INSTITUTIONAL REVIEW BOARD
for the
PROTECTION OF HUMAN SUBJECTS
Office of Grants and Contracts
University of Massachusetts Dartmouth
North Dartmouth, MA 02747
TABLE OF CONTENTS
I. STATEMENT OF ETHICAL PRINCIPLES, INSTITUTIONAL POLICY & APPLICABILITY
A. ETHICAL PRINCIPLES
1. "Belmont Report"
2. Source of Funding
B. INSTITUTIONAL POLICY
1. Institutional Responsibility
2. Director of Grants and Contracts Responsibility
3. All human subject research requires IRB approval
4. All human subject research requires informed consent
5. Institutional assurance of responsibility
6. Institutional responsibility to federal, state and local laws
7. Establishment of one IRB
8. Support for IRB
9. Institutional awareness of human research
10. Institutional record keeping
11. Administrative overview
12. Protection of fetuses and pregnant women
13. Protection of prisoners
14. Protection of potentially vulnerable groups
15. Protective interaction with other IRB's
16. General distribution of these policies
C. APPLICABILITY
1. General
2. Exclusions
3. Exemptions, public officials, required confidentiality
4. Exemption, wholesome food
II. IMPLEMENTATION
A. RESPONSIBILITIES OF RESEARCH INVESTIGATORS AND THEIR SUPERVISORS
1. Determination of human subject involvement
2. Preparation of protocol
3. Ethical consideration and risk to human subjects
4. Submission of protocol to the Research Administrator
5. Submission of a supplement to an original protocol to the
Research Administrator
6. Complying with IRB decisions
7. Providing basic elements of informed consent
8. Providing additional elements of informed consent.
9. Documentation of informed consent
10. Retention of signed consent documents
11. Submission of progress reports on the research
12. Submission of injury reports and reports of unanticipated
problems involving risks
13. Reporting changes in the research
14. Reporting of noncompliance
15. Attending IRB meetings
16. Notifying the Research Administrator concerning investigation
of new drugs
B. RESPONSIBILITIES OF THE RESEARCH ADMINISTRATOR
1. The Research Administrator of the Institution shall be a member
of the IRB
2. Institutional determinations concerning exemptions, sponsorship,
and certification
3. Comply with the Investigational New Drug or Device Certification
Requirement
4. Certification requirement in cases of supplements to HHS funded
protocols
5. Retention of signed consent documents
6. Reporting requirements
C. IRB STRUCTURE
1. Institutional establishment of the IRB
2. IRB membership requirements
3. IRB membership lists and qualifications
D. IRB AUTHORITY AND RESPONSIBILITIES
1. IRB review of research
2. Documentation of informed consent
3. Waiver or alteration of informed consent
4. Observation of the consent process and the research
5. Frequency of review
6. Continuing review
7. Verification of change
8. Authority to suspend or terminate approval of research
9. Information dissemination and reporting requirements
E. IRB PROCEDURES
1. IRB receives protocol
2. Determination of review procedure
3. Expedited review
4. Full committee review
5. IRB notification to research investigators and the Research
Administrator of decision(s)
6. Appeal of IRB determination
UNIVERSITY OF MASSACHUSETTS DARTMOUTH, hereinafter referred to as
"Institution", hereby gives assurance that it will comply with the Department
of Health and Human Services (HHS) regulations for the Protection of Human
Research Subjects (45 CFR 46, as amended) as specified below.
I. STATEMENT OF ETHICAL PRINCIPLES, INSTITUTIONAL POLICY AND APPLICABILITY.
A. ETHICAL PRINCIPLES
1. "Belmont Report"
This Institution is guided by the ethical principles regarding
all research involving humans as subjects as set forth in the
report of the National Commission for the Protection of Human
Subjects of Biomedical and Behavioral Research entitled Ethical
Principles and Guidelines for the Protection of Human Subjects
of Research (the "Belmont Report") [45 CFR 46.103].
2. Source of Funding
In addition, the requirements set forth in Title 45, Part 46 of
the Code of Federal Regulation (45 CFR 46) will be met for all
applicable HHS-funded research and, except for the requirements
for reporting information to HHS, all other funded research
without regard to source of funding.
B. INSTITUTIONAL POLICY
1. Institutional Responsibility
This Institution acknowledges and accepts its responsibilities
for protecting the rights and welfare of human subjects of
research covered by this assurance.
2. Director of Grants and Contracts Responsibility
This institution assigns administration of these responsibilities
to the Director of the Office of Grants and Contracts hereinafter
referred to as "Research Administrator".
3. All human subject research requires IRB approval
It is the policy of this Institution that, except for those
categories specifically exempted by 45 CFR 46, all research
covered by this assurance will be reviewed and approved by an
Institutional Review Board (IRB) which has been established under
an assurance of compliance negotiated with HHS. The involvement
of human subjects in research covered by this policy will not be
permitted until the IRB has reviewed and approved the research
protocol and informed consent has been obtained in accord with
and to the extent required by 45 CFR 46.116. The IRB will review
all human subject research on a continuing basis at appropriate
intervals, but not less than once per year.
4. All human subject research requires informed consent
It is the policy of this Institution that unless informed consent
has been specifically waived by the IRB in accordance with
procedures described herein or unless the research is not covered
by these regulations, no research investigator shall involve any
human being as a subject in research unless the research
investigator has obtained the legally effective informed consent
of the subject, or the subject's legally authorized
representative.
5. Institutional assurance of responsibility
This Institution acknowledges that it bears full responsibility
for the performance of all research involving human subjects,
covered by this assurance.
6. Institutional responsibility to federal, state and local laws
This Institution bears full responsibility for complying with
federal, state, or local laws as they may relate to research
covered by this assurance.
7. Establishment of one IRB
This Institution has established and will maintain one IRB in
accordance with 45 CFR 46. This IRB has the responsibility and
authority to review, approve, disapprove, or require changes in
appropriate research activities involving human subjects.
8. Support for IRB
This Institution has provided and will continue to provide both
meeting space for the IRB, and sufficient staff to support the
IRB's review and record keeping duties.
9. Institutional awareness of human research
This Institution encourages and promotes constructive
communication among the research administrators, department
heads, research investigators, clinical care staff, IRB's other
institutional officials and human subjects as a means of
maintaining a high level of awareness regarding the safeguarding
of the rights and welfare of the subjects.
10. Institutional record keeping
This Institution will maintain documentation of IRB activities as
prescribed herein. [45 CFR 46 115]
11. Administrative overview
This Institution will exercise appropriate administrative
overview, carried out at least annually, to insure that its
practices and procedures designed for the protection of the
rights and welfare of human subjects are being effectively applied
and are in compliance with the requirements of 45 CFR 46 and this
assurance.
12. Protection of fetuses and pregnant women
This Institution will comply with the policies set forth in 45
CFR 46 Subpart B, which provide additional protection pertaining
to research, development, and related activities involving
fetuses, pregnant women, and in vitro fertilization of human ova.
13. Protection of prisoners
This Institution will comply with the policies set forth in 45
CFR 46 Subpart C, which provide additional protection for
prisoners involved in research.
14. Protection of potentially vulnerable groups
This Institution, in addition to complying with the requirements
of 45 CFR 46 Subpart D, will consider additional safeguards in
research when that research involves children, individuals
institutionalized as mentally disabled and other potentially
vulnerable groups.
15. Protective interaction with other IRB's
This Institution will comply with the requirements of 45 CFR
46.114 regarding cooperative research projects. When research
covered by this assurance is conducted at or in cooperation with
another entity, all provisions of this assurance remain in effect
for that research. This Institution may accept, for the purpose
of meeting the IRB review requirements, the review of an IRB
established under another assurance of compliance with HHS. Such
acceptance must be in writing, approved and signed by this
institution's Research Administrator, approved and signed by
correlative officials of the other cooperating institutions. A
copy of the signed agreement must be forwarded to the Office of
Protection from Research Risks (OPRR), at Health and Human Services
(HHS).
16. General distribution of these policies
This Institution shall provide each individual at the Institution
conducting or reviewing human subject research (e.g., PIs,
department heads, clinical care staff, research administrators,
IRB members) with a copy of this institutional assurance of
compliance and copies of any future modifications which may be
made to this assurance, with the exception of changes in IRB
membership.
C. APPLICABILITY
1. General
Except as noted in 2-4 below, this assurance is applicable to all
activities which, in whole or in part involve funded research to
or through the university or its foundation with human subjects
if:
a. the research is sponsored by this Institution (faculty or
staff entitlements shall not be considered institutional
sponsorship) or
b. the research is conducted by or under the direction of any
employee or agent of this Institution in connection with his
or her institutional responsibilities, or
c. the research involves the use of this institution's nonpublic
information to identify or contact human research subjects or
prospective subjects.
2. Exclusion
Funded research involving the use of perceptual/cognitive
material, standard tests (educational, cognitive, diagnostic,
aptitude, achievement), survey procedures, interview procedures
or observations of public behavior are exempt from these
assurances unless:
a. information obtained is recorded in such a manner that human
subjects can be identified, directly or through identifiers
linked to the subjects; and
b. any disclosure of the 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 or employability.
3. Exemptions, public officials, required confidentiality
Funded 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 (I,A,2) are exempt if:
a. the human subjects are elected or appointed public officials
or candidates for public office or in the case of
non-federally funded research public figures or
b. Federal statute(s) require(s) without exception that the
confidentiality of the personally identifiable information
will be maintained throughout the research and thereafter.
[45 CFR 46.101(b)(3)(ii)]
4. Exemption, wholesome food
Also exempt are taste and food quality evaluation studies, if
wholesome foods without chemical additive are consumed or if a
limited amount of a food is consumed that contains a food
additive or agricultural chemical at or below a level approved by
the Food and Drug Administration, the Environmental Protection
Agency, or the Animal Plant Health Inspection Service of the U.S.
Department of Agriculture. [45 CFR 46.101 (b)(6)]
II. IMPLEMENTATION
A. RESPONSIBILITIES OF RESEARCH INVESTIGATORS AND THEIR SUPERVISORS
Principal research investigators must be full-time paid staff of UMD.
In cases where the principal investigator is a part-time or
unsalaried faculty member, a full-time faculty member who will take
responsibility for supervising the project must be designated as
co-investigator and their supervisor must approve such arrangement by
signing the institution's Final Approval Form. Research investigators
who have attending privileges at affiliated hospitals, but have no
faculty appointments are specifically excluded from submitting
protocols for consideration by this IRB.
1. Determination of human subject involvement.
a. Research investigators and their supervisor shall make the
preliminary determination as to whether funded research will
involve human subjects as defined in these assurances.
b. When it is not clear whether the funded research involves
human subjects, research investigators should seek assistance
from the Research Administrator in making this decision.
2. Preparation of protocol.
a. Research investigators shall prepare a protocol giving a
complete description of the proposed research. In the
protocol, research investigators shall make provisions for
the adequate protection of the rights and welfare of
prospective research subjects and insure that pertinent laws
and regulations are observed. This requirement is not
applicable where research is exempt under these assurances.
b. Research investigators shall include samples of proposed
informed consent forms with the protocol.
c. Research investigators shall include with the protocol:
(1) The Institutional Final Approval Form (completed at
least up to and including the signature of the
supervisor of the Research Investigator).
(2) The institutional Application Form for IRB Review of the
protocol.
(3) The budget, if applicable, for the protocol.
(4) Letter(s) of support from other departments or agencies
involved in the protocol, if applicable.
(5) Letter(s) of support from parties outside the
Institution involved in the protocol, if applicable.
(6) State clearinghouse (A-95) or OMB circulars, if
applicable.
(7) Letter(s) of indemnification, if applicable.
(8) Documentation of previous clinical trials, if applicable.
3. Ethical consideration and risk to human subjects.
The supervisor of a research investigator, through appropriate
procedures established within their respective departments or
divisions, is responsible for reviewing research protocols for
ethical considerations and risk to human subjects.
4. Submission of protocol to the Research Administrator.
Research investigators and their supervisors shall be responsible
for insuring that all protocols of research involving human
subjects is submitted to the Research Administrator.
5. Submission of a supplement to an original protocol to the
Research Administrator. Research investigators shall be
responsible for submitting a supplement and the original protocol
to the Research Administrator when:
a. it is proposed to involve human subjects, and the activity
previously had only indefinite plans for the involvement of
human subjects, or
b. it is proposed to involve human subjects, and the activity
previously had no plans for the involvement of human
subjects, or
c. it is proposed to change the involvement of human subjects
and that involvement is significantly different from that
previously approved by the IRB.
6. Complying with IRB decisions.
a. Research investigators shall be responsible for complying
with all IRB decisions, conditions and requirements.
b. Unless otherwise authorized by the IRB, research
investigators are responsible for insuring that legally
effective informed consent shall:
(1) be obtained from the subject or the subject's legally
authorized representative;
(2) be in language understandable to the subject or their
representative;
(3) be obtained under circumstances that offer the subject
or their representative sufficient opportunity to
consider whether the subject should or should not
participate; and,
(4) not include 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 research investigator, the
sponsor, the Institution or its agents from liability
for negligence.
7. Providing basic elements of informed consent. [45 CFR 40.11 C]
Unless otherwise authorized by the IRB, research investigators at
a minimum shall provide the following information on each
subject:
a. 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;
b. A description of any reasonably foreseeable risks or
discomforts to the subject;
c. A description of any benefits to the subject or to others
which may reasonably be expected from the research;
d. A disclosure of appropriate alternative procedures or courses
of treatment, if any, that might be advantageous to the
subject;
e. A statement describing the extent, if any, to which
confidentiality of records identifying the subject will be
maintained;
f. 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, or where further
information may be obtained;
g. An explanation of whom to contact for answers to pertinent
questions about the research and research subject's rights,
and whom to contact in the event of a research related injury
to the subject; and,
h. 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.
8. Providing additional elements of informed consent.
When required by the IRB, the research investigator shall provide
one or more of the following additional elements of information
to each subject:
a. A statement 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
unforseeable;
b. Anticipated circumstances under which the subject's
participation may be terminated by the research investigator
without regard to the subject's consent;
c. Any additional costs to the subject that may result from
participation in the research;
d. The consequences of a subject's decision to withdraw from the
research and procedures for orderly termination of
participation by the subject;
e. A statement that significant new finding 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,
f. The approximate number of subjects involved in the study.
9. Documentation of informed consent. [45 CFR 46.117]
a. Research investigators shall be responsible for insuring that
informed consent is documented by the use of a written
consent form approved by the IRB and signed by the subject or
the subject's legally authorized representative, unless this
requirement is specifically waived by the IRB.
b. Research investigators shall insure that each person signing
the written consent form is given a copy of that form.
c. Research investigators may use a consent form which is either:
(1) A written consent document that embodies the elements of
informed consent required by these assurances. This form
may be read to the subject or the subject's legally
authorized representative, but in any event, the
research investigator shall give either the subject or
the representative adequate opportunity to read the form
before signing it, or;
(2) A "short form" written consent document stating the
elements of informed consent required by IIA(8) have
been presented orally to the subject or the subject's
legally authorized representative. When the "short form"
is used, research investigators shall insure that:
(a) A witness is present at the oral presentation;
(b) The short form is signed by the subject or the
representative;
(c) The witness signs both the short form and a copy of
the written summary of the oral presentation;
(d) The person obtaining consent signs a copy of the
summary;
(e) A copy of both the short form and summary is given
to the subject or the representative, and
(f) The written summary of what is to be said to the
subject or the representative receives prior
approval of the IRB.
10. Retention of signed consent documents.
a. Research investigators are responsible for placing the
consent documents signed by human research subjects in a
repository approved by the Research Administrator. For both
in- and outpatients this shall be a locked file cabinet in
the investigator's office. In addition, the confidentiality
of consent documents shall be maintained according to current
standards of professional practice.
b. If the Consent Form is placed in the subject's chart, than a
duplicate must be filed as well as described in (11a.).
11. Submission of progress reports on the research.
Research investigators are responsible for reporting the progress
of the research to the Research Administrator, as often as, and
in the manner prescribed, by the IRB, but no less than once per
year.
12. Submission of injury reports and reports of unanticipated
problems involving risks.
a. Research investigators are responsible for reporting promptly
through their supervisor, to the Research Administrator, any
injuries to human subject.
b. Research investigators are responsible for reporting promptly
through their supervisor, to the Research Administrator, any
unanticipated problems which involves risks to the human
research subjects or others.
13. Reporting changes in the research.
a. Research investigators are responsible for reporting promptly
through their supervisors, to the Research Administrator,
proposed changes in a research activity.
b. Changes in research during the period for which the IRB
approval has already been given shall not be initiated by
research investigators without IRB review and approval,
except where necessary to eliminate apparent immediate
hazards to the subject.
14. Reporting of noncompliance.
Research investigators and their supervisor are responsible for
reporting promptly to the Research Administrator, and the IRB,
any noncompliance with the requirements of this assurance, or
the determination of the IRB.
15. Attending IRB meetings.
To facilitate the review of research and the protection of the
rights and welfare of human subject, research investigators and
their supervisors are encouraged to, attend IRB meetings when
invited by the IRB.
16. Notifying the Research Administrator concerning investigation of
new drugs. The research investigators shall be responsible for
notifying the Food and Drug Administration (FDA) and the
Research Administrator whenever it is anticipated that an
investigational new drug or device exemption shall be required.
B. RESPONSIBILITIES OF THE RESEARCH ADMINISTRATOR
1. The Research Administrator of the Institution shall be a member
of the IRB ex officio without a vote.
2. Institutional determinations concerning exemptions, sponsorship,
and certification.
a. The Research Administrator shall receive from the research
investigators, through their supervisors all research
protocols, which involve human subjects and are covered by
these assurances.
b. The Research Administrator is responsible for reviewing the
preliminary determinations of research investigators and
their supervisors for:
(1) notifying the IRB of such determinations; and
(2) recommending whether research protocols which do involve
human subjects qualify for an expedited process or for
exemption from coverage.
c. The Research Administrator shall forward all research
protocols involving human subjects to the IRB for review.
d. All exempted research protocols and all protocols approved by
the IRB which are being submitted for HHS funding shall be
forwarded to HHS by the Research Administrator. When an IRB
approves a protocol on condition that the research
investigator make modifications to the protocol, the Research
Administrator shall not forward the protocol to HHS until the
Research Administrator has determined that such modifications
are made. As appropriate, the IRB or the Research
Administrator may negotiate protocol modifications with the
research investigator. Each protocol submitted to HHS by the
Research Administrator must include:
(1) certification that the research was reviewed and
approved by the IRB, established under this assurance.
(The identification numbers of this assurance and the
IRB must be included in the certification); or
(2) certification that the research was reviewed and
approved by an IRB established under another assurance.
(The identification was established along with the
certification); or
(3) notification that the research was determined to be
exempt from coverage, or that coverage was waived.
e. The Research Administrator shall keep research investigators
aware of decisions and administrative processing affecting
their respective protocols and shall return all disapproved
protocols to the research investigators.
3. Comply with the Investigational New Drug or Device Certification
Requirement.
a. The Research Administrator shall identify the test article
(i.e., drug, biologic, or device) in the certification to HHS
when the proposal involves a test article and state whether
the 30-day interval required for test articles has elapsed or
was waived by the FDA.
b. If the 30-day interval has expired, the Research
Administrator shall state in the certification to HHS whether
the FDA has requested that the sponsor continue to withhold
or restrict the use of the test article for application in
human subjects.
c. If the 30-day interval has not expired and a waiver has not
been issued, the Research Administrator shall send a
statement to HHS upon expiration of the interval.
4. Certification requirement in cases of supplements to HHS funded
protocols. The research administrator is responsible for
submitting a certification to HHS, and when otherwise required by
HHS, a supplement to an original protocol, when:
a. it is proposed to involve human subjects, and the activity
previously had only indefinite plans for the involvement of
human subjects, or
b. it is proposed to involve human subjects, and the activity
previously had no plans for the involvement of human
subjects, or
c. it is proposed to change the involvement of human subjects
and that involvement is significantly different from that
which was initially approved by the IRB. In addition, the
Research Administrator shall insure that no human subjects
are involved in research projects for which the filing of
supplement is required by HHS, prior to review of the
submitted supplement and approval by appropriate HHS
officials.
5. Retention of signed consent documents.
The Research Administrator shall designate procedures for the
retention of the signed consent documents. (See II.A.11) These
documents shall be retained for at least three years after
termination of the last IRB approval period.
6. Reporting requirements.
The Research Administrator shall be responsible for promptly
reporting information, as appropriate, to the IRB, the OPRR, and
research investigators and their supervisors on a variety of
issues. Information may flow from sources such as human subjects,
research investigators, IRB's or other institutional staff.
Specifically, the Research Administrator shall:
a. Report promptly on the OPRR an instance of injuries to
subjects and unanticipated problems involving risks to
subjects or others;
b. Report to the IRB information received concerning
noncompliance by research investigators, injuries to
subjects, unanticipated problems involving risks, changes
proposed in research activities and the progress of the
research;
c. Maintain information concerning the IRB's reasons for the
termination of suspension of IRB approval; and
d. Report promptly any changes in IRB membership to the OPRR.
C. IRB STRUCTURE
1. Institutional establishment of the IRB (Committee for the
Protection of Human Subjects).
a. The Institutional Committee for the Protection of Human
Subjects is established within the University to review
funded research involving human subjects. Five members of the
IRB are appointed by the President and four members are
appointed by the Faculty Federation of University of
Massachusetts Dartmouth. Members of the IRB are appointed for
three year terms, such terms to be staggered so that no more
than three terms terminate concurrently.
b. The Chairman of the IRB is elected for a one year term by a
majority vote of the IRB membership. The term of the Chairman
may be extended no more than one additional year with the
consent of a majority of the IRB membership. The Chairman
shall appoint for a term of one year, a Vice Chairman, who
will serve in the absence or incapacity of the Chairman.
2. IRB membership requirements.
a. The IRB is comprised of nine (9) appointed members from
diverse backgrounds to promote complete and adequate review
of research activities covered by this assurance, and have
the professional competence necessary to review the specific
research activities which will be assigned to it. [45 CRF
46.107(a)]
b. The IRB is sufficiently qualified through the experience and
expertise of its members, and the diversity of the members'
backgrounds including consideration of the racial and
cultural backgrounds of members and sensitivity to such
issues as community attitudes, to promote respect for its
advice and counsel in safeguarding the rights and welfare of
human subjects. [45 CFR 46.107(a)]
c. When research is reviewed involving a category of vulnerable
subjects (e.g., prisoners, children, individuals
institutionalized as mentally disabled), the IRB shall
determine whether to include in its reviewing body one or
more individuals who has as a primary concern the welfare of
these subjects. [45 CFR 46.107(a)]
d. Every nondiscriminatory effort will be made to ensure that
the IRB will not consist entirely of men or entirely of
women. The IRB cannot be composed entirely of members of one
profession or academic specialty. [45 CFR 46.107(b)]
e. The IRB include members representing a variety of professions.
f. The IRB includes at least one member whose primary expertise
is in a non scientific area. [45 CFR 46.107(c)]
g. The IRB includes at least one member who is not otherwise
affiliated with the Institution and who is not a part of the
immediate family of a person affiliated with the Institution.
[45 CFR 46.107(d)]
h. No IRB member shall participate in the IRB's initial or
continuing review of any project in which the member has a
conflicting interest, except to provide information requested
by the IRB. [45 CFR 46.107(e)]
i. The IRB may, at its discretion, invite individuals with
competence in special areas to assist in the review of
complex issues which require expertise beyond or in addition
to that available on the IRB. These individuals may not vote
with the IRB. [45 CFR 46.107(f)]
3. IRB membership lists and qualifications.
The names and qualifications of the members of the IRB are
enclosed in accordance with [45 CFR 46.103(b)(3)].
D. IRB AUTHORITY AND RESPONSIBILITIES
1. IRB review of research.
a. The IRB shall have the responsibility to review and the
authority to approve, require modification in, or disapprove,
research involving human subjects. [45 CFR 46.109(a)]
b. The IRB shall approve research based on the IRB's
determination that the following requirements are satisfied:
[45 CFR 46.111(a)]
(1) Risk to subjects are minimized: [45 CFR 46.111(a)(1)]
(a) by using procedures which are consistent with sound
research design and which do not unnecessarily
expose subjects to risk, and
(b) whenever appropriate 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 knowledge that may reasonably be expected
to result. In evaluating risks and benefits, the IRB
shall 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 shall not
consider long-range effect of applying knowledge gained
in the research as among those research risks that fall
within the purview of its responsibility. [45 CFR
46.11(a)(3)]
(3) Selection of subjects is equitable. In making this
assessment, the IRB shall take into account the purposes
of the research, the setting in which the research will
be conducted, and the population from which subjects
will be recruited. [45 CFR 46.111(a)(3)]
(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 46.117. [45 CFR 46.111(a)(4)]
(5) Informed consent will be appropriately documented, in
accordance with, and to the extent required by 45 CFR
46.117. [45 CFR 46.111(a)(5)]
(6) Where appropriate, the research plan makes adequate
provision for monitoring the data collected to insure
the safety of subjects. [45 CFR 46.111(a)(6)]
(7) Where appropriate, there are adequate provisions to
protect the privacy of subjects and to maintain the
confidentiality of data. [45 CFR 46.111(a)(7)]
(8) Where some or all of the subjects are likely to be
vulnerable to coercion or undue influences, such as
persons with acute or severe physical or mental illness,
or persons who are economically or educationally
disadvantaged, appropriate additional safeguards will
be included in the study to protect the rights and
welfare of these subjects. [45 CFR 46.111(b)]
2. Documentation of informed consent. [45 CFR 46.117]
a. The IRB shall require documentation of informed consent by
use of a written consent form, or may waive the requirement
for the research investigator to obtain a signed consent form
for some or all subjects if the IRB determines that:
(1) 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
(2) The research presents no more than minimal risk of harm
to subjects and involves no procedures for which written
consent is normally required of the research context.
b. When the documentation requirement is waived, the IRB may
require the research investigator to provide subjects with a
written statement regarding the research.
3. Waiver or alteration of informed consent. [45 CFR 46.117(c)]
The IRB may approve a consent procedure which does not include,
or which alters, some or all of the elements of informed consent
set forth in 45 CFR 46.116(a) & (b), or waive the requirement to
obtain informed consent provided the IRB finds and documents
that:
a. The research is to be conducted for the purpose of
demonstrating or evaluating:
(1) federal, state or local benefit or service programs
which are not themselves research programs.
(2) procedures for obtaining benefits or services under
these programs, or
(3) possible changes in or alternatives to these programs
or procedures; and
b. The research could not practicably be carried out without
the waiver or alteration.
c. The research involves no more than minimal risk to the
subjects;
d. The waiver or alteration will not adversely affect the rights
and welfare of the subject;
e. Whenever appropriate the subjects will be provided with
additional pertinent information after participation.
4. Observation of the consent process and the research.
The IRB shall have the authority to observe or have a third party
observe the consent process and the research.
5. Frequency of review.
a. The IRB shall determine, in its review of research protocols,
which projects will require IRB review more often than
annually.
b. Except as may be otherwise provided in this assurance, all
convened IRB meetings shall be conducted under and pursuant
to Robert's Rules of Order.
c. Convened meetings of the IRB shall occur:
(1) At least once four times per year; and
(2) At the call of the Research Administrator, or
(3) At the call of the Chairman when the Chairman judges the
meeting to be necessary or advantageous; and
(4) At the call of the Chairman upon the receipt of a joint
written request of three or more members.
6. Continuing review.
The IRB shall conduct continuing review of research at intervals
appropriate to the degree of risk, but not less than once per
year.
7. Verification of change.
The IRB shall determine which projects need verification from
sources other than the research investigators that no material
changes have occurred since previous IRB review.
8. Authority to suspend or terminate approval of research.
The IRB shall have authority to suspend or terminate approval of
research that is not being conducted in accordance with the IRB's
decisions, conditions and requirements or that has been
associated with unexpected serious harm to subjects.
9. Information dissemination and reporting requirements.
a. The IRB shall have the authority and be responsible for
promptly reporting information to the Research Administrator,
the OPRR or both on a variety of issues. In conjunction with
this requirement the IRB must be prepared to receive and act
on information received from a variety of sources, such as
human subjects, research investigators, the Research
Administrator, or other institutional staff. For reporting
purposes, the IRB will follow the procedures described below:
(1) Any serious or continuing noncompliance by research
investigators with the requirements of the IRB, this
information shall he reported promptly to the Research
Administrator and the OPRR.
(2) Minutes of IRB meetings which shall be in sufficient
detail to show the names of attendees at the meetings;
actions taken by the IRB; the vote on these actions
including the number of members voting for, against, and
abstaining; the basis for requiring changes in or
disapproving research; a written summary of the
discussion of controverted issues and their resolution;
and dissenting reports and opinions. If a member in
attendance has a conflicting interest regarding any
project, minutes shall show that this member did not
participate in the review, except to provide information
requested by the IRB. Minutes of IRB meetings are
submitted to the Vice President for Academic Affairs of
the Institution.
(3) Records of continuing review activities.
(4) Copies of all correspondence between IRB and the
research investigators.
(5) A list of IRB members as required by 45 CFR 46.103 (b)
(3).
(6) Written procedures for the IRB as required by 45 CFR
46.103 (b) (4).
(7) Statements of significant new findings provided to
subjects as required by 45 CFR 46.116 (b) (5).
b. The IRB shall provide for the maintenance of records relating
to a specific research activity for at least three (3) years
after termination of the last IRB approval period for the
activity.
c. IRB records shall be accessible for inspection and copying by
authorized representatives of HHS at reasonable times and in
a reasonable manner, or shall be copied and forwarded to HHS
when requested by authorized HHS representatives.
E. IRB PROCEDURES
1. IRB receives protocol.
The IRB chairman shall receive all research protocols involving
human subjects from the Research Administrator.
2. Determination of review procedure.
a. The IRB chairman shall determine whether the research
protocol meets the criteria necessary for an expedited review
process or of exemption form coverage under 45 CFR 46.101 (b).
b. The IRB Chairman refers all research protocols to either full
committee review or expedited review.
3. Expedited review.
a. The eligibility of some research for review through the
expedited procedure is in no way intended to negate or modify
the policies of this Institution or other requirements of 45
CFR 46.
b. The IRB may use the expedited review procedure to review
minor changes in previously approved research during the
period for which approval is authorized.
c. The only other research for which the IRB may use an
expedited review procedure is that which involves no more
than minimal risk to the subjects X in which the only
involvement of human subjects will be in one or more of the
following categories:
(1) Collection of hair and nail clippings, in a non
disfiguring manner; deciduous teeth and permanent teeth
if patient care indicates a need for extraction.
(2) Collection of excreta and external secretions including
sweat, uncanulated saliva, placenta removed at delivery,
and amniotic fluid at the time of rupture of the
membrane prior to, or during labor.
(3) Recording of data from subjects 18 years or age or older
using non invasive 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 or the subject's privacy. It does not include
exposure to electromagnetic radiation outside the
visible range (for example, x-rays, microwaves).
(4) Collection of blood samples by venipucture, in amounts
not to exceed 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.
(5) Collection of both supra- and sub gingival 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.
(6) Voice recordings made for research purposes such as
investigations of speech defects.
(7) Moderate exercise by healthy volunteers.
(8) The study of existing data, documents, records,
pathological specimens, or diagnostic specimens.
(9) 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 subjects.
(10) Research on drugs or devices for which an
investigational new drug exemption or an investigational
device exemption is not required.
(11) Any other category specifically added to this list by
HHS and published in the Federal Register.
d. Expedited review shall be conducted by the IRB chairperson or
by one or more of the experienced IRB members designated by
the chairperson to conduct the review.
e. The IRB member(s) conducting the expedited review may
exercise all of the authorities of the IRB except that the
reviewer(s) may not disapprove the research. The reviewer(s)
shall refer any research protocol which the reviewer(s) would
have disapproved to the full committee for review. The
reviewer(s) may also refer other research protocols to the
full committee whenever the reviewer(s) believes that full
committee review is warranted.
f. When the expedited review procedure is used, the IRB
chairperson or member(s) conducting the review shall inform
IRB members of research protocols which have been approved
under the procedure.
g. At a convened IRB meeting, any member may request that an
activity which has been approved under the expedited
procedure be reviewed by the IRB in accordance with non
expedited procedures. A vote of the members shall be taken
concerning the request and the majority shall decide the
issue.
4. Full committee review.
a. Research protocols scheduled for review shall be distributed
to all members of the IRB prior to the meeting.
b. When it is determined that consultants or experts will be
required to advise the IRB in its review of a protocol, the
research protocol shall also be distributed to the
consultants or experts prior to the meeting.
c. All IRB initial review and continuing review shall be
conducted at convened meetings and at timely intervals.
d. A majority of the membership of the IRB constitutes a quorum
and is required in order to convene a meeting for the review
of research protocols.
e. An IRB member whose concerns are primarily in non-scientific
areas must be present at the convened meeting before the IRB
can conduct its review of research.
f. For a research protocol to be approved it must receive the
approval of a majority of those members present at the
convened meetings
g. The IRB may have no member participating in the IRB's initial
or continuing review of any project in which the member has a
conflicting interest, except to provide information requested
by the IRB.
h. In cases where research activities were initially approved
under expedited procedures and subsequently reviewed by
non-expedited procedures, the decisions reached at the
convened meeting shall supersede any decisions made through
the expedited review.
5. IRB notification to research investigators and the Research
Administrator of decision(s).
a. The IRB shall notify the research investigators and the
Research Administrator in writing of the IRB's decisions,
conditions, and requirements.
b. The IRB shall also provide to the research investigator
reasons for the IRB's decision to disapprove a research
protocol and an opportunity for the research investigator to
respond. Reasons for disapproval shall also be transmitted to
the Research Administrator.
6. Appeal of IRB determination.
a. A principal investigator whose research proposal for the use
of human research subjects has been declined by the IRB may
appeal that determination by providing the IRB chairman with
information which would merit reconsideration.
b. Appeal of a reconsidered determination of federally supported
research involving human research subjects may be submitted
to the U.S. Department of Health and Human Service, National
Institutes Of Health, Office for Protection from Research
Risks.
c. Appeal of a reconsidered determination of non-federally
funded research involving human research subjects may be
submitted for final determination to a mutually agreeable
IRB.
