STONEHILL
C O L L E G E
Stonehill College
Institutional Review Board
for Research Involving Human Participants
I. Institutional
Review and Approval
VI. Expedited
Review Categories
IX. RESPONSIBILITIES
OF INVESTIGATORS
I. Institutional Review and Approval
Procedures
for the Stonehill College Institutional Review Board (IRB) on research
involving human participants are meant to safeguard the rights and welfare of
human participants in all research under the College’s sponsorship. The College
seeks to comply with all federal regulations requiring the establishment and
operation of such a board.[1]
Forms of research involving human
participants, as defined in this document and conducted at Stonehill College or
under its sponsorship at another location, must be reviewed and approved by the
College’s IRB.
Research that the IRB approved may
be subject to further review and approval or disapproval by College officials.
However, those officials may not approve research if the IRB has not approved
it.
The ultimate responsibility
for treatment of human research participants rests with the researcher and with
Stonehill College. The Stonehill College IRB exists as a safeguard to promote
ethical and responsible treatment of participants in research. Stonehill
College and federal policies require that each project involving studies with
human participants be reviewed to consider:
a.
The
rights and welfare of the participants involved,
b.
The
appropriate guidelines for the selection of human participants,
c.
The
appropriateness of methods used to secure informed consent,
d.
The
review of the research at timely intervals, and
e. The balance of risks and potential benefits of the investigation.
II. IRB Administration
Membership: The IRB is appointed by the
Academic Vice President. IRB members are ordinarily appointed for a three-year
term and may be reappointed. There are at least seven members of the IRB with
various backgrounds and fields of expertise, including at least one
representative from outside of the College. Appointment of members to the IRB
will be made to ensure, where possible, a variety of professional and academic
disciplines.
If the IRB reviews research that involves a vulnerable category of participants, such as children, prisoners, pregnant women, or mentally disabled persons, it will consider including one or more people who are knowledgeable about and experienced in working with these persons. These invited members do not vote.
The IRB may invite people competent in special areas
to assist them in their review of issues that require expertise beyond or in
addition to that available on the IRB. These invited members do not vote.
Meetings: The IRB meets once a month
in formal session during the academic year. The times of these monthly meetings
are announced.
Who must submit a proposal
for review:
The IRB reviews research proposals sponsored by members of the faculty, staff,
or administration of Stonehill College. When individuals from an institution
other than Stonehill College wish to conduct research on its campus, a faculty
member of the College must sponsor the application to the IRB.
Student research: Stonehill College students
are bound by the same IRB policies and procedures as the faculty and staff. The
IRB will not review any student-submitted application unless the application is
sponsored by a faculty or staff member familiar with the student and the
proposed research. Policies included later in this document specify which
student research is exempt from IRB review.
Deadline for submission of
applications:
Applications must be submitted at least 10 calendar days before an IRB meeting.
Late applications will be deferred until the next meeting. Individuals who in
some cases cannot meet this deadline should contact the chairperson of the IRB.
III. Definitions
Activities
within the scope of the IRB's responsibilities include research, development,
and related activities, which would normally be construed as biomedical or
behavioral investigations involving human participants. Included are studies
involving not only adults and children, but also investigations of prenatal
life and the deceased. Studies or procedures utilizing organs, tissues, or
bodily fluids of a human being are also included, as are the use of graphic,
written, or recorded information about individuals even when other institutions
or investigators have collected this information.
For the purposes of IRB review,
Stonehill College stipulates the following definitions:
Research: Any systematic
investigation, including research, development, testing and evaluation,
designed to develop or contribute to the well-being of participants and to
general knowledge. Activities that meet this definition constitute
"research" for the IRB, whether or not they are considered research
in other contexts.
Excluded from this definition are
activities whose sole purpose is instructional; also excluded are activities
whose purpose is related to routine course or program development. However,
when such research involves students outside of the course, the investigator
should apply for exemption or IRB approval.
This definition applies to:
a.
Persons
or programs requesting extramural (federal, state, or private) funds for
research or training
b.
Faculty,
staff, and administration engaged in research as part of their professional
role within the College or as part of their job assignment
c.
Students
conducting research as part of an independent study or the Honors Program
d. Individuals from outside the College conducting
research at Stonehill College.
Minimal risk: The probability of 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. Investigators must request a
clarification from the IRB regarding activities or procedures that are seen by
the investigator as questionable in terms of their inclusion in this
description.
Children: Children are "persons
who have not attained the legal age for consent to treatments or procedures
involved in the research, under the applicable law of the jurisdiction in which
the research will be conducted." 45 CFR
46.402(a).
IRB approval: Means that the IRB has reviewed the research and that the research will be conducted within the policies and procedures outlined in this booklet and within the constraints of other institutional and federal requirements. IRB approval does not necessarily include approbation of the research itself.
IV. Types
of IRB Review
In
conformity with Federal Regulations and Stonehill policy, there are three separate avenues for review of research involving
human participants. All three types use the same application form with the
appropriate boxed checked off.
Full IRB
Review:
Research involving more than minimal risk to the participant requires review by
the full IRB using risk/benefit analysis. Research using children or vulnerable
populations requires review by the full IRB.
Expedited
Review:
Research involving no more than minimal risk and in which the only involvement
of participants will be in one or more of the categories defined by Federal
Policy 46.110 requires review by the chair and selected members of the IRB. See
below for eligibility criteria.
Exempt Review: Research of minimal or no
risk as defined by Federal Policy 46.101b requires review by the IRB chair
only. See pages below for eligibility
criteria.
The following types of activities are not intended to fall under IRB review: Non-intrusive observation of participants in public settings; data-gathering from class members solely for classroom purposes; and needs assessment or evaluation data intended to remain within the Stonehill College community.
For informed consent, see
below.
The final determination of
level for review is made by the Chair of the IRB in conjunction with the
IRB. Allow at least ten days for
review. No research may be
initiated prior to formal written approval from the IRB.
V. Exempt
Review Categories
The
following categories are exempt from full IRB review, but must be reviewed by
the chair of the IRB (Federal Policy 46.101b):
1. Instructional strategies in educational settings: Research conducted in
established or commonly accepted educational settings are exempt from full IRB
review if they involve normal educational practices such as:
a.
research
on regular and special educational instructional strategies, or
b.
research
on the effectiveness of, or the comparison among, instructional techniques,
curricula, or classroom management methods.
This
category may be applied to research involving children. All other research on children requires full
review.
2. Surveys/interviews;
standardized educational tests; observation of public behavior: Research
involving the use of educational tests (cognitive, diagnostic, aptitude,
achievement), survey procedures, interview procedures or observation of public
behavior, are exempt from full IRB review if:
a.
Information
obtained is recorded in such a manner that human participants cannot be
identified, directly or through identifiers linked to the participants, and
b.
disclosure
of the human participants’ responses outside the research could not reasonably
place the participants at risk of criminal or civil liability or be damaging to
the participant’s financial standing, employability, or reputation, or
c.
needs
assessment or evaluation data intended to remain within the Stonehill community
and not circulated on the website, in written documents, or in public
presentations.
Surveys or interviews on sensitive
or personal topics which may cause stress to study participants are not exempt
from IRB review.
Surveys or interviews with children
are not exempt.
3. Public officials;
surveys/interviews; educational tests; observation of public behavior: Research involving the use
of educational tests (cognitive, diagnostic, aptitude achievement), survey
procedures, interview procedures, or observation of public behavior if:
a.
the
human participants are elected officials or candidates for public office; 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.
4. Existing data; records
reviews; pathological specimens: Research involving the collection or study of
existing data, documents, records, and pathological specimens are exempt from
full IRB review, if these sources are publicly available or if the information
is recorded in such a manner that participants cannot be identified directly or
through identifiers linked to the participants.
Records considered private based on federal and state
statute, including medical records and education records, require written
release by the study participant or by the custodian of the record. Researchers are cautioned that review of
private records involving access to and/or recording of identifiable
information is not exempt from IRB review and requires written consent of the
study participant. Existing public
records do not require prior consent of participants to review the records.
Pathological or diagnostic specimens
which are considered waste and are destined to be destroyed can be used in
research and are considered exempt from IRB review if there are no patient
identifiers linked to the specimen and if the data is not intended to be used
in the diagnosis or treatment of a patient.
(If either of these conditions apply, consent of the research
participant is required and a higher level of IRB review is required.)
Specimens retrieved as extra during a clinical procedure require review at a
higher level and require written consent from the participant.
Inclusion of fetal tissue in the
pathological specimens category of exempt research is prohibited by regulation.
5. Public service programs;
demonstration projects: Research and demonstration projects are exempt from full IRB review if
they are conducted by, or participant to, the approval of department or agency
heads, and which are designed to study, evaluate or otherwise examine:
a)
public
benefit or service programs;
b)
procedures
for obtaining benefits or services under those programs;
c)
possible
changes in, or alternatives to, those programs or procedures; or
d)
possible
changes in the methods or levels of payment for benefits or services under
those programs.
6. Taste testing and food
quality evaluation: Taste and food quality evaluation and consumer acceptance studies:
a.
if
wholesome foods without additives are consumed (all food tested must be GRAS,
or Generally Recognized As Safe); or
b.
if
a food is consumed that contains a food ingredient at or below the level and
for a use found to be safe, or agricultural, chemical or environmental
contaminant at or below the level found to be safe, by the Food and Drug
Administration or approved by the Environmental Protection Agency or the Food
Safety Inspection Service or the U.S. Department of Agriculture.
This category may be applied
to research involving children; however, written parental consent to include
children in taste testing studies is required.
VI. Expedited
Review Categories
Research
in the following (minimal risk) categories are eligible for approval on the
basis of a review by the IRB Chair and selected IRB members (Federal Policy
46.110).
Applicability: Research activities that
present no more than minimal risk to human participants, and involve only
procedures listed in one or more of the following categories, may be reviewed
by the IRB through the expedited review procedure authorized by 45 CFR 46.110
and 21 CFR 56.110. The activities listed should not be deemed to be of minimal
risk simply because they are included on this list. Inclusion on this list
merely means that the activity is eligible for review through the expedited
review procedure when the specific circumstances of the proposed research
involve no more than minimal risk to human participants.
The categories in this list apply regardless of the age of
participants, except as noted.
The expedited review procedure may not be used where identification of
the participants and/or their responses would reasonably place them at risk of
criminal or civil liability or be damaging to the participants’ financial standing,
employability, insurability, reputation, or be stigmatizing, unless reasonable
and appropriate protections will be implemented so that risks related to
invasion of privacy and breach of confidentiality are no greater than minimal.
The expedited review procedure may not be used for classified research
involving human participants.
The standard requirements for informed consent, or its waiver,
alteration, or exception, apply regardless of the type of review—expedited or
convened—utilized by the IRB.
Research categories one through
seven pertain to both initial and continuing IRB review.
1. Clinical studies of drugs and medical devices only when condition i) or ii) is met.
a.
Research
on drugs for which an investigational new drug application (21 CFR Part 312) is
not required. (Note: Research on marketed drugs that significantly increases
the risks or decreases the acceptability of the risks associated with the use
of the product is not eligible for expedited review.)
b.
Research
on medical devices for which an investigational device exemption application
(21 CFR Part 812) is not required; or the medical device is cleared/approved
for marketing and the medical device is being used in accordance with its cleared/approved
labeling.
2.Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
a.
from
healthy, nonpregnant adults who weigh at least 110 pounds. For these
participants, the amounts drawn may not exceed 550 ml in an 8 week period and
collection may not occur more frequently than 2 times per week; or
b.
from
other adults and children, considering the age, weight, and health of the
participants, the collection procedure, the amount of blood to be collected,
and the frequency with which it will be collected. For these participants, the
amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week
period and collection may not occur more frequently than 2 times per week.
3. Prospective collection of biological specimens for research purposes by noninvasive means.
Examples: i) hair and nail clippings in a
nondisfiguring manner; ii) deciduous teeth at time of exfoliation or if routine
patient care indicates a need for extraction; iii) permanent teeth if
routine patient care indicates a need for extraction; iv) excreta and external
secretions (including sweat); v) uncannulated saliva collected either in an
unstimulated fashion or stimulated by chewing gumbase or wax or by applying a
dilute citric solution to the tongue; vi) placenta removed at delivery;
vii) amniotic fluid obtained at the time of rupture of the membrane prior to or
during labor; viii) supra- and subgingival dental plaque and calculus, provided
the collection procedure is not more invasive than routine prophylactic scaling
of the teeth and the process is accomplished in accordance with accepted
prophylactic techniques; ix) mucosal and skin cells collected by buccal
scraping or swab, skin swab, or mouth washings; x) sputum collected after
saline mist nebulization.
4. Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications.)
Examples: i) physical sensors that are applied
either to the surface of the body or at a distance and do not involve input of
significant amounts of energy into the participant or an invasion of the
participant’s privacy; ii) weighing or testing sensory acuity;
iii) magnetic resonance imaging; iv) electrocardiography,
electroencephalography, thermography, detection of naturally occurring
radioactivity, electroretinography, ultrasound, diagnostic infrared imaging,
doppler blood flow, and echocardiography; v) moderate exercise, muscular
strength testing, body composition assessment, and flexibility testing where
appropriate given the age, weight, and health of the individual.
5. Research involving materials (data, documents,
records, or specimens) that have been collected, or will be collected solely
for nonresearch purposes (such as medical treatment or diagnosis). (NOTE: Some
research in this category may be exempt from the HHS regulations for the
protection of human participants. 45 CFR
46.101(b)(4). This listing refers only to research that is not exempt.)
6. Collection of data from voice, video, digital, or image recordings made for research purposes.
7. Research on individual or group characteristics
or behavior (including, but not limited to, research on perception, cognition,
motivation, identity, language, communication, cultural beliefs or practices,
and social behavior) or research employing survey, interview, oral history,
focus group, program evaluation, human factors evaluation, or quality assurance
methodologies. (NOTE: Some research in this category may be exempt from the HHS
regulations for the protection of human participants. 45 CFR
46.101(b)(2) and (b)(3). This listing refers only to research that is not
exempt.)
8. Continuing review of research previously approved by the convened IRB as follows:
a)
where
the research is permanently closed to the enrollment of new participants; all
participants have completed all research-related interventions; and the research remains active only for
long-term follow-up of participants; or
b)
where
no participants have been enrolled and no additional risks have been
identified; or
c) where the remaining research activities are limited to data analysis.
Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two through eight do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.
VII. Informed
Consent
In
most research, the investigator must obtain informed consent from each of the
participants; or, in the case of those not able to give informed consent (e.g.,
children, mentally challenged), informed consent must be obtained from their
guardians or legal representatives. A copy of the informed consent form should
be given to the person signing the form.
In clear and non technical language, participants
must be informed that:
1.
The
fact that the study is research.
2.
The
purpose of the research.
3.
The
expected duration of the participant's participation.
4.
The
procedures to be followed.
5.
Any
reasonably foreseeable risks or discomforts.
6.
Appropriate
alternative procedures or course of treatment, if any that might be
advantageous to the participant.
7.
The
extent, if any, to which confidentiality of data and privacy of participants
will be maintained.
8.
For
research involving more than minimal risk, whether any compensation and whether
any medical treatments are available if injury occurs.
9.
Whom
to contact for answers to pertinent questions about the research, subjects'
rights, and research related injury to the participant.
10.
The
fact that participation is voluntary and that the participant may withdraw his
or her consent at any time without penalty or loss of benefits.
There are two procedures, which may be used to obtain
informed consent:
1.
The
participant or a legal representative signs a written informed consent
document, which embodies the ten elements above.
2.
The
participant or a legal representative signs a document indicating that the
subject had the above representative sign a document indicating that the
participant had the above eleven elements explained to him/her orally and that
he/she understand this oral description and he/she agrees to participate in the
activity described.
In this case, however, an auditor witness to the oral presentation must be present. A written summary of the oral presentation must be submitted to and approved by the IRB. A copy of this presentation is to be retained by the IRB.
There may be cases in which the use of either of
these procedures for obtaining informed consent may be considered inappropriate
by the investigator because they would adversely affect the experimental design
or procurement of valid results. Accordingly, modifications to the above
informed consent procedures can be recommended to the IRB. However, all
modifications must be approved prior to implementation of the proposed
research. This approval must be recorded in the IRB’s minutes.
No such modification will be approved unless and
until the IRB determines:
1.
That
the risk to any human participant is, in fact, minimal, justifying a less full
disclosure in the informed consent procedures than would normally be required;
or,
2.
That
the use of either informed consent procedure would, in fact, invalidate
objectives of considerable immediate consequence, and that the use of any
reasonable alternative means for attaining these objectives would be less
advantageous to the participant.
VIII. REVIEW
AND APPROVAL
Specific
review and approval procedures of the IRB are as follows:
- Upon receipt of the
necessary number of copies of the research protocol, the Chairperson of
the IRB or checks to insure that the properly completed accompanying forms
are present and that the necessary description of the research is
provided. Copies are then distributed to members of the IRB.
- Upon request of the
IRB, the principal investigator may be asked to provide additional
information or to appear in person before the committee to present a full
explanation of risks and protection for the human participants. Any
investigator may ask to appear before the Board to describe the proposed
research.
- In cases where it is
deemed necessary by the Board, consultants to the IRB may be asked to
comment on a proposed research activity.
- A quorum for the IRB to
conduct business is a majority of the total membership. The IRB may not
have a member participate in the its initial or continuing review of any
project in which the member has a conflicting interest, except to provide
information requested by the IRB.
- The IRB will decide by
a majority of the members present:
a)
To
approve the proposal.
b)
To
approve the proposal with restrictions or conditions.
c) To defer the proposal, pending changes in the application or receipt of additional information from the investigator or consultants to the IRB.
d) To disapprove the proposal.
- Minutes are kept of all IRB meetings. Records will be retained by the IRB for a period of three years.
- The IRB chairperson
will inform the principal investigator of the decision of the Board.
a) If changes are recommended by the Board, the IRB chairperson or designated member will communicate these through the minutes to the investigator.
b)
The
IRB chairperson or designated member will be responsible for review and
approval of the investigator's submitted changes.
c)
If
the investigator deems it necessary to make further changes, these can be
submitted to the chairperson or designated IRB member for review and approval.
d)
If
there are changes in the study which the chairperson or designated board member
feels may change the level of risk to human participants, the investigator will
be requested in writing to submit the proposal to the full Board for further
review.
8. Adverse decisions may be appealed by re-review of the proposal. Appeals will be heard when the principal investigator has revised the proposal or provides additional information.
9. The IRB has the authority to suspend or terminate approval of research that is not being conducted in accordance with IRB requirements or that has been associated with unexpected harm to participants. A list of the reasons for any suspension or termination will be provided to the investigator and all appropriate department heads and deans.
IX. RESPONSIBILITIES
OF INVESTIGATORS
- Familiarize themselves
with these guidelines and to discuss with members of the IRB any questions
regarding proposed research activities.
- Submit either an
adequately prepared IRB form for each research project involving human
participants.
- Notify the IRB of any
physical, psychological, or social injury suffered by a research
participant because of his or her participation in a research activity.
- Make provisions to keep
records, documents, and informed consent forms normally for at least three
years following the completion of the project or activity, or for a longer
period as judged necessary.
- Take proper measures to
insure confidentiality and security of all information obtained from the
subjects.
- Retain adequate records
relating to IRB-approved research for a period of three years following
completion of the research.
X. REPORTING MISCONDUCT AND NON COMPLIANCE
Research
investigators are responsible for reporting to the IRB any instance of serious
or continuing non-compliance with the IRB policies and procedures or the
requirements or determinations of the IRB.