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The Handbook for Ensuring Protection of Human Research Subjects
ULM POLICY FOR PROTECTION OF
HUMAN RESEARCH SUBJECTS
All research projects, involving human subjects, conducted by The University of Louisiana at Monroe (ULM) faculty, students, or staff (including collaborative projects with other institutions and agencies) must be reviewed and approved by the ULM Institutional Review Board (IRB). Before submitting a project for review, investigators are urged to read the ULM Policy for the Protection of Human Subjects.
^ Back to Top ^Introduction Biomedical
and Behavioral Research may be accompanied by a variety of risks to
human volunteers. Such risks may be physical, psychological, or
financial in nature. For this reason, the justification for such
activities must be carefully weighed against ethical, moral and legal
considerations – some of which are not always self-evident.
Justification must include consideration of the potential value of the
research activity in relation to all possible risks, the scientific
merit of the investigative approach, the adequacy of the experimental
design in minimizing risks, the protection of the individual rights of
the subjects involved, and the adequacy of informed consent measures as
well as the potential legal liability incurred by the sponsoring
institution. Careful attention must be given to security of informed
consent from the volunteer subject. While the
fundamental safeguard for the proper conduct of research rests on the
moral integrity and sound professional judgment of the investigator,
the responsibility for establishing high standards in research is
shared by his/her professional colleagues, department head and
institution. Accordingly, it is necessary to establish a consistent
institutional policy, which both safeguards the health and welfare of
volunteer subjects and provides investigators an opportunity to pursue
meaningful research involving human subjects. The ethical principles
and guidelines embodied in the Report of the National Commission for
the protection of Human Subjects of Biomedical and Behavioral Research,
commonly known as "The Belmont Report," are believed to be a suitable
basis of such a policy and are accepted by The University of Louisiana
at Monroe. All investigators are expected to be familiar with this
report (See Appendix A). ^ Back to Top ^ I. Procedure for Submitting Projects for Review TIMING OF SUBMISSIONS:
All project proposals requiring IRB approval must be received by OSPR
at least five working days prior to the meeting at which the project is
to be reviewed. The intent of this requirement is to ensure the
individual board members will have an opportunity to adequately study
the proposal prior to a meeting of the full board. This five working
day requirement is in addition to all other on campus administrative
review procedures, which may be applicable to an individual
proposal.
Proposals,
which are to be forwarded to an off-campus-funding agency, must be
submitted well in advance of any deadlines established by the funding
agency. Investigators are reminded that a minimum of one week is
required for completion of the on-campus administrative review process
for grant proposals, which do not require IRB approval. All submissions must be in the form of a final project proposal and include the following information: Purpose of the project and its significance. Justification for using humans as experimental subjects in the project. Identification of possible risks to the subject and specific measures designed to minimize such risks. Experimental plan including a detailed explanation of how subjects will be recruited and selected for the project. Informed consent measures including a sample of all written documents to be furnished to volunteer subjects (see Part V).
At the time request for review is submitted, OSPR will verify
training requirement for each individual listed on the project. Per
ULM’s Human Subject Protections Policy, all individuals, faculty, staff
and students included, working in human research must take training
before commencing any research on human subjects. Training is valid for
two years, after which time, individuals are required to take refresher
courses. ULM IRB Committee will not review the protocol until all
individuals listed on the request for review have successfully passed
the training requirement. A completed IRB Request for Review
must be attached as the cover sheet for all project proposals and must
be approved by the department head having administrative authority over
the investigator. (Copies of IRB forms may be obtained from OSPR’s website). Within
one week of the committee's review of the protocol, OSPR will notify
the lead investigator of the IRB's decision and recommendations.
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II. ULM Institutional Review Board Review Process The
Board is responsible for ensuring that all research projects conducted
by individuals representing themselves as members of the University and
involving
human subjects are conducted in compliance with the ULM policies
established for the protection of human subjects. The Board shall
review and have authority to approve, require modifications in, or
disapprove all research activities covered by these policies. The
Board shall require that information given to subjects as part of
informed consent is in accordance with Parts V and VI of this policy.
The Board may require that information, in addition to that
specifically mentioned in Part V, be given to the subjects when in the
Committee’s judgment the information would meaningfully add to the
protection of the rights and welfare of subjects.
The Board shall require documentation of informed consent or may waive documentation in accordance with Part VI, Section C. The
Board shall notify (in writing) OSPR of its decision to approve or
disapprove the proposed
research activity, or of modifications required to secure Board’s
approval of the research activity. If the Board decides to disapprove a
research activity, a statement of the reasons for disapproval shall be
provided in its written notification and the investigator will be given
an opportunity to respond in person or in writing. OSPR will in turn
notify investigators of the Board's decisions and recommendations. The
Board shall be responsible for conducting continuing review of research
covered by this policy at intervals appropriate to the degree of risk,
but no less than once per year, and shall have authority to observe or
have a third party observe the consent process and the research.
^ Back to Top ^ III. Projects for Which this Policy Applies- Except
as provided in Section B of this part, this policy applies to
all research involving human subjectsconducted by or under the
supervision of University employees whether funded in whole or in part
by an intramural or extramural grant, contract, cooperative agreement
or fellowship.
Research
activities in which the only involvement of human subjects will be in
one or more of the following categories are exempt from this policy.
However, these projects must meet basic ethical standards, and must be
reviewed by the IRB and found to meet federal criteria for exemption:
Research
conducted in established or commonly accepted educational settings,
involving normal education practices, such as (i) research on regular
and special educational instructional strategies, or (ii) research on
the effectiveness of or the comparison among instructional techniques,
curricula, or classroom management methods. 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. Research
involving survey or interview procedures, except where all the
following conditions exist: (i) responses are recorded in such a manner
that the human subjects can be identified, directly or through
identifiers linked to the subjects, (ii) the subject’s responses, if
they became known outside the research, could
reasonable place the subject at risk of criminal or civil liability or
be damaging to the subject’s financial standing or employability, and
(iii) the research deals with sensitive aspects of the subject’s own
behavior, such as illegal conduct, drug use, sexual behavior, or use of
alcohol. Research
involving the observation (including observation by participation) of
public behavior, except where all the following conditions exist: (i)
observations are recorded in such a manner that the human subjects can
be identified directly or through identifiers linked to the subjects,
(ii) the observations recorded about the individual, if they became
known outside the research, could reasonable place the subject at risk
of criminal or civil liability or be damaging to the subject’s
financial standing or employability, and (iii) the research deals with
sensitive aspects of the subject’s own behavior, such as illegal
conduct, drug use, sexual behavior, or use of alcohol. Research
involving the collection or study of existing data, documents, records,
pathological specimens, or diagnostic specimens, if these sources are
publicly available or of the information is recorded by the
investigator in such a manner that subjects cannot be identified,
directly or through identifiers linked to the subjects. Each
subpart of this policy statement contains a separate section describing
to what the subpart applies. Research, which is covered by more than
one subpart, shall comply with all applicable subparts.
^ Back to Top ^ IV. Criteria for Board’s Approval of Research
Before
approving research covered by this policy, the Board shall determine
that all of the following requirements are satisfied: 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. 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 Board will consider only those
risks and benefits that may result form the research (as distinguished
from risks and benefits of therapies subjects would receive even if not
participating in the research). Selection of subjects is equitable. In
making this assessment the Board will take into account the purposes of
the research and the setting in which the research will be conducted. 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 Part V. of this policy. Informed consent will be appropriately documented, in accordance with, and to the extent required by Part VI. Where
appropriate, the research plan makes adequate provision for monitoring
the data collected to ensure the safety of subjects. Where appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
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 additional safeguards have been included in
the study to protect the rights and welfare of these subjects.
^ Back to Top ^V. General Requirements for Informed Consent
Except
as provided elsewhere in this or other subparts, no investigator may
involve a human being as a subject in research covered by these
guidelines unless the investigator has obtained legally effective
informed consent of the subject or the subject’s legally authorized
representative. An investigator shall seek such consent only under
circumstances that provide the prospective subject or the
representative sufficient opportunity to consider whether or not to
participate and that minimize the possibility of coercion or undue
influence. The information that is given to the subject or the
representative shall be in language understandable to the subject or
the representative. No informed consent, whether oral or written, may
include an exculpatory language through which the subject or the
representative is made to waive or appear to waive any of the subject’s
legal rights, or releases or appears to release the investigator, the
sponsor, the University or its agents from liability for negligence. - Basic elements of informed consent.
Except
as provided in Section C of this part, in seeking informed consent the
following information shall be provided to each subject: A
statement that the study involves research, an explanation of the
purposes of the research and the expected duration of the subject’s
participation, a description of the procedures to be followed, and
identification of any procedures which are experimental; A description of any reasonably foreseeable risks or discomforts to the subject; A description of any benefits to the subject or to others which may reasonably be expected from the research; A disclosure of appropriate alternative procedure or courses of treatment, if any, that might be advantageous to the subject; A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained; For
research involving more than minimal risk, an explanation as to whether
any compensation and an explanation as to whether any medical
treatments are available if injury occurs and, if so, what they consist
of, and where further information may be obtained; An
explanation of whom to contact for answers to pertinent questions about
the research and research subjects’ rights, and whom to contact in the
event of research-related injury to the subject; and A
statement that participation is voluntary, refusal to participate will
involve no penalty or loss of benefits to which the subject is
otherwise entitled and the subject may discontinue participation at any
time without penalty or loss of benefits to which the subject is
otherwise entitled.
- Additional elements of informed consent.
When appropriate, one or more of the following elements of information shall also be provided to each subject:
A
subject that the particular treatment or procedure may involve risks to
the subject (or to the embryo or fetus, if the subject is or may become
pregnant) which are currently unforeseeable; Anticipated
circumstances under which the subject’s participation may be terminated
by the investigator without regard to the subject’s consent; Any additional costs to the subject that may result from participation in the research; The
consequence of a subject’s decision to withdraw from the research and
procedures for orderly termination of participation by the subject; A
statement that significant new findings developed during the course of
the research which may relate to the subject’s willingness to continue
participation will be provided to the subject; and The approximate number of subjects involved in the study.
- The
Board may approve a consent procedure which does not include, or which
alters, some or all of the elements of informed consent set forth
above, or waive the requirement to obtain informed consent provided the
Board finds and can document that the research could not be practically
carried out without the waiver or alteration.
^ Back to Top ^ VI. Documentation of Informed Consent
Except
as provided in Section C of this part, informed consent shall be
documented by the use of a written consent form approved by the Board
and signed by the subject or the subject’s legally authorized
representative. A copy shall be given to the person signing the form. Except as provided in Section C of this part, the consent may be either of the following: A
written consent document that embodies the elements of informed consent
specified in Section V of this policy. This form may be read to the
subject’s legally authorized representative, but in any event, the
investigator shall give either the subject or the representative
adequate opportunity to read it before it is signed; or A
"short form" written consent document stating that the elements of
informed consent specified in Section V have been presented orally to
the subject or the subject’s legally authorized representative. When
this method is used there shall be a witness to the oral presentation.
Also, the Board shall approve a written summary of what is to be said
to the subject or the representative. Only the short form itself is to
be signed by the subject or the representative. However, the witness
shall sign both the short form and a copy of the summary, and the
person obtaining consent shall sign both the short form and a copy of
the summary, and the person obtaining consent shall sign a copy of the
summary. A copy of the summary shall be given to subject or the
representative, in addition to a copy of the "short form."
The
Board may waive the requirement for the investigator to obtain a signed
consent form for some or all subjects if it finds either: That
the only record linking the subject and the research would be the
consent document and the principal risk would be potential harm
resulting from a breach of confidentiality. Each subject will be asked
whether the subject wants documentation linking the subject with the
research, and the subject’s wishes will govern; or That
the research presents no more than minimal risk of harm to subjects and
involves no procedures for which written consent is normally required
outside the research context.
In
cases where the documentation requirement is waived, the Board may
require the investigators to provide subjects with a written statement
regarding the research. ^ Back to Top ^ VII. Additional Protections Applicable to Specially Defined Subject Populations and Research Projects
Certain
subject populations and research projects possess characteristics,
which necessitate specific additional protections and/or
considerations. These are defined in The Code of Federal Regulations Title 45 Part 46 as revised January 15, 2009 – Protection of Human Subjects – and are included in this policy by reference:
Subpart B, Sections 46.201 – 46.207
Additional Protections for Pregnant Women, Human Fetuses, and Neonates Involved in Research.
Subpart C, Sections 46.301 – 46.306 Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects.
Subpart D, Sections 46.401 – 46.409 Additional Protections for Children Involved as Subjects in Research.^ Back to Top ^ VIII. Expedited Review Procedures
Research
projects deemed to involve only minimal risk or minor changes in
previously approved projects may be reviewed on an expedited basis.
Such reviews shall be carried out by the Board Chairperson or by one or
more experienced reviewers designated by the chairperson from among
members of the Committee. In reviewing the research, the reviewers
shall exercise all of the authorities of the Board except that the
reviewers may not disapprove the research. Board members shall receive
written notification of all projects subjected to an expedited review
and shall be apprised of the outcomes of all such reviews. Examples of projects, which may qualify as minimal risk activities, include:
Collection
of: hair and nail clippings, in a nondisfiguring manner; deciduous
teeth; and permanent teeth if patient care indicates a need for
extraction. Collection of excreta and
external secretions including sweat, uncannulated saliva, placenta
removed at delivery and amniotic fluid at the time of rupture of the
membrane prior to or during labor.
Recording
of data from subjects 18 years of age or older using noninvasive
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).
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.
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.
Voice recordings made for research purposes such as investigations of speech defects.
Moderate exercise by health volunteers.
The study of existing data, documents, records, pathological specimens, or diagnostic specimens.
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 subject’s behavior and the
research will not involve stress to subjects.
^ Back to Top ^ IX. Definitions
Board means the ULM Institutional Review Board. Institution means any public entity or agency (including federal, state, and other agencies). Legally authorized representative
means an individual or judicial 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. Research
means a systematic investigation designed to develop or contribute to
generalizable knowledge relating broadly to public health, including
behavioral and social-sciences research. The term encompasses basic and
applied research and product development. Activities, which meet this definition,
constitute "research" for purposes of this policy, 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.
Human subject
means a living individual about whom an investigator (whether
professional or student) conducting research obtains (1) data through
intervention and interaction, or (2) identifiable private information. Intervention
includes both physical procedures by which data are gathered (for
example, venipuncture) and manipulations of the subject or the
subject’s 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 a context in which an individual can
reasonable 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 reasonable expect will not be
made public (for example, a medical record). Private information must
be individually identifiable (i.e., the identity of the subject is or
may be readily be ascertained by the investigator or associated with
the information) in order for obtaining the information to constitute
research involving human subjects. Minimal risk
means that the risks of harm anticipated in the proposed research are
not greater, considering probability and magnitude, than those
ordinarily encountered in daily life or during the performance of
routine physical or psychological examinations or tests.
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