjects (students) should not place himself or herself in the
position of suggesting that participation is required to fulfill the
requirements of the course. In such a
situation, a description of alternatives for those who choose not to
participate should be made available.
The language of the consent form shall be clear and understandable to
the subject, including those who may not use English as their first
language. None of the subjects' legal
rights may be waived, and neither the project, the University, the college, nor
the researcher(s) may be waived from responsibility.
An acceptable consent form should contain explicit information
that states and/or describes:
the project is research;
participation is voluntary and will result in no loss of benefits
to which the subject is entitled;
the purpose of the research;
the procedures to be followed;
the risks to the participant that may occur if he or she chooses
to participate;
the benefits that may follow should the individual decide to
participate;
how the participant may withdraw from the study without penalty;
how the results will be used;
the level at which the results will be aggregated;
to whom the results will be reported; and
what the participant may do and who she or he may contact if
there is a problem, e.g., names, addresses, and phone numbers of the
researcher(s) and, in the case of a master's or doctoral project, that of the
thesis advisor also.
4.5a Guidelines
for Writing Informed Consent Forms[3]. The purpose of an Informed Consent to
Participate in a Research Study Form is to tell participants exactly what they
will have to do in a study and to obtain their agreement to participate (see
Appendix C).
Although it is not required that
consent forms be standardized, the following guidelines are helpful in writing
one for any study involving human subjects.
(1) Description of the Study and the
Participant's Role:
Describe
the study in non-technical language specifying what the participants will do
and how long they will do it.
Participants cannot really give their informed consent unless they know
exactly what they are consenting to do.
Example:
This is a study of visual attention. You will watch a computer screen and press a
key when you see certain shapes and letters.
You will do this for about an hour.
(2) Permission to Withdraw from the Study:
An
important protection for participants is the right to withdraw from a study
without penalty. The consent form should
tell participants that they can withdraw from the study and describe the
procedure for doing so.
Example:
You may withdraw from the experiment at any time
you feel uncomfortable and do not want to continue. There will be no penalty for stopping. You will still receive your experimental
credit and your pay for the time you have participated. If you want to stop at any time, tell the
experimenter and leave the room.
(3) Use of Data:
In the
Informed Consent Form, explain clearly how the data you collect about the
participants will be handled. The most
secure procedure is to collect no identifying information (e.g., no names or
social security numbers).
Example:
You will not put your name or any identifying
information on any of the surveys and tests.
Therefore, the information you give will be completely anonymous.
Although
this procedure is possible for some surveys and observational studies, it is
not practical for most studies.
Therefore, a coding procedure should be used in which the person's name
is linked to a code number. The code
number is used on all data. A list
linking the code number with the person's name is kept secure and destroyed as
soon as possible.
Example:
The information gathered in this study will be
handled in a secure manner to protect you.
Your data will be identified by a code number that can be linked to your
name only by a code list which will be kept in a secure place and destroyed
after the study is completed. Reports
written about the study will not identify you in any way; only data about
groups will be reported.
It is
probably impossible to remove identifying information from videotapes. Therefore, it is necessary to describe to
participants who will view their tapes and when the tapes will be erased.
Example:
Your actions in the study will be videotaped. Later, your videotape will be shown to six
(6)
Do not
promise that your data are completely secure since it is possible that any data
could be obtained by court order---even over the objection of the experimenter.
(4) Contact
Tell
the participants how they can contact you or the faculty member supervising
your research if they have questions or concerns about the study.
Example:
If you have any questions or concerns about the
study, you may contact [the Experimenter's Name] at [Phone Number] or at
[Mailing Address],
(5) Signature:
End the
consent form with a consent statement and a line for the participant's
signature and date. If the participant
is a minor, see section 5.0 in this Manual.
Example:
I agree to participate in the study described
above.
_________________________ ________________Signature of
Participant Date
(6) Copies:
You
will need two (2) signed copies of each participant's Informed Consent
Form. Keep the one signed form for your
records; give the other signed form to the participant for his or her records.
4.6 Research in Progress
Once a project has been approved,
the Human Subjects Committee must review it on an annual basis until the
project has been completed. It is the
principal investigator's responsibility to present the Committee with progress
reports on dates determined by the Committee.
Failure to do so will be taken as a breach of the Human Subjects
regulations, and the study will come to a halt until the Committee has reviewed
the situation.
If it is discovered that a project
has commenced that has not been cleared by the Human Subjects Committee, the
Chair of the Committee shall notify the principal investigator to halt the
investigation and notify the Provost of the University of the action
taken. The full Human Subjects Committee
shall review the situation, recommend action, and forward the review and
recommended actions to the Provost. The
Provost will pursue appropriate actions which may include referring the case
back to the Committee for implementation of recommended actions.
4.7 Inter-Institutional Research. There may be some cases in which research
proposed by a researcher in one institution will actually be conducted with
human participants in another institution.
For example, a medical researcher in orthopedics in a university teaching
hospital proposes research that involves students enrolled in physical therapy
programs in two nearby but separate universities. This research will be conducted out of the
physician's home institution. In another
case, a faculty member in education proposes research out of his home institution
with adolescents in four middle schools.
Instances of inter-institutional
research involve procedures different than procedures followed when the
proposed research involves participants in the researcher's home
institution. In the case of a
(1) Submit the proposal to the University's Human
Subjects Committee for review and approval; if the proposal meets the criteria
for approval, the Committee will provide conditional approval.
(2) The researcher then submits the conditionally
approved proposal and copy of the letter from the Human Subjects Committee to
the appropriate review body (e.g., Institutional Review Board or Human Subjects
Committee) at the institution where the proposed research will take place.
(3) Upon the other institution's review and
approval of the proposal, the researcher then informs the Human Subjects
Committee of the approval by submitting the approval letter and copy of the
final, approved proposal to the Chair who will keep the letter and proposal on
file.
(4) The Human Subjects Committee will then inform
the researcher in writing of full unconditional approval of the proposal.
In the case where a researcher from
another institution seeks to conduct his or her research at the
(1) Gain approval or conditional approval of the
proposed research from his or her home institution.
(2) Submit a copy of the proposed research proposal
and evidence of approval or conditional approval from the home institution to
the Chair,
(3) The review procedures from this point remain
the same; that is, a determination of the status of the proposal for exemption,
expedited review, or full committee review will be made and the results of the
review will be made available to the investigator in writing.
(4) The Chair of the
5.0 Conducting Research with
Special Populations: Children and
Adolescents
Research with vulnerable populations
such as children and adolescents has been regulated in earnest since 1974 with
the passage of the National Research Act (PL93-348) and the work of the
National Commission for the Protection of Human Subjects in Biomedical and
Behavioral Research. In addition to the Belmont Report, the Commission also
issued an extensive appendix concerning its "Report and
Recommendations: Research Involving
Children" (National Commission, 1978).
In this report, the Commission exerted the first explicit attempt to
distinguish the unique problems associated with the use of children as research
subjects. Concurrently, the
The history of research using
children has, unfortunately, been dominated by patterns of exploitation and
abuse throughout the centuries (Lederer & Grodin, 1994). With
the advent of concern for and actions in behalf of humane treatment of children
and adolescents as research subjects in the latter half of the twentieth
century, new issues have emerged. Chief
among them is promoting the health and well-being of children and adolescents
through advances undertaken in research versus protecting child and adolescent
research subjects from exploitation and harm.
Children and adolescents are exceptionally vulnerable to potential
exploitation and harm "...because of their more limited cognitive
competencies and experiential backgrounds, which constrain their capacities to
understand and defend their rights as research participants and to make
reasoned decisions concerning research participation...[and also] because of
their limited social power..." (Thompson, 1990, p. 1).
Issues relating to research with
children and adolescent subjects are both sensitive and complex and extend
across multiple fields and disciplines.
Two essential issues with unique implications in child and adolescent research
in any field or discipline are further examined in this Manual. It is important that investigators who
propose research with children and/or adolescents be thoroughly aware of these
issues and sensitive to them in the development of their research designs.
5.1 Risk Assessment with Children and Adolescents
Federal regulations specify degrees
of risk and benefit to minors as subjects in research studies. Such distinctions in degree lead to different
requirements for the Human Subjects Committee's review of the proposed research
with particular focus placed on the nature of the procedures being used with
the subjects. Research study categories
are described below and includes examples of the types of projects included in
each category and the requirements for approval.
5.1a Research not involving greater than minimal
risk. This category is determined by
the degree of intervention that a research design imposes on children or
adolescents. It refers to two types of
research: one that involves no direct intervention with children or adolescents
and a second that involves direct intervention with children or
adolescents. The case where research is
designed with no direct intervention
is included in the research design is illustrated by the following: