Section
1: Preface
1.1
Statement of Ethical Principles
Murray State University
(MSU) is committed to excellence in teaching, research, and public service
and to the conduct of these activities with the highest possible ethical
standards. For activities involving humans, Murray State
University is guided by
the ethical principles as set forth in the Declaration of Helsinki, and the
National Commission for the Protection of Human Subjects of Biomedical and
Behavioral Research entitled The Belmont
Report: Ethical Principles and Guidelines for the Protection
of Human Subjects of Research. In addition, the requirements set forth in
Title 45, Part 46 of the Code of Federal Regulations will be followed for all
applicable Department of Health and Human Services (DHHS) funded research
and, except for the requirements for reporting information to DHHS, for all
other activity without regard to source of funding.
1.2
Mission
The MSU Institutional
Review Board (IRB) reviews research protocol applications involving human
subjects in order to ensure the rights of subjects are protected, including
but not necessarily limited to ensuring that the research conforms to the Code
of Federal Regulations.
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Section
2: Murray
State University
Policy on Human Subjects
Safeguarding the rights
and welfare of humans in activities is a general institutional policy, with
oversight delegated by the President through the Provost to the Institutional
Review Board (IRB). Any research involving humans (including pilot studies)
which originates at Murray State or is conducted with the assistance of
personnel at Murray
State University
-- whether the investigator is a faculty member, staff member, student, or
administrator -- is subject to review and approval by the IRB.
Before the IRB will review any protocol, the principal investigator, and if
the PI is a student the faculty mentor, must submit certification of current
training in the protection of human subjects in research. This training
may be done through a web-based training module, through attendance at a
training session or in other ways approved by the IRB. (Researchers
should contact the IRB Coordinator for more information and for a current
list of approved training modules.) To submit an activity to the IRB, the
investigator must file a protocol, or a description of the procedure(s) to be
used to gather information from human participants. The IRB must approve the
protocol prior to the collection of any data or information from the
participants. In order to approve proposed protocols, the IRB shall determine
that all of the following requirements are satisfied:
A. Risks to humans are minimized by using
procedures which are consistent with sound research design and which do not
unnecessarily expose participants to risk, and whenever appropriate, by using
procedures already being performed on the participants for diagnostic or
treatment purposes.
B. Risks to humans are reasonable in relation
to anticipated benefits, if any, to participants, and the importance of the
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 activity (as distinguished from risks and benefits of
interventions participants would receive even if not participating in the
activity).
C. Selection of participants is equitable. In
making this assessment the IRB shall take into account the purposes of the
activity and the setting in which the activity will be conducted.
D. Informed consent will be sought from each
prospective participant or the participant’s legally authorized
representative, in accordance with, and to the extent required by 45 CFR 46.116.
E. Informed consent will be appropriately
documented, in accordance with, and to the extent required by 45 CFR 46.117.
F. Where appropriate, the activity plan
makes adequate provisions for monitoring the information collected to ensure
safety of participants.
G. Where appropriate, there are adequate
provisions to protect the privacy of humans and to maintain the
confidentiality of data. Where some or all of the participants are likely to
be vulnerable to coercion or undue influence, such as persons with acute or
severe physical or mental illness, or persons who are economically or
educationally disadvantaged, appropriate additional safeguards will be
included in the study to protect the rights and welfare of these
participants.
Principles
that assist the IRB in protecting the rights and welfare of humans include
the following existing codes:
1. The Declaration of Helsinki;
recommendations guiding physicians in clinical research adopted by the World
Health Organization, 1964 (5th revision adopted October, 2000).
2. Ethical Principles in the
Conduct of Research with Human Participants; adopted by the American
Psychological Association, 1973 (current version revised 2003).
3. 45 CFR 46, Code of Federal Regulations for the
Protection of Human Research Subjects, Final Regulations for the Protection
of Human Research Subjects
(Revised June 23, 2005 as the Federal Policy for the Protection of Human
Subjects).
4. The Belmont Report: Ethical Principles and Guidelines
for the Protection of Human Subjects of Research (April
18, 1979)
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Section 3: Definitions
Assent: agreement by an individual not competent to give
legally valid informed consent (e.g. a child or cognitively impaired person)
to participate in research.
Children: persons who have not attained the legal age for
consent to treatments or procedures involved in research, under the
applicable law of the jurisdiction in which the research will be
conducted. In Kentucky,
the legal age is 18.
Faculty
Mentor: for
research conducted by students, the Murray State University faculty member
who instructs the student investigator on appropriate research methodology,
who ensures that the student investigator has the knowledge and skills
necessary to complete the research, who commits to assisting the student
investigator with development of the research protocol, and who accepts
responsibility for the conduct of the activity, the supervision of
participants, and the maintenance of informed consent documentation as
required by the IRB. The faculty mentor must certify that the
student(s) will conduct the study in an ethical manner that complies with all
relevant MSU policies and procedures.
IRB
or Institutional Review Board: the IRB is an
administrative body within Murray State University, established by
appointment from the Provost of the University, to protect the rights and
welfare of human participants in research who are recruited to participate in
research activities conducted under the auspices of Murray State University.
IRB
Approval: 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, the institution, and federal requirements.
Human
Research: any systematic investigation using humans,
including research development, testing, and evaluation, designed to develop
or contribute to generalizable knowledge (45 CFR
46.102(d)). All classroom activities that involve human subjects and
that may be published, disseminated, or presented beyond the class must come
before the IRB. The terms research
and activity are used interchangeably
in these guidelines.
Human
Participants: living individual(s) about whom an investigator
conducting research obtains (1) data through intervention or interaction with
the individual, or (2) identifiable private information (45 CFR 46.102(f)).
Informed
Consent: a person’s voluntary agreement, based upon
adequate knowledge and understanding of relevant information, to participate
in research or to undergo a diagnostic, therapeutic, or preventive procedure.
In giving informed consent, subjects may not waive or appear to waive any of
their legal rights, or release or appear to release the investigator, the
sponsor, the institution or agents thereof from liability for negligence (45
CFR 46.116; 21 CFR 50.20 and 50.25).
Minimal
Risk: 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.
Permission: the agreement of parent(s) or guardian(s) to the
participation of their child or ward in research.
Principal
Investigator: the lead researcher,
suitably qualified by education, training and experience to direct a
particular well-defined protocol; the person who takes direct responsibility
for the design of and completion of a research project. The Principal
Investigator (PI) is directly accountable for protecting the dignity, rights,
safety and well being of the research subjects and for ensuring the collection
of high quality, accurate data that is obtained in accordance with IRB
approval and university procedures and guidelines. The PI may enlist
the assistance of other qualified personnel to help with data collection but
s/he is ultimately responsible for the conduct of the research project.
Prisoner: any individual involuntarily confined or detained
in a penal institution.
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Section
4: IRB Structure
The IRB consists of a
minimum of five members with varying backgrounds to promote
complete and adequate review of research activities commonly conducted by the
institution. All appointments to the
IRB shall be in accordance with 45 CFR 46.107 and same is incorporated here
in as if copied word for word.
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Section
5: Time Needed For Review
The full IRB meets monthly
during the academic year. Meeting dates for each semester are available at
the beginning of each semester from the Office of Sponsored Programs. IRB
applications (new or updated) for the full board (Level 3 review) must be
submitted for review by the published due date prior to the scheduled board
meeting for consideration by the Full Board Review process. The IRB’s disposition of the application is forwarded to the
applicant within 1 to 2 weeks of the IRB meeting. Any required revisions must
be submitted and approved by the IRB. The initial review will determine
whether revisions need to go to the full Board or whether they may be
reviewed by a subcommittee.
New or continuing projects
considered under the Level 1 or 2 categories will be considered as they are
received. Level 1 and 2 projects generally require 1-2 weeks for review and
notification from the date of receipt. Any required revisions must be
submitted and approved and are generally acted upon within 1 to 2 weeks.
The IRB cannot and will not review protocols for projects that are
already in progress or that have been completed.
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Section
6: Types of IRB Review and Approval
It is the policy of Murray State University
that the IRB will utilize Department of Health and Human Services (DHHS)
criteria for all activities involving humans. According to DHHS, research can
be categorized into three types of activities, and there are three types of
review. The Murray State University IRB has affirmed the letter and spirit of
the DHHS criteria by requiring that review of research from the DHHS Level 1
category be handled by the IRB Coordinator or the IRB Chair. For this level
of review, the research must belong to one or more of the activities defined
under Section 6.1 below. For activities to be
considered for Level 2 review, the research must
belong to one or more of the activities defined under Section
6.2 below or be a minor change to a previously approved protocol. Minor change is defined as a change
that does not increase or alter the risks to the subject as determined during
the initial approval process. An example would be a change to a data
collection tool or the addition of a data collection process in which no
additional procedures are required of the participant and the level of risk
is not increased. Level 2 research is reviewed by a subcommittee of the IRB.
Research that does not fall within the scope of the Level 1 or Level 2
categories must be reviewed by the full Board as a Level 3 study. The
investigator is responsible for identifying the category s/he feels is
appropriate. The IRB must concur with that selection. It is the researcher’s
responsibility to contact the IRB Coordinator if help is needed in making
this determination. Final determination of the correct category for a
research activity will be made by the IRB.
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6.1 Activities Considered under the Level 1 Category
Activities involving no
more than minimal risk to participants and in which the only involvement
of humans will be in one or more of the following categories will be reviewed
by the IRB as Level 1 application. This category does not apply
to research involving prisoners, fetuses, pregnant women, or human in vitro
fertilization. In order to establish an individual activity as Level
1, the principal investigator must complete the Application
for Approval of Investigations Involving Human Participants.
Final determination of the correct category for a research activity will be
made by the IRB.
The following six categories of activities are to
be considered within the Level 1 review category process. The investigator
must select one of the following activities that fits
his/her research and submit an application for Level 1 approval to the IRB
for review.
1. Activities conducted in established
or commonly accepted educational settings, involving normal educational
practices, such as research on regular and special education instructional
strategies, or research on the effectiveness of or the comparison among
instructional techniques, curricula, or classroom management methods.
2. Activities involving the use of
educational tests (cognitive, diagnostic, aptitude, or achievement), survey
or interview procedures, or observation of public behavior unless:
a. information obtained is recorded in
such a manner that the human participants can be identified, directly or
through identifiers linked to the participant; and
b. any disclosure of the participant’s
responses, if they became known outside the endeavor, could reasonably place
a participant at risk of criminal or civil liability or be damaging to the
participant’s financial standing, employability, or reputation.
Research
in Category 2 that involves children cannot be considered Level 1 unless
such studies involve (a) educational tests (research with children that
involves educational tests is Level 1), or (b) observation of public
behavior when the investigator does not participate in the activities being
observed.
3. Activities involving the use of
educational tests (cognitive, diagnostic, aptitude, or achievement), survey
or interview procedures, or observation of public behavior that is not exempt
under Category 2 of this section if:
a. the participants are elected or
appointed by public 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. Activities involving the collection
or study of existing data, documents, records, pathological specimens, or
diagnostic specimens, if these sources are publicly available or if the
information is recorded by the investigator in such a manner that
participants cannot be identified, directly or through identifiers linked to
the participants.
5. Research and demonstration projects
which are conducted by or subject to the approval of Federal 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 methods or levels of
payment for benefits or services under those programs.
6.
Taste and food quality evaluation and
consumer acceptance studies, (a) if wholesome foods without additives are
consumed 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 of
the Food Safety and Inspection Service of the U.S. Department of Agriculture.
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6.2
Activities
Considered under the Level 2 Category
Activities involving no
more than minimal risk to participants and in which the only
involvement of humans will be in one or more of the following categories,
will be reviewed by the IRB as a Level 2 application. In order to
establish an individual activity as Level 2, the principal investigator must
complete the Application
for Approval of Investigations Involving Human Participants.
Final determination of the correct category for a research activity will be
made by the IRB.
The following nine categories of activities are to be considered
within the Level 2 review category process. The investigator must
select one of the following activities that fits
his/her research and submit an application for Level 2 approval to the IRB
for review.
1.
Clinical studies of drugs and medical
devices only when condition (a) or (b) 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 level 2 review), or
b.
Research on medical devices for which
(i) an investigational device exemption application
(21
CFR Part 812) is not required; or (ii) 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 subjects, 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 subjects, the collection
procedure, the amount of blood to be collected, and the frequency with which
it will be collected. For these subjects, 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: (a) Hair and nail
clippings in a nondisfiguring manner; (b) deciduous
teeth at time of exfoliation or if routine patient care indicates a need for
extraction; (c) permanent teeth if routine patient care indicates a need for
extraction; (d) excreta and external secretions (including sweat); (e) uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric acid
solution to the tongue; (f) placenta removed at delivery; (g) amniotic fluid
obtained at the time of rupture of the membrane prior to or during labor; (h)
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; (i)
mucosal and skin cells collected by buccal scraping
or swab, skin swab, or mouth washings; (j) 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: (a) 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 subject or an invasion of the
subject’s privacy; (b) weighing or testing sensory acuity; (c) magnetic
resonance imaging; (d) electrocardiography, electroencephalography, thermography, detection of naturally occurring
radioactivity, electroretinography, ultrasound,
diagnostic infrared imaging, doppler blood flow,
and echocardiography; (e) 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).
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.
8.
Continuing review of research
previously approved by the convened IRB as follows:
a.
Where (i)
the research is permanently closed to the enrollment of new subjects; (ii)
all subjects have completed all research-related interventions; and (iii) the
research remains active only for long-term follow-up of subjects; or
b.
Where no subjects have been enrolled
and no additional risks have been identified; or
c.
Where the remaining research activities
are limited to data analysis.
9.
Continuing review of research, not
conducted under an investigational new drug application or investigational
device exemption where categories one (1) through eight (8) under Level
2 review 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.
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6.3
Activities Considered under the Level 3 Category
Any research or training
project involving the use of humans which does not fall into the Level 1 or
Level 2 Review categories must be submitted to the IRB for a Level 3,Full Board evaluation. For new activities, the principal
investigator must complete and submit the Application
for Approval of Investigations Involving Human Participants.
For continuing activities, investigators should use the Project
Update and Closure Form.
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6.4 Continuing Activities
Level 1, 2, and 3 activities
may only be approved for a maximum of a twelve-month period. Any such
activities that continue beyond the approval period must be submitted to the
IRB for continuing review. Federal regulations (45 CFR 46) require this
review to occur on or before the approval end date of the previous IRB
review. All activities that were submitted for IRB review, whether Level
1, 2 or 3, must be reported on at least annually to the IRB until the
research is completed. The IRB may require that a protocol be reviewed more
often than annually if, for example, it determines that the research involves
more than minimal risk or if there is concern that initial results of the
research may change the risk/benefit analysis (45 CFR 46.103(b)(4)(ii)). Each
year (or more frequently if required by the IRB) for the duration of the
project, a Project
Update and Closure form must be submitted to and processed by
the IRB no later than the anniversary of the latest approval date. The Project Update and Closure Form must be
processed in sufficient time for review and approval to occur. If
ongoing research is not approved for continuation by the end of the approval
period, then all data
collection and subject recruitment must immediately stop and the entire
protocol will need to be submitted as a new application for review. Failure
to submit the Project Update and Closure
Form within the stated time frame will result in the closure of
the study due to noncompliance and the MSU IRB will no longer accept
responsibility for oversight of the research. Refer to Section
8 for additional
information on continuing review of projects.
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6.5 Project Closure
When the research study has been completed, the Project
Update and Closure form must be submitted to the IRB
Coordinator. Failure to do so will result in the closure of the study
due to noncompliance and the MSU IRB will no longer accept responsibility for
oversight of the research. The Project
Update and Closure Form is due for review by the IRB by the
closing date stated in the most recent approval letter.
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6.6 Special Regulations
Special regulations apply to activities involving fetuses, pregnant
women, human in vitro
fertilization, prisoners, and children. Any activities involving these
populations may have specific regulations governing their conduct.
Investigators should refer to the specific federal regulations (45 CFR 46
Subparts B, C, D) or contact the MSU IRB Coordinator.
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6.7 Changes to Proposed Research
No changes may be made to an approved protocol
without the prior
approval of the IRB except when the
change is necessary to eliminate immediate hazards to the participants (45
CFR 46.103(b)(4)(ii)). If changes are required,
the researcher must submit an Application
for an Amendment to a Previously Approved Protocol form to the IRB
and the change must be approved at the appropriate level before it may be
implemented. Minor changes to a previously approved Level 3 protocol may be
reviewed by the IRB subcommittee. Minor
change is defined as a change that does not increase or alter the
risks to the subjects as determined during the initial approval process. An
example would be a change to a data collection tool or the addition of a data
collection process in which no additional procedures are required of the
participant and the level of risk is not increased. In the case where change
is necessary to eliminate immediate hazards to the participants, the
researcher must notify the IRB immediately and submit the Application for
an Amendment to a Previously Approved Protocol form within 3
calendar days of the change. The IRB will then review the change and
make a decision on whether to allow the project to continue and whether
further changes to the protocol are required to protect the rights and
welfare of the subjects.
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Section 7: Initial IRB Review
Process
A. The principal investigator prepares the IRB
application packet (protocol form and all relevant attachments) according to
IRB guidelines and submits the following hard copies to the IRB Coordinator:
§
One original for Level 1 Review
§
One original and two copies for
Level 2 Review
§
One original and seven copies for
Level 3 Review.
The protocol form and all attachments must also be
submitted electronically to irb@murraystate.edu.
B. The complete application packet is
submitted to the IRB in the Office of Sponsored Programs by the published
date prior to a scheduled IRB meeting for a Level 3 Review or at any time
during the academic year when classes are in session for a Level 1 or 2
Review. NOTE: The IRB does not meet during the months of June and
July.
C. The application is logged in and receives
a unique identification number. The principal investigator (or faculty mentor if the PI is a
student) is notified of the number and receipt of IRB application.
D. A Technical Review is
conducted to determine that the IRB application is complete and contains all
required information and signatures as
set forth in the application form. Incomplete application packets will
be returned to the principal investigator with a memo stating deficiencies.
Once corrected, the application may be resubmitted for review and will be
reviewed under the schedule stated in Section 7.B.
E. Complete IRB applications will be reviewed
by the designated category on the application as follows:
1. Level 1 Review: the IRB Coordinator or IRB Chair
reviews the project and makes a decision on the application. The
decision by the IRB Coordinator or the IRB Chair to decline a Level 1
protocol must be reviewed by the full Board. A summary of all projects
accepted for Level 1 review is recorded in the minutes of the IRB monthly
meeting.
2. Level 2
Review: an IRB subcommittee reviews the project and makes a decision on
the application. A list of all protocols is submitted to the full
Board. A summary of all projects accepted for Level 2 review is recorded in
the minutes of the IRB monthly meeting. The decision by the subcommittee to
decline a Level 2 protocol must be reviewed by the full Board.
3. Level 3 Review: All IRB members review the
application at the monthly IRB meeting. The principal investigator and/or the
faculty mentor (if the principal investigator is a student) will be asked to
be present to respond to IRB inquiries. In the case when IRB members
are sponsors for a student application or are themselves an applicant or
where there is a conflict of interest, those members may not vote on those
applications.
F.
The IRB disposition of the application is forwarded to the applicant by the
IRB Coordinator within one to two weeks following the IRB meeting. If
the applicant is a student, communication will be sent only to the faculty
mentor, who has the responsibility to transmit the IRB response to, and work
with, the student. The final disposition of the protocol will also be
reported to the University administration via the Provost’s office
representative who serves
as a non-voting ex officio member of the IRB. Review of all approved projects
involving humans will be required at least annually by the IRB.
A Project
Update and Closure Form must be submitted for IRB review by
no later than the anniversary of the approval date given in the latest
letter. Refer to Section 6.4 and Section 8 for a discussion of the continuing
review process. When
a project has been completed, the principal investigator must officially
notify the IRB that the project has been closed by submitting a completed Project
Update and Closure Form no later than the anniversary of
the approval date given in the latest letter. Refer to Section 6.5
for a discussion of
project closure.
G.
Appeal of IRB Determination: If a protocol has been approved pending or
if the vote on a protocol has been deferred, the Principal Investigator (PI) or faculty mentor if the PI is a
student may submit a written request for reconsideration to the IRB Coordinator.
The PI may also submit any additional information for review if
desired. The Coordinator shall submit the written request for review
along with additional information, if any, to the subcommittee which reviewed
the protocol originally or if the original protocol was last reviewed by the
full Board, to the full Board. If the subcommittee does not approve the
protocol upon reconsideration, the PI or faculty mentor if the PI is a
student may submit a written request for full Board review. In conjunction
with a full Board review, the Coordinator or PI or faculty mentor may also
submit a written request for a meeting between the full Board and the PI
and/or faculty mentor if it is believed that such will enhance the
approval process. The decision of the full Board will be final. Under
no circumstances will a subcommittee be asked to meet with the PI and/or faculty mentor as this
would be a breach of confidentiality for those members.
As required by Federal guidelines, there is no appeal
process for a declined protocol. The IRB’s
decision is final. The IRB will provide the investigator (or faculty
mentor if the PI is a student) with a statement setting forth the reasons
that the protocol was denied and providing the PI (or faculty mentor if the
PI is a student) an opportunity to respond in person or in writing. If
the PI chooses to do so, s/he may then make appropriate changes to the
protocol and resubmit the project as a new protocol for IRB review.
Under
no circumstances may any entity of the University allow a protocol to be
conducted when it has been declined by the IRB. However, the University
administration may decline to allow a protocol approved by the IRB to be
conducted if it is determined that this action is in the best interest of the
University.
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Section
8: Procedure for Continuing Review of Projects
All research that has been
approved by the IRB must be reviewed
at least annually regardless of whether the research was
classified as Level 1 or Level 2 (previously called “expedited” review) or
Level 3 (previously called “full” review). NOTE: The IRB may require
that a protocol be reviewed more often than annually if, for example, it
determines that the research involves more than minimal risk or if there is
concern that initial results of the research may change the risk/benefit
analysis.
If the approved research
activity or data analysis will continue beyond the end date as stated in the
most recent approval letter, an application for continuing review of the
project must be submitted to the IRB (using the Project
Update and Closure Form) at least one week before the
expiration date for Level 1 or Level 2 (previously called “expedited”)
protocols or by the deadline for the next full Board meeting before the expiration
date for Level 3 (previously called “full”) protocols. The principal
investigator should complete this application. If the investigator is a
student, the student’s faculty sponsor must approve the application.
The application for continuing review should be filled out on the IRB website
and then saved and printed. One signed paper copy of the form must be
submitted to the IRB for inclusion in the file and one electronic copy must
be submitted to the IRB for dispersal to the appropriate reviewers. A
paper copy of the latest approved consent form or cover letter, if required
for the research, must also be submitted for updating.
The IRB disposition of the
application for continuing review is forwarded to the applicant by the IRB
Coordinator within two weeks following the IRB meeting. If the
applicant is a student, communication will be sent only to the faculty
mentor, who has the responsibility to transmit the IRB response to, and work
with, the student. NOTE: If the research approval expires before
the application for Project Update and Closure is processed, the principal
investigator and/or the faculty sponsor must resubmit the entire protocol for
the review and approval process. Adverse events must be reported to
the IRB in writing immediately following any such occurrence; reporting of
such events cannot be delayed until application for continuing review. Continuing
review is handled in the same manner as the initial IRB review. Refer
to Section 7 for more information.
Failure to complete the
Project Update and Closure Form
in the stated time frame will result in the closure of the study due to
noncompliance and the MSU IRB will no longer accept any responsibility for
oversight of the research. All subject recruitment and data collection on the study
must stop immediately and cannot resume until the principal investigator has
completed and submitted to the IRB a new Application
for Approval of Investigations Involving Human Participants and
that application has been reviewed and approved.
The IRB may choose to
conduct targeted audits of studies to insure that no material changes have
occurred since previous IRB review (45 CFR 46.103(b)(4)(ii)).
In such cases, the IRB Coordinator will notify the Principal Investigator (or
the faculty mentor if the PI is a student), by official letter of the
upcoming audit and request that necessary records be made available for
review. A report of the audit findings will be presented to the IRB at the next full Board
meeting or sooner if deemed appropriate by the IRB Coordinator should the
audit indicate the need to take
immediate actions to address any issues that could affect the subjects’
informed choice to participate in the research.
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Section 9: Advertising for Human
Participants
Advertising for
prospective participants must receive prior approval of the IRB. Coercive
statements or grossly liberal compensation must be avoided and risks and
benefits must be mentioned.
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Section
10: Activities Involving Other Sites
Some research activities
collect data from other sites or in collaboration with other organizations.
In the instances when this occurs, the IRB must have a letter of approval
from the cooperating institution(s). The approval letter must include
the following items:
· The individual giving approval is the person
signing the letter and is in a position to authorize the commitments being
made in the letter.
· The letter must be on the cooperating institution's
letterhead or must give the name and address of the institution in the body
of the letter.
· Any expectations by the cooperating institution as
a result of the research must be itemized in the letter.
· An indication of the understanding of the uses of
the data collected, the data collection measures, and the handling of the
data must be evident.
The IRB expects the
permission letter to be included as part of the application. Research may
not begin at a site until the investigator places a copy of the site
permission letter on file with the IRB Coordinator.
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Section
11: Internet Research
Safeguarding the rights
and welfare of humans in activities is a general Institutional policy, with
oversight delegated by the President through the Provost to the Institutional
Review Board (IRB). Any research involving humans that originates at Murray State University
-- whether the investigator is a faculty member, staff member, student, or
administrator -- is subject to review and approval by the IRB. This
restriction applies to all activities that include the collection of data for
research purposes, even when this collection occurs via the Internet.
To submit an activity to the IRB, the investigator must use the Application
for Approval of Investigations Involving Human Participants
to file a protocol containing a description of the procedure(s) to be used to
gather information from human participants. The IRB must then approve the
protocol prior to the collection of any data or information from the
participants. In order to use the programs provided by the Center for
Teaching, Learning and Technology (CTLT) office which facilitate survey
research, an applicant must provide CTLT with an approval statement from the
IRB. Compliance with University regulations is a matter of professional
ethics.
The use of the Internet as
a medium for research continues to increase. While it provides many
advantages, it can also complicate the process of human subjects
protection. Research using electronic communication cannot be promoted
as anonymous, even if attempts are made to secure the transmission of
data. In addition to interception of data, there exists the possibility
of spyware that can track keystrokes on computers and/or electronic
surveillance of employee computer use. Please contact the IRB to
discuss how to best handle the process of informed consent for internet
research. In most cases, written documentation of informed consent can
be waived, but it should be recognized that no guarantees can be made
regarding the tracking or interception of subject responses by third parties.
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11.1 Required Statement for
Internet Research
All consent statements for
online survey research must include the following information:
All survey responses that the researcher receives will be treated
confidentially and stored on a [state how stored (e.g., secure server,
encrypted hard drive, encrypted file, unencrypted hard drive, etc.)].
However, given that the surveys can be completed from any computer (e.g.,
personal, work, school), we are unable to guarantee the security of the
computer on which you choose to enter your responses. As a participant
in this study, the researcher wants you to be aware that certain “keylogging” software programs exist that can be used to
track or capture data that you enter and/or websites that you visit.
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Section
12: Conflict of Interest
As a part of the informed
consent process, a researcher is ethically responsible for notifying the IRB
and potential research subjects of any possible conflict of interest.
Conflict of interest may occur where 1) the researcher has a personal
economic interest in the outcome of the study, 2) the researcher acts as an
officer or a director of any outside entity that has financial interests in
the outcome of the research study or 3) the researcher is recruiting potential
subjects from persons over whom the investigator holds significant influence
or power (i.e., students within the researcher’s own classroom, employees in
the researcher’s workplace where the researcher is in a position of
administration, etc.)
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Section
13: The Informed Consent Process
Every person (faculty,
staff, student, or administrator) at Murray State
University must obtain
the informed consent of any participant. Obtaining the informed consent of
participants is a matter of professional ethics in every discipline at the
University. A sample consent document is
included in these Procedures and Guidelines. The IRB strongly suggests that
investigators use the sample as the structure for their consent forms.
The investigator must
ensure that the circumstances under which consent is sought will provide the participants
(or their representative) with sufficient opportunity to consider whether or
not to participate. The circumstances must also minimize the possibility of
coercion or undue influence that might be experienced by the participants.
Many times the situation of the participants may be inherently coercive;
i.e., their freedom of choice may be restricted by the nature of their
employment, their age, associations with certain groups, or their mental or
physical capacities. Restriction of freedom of choice may also occur due to
confinement in a mental hospital or in a jail, penitentiary, or correctional
institution. Participants in any of these categories are not excluded;
rather, the investigator must make special efforts to ensure that potential
participants are given every opportunity to exercise free choices in
consenting to participate.
The consent document is
not meant to be merely a legal record of the consent process, nor is it meant
to be the only communication between the investigator and the prospective
participant. On the contrary, the document should be one part of the total
process. Broadly, the informed consent document communicates to the
prospective participant:
· purpose, procedures, risks and benefits of the
activity
· the participant’s rights in participating
· the freedom to decline to participate without any
jeopardy
· contact information should the participant have
questions about the conduct of the research pertaining to their rights as a
participant
If applicable, the
alternative treatments available will be explained. The individual will also
be given the opportunity to obtain further information and answers to
questions related to the study. The consent form should serve as a written
summary of the exact information that was presented to the prospective
participants before their agreement to participate in the study. As such, it
will provide a useful reference for both the subject and the
investigator. Participants agreeing to the study sign the consent
form. If the consent form is multiple pages, participants must initial
each page. Participants must be given a copy of the consent form to
keep. It is the responsibility of the researcher to ensure that informed
consent documents are written with vocabulary and a reading level
comprehensible to the researcher’s target population.
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13.1
Waivers to Obtaining Written Informed Consent
Under certain
circumstances, the use of written consent documents may be waived by the IRB.
Requests for waiver must be fully justified by the investigator when
submitting an application to the IRB. The IRB may waive the requirement
for the investigator to obtain a signed consent form for some or all of the
subjects if it finds either:
1. The only record linking the
participant and the activity would be the consent document and the principal
risk would be the potential harm resulting from a breach of confidentiality
2. The activity presents no more than
minimal risk of harm to participants and involves no procedures for which
written consent is normally required outside of the activity context. This
type of waiver applies especially to anonymous interviews (including
face-to-face and telephone interviews) wherein the investigator’s sole
knowledge of the identity of the interviewee would come from the consent
document (45 CFR 46.117(c)).
Waiver of written consent procedures does not imply
waiver of the investigator’s responsibility to obtain consent from the
participant. In all cases, the investigator must provide the participant with
a statement of the study that includes all relevant elements of informed
consent. It is the recommendation of the MSU IRB that, wherever practicable,
when written documentation of consent is waived, a cover letter be submitted
to participants which outlines the purpose and procedures of the project with
a statement such as “completion of the survey and/or return of the
questionnaire indicates consent to participate in the study.” A sample cover letter may be found at the end
of this document.
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13.2 Obtaining Oral Consent by Oral Presentation
If oral presentation is
necessary due to limited literacy or language comprehension, the participant
or his/her legal representative will be asked to sign a short form stating
that the basic consent form elements have been orally presented. Both the
short consent form and the oral presentation must be approved by the IRB. It
is the researcher’s responsibility to ensure that the language used in the
short consent form and the oral presentation is comprehensible to the target
population. A witness must also be present for this presentation and must
sign both the short form and a written summary of the oral presentation as
does the investigator. The participant or his/her legal representative must
be furnished with a copy of both signed documents.
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13.3
Alterations to the Informed Consent Process
1. The IRB may approve a procedure that
does not include or that alters some or all of the elements of, or dispenses
with, informed consent if the activity is to be conducted by or subject to the
approval of state or local government officials and is designed for the
purpose of studying, evaluating, or examining: a) federal, state, or local
benefit of service programs that are not themselves research programs, b)
procedures for obtaining benefits or services under these programs, c)
possible changes in or alternatives to these programs or procedures, or
d) possible changes in methods or levels of payment for benefits or services
under those programs; and e) if the research could not be
carried out practicably without the waiver or alteration (45 CFR 46.116(c)).
2.
The IRB may approve a procedure that
does not include or that alters some or all of the elements of, or dispenses
with, informed consent if: a) the activity involves no more than minimal risk
to the participants; b) the waiver or alteration of normal consent procedures
will not adversely affect the rights and welfare of the participants; c) the
activity could not practicably be carried out without the waiver or
alteration; and d) whenever appropriate, the participants will be provided
with additional pertinent information after participation (45 CFR 46.116(d)).
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13.4
Categories of Participants Receiving Informed Consent
Except as otherwise
determined by the IRB, every participant who is a physically and mentally
able adult must provide consent to participate in the activity prior to the
start of that activity. The ideas of mental and physical normalcy revolve
around the ability of the participant to provide truly informed and voluntary
consent. Variations from this norm may be a function of age or the
circumstances of the participant.
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13.4.1
Children
Obtaining permission to
conduct research involving children -- that is, persons under 18 years old --
requires special attention to the child’s age, his/her ability to understand
what is asked of him/her, and his/her relationship to parents or guardians.
In all cases, the investigator must demonstrate respect for the rights of the
subject within the proposed consent procedures, which should be
developmentally appropriate to the age and circumstances of the subject.
Unless waived by the IRB, if the participant is a minor then written
parental/guardian permission must first be obtained. A sample parental/guardian permission form is
found at the end of this document. For children with parental permission, an
assent form must be signed by those child participants capable of reading and
understanding a simplified version of the permission form signed by the
parent or guardian. The child's assent form must be separate from the
parental permission form. As part of the IRB protocol application, the
researcher must submit a copy of both the intended assent form and the
parental permission form. For those participants who are too young to read an
assent form, but who would be capable
of understanding an oral explanation of the procedures, a copy of the oral
explanation to be given must accompany the request for IRB approval, and be
signed by the individual responsible for the oral explanation. The age,
maturity, and psychological state of the participants must be taken into
account by the principal investigator when creating an assent form or an oral
presentation to obtain oral assent from such participants. Investigators
should carefully review 45 CFR 46.408 for additional specific requirements for
permission by parents or guardians and for assent by children. Sample child and adolescent assent forms are found at the end of this
document.
Parental Permission: Parental (or legal guardian) permission in
writing is required for all minors, under the age of
18, who participate in research activity.
Adolescent’s Written Assent: A child’s written assent is needed (in addition to parental permission)
when the child is considered old enough to read and comprehend a
well-constructed assent form. However, the investigator should use
supplementary verbal explanations wherever needed.
Child’s Assent: For children who can read but may not comprehend
an assent form, the investigator should provide an explanation in a form the
child can understand (in addition to parental permission). A conversational
question-and-answer setting is often necessary to achieve this goal. In
addition, the child’s assent should be positive, that is, not merely lacking
in dissent. If the child is old enough to render a signature, investigators
are required to obtain a signed assent form.
Very Young Children:
For children who cannot read (e.g., infants, toddlers, or preschoolers) the
investigator should give explanations that match the level of understanding.
In many instances, the children’s nonresistant behavior may be interpreted as
assent, but the investigator must use special care to discontinue the
participation of children who appear to experience undue stress from the
activities procedures. A verbal script must be submitted as part of the
protocol.
Wards of the State: Children
who are wards of the state may participate in activities only under very
limited circumstances with the appointment of an advocate for the child for
the duration of the activity.
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13.4.2 Vulnerable and Special
Populations
Besides children, numerous
other types of subjects require special attention when obtaining informed
consent. In all cases, the guiding principle is respect for the rights of the
potential participant. The Belmont
Report contains an important section on the application of its standards
to informed consent. Every investigator should carefully examine this
material.
Among the types of
participants for which the investigator should have special concern in
obtaining informed consent are the following:
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13.4.2.1
Prisoners
Obtaining the informed
consent of prisoners to participate in an activity requires attention to
their circumstances. The activity should not provide the prisoners with
advantages that would outweigh their ability to weigh the risks involved in
the activity. Moreover, the consent form should make it clear to prisoners
that participation will have no effect upon their parole or treatment. Investigators
proposing research that involves prisoners should allow additional time for the
review process in order that a prisoner representative can be included in the
IRB review (as required by 45 CFR 46.304).
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13.4.2.2
Cognitively Disabled
The use of patient
advocates appointed or approved by the IRB is necessary to guard patient
interests. For research involving adults who have been determined to have or
are suspected of having a limited capacity to provide informed consent (which
may include, but is not limited to, the elderly), a process for determining
the competency of the research subject will be required. For research
that meets the IRB standards for Level 1 or 2 review,
the IRB may allow competency to be determined by the researcher
through a series of question and answer discussions with the potential
research participant. However, for research that requires Level 3
review or for Level 1 or 2 research that the IRB determines involves a
population in which competency to consent is of particular concern (e.g.,
including but not limited to nursing home residents, Alzheimer’s patients,
elderly patients in a Veterans Administration hospital), and/or the nature of
the study is believed to be such as to indicate that an independent
investigation of competency is warranted, a qualified third party, such as a
speech pathologist, physician or psychologist who is not a member of the
research team, may be required to determine competency for informed consent.
It is the responsibility
of the researcher to determine if a potential participant has been declared legally
incompetent. If this has been done, permission to enroll the potential
participant in a research study must be sought from the legal guardian.
In cases where a potential
participant has not been declared legally incompetent but said person
displays signs of incompetency, consent/assent must be obtained from that
person (unless comatose or otherwise totally mentally incapacitated) and must
also be obtained from the person(s) who normally make decisions concerning
the care and well-being of the potential participant, such as next of kin,
health care surrogate, if applicable, or person with Power of Attorney for
such decisions. If after obtaining what was believed by the researcher
at the time to be informed consent from the participant, information gleaned
during the course of the research indicates an issue as to the individual’s
mental capacity such that informed consent is not obtainable from the
participant, the researcher must obtain consent from the person(s) who
normally make decisions concerning the care and well-being of the potential
participant, such as next of kin, health care surrogate, if applicable, or
person with Power of Attorney for such decisions.
If the potential
participant refuses his/her consent/assent, it is ethically unacceptable to
enroll this person in a research study regardless of the consent of a
care-giver, health care surrogate or person with Power of Attorney.
In any case wherein informed
consent has been obtained from one other than the potential participant, a
copy of the document indicating legal guardianship, Power of Attorney, health
care surrogate, or other such documentation granting authority to the
individual providing consent to make such decisions for the participant shall
be retained by the researcher and placed in the research file.
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13.4.2.3 Fetuses, pregnant women, and human
in vitro fertilization
Regulations require additional
safeguards for the conduct of activities involving fetuses, pregnant
women, and human in vitro fertilization. Among the recommendations are
systems for monitoring the acquisition of informed consent as well as other
aspects of the activity.
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Universities, and the
association of investigators with them, provide investigators with a ready
pool of research subjects: students. To protect students against coercion
when research is conducted in the classroom setting, the MSU IRB has
determined that there must be a defined break between when the class period
finishes and when the research begins. During the class time, the researcher
and/or faculty member may announce that the study will take place, give
potential subjects information about the study, including purpose and time commitment, and
answer any questions that the potential participants might have. However, the
research itself can only
be conducted at the end
of the class period. At the end of the class period, students must be given a
short break (for example, 2-5 minutes) to allow uninterested persons time to
leave. At the designated time, the researcher may return to the classroom to
administer the study to those students who have voluntarily chosen to
return/remain and to participate. (Please note: Faculty members may not
specifically recruit members of their own classes to participate in their
research projects unless special measures are taken to avoid coercion.
Someone other than the faculty member must obtain the informed consent of the
students if the faculty member intends to use his/her own students as
research subjects and/or the identity of those who choose not to participate
must be protected until such time as the teacher/student class relationship
has been completed. The person who will invite the students to participate in
the study must have certification of training in the protection of human
subjects in research on file in the IRB office and must be identified on the protocol approval form. In all cases, the IRB
will work with the researcher(s) to design a recruitment and informed consent
process that provides adequate protection for participants in human subjects
in research.)
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13.4.3 Other Groups
Other groups, such as the
elderly, the economically disadvantaged, the very sick, and the
institutionalized are described as vulnerable populations by the Belmont
Report and are therefore provided similar protection when used as
participants. (See Section 13.4.2 above.)
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13.5 Notable Risk Projects
When an activity involves
greater than minimal risk, the participant needs a reasonable enumeration of
the risks in order to decide whether or not to participate. The list should
not be constructed either to minimize real risks or to overstate them.
Projects with risks should also list protection measures used to lower the
risk potential or to ensure safety while the subject encounters the risks. If
a project presents one or more risks, an injury clause needs to be included
in the consent document.
Although the regulations
specifically mention only the preceding special categories of participants,
the overall intent is clear. Whenever the potential participants of research
have special features or circumstances that might alter their ability to
render informed and voluntary consent to participate in activities, the
investigator has special responsibilities. There is no way to anticipate
every situation. Therefore, investigators must use extreme care to respect
the rights of potential participants in developing the means of obtaining
their informed consent. The IRB may choose to conduct targeted audits of
studies to insure that no material changes have occurred since previous IRB
review (45 CFR 46.103(b)(4)(ii)). In such cases, the
IRB Coordinator will notify the researcher (or the faculty mentor if the
researcher is a student) by official letter of the upcoming audit and request
that necessary records be made available for review. A report of the audit
findings will be presented to the IRB at the next full Board meeting or sooner if deemed appropriate by
the IRB Coordinator should the audit indicate the need to take immediate
actions to address any issues that
could affect the subjects’ informed choice to participate in the research
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13.6
Audiotapes
Voice recordings
are considered identifiable information; therefore, an investigator cannot
promise anonymity to subjects participating in a project where they will be audiotaped. In addition to any signed consent documents,
it is also recommended that the audiotape record both verbal permission of the participant and information
advising the participant that his/her identity will be associated with the
information he/she provides. Oral history and ethnography provide good
examples of interview methods holding generally minimal risk but which also
may make use of audiotapes that will not be erased at the conclusion of the
immediate activity.
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13.7
Anonymous Questionnaires
Many types of survey
research use anonymous questionnaires returned by mail or placed in drop-box
locations. A participant is anonymous only if his/her identity remains
individually unknown to the investigator. Where the identity is known but
held secure from being known by others, the investigator is said to be maintaining
the confidentiality of the identity. With anonymous questionnaires, the
investigator may fulfill the requirements of informed consent by providing
the participant with a cover letter or set
of instructions that includes the following items, as applicable:
§
An explanation of the activity, its
purpose and duration of participation time.
§
A statement indicating anonymity.
§
Indication that the return of the
questionnaire will constitute the participant’s consent to participate.
§
A statement of voluntariness must be
included.
§
Contact information should the participant
have questions about the conduct of the research or their rights as a
participant.
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Section
14: Retaining and Storing Signed Informed Consent Documents and Data
Signed informed consent
forms are legal documents, and the researcher has legal responsibilities in
handling them. They should be stored in a secure location at Murray State University
that is accessible to the University in the event that an inquiry should
require an examination of them. The specific location (including room and
building) of the documents must be explained in the IRB application.
Data that can be linked to a subject should be treated in the same manner as
a signed informed consent form. Access to these documents should be
limited to those persons who have a need to know their contents, ordinarily
the investigator (and co-investigators), a representative of the IRB (usually
the Chair), the IRB Coordinator on behalf of the University, and authorized
federal officials. In compliance with federal regulations consent documents
must be retained for a period of three (3) years following the completion of
the research. It is required that any parental permission and assent forms
from minors are retained until one (1) year after the minor reaches legal
age.
Consent documents become
part of the IRB file of a project and, as such, are subject to Federal audit.
Therefore, the IRB will review carefully both the content of and the storage
provisions for all consent forms.
Data collected from
subjects that cannot be linked to a subject do not require the same secured
handling as those documents that contain identifying information or which could
be linked to a particular individual. This type of data is not required
to be stored in a locked location within Murray State
University, but the data shall be available for review
and certification at any time during the period that the identifying
information is held.
An investigator who leaves the University prior to the end of the
three-year retention period for consent forms should notify the IRB of this
fact, specifying the new location of the consent documents. If consent
documents are maintained by a graduate student or research assistant during
data collection, they must be turned over to the responsible faculty member
after data collection is completed. A change of location within the
University that results in a new storage place for consent forms must also be reported to the IRB.
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Section
15: Deceptive Research
Research activities that do
not fully disclose the purpose of the research to the subjects are those that
are said to be deceptive.
Any deceptive research should be carefully weighed in terms of the
justification for the need to deceive the subject and alternative methods for
conducting the research that do not involve deception. The IRB will
decide if the information being withheld from the subjects is an important
element in the subject’s decision to participate. If the IRB decides
that the information being withheld is an important element, then the
research will not be approved. At a minimum, subjects must be informed
in a consent form that full information is not being disclosed to them.
Any research involving deception must involve a full debriefing.
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Section 16: Requests for Student
Information: The Buckley Amendment (FERPA)
The Family Educational
Rights and Privacy Act (FERPA) more commonly known as the Buckley
Amendment, deals with primary rights of students. Basically, these
rights are 1) the students’ right to inspect and review educational records,
2) their right to seek to amend educational records and 3) their right to
have some control of the disclosure of information from educational
records. The FERPA officer on the MSU campus must review any research
using Murray State University
student information before that research is submitted to the IRB for
approval. A statement from the FERPA officer outlining precisely which
information the researcher may obtain from the student records and how this
information may be obtained must be submitted with the protocol for review by
the IRB.
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Section
17: Research Performed on the Murray State
Campus by non-MSU Affiliated Personnel or Students
The MSU IRB has no control
over research that is accomplished by off-campus (not affiliated with MSU)
researchers through direct collection of data from MSU personnel or
students. However, if a non-MSU researcher involves any MSU personnel
or students in the contacting of potential participants, gathering of data,
or dissemination of forms, then the research must come before the MSU IRB for
approval. The IRB cautions subjects who choose to participate in
research conducted by non-MSU affiliated researchers to be sure that the
research meets all of the requirements of informed consent so that they can
be certain that their rights as a research subject are protected.
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Section 18:
Adverse Event
Federal Policy requires IRBs to have and follow written procedures for “prompt
reporting to the IRB of any unanticipated problems involving risks to human
subjects or others” (45 CFR 46.103 (b) (5)). Investigators carry the responsibility for
timely reporting of adverse events to the IRB to ensure that the IRB is
cognizant of any new information that might affect its assessment of the
benefit-to-risk ratio of research study participation and/or the adequacy of
research protocol provisions for protecting the welfare of research
subjects. To report an adverse event, the IRB investigator must
complete the Adverse
Event Form and submit it to the IRB Administrator, within
three (3) calendar days of identifying the adverse event. The IRB
Administrator will immediately share the information with the IRB Chair for review
and consideration of next steps. A copy of the Adverse Event Form will be sent to the
department head or office director of the investigator, to the MSU Provost,
and to the University General Counsel.
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Section
19: Problems Reported to the IRB
In the course of
protecting human subjects involved in research, the IRB will respond to any
problem or complaints raised directly or by third party reporting, to any
member of the Board. When notified of a problem or complaint, the IRB Chair
and IRB Coordinator will review the issue and determine appropriate action.
If warranted, the Murray State General Counsel may be involved in the
investigation and the research may be suspended. Targeted audits of the
research may be undertaken if deemed appropriate by the IRB Chair and/or the
majority of the IRB.
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Section
20: Misconduct in Human Participants Research
It is the ethical
responsibility of all Murray
State University
personnel to obtain the approval of the IRB when undertaking any research
which involves the use of human participants. Any desired changes to
the protocol approved by the IRB shall be resubmitted to the IRB for
approval. Moreover, it is unethical and a violation of the IRB’s policies and guidelines to deviate from the
protocol as approved by the IRB in conducting research or to misrepresent
information or omit any material information regarding a protocol. In
the event that the IRB policies and guidelines are not adhered to and the
research is completed, the following procedure has been approved by the
Provost:
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20.1
Thesis Research
1. Upon receipt by the IRB or any member of the IRB of
an allegation that thesis research involving human participants has been
conducted without IRB approval, the IRB shall issue a letter to the student
and faculty sponsor notifying each of the allegation. The letter shall
also contain notification of a meeting to be held by the IRB at a specified
place, date, and time at which time the student and/or faculty sponsor shall
be allowed to present any and all evidence supporting his/her position.
The IRB will then render its decision within seven (7) working days of the
meeting, setting forth its review of the evidence, findings, and
determination. A copy of the IRB’s decision
shall be sent to the faculty sponsor and the student. The IRB’s decision shall be final.
a.
If it is determined by the IRB that research
involving human participants has occurred without prior IRB approval, a
letter shall be forwarded to the coordinator of graduate programs indicating
that upon presentation of the thesis to the coordinator of graduate programs
for signature and approval, the graduate coordinator may sign a form which
allows the student to graduate, but the University will not allow the thesis
to be bound and placed in the library. If the IRB determination occurs
subsequent to the placement of the thesis in the library, a letter shall be
sent to the Graduate Admissions office requiring removal of the thesis from
the library. Such notifications shall likewise indicate that use of
this material in a future publication is unethical because prior approval
from the IRB was not obtained as required in the MSU Guidelines for the Preparation of the Master's
Thesis. Both the student and faculty sponsor shall
receive a copy of any such notification. If an infraction is found, a
copy of the IRB determination shall also be sent to all members of the
student’s thesis committee. If an infraction is found, the faculty
sponsor shall also receive a separate letter requiring IRB training or
retraining, as the IRB deems appropriate. A copy of the faculty
sponsor’s letter and IRB determination shall be sent to the faculty sponsor’s
department Chair (or Dean if the sponsor is also the department Chair).
2. A second infraction of this rule by a faculty or staff
member shall result in a letter from the IRB requiring additional IRB
retraining. A copy of this letter shall be forwarded to the faculty
member’s Chair, Collegiate Dean, and to the Provost. If a staff member,
a copy shall be forwarded to the staff member’s supervisor. If a second
infraction is found to have been committed by a faculty member, the board
shall recommend to the Provost that s/he send a letter to the faculty member,
the faculty member’s Chair, Collegiate Dean, and departmental graduate
faculty recommending suspension of the faculty member from the graduate
faculty and/or from supervision of student research for a time certain.
3. Upon three (3) or more violations of this rule by a
faculty sponsor the IRB shall institute an inquiry pursuant to Murray State University’s
Policies and Procedures to Deal with Misconduct in
Research.
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20.2
Faculty, Staff, and/or Student Research – Failure to Obtain IRB Approval
1. Upon receipt by the IRB or any member of the IRB of an allegation that
research on human participants has been conducted by a faculty/staff member
or by a student who is sponsored or otherwise supervised by a faculty/staff
member without receiving approval from the IRB, the IRB shall issue a letter
to the faculty/staff member and student, if applicable, notifying the
faculty/staff member and student, if applicable, that an allegation has been
made. The letter shall also contain notification of a meeting to be
held by the IRB at a specified place, date, and time at which time the
faculty/staff member and student, if applicable, shall be allowed to present
any and all evidence supporting his/her position. The IRB will render
its decision within seven (7) working days of the meeting, setting forth its
review of the evidence, findings, and determination. A copy of the IRB’s decision shall be sent to the faculty/staff member
and student, if applicable. The IRB’s
determination shall be final.
a.
If it is determined by the IRB that
research involving human participants has occurred without prior IRB approval
then a letter shall also be sent to the faculty/staff member and to the
student, if applicable, notifying each that no publication or presentation of
the research materials or findings outside the classroom shall be
allowed. The faculty/staff member shall be required to undergo IRB
training or retraining, as the IRB deems appropriate. A copy of the
faculty letter along with the IRB determination shall also be sent to the
faculty member’s department Chair (or Dean, if the faculty member is also the
department Chair) or the staff member’s supervisor.
2.
A second infraction of this rule by a
faculty or staff member shall result in a letter from the IRB requiring additional
IRB retraining. A copy of this letter shall be forwarded to the faculty
member’s Chair, Collegiate Dean, and to the Provost. If a staff member,
a copy shall be forwarded to the staff member’s supervisor. If a second
infraction is found to have been committed by a faculty member, the board
shall recommend to the Provost that s/he send a letter to the faculty member,
the faculty member’s Chair, Collegiate Dean, and departmental graduate
faculty recommending suspension of the faculty member from the graduate
faculty and/or from supervision of student research for a time certain.
3.
Upon three (3) or more violations by a
faculty or staff member, the IRB shall
institute an inquiry pursuant to Murray
State University’s
Policies and Procedures to Deal with Misconduct in
Research.
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20.3
Faculty, Staff, and/or Student Research – Deviation from Approved Protocol
1.
Upon receipt by the IRB or any member
of the IRB of an allegation that research on human participants has been
conducted in a manner other than as specified in the protocol approved by the
IRB, that any information included in the protocol, as approved, is
incorrect or is such that material information has been omitted form the
protocol, or that research has been conducted in such manner as to violate
IRB procedures and guidelines and/or any recognized IRB policies, the IRB
shall issue a letter to the faculty/staff member and student, if applicable,
notifying the faculty/staff member and student, if applicable, that an
allegation has been made. The letter shall also contain notification of
a meeting to be held by the IRB at a specified place, date, and time at which
time the faculty/staff member and student, if applicable, shall be allowed to
present any and all evidence supporting his/her position. The IRB will
render its decision within seven (7) working days of the meeting, setting
forth its review of the evidence, findings, and determination. A copy
of the IRB’s decision shall be sent to the
faculty/staff member and student, if applicable. The IRB’s determination shall be final.
2.
If it is determined by the IRB that
any part of a research project was conducted in a manner other than as
specified in the approved protocol, that any information included in the
protocol, as approved, is incorrect or is such that material information has
been omitted form the protocol, or that research has been conducted in such
manner as to violate IRB procedures and guidelines and/or any recognized IRB
policies, the IRB shall issue a letter to the faculty/staff member and to the
student, if applicable, notifying each of the IRB’s
determination. The faculty/staff member shall be required to undergo
IRB training or retraining as the IRB deems appropriate. Depending on
the severity of the breach of protocol, potential penalties may also include,
but are not limited to, a letter of reprimand, prohibition of publication or
presentation of the research materials or findings outside the classroom,
recommendation that the faculty member be suspended from the graduate faculty
and/or from supervision of student research for a time certain, and/or
institution of an inquiry pursuant to MSU Policies and Procedures to Deal with Misconduct in
Research. Should the IRB determine that the
faculty/staff member is engaging in a pattern (three (3) or more) of
deviating from approved protocols, providing inaccurate information to the
IRB, omitting from protocols material information, or otherwise violating IRB
procedures and guidelines and/or any recognized IRB policies, even if such
deviations, inaccuracies, omissions, or violations are minor in nature, the
IRB reserves the right to treat such pattern as a basis to pursue an inquiry
under Murray State University’s Policies and Procedures to Deal with Misconduct in
Research. A copy of any determination by the IRB shall
be forwarded to the faculty member’s department Chair (or Dean if the faculty
member is also the department Chair) or the staff member’s supervisor.
Should the IRB recommend that a faculty member be suspended from the graduate
faculty and/or from supervision of student research, a copy shall also be
forwarded to the Provost, Collegiate Dean, and departmental graduate faculty.
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Section
21: Reporting Requirement
The IRB Coordinator shall
promptly report to the IRB, the Provost and the University General Counsel
any unanticipated problems involving risks to subjects or others, any serious
or continuing non-compliance, and any suspension or termination of IRB
approval. As required by the federal regulations (45 CFR 46.103(b)(5)), the
Office for Human Research Protections (OHRP) will be notified of such issues
involving research studies that are funded by any agency of the Department of
Health and Human Services as required in OHRP's Guidance on Reporting Incidents to OHRP
and Guidance on Reviewing and Reporting Unanticipated
Problems. Other funding agencies will be notified as required
in their guidance documents. If the report is the result of serious or
continuing non-compliance, the IRB reserves the right to treat such as a basis
to pursue an inquiry under Murray
State University’s
Policies
and Procedures to Deal with Misconduct in Research as
outlined in section 20.3.2 above.
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Section
22: Examples
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