Policies and Procedures
1.0 INSTITUTIONAL RESPONSIBILITIES
1.1. Campus policies and federal requirements regarding research
with human subjects are implemented by the Institutional Review
Board for the Protection of Human Subjects in Research (IRB). The
members of the IRB are appointed by the Associate Provost.
Composition and appointment of the IRB is described in Section
1.2. The protection of human subjects from undue risks and
deprivation of personal rights and dignity can best be achieved
through consideration of three issues: 1) that subject
participation is voluntary, indicted by free and informed consent
(the subject is free to withdraw at any time without jeopardy and
may request that his/her data be destroyed); 2) that the degree,
nature, and management of risk to the subject and the researcher
have been delineated explicitly by the researcher; and 3) that
appropriate balance exists between potential benefits of the
research to the subject and/or to society and the risks assumed by
1.3 The IRB has the ultimate responsibility to determine risk with
regard to human subject research and to approve or not approve such
research performed under the sponsorship of the University or its
2.0 SCOPE OF THE REVIEW
2.1 The institution must review biomedical and behavioral research
involving human subjects conducted at or sponsored by the
University in order to protect the rights of human subjects of such
research. Activities which are not research but which nevertheless
involve people are not covered by this policy, but rather by other
appropriate codes of conduct. Research is defined by the
Uniform Federal Policy for the Protection of Human
Subjects as "a systematic investigation, including
research development, testing and evaluation, designed to develop
or contribute to generalized knowledge." Activities which meet this
definition constitute research for purposes of this policy, whether
or not they are conducted or supported under a program that is
considered research for other purposes. For example, some
demonstration and service programs may include research activities.
Research activities involving people are divided into three
A. Exempt Research. The IRB will review all protocols
involving human subjects and determine whether the proposed
research is exempt. Researchers should fill out the application and
designation of exempt status will be determined by the Chair of the
IRB if warranted.
B. Expedited Review: Research Involving No More Than Minimal
Risk to Human Subjects. Minimal risk means that the
probability and magnitude of harm or discomfort anticipated in the
research are not greater in and of themselves than those ordinarily
encountered in daily life or during the performance of routine
physical or psychological examinations or tests. Research in this
category may receive expedited review (see Section 5.0).
Researchers should submit proposals in the same manner as for
proposals involving more than minimal risk (described in Sections
3.0 and 4.0), but should specifically state in the cover memo that
research involves "no more than minimal risk" and that expedited
review is requested.
C. Full Review: Research Involving More Than Minimal Risk to
Human Subjects. Research in this category shall be
reviewed by the IRB according to the procedures set out in Sections
5.0 through 8.0. Researchers should submit complete documentation
of their research proposals as described in Sections 3.0 and
2.2 Human Subject research conducted and/or sponsored by the
University includes that conducted and/or sponsored by University
employees, emeriti faculty, auxiliary employees, and/or students
including student/faculty collaborative research under the auspices
of the University.
A. For purposes of clarifying the researcher's legal rights and
responsibilities, research or related activities conducted under
the auspices of the University are defined to be any research or
related activity involving human subjects that utilize Lesley
University's time, facilities, resources, and/or students.
B. Lesley University affiliated investigators are afforded the
normal legal protection by the University, provided that their
activities have IRB approval and provided that they are working
within the scope of their employment or University association. It
is important to recognize that unless these conditions have been
met, the University will not be in a position to protect Lesley
University-affiliated investigators performing research with human
2.3 Extramural Support
Research requesting extramural support and planning to perform
activities involving human subjects under the auspices of the
University are required to submit an application for funds through
the IRB. All extramural support requests should be submitted to the
IRB a reasonable time in advance of deadline, receipt or submission
dates specified by the operating agencies. Completed IRB review
can, under no circumstances, be expected in less than 15 working
days from receipt of a correctly completed application.
2.4 Student/Faculty Collaborative Research
Collaborative Research (student/faculty), where the faculty
member is considered the principal investigator, must be submitted
through the channels described below under Section 3.0,
2.5 Student Research Activities
Students conducting research involving human subjects must first
submit a statement of research and research methodology to the
department in which the research will be conducted.
2.6 The sponsoring faculty member forwards the protocol to the
2.7 Researchers are entitled to a timely review of research
proposals. The IRB will normally complete its review
within 15 working days of the submission of a complete, properly
formatted proposal. In the event that the agenda of the IRB is
full, and the IRB is unable to complete review of proposals within
15 working days, the researchers shall be informed properly. Upon
request from researchers, the agenda of the IRB shall be reviewed
to prioritize proposals by urgency for starting the research. In
the case of expedited review, working days will normally be
calculated based on days the campus is open. In cases of full
review, only faculty work days in regular sessions are
3.0 APPLICATION PROCEDURES
3.1 Researchers are required to submit a protocol describing the
research or activity to the IRB. The chair and (depending on the
nature of the research) the Board then reviews the protocol and
takes action regarding approval.
3.2 All procedures related to the preparation of appropriate
protocols as well as processes leading to their submission to the
IRB are the responsibility of the University departments and
3.3 The IRB requires an application form and any other relevant
documents such as surveys, questionnaires and consent forms. IRB
review should be completed no later than 30, but not less than 15,
working days from the submission of a complete, properly formatted
A. The Application Form should include the
duration of research. If the research extends beyond one year, it
is subject to annual review by the IRB. A sample of the form is
available from the IRB website.
B. The application is a description of the research and an
explanation of how the research complies with institutional
policies regarding human subjects, and contains the information
1. Abstract: This section should state the relation of
the proposed research to previous scientific investigations in the
field including relevant laboratory and animals studies. Clear
justification for the participation of human subjects at this stage
of the investigation must be given. Researchers should keep in mind
that most members of the IRB are not experts in the research being
reviewed. Adequate lay language explanations should be provided to
allow the members of the IRB to understand the objectives, the
methods, and the research implications, as well as the conditions
and risks to which human subjects will be exposed.
2. Methodology: A detailed description of all
procedures to be performed on human subjects for the purposes of
research must be included. Observational or interview subjects for
the purposes of research must be included. Observational or
interview studies should indicate the type of contacts and
interactions with subject and the means of observation to be used.
WHEN QUESTIONNAIRES ARE TO BE ADMINISTERED, A COPY SHOULD BE
INCLUDED. Standard psychological tests should be identified.
Special attention will be given to issues of confidentiality in
behavioral studies. In cases where information provided to subjects
regarding procedures and purposes of the study would invalidate the
objectives, the investigator procedures and purposes of the study
would invalidate the objectives, the investigator should report to
the IRB specific reasons for not informing subjects of the
Devices or activities that are not customarily encountered by
the subjects in their daily living or unusual applications of such
devices or activities must be described in detail.
Any special procedures involving unusual electrical devices,
radioisotopes, or investigational new drugs (IND's) must also be
described. Approval from appropriate campus or federal agencies
must be obtained before IRB approval can be granted. Unusual
electric devices must have Occupational Health and Safety approval.
Radioisotopes or research involving any source of radiation must be
first approved by the Environmental Health and Occupational Safety
Committee, and "new" drug use must be first approved by the Federal
A tentative time schedule for the various procedures--or
flow-chart where appropriate--should be provided showing how long
each aspect of the study will take, the frequency and timing of
ancillary procedures, the nature and duration of human discomfort,
and the precise location in which the study is to be conducted.
Frequency, duration, and location of interviews or observations
should be indicated in behavioral or social science studies.
Identify all personnel who will participate in or assist in the
conduct of this research. Identify each individual by name, title
and responsibility in this research project. Briefly outline each
individual's qualifications. For procedures requiring special
skills on the part of the investigators, licenses, accreditation,
and/or background of the investigators that qualify them for
performance of those procedures should be indicated.
3. Participants: Effects of sample size on the
magnitude of risk and problems of risk management will be
considered by the IRB.
Justification must be provided for the use of subject groups
that are members of a population whose capability of providing
informed consent is or may be absent or limited. These include
children, persons with diminished mental capacity, the senile who
are confined to institutions (whether by voluntary or involuntary
commitment), and the unborn child or fetus. A pregnant woman's
ability to provide consent is limited insofar as she and the unborn
child can participate only in activities where: (1) the purpose is
to meet the health needs of the mother, and the fetus will be
placed at risk only to minimum extent to meet such needs; or (2)
the risk to the fetus is minimal.
A detailed and specific discussion of potential problems
involving the subject groups must be given.
4. Potential Risks: A discussion of the risks (see
Section 18.0 for definitions), if any, to the subject is required.
Such deleterious effects may be physical, psychological or social.
Some research involves neither risk nor discomfort, but rather
violations of normal expectations. Such violations, if any, should
A discussion of the management of risk is required. Procedures
for protecting against or minimizing potential risks should be
described (including confidentiality safeguards). An assessment of
their likely effectiveness should be discussed. Management of risk
procedures ranges from those applicable to a group (such as the
exclusion of pregnant or potentially pregnant women from a study
involving a new drug) to those applicable to an individual subject.
(The IRB provides researchers with procedures for management of
5. Potential Benefits: This section must provide a
justification for the proposed study. The discussion should focus
on the significance of the new knowledge that is being sought and
an evaluation of the benefits to individuals and/or society with
respects to the risks involved in the study.
6. Confidentiality and Anonymity: The researcher will
describe how the identity of participants and their confidential
information will be protected, including but not limited to:
a. The separation of informed consent documents and research
results such as completed surveys or data gathered.
b. The assignment of identifiers designed to protect participant
anonymity; this does not suggest, however, that anonymity is
required. If participants' anonymity is not maintained then the
researcher must describe why, specifically, participants will not
c. The protection of confidentiality in publications;
d. The disposition of research materials and informed consent
7. Other: The IRB relies on the expertise of the
researchers to provide insight about any peripheral benefits or
potentially harmful effects of the conduct of the research. Based
on your past experience and knowledge, please identify any
extraordinary moral, legal, or ethical concerns, either beneficial
or harmful, which may have been linked to this type of
4.0 DOCUMENTATION OF INFORMED CONSENT
A. Except as provided in item C. of this section, informed
consent shall be 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. A COPY SHALL BE GIVEN TO THE
PERSON SIGNING THE FORM.
B. Except as provided in item C. of this section, the consent
form may be either of the following:
1. A written consent document that embodies the elements of
informed consent (see Section 4.1). This form may be read to the
subject or 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;
2. A short form written consent document stating that the
elements of informed consent (see Section 4.1) 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 IRB shall approve a written
summary of what is to be said to the subject or the representative.
The witness shall sign both the short form and a copy of the
summary, and the person actually obtaining consent shall sign a
copy of the summary. A copy of the summary shall be given to the
subject or the representative, in addition to a copy of the short
C. The IRB may waive the requirement for the investigator to
obtain a signed consent form for some or all subjects if it finds
1. 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 he/she wants documentation linking
the subject with the research, and the subject's wishes will
2. 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 of the research context.
D. In cases in which the documentation requirement is waived,
the IRB may require the investigator to provide subjects with a
written statement regarding the research.
E. If subjects are to be compensated, the nature of the
compensation and its influence on subject participation must be
discussed. Experimental subjects may be reasonably reimbursed for
their participation in an experiment. Compensation to subjects
should never constitute an undue inducement or coercion.
4.1 The Consent Form: The researcher conducting a
project that might place any individual at risk is obligated to
obtain and document legally effective informed consent. Informed
consent means the knowing consent of an individual of his/her
legally authorized representative so situated as to be able to
exercise choice without undue inducement or any element of force,
fraud, deceit, duress, or other form of constraint or coercion.
(The IRB website provides a sample consent form.)
4.2 Requirements for Informed Consent: Except as
provided elsewhere in this policy, no investigator may involve a
human being as a subject in research covered by this policy unless
the investigator has obtained the 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 any exculpatory language through which the
subject or the representation 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 institution or its
agents from liability for negligence.
A. Basic elements of informed consent. Except as
provided in item C. or item D. of this section when seeking
informed consent, the following information shall be provided to
1. 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
2. A description of any reasonably foreseeable risks or
discomforts to the subject;
3. A description of any benefits to the subject or to others
which may reasonably be expected from the research;
4. A disclosure of appropriate alternative procedures or courses
of treatment, if any, which might be advantageous to the
5. A statement describing the extent, if any, to which
confidentiality of records identifying the subject will be
6. 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
7. 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 a research-related injury to the
8. 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.
B. Additional elements of informed consent. When
appropriate, one or more of the following elements of information
shall also be provided to each subject:
1. A statement that the particular treatment or procedures may
involve risks to the subject (or to the embryo or fetus, if the
subject is or may become pregnant) which are currently
2. Anticipated circumstances under which the subject's
participation may be terminated by the investigator without regard
to the subject's consent;
3. Any additional costs to the subject that may result from
participation in the research;
4. The consequences of a subject's decision to withdraw from the
research and procedures for orderly termination of participation by
5. 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
6. The approximate number of subjects involved in the
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 above, or waive the requirement of obtain
informed consent provided the IRB finds and documents that:
1. The research of demonstration project is to be conducted by
or subject to the approval of state or local government officials
and is designed to study, evaluate, or otherwise examine:
a. Public benefit of service programs;
b. Procedures for obtaining benefits or services under those
c. Possible changes in or alternatives to those programs or
d. Possible changes in methods or levels of payment for benefits
or services under those programs; and
2. The research could not practicably be carried out without the
waiver or alternation.
D. The IRB may approve a consent procedure which does not
include, or which alters, some or all the elements of informed
consent set forth in this section, or waive the requirements to
obtain informed consent provided the IRB finals and documents
1. The research involves no more than minimal risk to the
2. The waiver or alteration will not adversely affect the rights
and welfare of the subjects;
3. The research could not practicably be carried out without the
waiver or alteration; and
4. Whenever appropriate, the subjects will be provided with
additional pertinent information after participation.
E. The informed consent requirements in this policy are not
intended to preempt any applicable federal, state, or local laws
which require additional information to be disclosed in order for
informed consent to be legally effective.
F. Nothing in this policy is intended to limit the authority of
a physician to provide emergency medical care to the extent which
the physician is permitted to do so under applicable federal,
state, or local law.
5.0 REVIEW OF THE APPLICATION BY THE IRB
5.1 Human subjects research that qualifies under the
classification "involving no more than minimal risk" may be
reviewed according to the procedures of expedited review. Expedited
review procedures apply to certain kinds of research involving no
more than minimal risk, and for minor changes in approved
A. The IRB may use the expedited review procedure to review
either or both of the following:
1. Some or all of the research appearing on the list of eligible
categories established by the Secretary of the U.S. Department of
Health and Human Services and found by the reviewer(s) to involve
no more than minimal risk.
2. Minor changes in previously approved research during the
period (of one year or less) for which approval is
B. Under an expedited review procedure, the review may be
carried out by the IRB chairperson or by one or more experienced
reviewers designated by the chairperson from among members of the
IRB. In reviewing the research, the reviewers may exercise all of
the authorities of the IRB except that the reviewers may not
disapprove the research. A research activity may be disapproved
only after review in accordance with the non-expedited
C. The IRB shall adopt a method for keeping all members advised
of research proposals that have been approved under the expedited
D. The appropriate federal department or agency head may
restrict, suspend, terminate, or choose not to authorize the use of
the expedited review procedure by this institution or the
5.2 All other research proposals are submitted to the Associate
Provost for incorporation into the agenda of the next IRB meeting
for discussion by the entire membership or quorum of the IRB. A
quorum, which is defined as the majority of the total membership
(one half the members plus one), must be present before the IRB can
5.3 The review performed by the IRB will determine whether the
subjects will be placed at risk.
A. The policy criterion for determining risk is defined as:
"Subject at risk" means any individual who may be exposed to the
possibility of injury, including physical, psychological, or social
injury, as a consequence of participation as a subject in any
research, development, or related activity which departs from the
application of those established and accepted methods which are
necessary to meet his/her needs or which increase the ordinary
risks of everyday life, including the recognized risks inhered in a
chosen occupation or field of service.
B. If risk is involved, the answers to the following three
questions will be weighted:
1. Are the risks to the subject so outweighed by the sum of the
benefits to the subject and the importance of the knowledge to be
gained as to warrant a decision to allow the subject to accept
2. Are the rights and welfare of any such subjects adequately
3. Is legally effective informed consent obtained by adequate
and appropriate methods in accordance with the provisions of the
Uniform Federal Policy for the Protection of Human
5.4 Researchers are encouraged to submit proposals for IRB
review during the fall and spring semesters or the winter term;
also, research proposals are accepted in the summer. Proposals
submitted in the summer will be evaluated in the same way and under
the same timeline as during the academic year.
6.0 ACTIONS BY THE IRB
6.1 IRB Review of Research
A. The IRB shall review and have authority to approve, require
modifications in (to secure approval), or disapprove all research
activities covered by this policy.
B. The IRB shall require that certain information be given to
subjects as part of informed consent.
C. The IRB shall require documentation of informed consent or
may waive the need for such documentation.
D. The IRB shall notify investigators and the institution in
writing of its decision to approve or disapprove the proposed
research activity or of modifications required to secure IRB
approval of the research activity. If the IRB decides to disapprove
a research activity, it shall include in its written notification a
statement of the reasons for its decision and give the investigator
an opportunity to respond in person or in writing.
E. The IRB shall conduct continuing review of research covered
by this policy at intervals appropriate to the degree of risk, but
not less than once a year, and shall have authority to observe or
have a third party observe the consent process and the
6.2 IRB Actions
The IRB, after review and discussion of the protocol and
application, may take one of four actions.
A. Approve the research
B. Require modification
C. Disapprove the research
D. Suspend or terminate research
6.3 IRB Approval of Research
A. In order to approve research covered by this policy, the IRB
shall determine that all of the following requirements are
1. Risks to subjects are minimized:
a. By using procedures which are consistent with sound research
design and which do not unnecessarily expose subjects to risk;
b. Whenever appropriate, by using procedures already being
performed on the subjects for diagnostic or treatment
2. Risks to the subjects are reasonable in relation to
anticipated benefits, if any, to subjects, and the importance of
the knowledge that may reasonably be expected to result. In
evaluating risks and benefits, the IRB should consider only those
risks and benefits that may result from the research (as
distinguished from risks and benefits of therapies subject would
receive even if not participating in the research). The IRB should
not consider possible long-term effects of applying knowledge
gained in the research (for example, the possible effects of the
research on public policy as among those research risks that fall
within the purview of its responsibility.
3. Selection of subjects is equitable. In making this assessment
the IRB should take into account the purpose of the research and
the setting in which the research will be conducted and should be
particularly cognizant of the special problems of research
involving vulnerable populations, such as children, prisoners,
pregnant women, mentally disabled persons, or economically or
educationally disadvantaged persons.
4. Informed consent will be sought from each prospective subject
of the subject's legally authorized representative.
5. Informed consent will be appropriately documented.
6. When appropriate, the research plan makes adequate provision
for monitoring the data collected to ensure the safety of
7. When appropriate, there are adequate provisions to protect
the privacy of subjects and to maintain the confidentiality of
B. When some or all the subjects are likely to be vulnerable to
coercion or undue influence, such as children, prisoners, pregnant
women, mentally disabled persons, or economically or educationally
disadvantaged persons, additional safeguards have been included in
the study to protect the rights and welfare of these
C. The research may involve some risk to the subjects. In such
cases the IRB may find that this risk is not unreasonable, that the
potential benefits outweigh the risks, and that risk management
procedures have been taken to minimize risks.
6.4 IRB Requirement for Modification of Research
This action involves modifications, major or minor, to some part
of the proposed study.
A. The IRB may require major modifications. This occurs when the
IRB feels that it has insufficient information to take action, or
when it feels that the research design contains significant risks
and should be revised to minimize those risks to human subjects.
The IRB may request that the investigator discuss problems with the
full IRB directly or through a selected number.
B. Minor modifications or conditions set by the IRB include such
items as revisiting the consent form to explain the procedures more
clearly, adding a version of a consent form in a language other
than English, restrictions on the use of certain procedures or
subject groups or requiring use of specified safeguards, etc. that
are necessary for the protection of human subjects. The IRB may
request the investigator to discuss problems with the full IRB
directly or though a selected member.
C. Modified research protocols must be resubmitted for approval.
The IRB may choose to expedite review (see Section 5.0) for
resubmissions involving minor modifications.
6.5 IRB Disapproval of the Research
In case of disapproval of the research, the IRB makes the
decision that the potential benefits of the research do not
outweigh the risks to the subject.
6.6 IRB Suspension or Termination of Approval of
The IRB has authority to suspend or terminate approval of
research that is not being conducted in accordance with the IRB's
requirements or that has been associated with unexpected serious
harm to subjects. Any suspension or termination of approval shall
include a statement of the reasons for the IRB's action and shall
be reported promptly to the investigator, the University President
or designee, and the appropriate federal department or agency
7.0 DISPOSITION OF THE RECOMMENDATIONS
7.1 Approvals, recommendations, restrictions, conditions, or
disapprovals are communicated to the researcher through the IRB. At
the time of transmittal of approval, the IRB will also inform the
researcher of the expiration date of approval.
7.2 If an application is not approved as conforming to Federal
and University policies, the IRB shall forward to the researcher a
statement setting forth in detail the reasons for the nonconformity
and the recommendations of the IRB for modification of the research
A. Compliance with recommendations is expected within 3 working
days of request if noncompliance is attributable to an incomplete
application, e.g., one of the following reasons: lack of consent,
assent, or similar form; missing or incomplete questionnaire(s),
surveys, scripts, or similar such forms; an incomplete application
for one of the aforementioned reasons or for any other reason(s),
for example, failure to adequately address any component of the
1. The researcher will be notified of noncompliance by three
methods: 1) phone call; 2) email; and 3) formal, written letter. If
the researcher wants to pursue the noncompliant research after 3
working days of noncompliance, then a new IRB application will have
to be submitted.
2. During the period of noncompliance no additional IRB
applications will be accepted from the researcher or student
research supervised by the researcher in noncompliance.
B. If noncompliance is for reasons other than an incomplete
application, for example potential risk has not been adequately
minimized, deception has not been adequately addressed, or some
other sampling or methodological concern, the researcher is
expected to address the concerns in writing to the IRB within 5
1. The researcher will be notified of noncompliance by three
methods: 1) phone call; 2) email; and 3) formal, written letter. If
the researcher wants to pursue the noncompliant research after the
5 working days of noncompliance, then a new application will have
to be submitted.
2. Considering the nature of this noncompliance additional IRB
applications may be submitted during the noncompliance
8.0 RIGHTS OF APPEAL
8.1 If the applicant believes that a proposal has been
disapproved because of incorrect, unfair, or improper evaluation by
the IRB, he/she may notify the University Provost or designee, who
shall direct a reconsideration of the proposal by the IRB.
Reconsideration of adverse final decisions on specific projects can
be requested by the affected researcher(s) and/or department(s).
The researcher may provide expanded information and explanation to
the IRB. The reconsideration shall take place and a decision shall
be reached within 15 working days of the IRB after the initial
negative decision. The researcher and the University Provost or
designee shall be notified of the results of the reconsideration
immediately by the IRB.
A. At any point in the entire appeals process, the researcher
may modify objectionable items to conform to IRB policy.
8.2 If satisfactory resolution has not been reached as a result
of the reconsideration, the following appeals procedure will be
A. Within 15 working days of the IRB thereafter, the affected
researcher(s) must show cause, to the University President or
designee, in writing, as to why the IRB should reverse the
1. An appeals committee of three (or more) tenured faculty (from
at least two of the schools or colleges) will be appointed by the
University President or designee to conduct a special appeals
review. A member of the IRB may be added to the special appeals
review committee to provide technical knowledge or other
appropriate information. At the request of the researcher, an
outside reviewer may be added to the appeals committee. The outside
reviewer will usually be a member of the IRB of another
2. The appeals committee shall:
a. Review the initial proposal and reconsideration materials,
submitted by researchers;
b. Review relevant minutes of the IRB;
c. Review IRB members' confidential evaluation forms; and,
d. Request any expertise necessary for their
3. The researcher may request an appearance before the IRB
and/or the special appeals committee through the Office of
Sponsored Projects or the IRB chair.
4. The special appeals committee may render one of the following
a. Return the proposal to the IRB for further
b. Affirm the original decision of the IRB denying approval to
the appealing researcher and/or department.
5. The University President, having received the information
from the IRB and the special appeals committee, shall make the
9.0 RECORDS AND DOCUMENTATION
A. The investigator(s) is required to make and keep written
records of the IRB reviews and decisions on the use of human
subjects and to obtain and keep documentary evidence of informed
consent of the subjects or their legally authorized representative.
Such forms must be retained on file by the responsible individual
for a minimum of five years after termination of the project.
B. Researchers will maintain records of research data.
C. Researchers will monitor the duration of their research to
assure that a renewal application is submitted if research will
continue beyond its initial anticipated duration and/or if it will
continue beyond one year.
D. The researchers must periodically review research results to
assure that: 1) unanticipated harm has not occurred; and 2) the
research protocol is producing adequate results such that benefits
of the research continue to balance risks to human subjects. If
unanticipated harm occurs or results are inadequate to assure a
balance of risks and benefit, the researcher must report
immediately to the IRB.
A. The IRB shall prepare and maintain adequate documentation of
IRB activities, including the following:
1. Copies of all research proposals reviewed, scientific
evaluations, if any that accompany the proposals approved, sample
consent documents, progress reports submitted by investigators, and
reports of injuries to subjects.
2. Minutes of IRB meetings which shall be in sufficient detail
to show attendance 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
disapproved research proposals; and a written summary of the
discussion of controversial issues and their resolution.
3. Records of continuing review activities.
4. Copies of all correspondence between the IRB and the
5. A list of IRB members.
6. Written procedures for the IRB.
7. Statements of significant new findings provided to
B. The records required by this policy shall be retained for at
least three years, and records relating to research that is
conducted shall be retained for at least three years after
completion of the research. The records of the IRB pertaining to
individual research activities will not be accessible outside the
IRB and the individual researcher, except for the purposes of audit
or inspection by federal agencies to assure compliance.
9.3 Institution- Lesley University
It is the responsibility of Lesley University through the IRB to
assure compliance with and provide documentation of compliance with
the Uniform Federal Policy for the Protection of Human
A. Each institution engaged in research which is covered by this
policy and which is conducted or supported by a federal department
or agency shall provide written assurance satisfactory to the
department or agency head that it will comply with the requirements
set forth in this policy:
1. Whenever research is engaged which is covered by this policy
and supported by a federal department or agency, written assurance
of compliance shall be submitted to the department or agency head
or kept on file within the Office for Human Research Protection,
U.S. Department of Health and Human Services, 200 Independence Ave.
S.W., Washington, D.C., 20201. Any report to federal department or
agency heads required by this policy shall also be submitted to the
Office for Human Research Protection if an assurance has been filed
2. In lieu of requiring separate submission of an assurance,
individual federal department or agency heads shall accept the
existence of a current assurance, appropriate for the research in
question, on file with the Office for Human Research Protection,
HHS and approved for federal wide use by that office. When the
existence of an HHS-approved assurance is accepted in lieu of
requiring submission of an assurance, reports (except
certification) required by this policy to be made to department and
agency heads shall also be made to the Office for Human Research
B. Federal departments and agencies will support research
covered by this policy only if Lesley University has an assurance
approved as provided in this section, and only if Lesley University
has certified to the department or agency head that the research
has been reviewed and approved by the IR provide for in the
assurance, and will be subject to continuing review by the IRB.
Assurances applicable to federally supported or conducted research
shall at a minimum include:
1. The Lesley University statement of principles governing the
discharge of its responsibilities for protecting the rights and
welfare of human subjects in research conducted at or sponsored by
Lesley University, regardless of whether the research is subject to
federal regulation. This may include an appropriate existing code,
declaration, or statement of ethical principles, or a statement
formulated by the institutional itself. This requirement does not
preempt provisions of this policy applicable to department or
agency-supported or regulated research. The requirement need not be
applicable to research classified as exempt or specific research
activities or classes of research for which, unless otherwise
required by law, federal department or agency heads have waived the
applicability of some or all provisions of this policy.
2. Designation of the IRB established in accordance with the
requirements of this policy and with provisions made for meeting
space and for sufficient staff to support the IRB's review and
3. A list of IRB members identified by name, earned degrees,
representative capacity, indications of experience (such as board
certifications, licenses, etc. sufficient to describe each member's
chief anticipated contributions to IRB membership) shall be
reported to the department or agency head, unless the existence of
an HHS-approved assurance is accepted. In this case, change in IRB
membership shall be reported to the Office for Protection from
Research Risks, HHS.
4. Written procedures which the IRB will follow, as embodied in
a. For conducting its initial and continuing review of research
and for reporting its findings and actions to the investigator and
b. For determining which projects require review more than
annually and which projects need verification from sources other
than the investigators that no material changes have occurred since
previous IRB review; and
c. For ensuring prompt reporting to the IRB of proposed changes
in a research activity, and for ensuring that such changes in
approved research, during the period for which IRB approval has
already been given, may not be initiated without IRB review and
approval except when necessary to eliminate apparent immediate
hazards to the subject.
5. Written procedures for ensuring prompt reporting to the IRB,
the University President or designee, and the federal department or
agency head of:
a. Any unanticipated problems involving risks to subjects or
other or any serious or continuing noncompliance with this policy
or the requirements or determinations of the IRB; and
b. Any suspension or termination of IRB approval.
c. The assurance shall be executed by the University President
or designee who is authorized to act for the institution and to
assume, on behalf of Lesley University, the obligations imposed by
this policy and shall be filed in such form and manner as the
federal department or agency head prescribes.
9.4 Federal Departments and Agencies
A. The federal department or agency head will evaluate all
assurances submitted in accordance with this policy through such
officers and employees of the department or agency and such experts
or consultants engaged for this purpose as the department or agency
head determines to be appropriate. The department or agency head's
evaluation will take into consideration the adequacy of the
proposed IRB in light of the anticipated scope of the institution
research activities and the types of subject populations likely to
be involved, the appropriateness of the proposed initial and
continuing review procedures in light of the probable risks, and
the size and complexity of the institution.
B. On the basis of this evaluation, the federal department or
agency head may approve or disapprove the assurance, or enter into
negotiations to develop an approvable one. The department or agency
head may limit the period during which any particular approved
assurance or class of approved assurances shall remain effective or
otherwise condition or restrict approval.
C. Certification is required when the research is supported by a
federal department or agency and not otherwise exempted or waived.
An institution with an approved assurance shall certify that each
application or proposal for research covered by the assurance has
been reviewed and approved by the IRB. Such certification must be
submitted with the application or proposal or by such later date as
may be prescribed by the department or agency to which the
application or proposal is submitted. Under no condition shall
research covered by this policy be supported prior to receipt of
the certification that the research has been reviewed and approved
by the IRB. Institutions without an approved assurance covering the
research shall certify within 30 days after receipt of a request
for such a certification from the department or agency, that the
application or proposal has been approved by the IRB. If the
certification is not submitted within these time limits, the
application or proposal may be returned to the institution.
10.0 DURATION OF APPROVAL
10.1 The IRB shall conduct at least an annual review of approved
research activities. Researchers should indicate the expected
overall duration of the research when submitting an initial
application. Renewal applications should be made before the date of
expiration of IRB approval, bearing in mind the time needed for
review and that research activity must cease at expiration date if
renewal has not been obtained.
10.2 The IRB will determine the term of approval and will notify
the researcher of the date of expiration of approval at the date of
10.3 Approval of a protocol is granted to the principal
investigator. If the principal investigator ceases to be
responsible for the study, approval automatically ceases. Should a
new principal investigator desire to continue the study,
reapplication (see 11.0 below) to the IRB is required.
11.0 RENEWAL APPLICATIONS AND MODIFICATIONS OF
11.1 Renewal of approved protocols is required annually and is
also required if the principal investigator changes. If during the
course of any research, training, or demonstration a change in
plans is made so that human subjects are now to be used, or that
the research methods or techniques are significantly different, or
new hazards are evident, a statement of such change in plans must
be submitted to the IRB and an approval of modification of the
existing protocol must be obtained. In general, any change which
alters the risk/benefit balance or which modifies the informed
consent in some way requires approval.
11.2 Renewal Applications
Renewal applications require:
A. A copy of the current or new consent form.
B. A copy of the previously approved protocol.
C. A status report which provides a brief discussion of the work
accomplished to date, including particularly:
1. The number of subjects studied (and the number approached who
2. A discussion of the experience of the subjects undergoing
study, with particular reference to any adverse events occurring to
them during the conduct of the study. Note that if no adverse
events have occurred, it should be stated, rather than omitting
this item altogether.
3. A brief description of the scientific or research results, if
any, to date.
11.3 Modification Applications
A. Modification applications require:
1. A copy of the current or new consent form.
2. A copy of the previously approved protocol.
3. A description of any modifications to the current or previous
protocol which are desired. For these, the description and
justification should proceed much as outlined for a new
application; that is, the background or reason for modification,
benefits, risks, etc. When responsible positions are assumed by new
personnel in the execution of the protocol (such as change of the
principal investigator), a description of the background of the
individuals with regard to the work described in the protocol (as
in the original application) should be given.
B. Progress reports should not be photocopies of papers (either
published or submitted for publication). The papers primarily
inform their readership of scientific advances. It is necessary to
inform the IRB, in as concise a manner as possible, of the results
as they influence the balance of benefit to risk to human subject.
Published papers may be appended as evidence of benefits of the
12.0 UNANTICIPATED PROBLEMS
Any unanticipated problems involving risk to subjects or others,
including adverse reactions to biologicals, drugs, radioisotope
labeled drugs, or to medical devices must be reported immediately
to the IRB and to any federal agency sponsoring the project by the
researcher. Reports should include:
A. Identification of individual(s) involved.
B. Identification of principal investigator, title of project
and project number.
C. A description of adverse reactions and any possible
association with the experimental procedures, drugs, medical
D. Any relevant information on the subject (previous exposure to
drugs, therapy, case history, background information, etc).
13.0 VIOLATIONS OF THESE POLICIES AND PROCEDURES
13.1 Noncompliance with these policies and procedures is subject
to disciplinary action and possible litigation. Violations of these
policies and procedures should be reported to the IRB
13.2 The IRB will review allegations of these policies and
procedures, and will follow the policies and procedures as set
forth in the Lesley University Policy on Maintenance of Integrity
in Research, and other regulations governing faculty, staff, and
student ethical conduct as appropriate.
13.3 If any research which is federally funded is found to be in
violation of any of the federally-mandated portions of this policy,
or of appropriate federal regulations regarding the protection of
human subjects, the IRB shall report such to the University Provost
or designee, who in turn shall report same to the appropriate
agency on behalf of the researcher, if the researcher fails to
13.4 Violations will follow the disciplinary procedures outlined
in the most current collective bargaining contract and/or Title V
regulations, as appropriate.
14.0 ADVICE AND CONSULTATION TO RESEARCHERS AND
14.1 Researchers and departments may call the IRB for
informational consultation. This panel will consist of current and
previous members of the IRB in addition to other individuals
approved by the IRB.
14.2 Any consultation extended is informational in nature; it is
neither interpretative nor decisional as these are the prerogatives
of the IRB in its review function.
In the event that issues related to the use of human subjects in
research at Lesley University are not covered by this policy, the
IRB will rely on the Uniform Federal Policy for the Protection
of Human Subjects.
16.1 This policy shall be amended when necessary by two-thirds
vote of the membership of the IRB.
16.2 Should major revision of this policy become necessary, the
Academic Deans and the All College Committee will be consulted to
provide advice to the Provost/Vice President for Academic
16.3 The final authority for amendment of these policies and
procedures and for the adoption of a new revision rests with the
17.0 MEMBERSHIP AND APPOINTMENT OF IRB
A. The IRB shall be comprised of no fewer than seven
B. The membership of the IRB shall include:
1. Associate Provost who serves as Director.
2. At least one faculty member from each college or school of
the University, chosen to assure representation by both scientific
and nonscientific personnel.
3. At least one person qualified to assess each of the following
risks: physical (medical), psychological, social.
4. At least one person qualified to assess the validity of
experimental design so the benefits of the research may be
5. At least one member from the community at large not otherwise
affiliated with Lesley University.
6. Additional members as necessary to provide special expertise
for adequate attention to the risks of certain research subject
C. Membership shall include a balanced representation of
ethnicity and gender.
D. New members will be selected by the Chair of the IRB in
consultation with past and present members of the IRB, university
or school deans and appropriate vice presidents. Members shall be
appointed by the University Provost or designee to serve
overlapping five-year terms.
E. The All College Committee will be informed of any changes in
18.1 Certification (Uniform Federal Policy definition)
Certification means the official notification by the institution
to the supporting department or agency, in accordance with the
requirements of this policy, that research project of activity
involving human subjects has been reviewed and approved by an IRB
in accordance with an approved assurance.
18.2 Cooperative Research (Uniform Federal Policy
Cooperative research projects are those projects covered by this
policy that involve more than one institution. In the conduct of
cooperative research projects, each institution is responsible for
safeguarding the rights and welfare of human subjects and for
complying with this policy. With the approval of the department or
agency head, an institution participating in a cooperative project
may enter into a joint review arrangement, rely upon the review of
another qualified IRB, or make similar arrangements for avoiding
duplication of effort.
18.3 Human Subject (Uniform Federal Policy definition)
Human subject means a living individual about whom an
investigator (whether professional or student) conducting research
A. Data through intervention or interaction with the individual;
B. Identifiable private personal information.
18.4 IRB (Uniform Federal Policy definition)
IRB means an institutional review board established in
accordance with and for the purposes expressed in this
18.5 IRB Approval (Uniform Federal Policy definition)
IRB approval means the determination of the IRB that the
research has been reviewed and may be conducted at an institution
within the constraints set forth by the IRB and by other
institutional and federal requirements.
18.6 Minimal Risk (Uniform Federal Policy definition)
Minimal risk means that the probability and magnitude of harm or
discomfort anticipated in the research are not greater in and of
themselves than those ordinarily encountered in daily life or
during the performance of routine physical or psychological
examinations or tests.
18.7 Physical Risk
Physical risks include any potential for physical injury or
deleterious effects to subject's health, either short term or long
18.8 Psychological Risk
Psychological risk refers to the impact of research that
interrupts the normal activity of human subjects resulting in
immediate and/or long-term stress that would not otherwise be
experienced by the individual.
A. Stress involves any situation that poses a threat to desired
goals or homeostatic organismic conditions and thus places strong
adaptive demands on the individual.
B. Stress can be experienced during the actual experimental
situation (immediate) and/or as a result of participation in the
experiment (long term).
C. Some examples of situations that may result in stress
1. Undue coercion
2. Exposure to noxious events
3. Request or demand for behaviors that are discrepant with
individuals, values, morals, and/or ethics.
4. The requirement of excess physical effort.
18.9 Research (Uniform Federal Policy definition)
Research means a systematic investigation, including research
development, testing and evaluation, designed to develop or
contribute to generalizable knowledge. Activities which meet this
definition constitute research for purposes of this policy, whether
or not they are conducted or supported under a program that is
considered research for other purposes. For example, some
demonstration and service programs may include research
18.10 Social Risk to Groups
Social risk to groups is the extent to which a subject formal or
informal group, as a collective, is exposed to loss with respect to
factors affecting the viability and vitality of the group. Such
loss includes (but is not limited to) derogatory labeling, overt
hostile reactions from the social environment, reduced access to
resources, diminished ability to recruit and retrain members,
negative effects on morale and other aspects of internal cohesion
and organization, violation of legally required procedures or risk
of damage claims through civil action where there is corporate
liability, reduced opportunities for communication, distortion of
group activities relative to established group purposes and
18.11 Social Risk to Individuals
Social risk to individuals is the extent to which an individual
subject is exposed to deprivation with respect to desired
relationships with and within both formal and informal social
groups, or normal opportunities for such relationships. Such
deprivations include (but are not limited to) derogatory labeling,
overt hostile reactions by others, diminished access to otherwise
available roles, negative effects on social standing or mobility,
reduced opportunity for communication, lost or endangered
membership in such groups.
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