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Approved July 27, 1998
Revised July 16, 2001
Revised October 6, 2003
Revised March 7, 2005
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1.
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GENERAL
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1.1
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Texas A&M University-Corpus Christi has a responsibility
to protect the rights and welfare of prospective research
subjects and to provide a favorable climate for the conduct
of scientific inquiry. In compliance with federal regulations,
the University requires all research involving human subjects
to be approved by the Texas A&M University-Corpus Christi
Institutional Review Board (IRB).
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1.2
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Researchers seeking approval for projects may obtain the
appropriate forms from the IRB Chair, an IRB member, or the
Office of Sponsored Programs.
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1.3
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This document shall automatically be updated to comply with
changes in federal regulations. Other changes will go through
the regular University review process.
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1.4
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The Chair of the IRB will report to the Provost and Vice
President for Academic Affairs in January of each year as
to the adequacy of this document and such other matters that
should be brought to the attention of the faculty related
to this document.
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2.
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SCOPE OF INSTITUTIONAL REVIEW BOARD
All activities involving research with human subjects in all fields of
University activity shall come under the purview of the Institutional
Review Board. This committee has the primary responsibility for maintaining
ethical standards of research involving human subjects at the University.
All projects will be reviewed at least annually. The IRB has authority
to approve or disapprove such research. It may require modifications
as a condition for approval. Following the review of the research,
the IRB will notify the investigators and the institution in writing
of its decision. If the IRB decides to disapprove a research activity,
it will provide the reasons for its decision and give the investigator
an opportunity to respond in person or in writing. Federal regulations
require the IRB to conduct continuing review of approved research at
intervals appropriate to the degree of risk, but not less than once
per year. The IRB has authority to observe or have a third party observe
the consent process and the research.
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3.
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ETHICS
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3.1
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TAMU-CC will use the following documents as guides for the
conduct of human subject research:
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(1)
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the World Medical Association’s “Declaration
of Helsinki,”
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(2)
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the American Psychological Association’s statement, “Ethical
Principles in the Conduct of Research with Human Participants,”
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(3)
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the Belmont Report of the National Commission for
the Protection of Human Subjects of Biomedical and
Behavioral Research, and
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(4)
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the Code of Federal Regulations, 45 CFR 46, Protection
of Human Subjects.
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3.2
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The subjects have recourse to the IRB at any time through
its Chairperson, if they feel they have not been dealt with
fairly. Copies of this document and those listed above will
be available for the investigator, as well as any other interested
persons, upon request to the Office of the Provost/Vice President
for Academic Affairs or the offices of the Deans. These materials
are also available from the Office of Sponsored Programs.
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4.
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MEMBERSHIP OF THE IRB
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4.1
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The membership of the IRB shall be composed of a member of the Ethics Council, two faculty members from each of the Colleges, a representative from the Library, and two persons from the community. All members are voting members. The faculty members are appointed by the process described in “University Committees and University Councils.” The community members are appointed by the President or the President’s designee. In addition, the committee make-up will reflect the guidelines established in the Code of Federal Regulations, 45 CFR 46, section 46.107, titled IRB membership. As stated in the guidelines, the membership will include persons of varying backgrounds to promote complete and adequate review of research activities commonly conducted by the University. The members will have expertise and experience in a variety of specified areas. Also, the membership should reflect diversity, including consideration of race, gender, and cultural backgrounds and sensitivity to community attitudes. (For more information, see 45 CFR 46.)
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4.2
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Terms of membership for faculty members shall be three years on an alternating basis. The community members shall serve two-year terms. The Ethics Council member will have a re-appointable, three-year term. The Chairperson of the IRB shall be elected from within the membership of the IRB for a two-year term by the IRB and shall be eligible for re-election. A vice chair will also be elected for a two-year term from within the membership of the IRB. A member of the IRB will be elected by the committee to serve a one-year term as secretary.
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5.
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MEETINGS OF THE IRB
The IRB shall meet monthly during the two regular semesters and at the
call of the Chair. A quorum shall be a simple majority. The IRB may
establish its own operating procedures within these prescribed guidelines.
Projects for review at its monthly meeting shall be received at least
10 working days prior to its monthly meeting.
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6.
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CRITERIA FOR APPROVING RESEARCH
To be approved by the IRB, human subjects research which is covered by
federal policy must meet all the following criteria:
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(1)
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risks to subjects are minimized by using procedures that
are consistent with sound research design and whenever appropriate,
use procedures already being performed on the subjects for
diagnostic or treatment purposes;
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(2)
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risks to subjects are reasonable in relation to anticipated
benefits to subjects, and the importance of the knowledge
that may reasonably be expected to result;
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(3)
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selection of subjects is equitable in terms of the purposes
of the research and the setting in which it will be conducted;
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(4)
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informed consent is sought from each prospective subject
and documented to include all appropriate information;
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(5)
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the protocol makes adequate provision for monitoring the
data collected to ensure the safety of the subjects;
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(6)
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adequate provision is made and documented to protect the
privacy of subjects and to maintain the confidentiality of
the data; and
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(7)
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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 their
rights and welfare.
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7.
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RESEARCH REVIEW CATEGORIES
The extent of the IRB review will depend upon the nature of the research.
There are three research review categories: exempt research, expedited
review, and full review.
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7.1
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Exempt Research
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7.1.1
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Certain categories of research
are exempt from the Protection of Human Subjects
policy in the Code of
Federal Regulations 45 CFR 46. The IRB Chair will determine,
based on the federal guidelines, whether a research
activity qualifies for exemption. Although exempt research
is not regularly reviewed by the IRB, the exempt research
form (and the informed consent form, if applicable)
must be on file with the IRB, and the research may
be reviewed at the committee’s discretion. If
the committee deems necessary, it may require a full
review.
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7.1.2
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Unless otherwise required by federal departments or
agencies, research activities in which the only involvement
of human subjects will be in one or more of the following
categories are generally exempt from full review by
the IRB:
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(1)
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Research conducted in established or commonly
accepted educational settings, involving normal
education practices, such as
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research on regular and special education
instructional strategies, or
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ii
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research on the effectiveness of or the
comparison among instructional techniques,
curricula, or classroom management methods.
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(2)
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Research involving the use of educational tests
(cognitive, diagnostic, aptitude, achievement),
survey procedures, interview procedures or observation
of public behavior, unless:
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i
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information obtained is recorded in such
a manner that human subjects can be identified,
directly or through identifiers linked
to the subjects; and
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ii
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any disclosure of human
subjects’ responses
outside the research could reasonably place
the subjects at risk of criminal or civil
liability or be damaging to the subjects’ financial
standing, employability, or reputation.
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(3)
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Research involving the use of educational tests
(cognitive, diagnostic, aptitude, achievement),
survey procedures, interview procedures, or observation
of public behavior that is not exempt under the
previous paragraph, if:
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i
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the human subjects are elected or appointed
public officials or candidates for public
office; or
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ii
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federal statute(s) require(s) without
exception that the confidentiality of the
personally identifiable information will
be maintained throughout the research and
thereafter.
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(4)
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Research involving the collection or study of
existing data, documents, records, pathological
specimens, or diagnostic specimens, if these
sources are publicly available or if the information
is recorded by the investigator in such a manner
that subjects cannot be identified, directly
or through identifiers linked to the subjects.
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(5)
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Research and demonstration projects that are
conducted by or subject to the approval of federal
department or agency heads, and that are designed
to study, evaluate, or otherwise examine:
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i
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public benefit or service programs;
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ii
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procedures for obtaining benefits or services
under these programs;
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iii
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possible changes in or alternatives to
those programs or procedures; or
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iv
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possible changes in methods or levels
of payment for benefits or services under
those programs
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7.1.3
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Research involving special or protected populations,
such as children, the elderly, prisoners, pregnant
women, and the handicapped, is subject to full review.
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7.2
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Expedited Review
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7.2.1
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Expedited review procedures are available for certain
kinds of research involving no more than minimal risk,
and for minor changes in approved research. Specifically,
research is eligible for expedited review if it involves
no more than minimal risk (see 45 CFR as amended) to
the subjects and the only involvement of human subjects
will be in one or more of the categories listed below:
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(1)
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Collection of: hair and nail clippings, in a
nondisfiguring manner; deciduous teeth; and permanent
teeth if patient care indicates a need for extraction.
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(2)
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Collection of excreta and external excretion
including sweat, uncannulated saliva, placenta
removed at delivery, and amniotic fluid at the
time of rupture of the membrane prior to or during
labor.
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(3)
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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 the input of matter or significant
amounts of energy into the subject or an invasion
of the subject’s privacy. It also includes
such procedures as weighing, testing sensory
acuity, electrocardiography, electroencephalography,
thermography, detection of naturally occurring
radioactivity, diagnostic echography, and electroretinography.
It does not include exposure to electromagnetic
radiation outside the visible range (for example,
X-rays, microwaves).
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(4)
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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 who are in good health and not pregnant.*
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(5)
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Collection of both supra- and subgingival dental
plague and calculus, provided the procedure is
not more invasive than routine prophylactic scaling
of the teeth and the process is accomplished
in accordance with accepted prophylactic techniques.
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(6)
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Voice recording made for research purposes such
as investigation of speech defects.
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(7)
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Moderate exercise of healthy volunteers.**
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(8)
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The study of existing data, documents, records,
pathological specimens, or diagnostic specimens.
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(9)
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Research on individual or
group behavior or characteristics of individuals,
such as studies
of perception, cognition, game theory, or test
development, where the research investigator
does not manipulate subjects’ behavior and
the research will not involve stress to the subjects.
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(10)
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Research on drugs and devices for which an investigational
new drug exemption or an investigational device
exemption is not required.
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(11)
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Any other category specifically added to this
list by HHS and published in the Federal Register.
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* Subjects must be informed orally of the risk
of bruising and infection.
** Moderate exercise does not include stress testing.
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7.2.2
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Informed consent is required, but the requirement
to obtain a signed consent form may be waived if:
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(1)
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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
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(2)
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The research presents no more than minimal risk
of harm to subjects and involves no procedures
for which written consent is normally required
outside of the research context.
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7.2.3
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In cases where the documentation requirement is waived,
the IRB may require the investigator to provide subjects
with a written statement regarding the research.
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7.3
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Full Review
All those projects not exempt or qualifying for expedited review
shall be subject to full review by the IRB.
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8.
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REVIEW PROCEDURES
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8.1
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Exempt Review
Under the exempt procedure, the researcher shall submit Form A
to the Chair of the IRB. The IRB Chair shall determine whether
a project is exempt from further review. Although exempt research
requires no action by the IRB, the board may choose to review
the forms on file at its discretion. If the Board deems necessary,
it may require a full review.
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8.2
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Expedited review
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8.2.1
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Research which involves no more than minimal risk
to the subject and falls under the categories established
by the Secretary of Health and Human Services (46 FR
8392), or research previously approved needing minor
changes, will normally be reviewed by the expedited
review procedures. However, the IRB may consider any
such research through a full review procedure, if it
so chooses.
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8.2.2
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Informed consent is required in the expedited review,
but the IRB may waive the requirement to obtain a signed
consent form, in accordance with the guidelines discussed
above in section 7.2.2.
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8.2.3
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In cases where the documentation requirement is waived,
the IRB may require the investigator to provide subjects
with a written statement regarding the research.
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8.2.4
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Under the expedited review procedure, the researcher
shall submit Form B to the IRB Chair. The Chair will
appoint a committee member to review the proposal.
A member of the IRB shall not review his/her own proposal.
If the reviewer finds that the research falls under
the guidelines for expedited procedures, the reviewer
has the authority to approve the project, require modifications
in the project, or recommend a full review by the IRB.
The reviewer will report his/her action at the next
IRB meeting. A research activity may be disapproved
only after a review by the full IRB. The reviewer shall
forward to the IRB Secretary the research proposal
and his/her decision to approve the proposed research
activity, or his/her modifications required to secure
the reviewer's approval, or a recommendation for full
IRB review. The IRB Secretary will make the proposal
and decisions available to all members of the IRB.
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8.3
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Full Review
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8.3.1
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Investigators are required to submit proposals to
the IRB Chair on Form B at least 10 days in advance
of the meeting in order to provide time for prior review.
The committee may approve the research as proposed;
it may approve the research pending specified modifications;
or it may reject the research proposal. If the IRB
gives approval pending specified modifications, the
principal investigator is required to submit written
assurance that conditions, restrictions, report requirements,
or changes imposed on the project will be followed.
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8.3.2
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The ultimate protection of safety,
confidentiality, and the rights of human subjects
will in all cases
take precedence over the importance and results of
the project. The definition used to determine if the
subject is “at risk” will be contained in
the Code of Federal Regulations on Protection of Human
Subjects (45 CFR 46 as amended).
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8.3.3
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No project or activity which involves humans will
be approved unless assurances of legally effective
informed consent are provided for or a waiver of signed
informed consent is approved on Form B by the IRB.
The elements of informed consent as outlined by article
46.116 of 45 CFR 46 are to be observed in all projects.
The Board will decide whether the method for securing
consent of the subject (by the principal Investigator)
is sufficient and appropriate. Additionally, in connection
with any project involving fetuses or pregnant women,
the IRB will oversee the actual process by which individual
consents are secured by sampling and monitoring the
progress of the activity at timely intervals.
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9.
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RECORDS
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9.1
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The IRB Secretary will obtain and maintain all appropriate
records--including, but not limited to, copies of all projects,
documentation of informed consent procedures, minutes, and
records of formal notification to/from principal investigators
of official actions--in the Office of Sponsored Programs.
All such records will be reviewed for informational content
and follow up by the Chair of the IRB.
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9.2
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All records obtained for compliance with 45 CFR 46 are considered
privileged institutional records and principal investigators
must protect and maintain the confidentiality of information
on individual subjects. Certification of approval of federally
funded projects including any required changes will be forwarded
by the IRB Chair to the Department of Health and Human Services.
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10.
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STATEMENT ON STUDENT RESEARCH
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10.1
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According to federal regulations, research
is defined as “a
systematic investigation, including research development,
testing and evaluation, designed to develop or contribute
to generalized knowledge.” If student projects are
not designed to contribute to further academic knowledge
in the discipline (e.g., conference presentations, professional
publications), then they are not considered research for
the purposes of this rule and therefore are not under the
review of the IRB. Student projects that are designed to
contribute to generalized knowledge should be submitted for
review to the IRB just as any other research project.
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10.2
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Research conducted by students must follow the same ethical
guidelines as all university research. The responsibility
for the ethical conduct of student research is jointly held
by the instructor and the student, each being fully responsible
for the research.
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Contact for Interpretation: Chair, Institutional Review Board
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