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Tusculum Institutional Review
Board (IRB) Handbook
A guidebook to the function and protocol of the Tusculum Institutional Review Board.
Latest revision: September 26, 2018
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Committee Membership
The Institutional Review Board (IRB) is a non-faculty Tusculum committee that falls under the jurisdiction of the Vice President of Academics (VPA). Members and the chair are appointed and serve at the pleasure of the VPA. IRB members must complete and provide verification of IRB training prior to serving and must provide verification of ongoing training no less than every five years. Policy, as well as full IRB review, will require a quorum (a minimum of half of all members voting in the affirmative).
Members of Tusculum’s IRB
2018-2019 IRB Chair:
Robert Gall (Psychology) e-mail: rgall@tusculum.edu IRB Members by College: College of Health Sciences Robert Gall (Psychology) – rgall@tusculum.edu Kate Smith (Psychology) – kjsmith@tusculum.edu College of Civic & Liberal Arts Michael Bodary (English) - mbodary@tusculum.edu Katherine Everhart (Social Sciences) - keverhart@tusculum.edu College of Science, Technology, & Mathematics Susan Monteleone (Biology) - smonteleone@tusculum.edu Merve Kester Thomas (Mathematics) - mkester@tusculum.edu College of Business Jack McCann (Business) - keverhart@tusculum.edu Harold Branstrator (Business) - hbranstrator@tusculum.edu College of Education Jeff Burleson (Education) - jburleson@tusculum.edu
Suzanne Byrd (Sports Study) - sbyrd@tusculum.edu
IRB Outside Member:
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2017-2018
IRB Chair:
Robert Gall (Psychology) e-mail: rgall@tusculum.edu
IRB Members:
Michael Bodary (English),
Jeff Burleson (Education),
Suzanne Byrd (Sports Study),
Michael Dillon (Business),
Erica Hutton (Criminal Justice),
Merve Kester (Mathematics),
Jack McCann (Business),
Katherine Smith (Psychology),
Erica Hutton (Criminal Justice),
IRB Outside Member:
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2016-2017
IRB Chair:
Katherine Smith (Psychology) e-mail: kjsmith@tusculum.edu
IRB Members:
Michael Bodary (English),
Jeff Burleson (Education),
Suzanne Byrd (Sports Study),
Michael Dillon (Business)
Lois Ewen (Nursing),
Erica Hutton (Criminal Justice),
Merve Kester (Mathematics),
Jack McCann (Business),
IRB Outside Member:
George Frye
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Table of Contents
Committee Membership.................................................................................................................. 2
Members of Tusculum’s IRB.......................................................................................................... 2
2018-2019 ........................................................................................................................... 2
2017-2018 ........................................................................................................................... 3
2016-2017 ........................................................................................................................... 4
Mission Statement. .......................................................................................................................... 7
Purpose of the Institutional Review Board (IRB) ........................................................................... 8
Statement of Principles of Tusculum‘s IRB ................................................................................. 10
Student Research in Non-Research and Research Courses and in Research Internships ............. 11
Approval by an individual professor ................................................................................. 11
Approval by a divisional subcommittee ........................................................................... 11
How Tusculum’s IRB Reviews Research Proposals .................................................................... 14
Research with Human Subjects Definition? ..................................................................... 14
Levels of Review .............................................................................................................. 14
Assessment of risk ............................................................................................................ 15
Levels of Review in Detail ............................................................................................... 16
Exempt from review ............................................................................................. 16
Expedited review due to minimal risk .................................................................. 17
Full Review ........................................................................................................... 18
Decisions ........................................................................................................................... 18
Approved............................................................................................................... 18
Approved with conditions: .................................................................................... 19
Deferred due to serious concerns: ......................................................................... 19
Disapproved .......................................................................................................... 19
Submitting An Application ........................................................................................................... 20
IRB Application Form ...................................................................................................... 20
Consent, Permission, or Assent Forms ............................................................................. 20
The Purpose of Obtaining Informed consent ........................................................ 20
The Contents of the Consent/Permission Form .................................................... 22
What to do with the Consent Form ....................................................................... 24
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Waiving the Requirement for a Consent Form ..................................................... 24
Requirements for Waiving the Documentation of Consent .................................. 24
Instructions for Preparing the Consent Form ........................................................ 25
Research with Vulnerable Populations ................................................................. 27
Instruments for Data Collection ........................................................................................ 29
Recruitment Materials ....................................................................................................... 29
IRB Training Verification ................................................................................................. 29
Important Additional Considerations ............................................................................................ 31
Safeguarding Information ................................................................................................. 31
Certificate of Confidentiality ............................................................................................ 32
Changes to the Protocol .................................................................................................... 34
Adverse Effects on Subjects ............................................................................................. 34
Renewed Approval............................................................................................................ 34
IRB Divisional Tracking for Research Course Assignments ....................................................... 35
Appendix: Definitions of Terms ................................................................................................... 36
Appendix: Template for Consent/Permission Form ..................................................................... 42
Appendix: IRB Divisional Tracking Form ................................................................................... 43
General Categories of IRB Submissions ....................................................................................... 44
Exempt .............................................................................................................................. 44
Expedited .......................................................................................................................... 45
Full Review ....................................................................................................................... 48
Appendix: Online Resources for IRBs ......................................................................................... 49
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Mission Statement.
Tusculum’s IRB reviews research with human subjects and promotes ethical research. Research
is defined as a systematic investigation whose purpose is to contribute to generalizable
knowledge. At Tusculum, research is not expected to expose subjects to any risk of physical
danger or psychological distress other than what they would typically encounter as part of daily
living. As such, the committee seeks to protect the health and welfare of human subjects
involved in research conducted by or on faculty, staff, and student affiliated with Tusculum.
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Purpose of the Institutional Review Board (IRB)
Tusculum is committed to the pursuit of high quality research and applied scholarship to
meet the needs and interests of the institution, the scientific community, and society. At the same
time, the Institution is committed to protecting the welfare of every person who may be involved
in research and training projects. Members of the Tusculum community, while upholding the
highest standards of freedom of inquiry and communication, accept the responsibility this
freedom offers: for competence, for objectivity, and for the welfare of every participant in a
project.
As such, Tusculum has established an Institutional Review Board (IRB) or Ethics Review
Board to review projects that involve human Subjects in order to ensure that each project
complies with the highest ethical standards. In addition to its mandated review functions, the IRB
is committed to serving as an educational resource for the Tusculum community.
The purpose of this document is to assist Tusculum investigators in the preparation and
submission of research proposals for review by the IRB. The policies and procedures of the IRB
are based on the rules and procedures mandated by DHHS Regulations for the Protection of
Human Research Subjects (45 CFR 46, as amended1) as well as the APA IRB Planning Guide.
It is the responsibility of the Tusculum IRB to protect human subjects and facilitate
research conducted by its faculty, staff, and students. When the IRB encounters questions about a
proposal, it will attempt to consult with someone knowledgeable in the investigator’s field of
study. If no one on the IRB meets this criterion, investigators may request that a particular person
who is an expert in the area and who is willing to act as a consultant to the IRB be involved in
1 http://www.hhs.gov/ohrp/humanparticipants/guidance/45cfr46.htm
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the review. Although that person will not be able to vote on a proposal, their recommendations
will be weighed heavily in the IRB’s decisions.
In accordance with the Belmont Report2, Tusculum’s IRB research policies and
procedures are designed to ensure respect for Subjects, beneficence, and justice in the conduct of
all research. Respect ensures that the dignity of all Subjects is protected by ensuring their safety
and privacy. Likewise, Subjects are expected to be able to make informed judgments about their
desire to participate in a research project, and vulnerable Subjects are provided with extra
protections. Beneficence demands that any costs to individual Subjects must be outweighed by
clear benefits. Justice is carried out by ensuring that populations are included or excluded only
for reasons directly related to the research project itself.
It is the responsibility of all members of the Tusculum community to observe these policies
and procedures for themselves and on behalf of their research subjects. Tusculum assumes no
legal responsibility for individuals who do not conform to the IRB’s regulations and receive IRB
approval for all research projects. Furthermore, failure to comply with the IRB’s regulations
could impugn the investigator's own name and the reputation of Tusculum and could lead to
restrictions on the research activity of the individual and the Institution.
Finally, all research projects involving the use of human Subjects must be reviewed by
the IRB. Additionally, individual researchers are not allowed to determine if their research is
except, as this is a function of the IRB. Submission and review procedures are described in this
Guide.
2 http://ohsr.od.nih.gov/guidelines/belmont.html
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Statement of Principles of Tusculum‘s IRB
Tusculum affirms the value and dignity of the individual person. The value of the person,
it is maintained, supersedes and anchors all other values. Persons are never to be treated as
merely a means but always, simultaneously, as ends in themselves.
The doctrine of the supreme worth of the person is reflected in American political society
in the theory of human rights that underlies the legal system. It is also articulated in such
statements as the United Nations' Universal Declaration of Human Rights (1948), the declaration
of the Helsinki Agreement (1964), and the Belmont Report (1979).
Moral principles not only serve as a basis of social unity but also can provide guidance
for individual decision-making. Cases of perplexity arise in various contexts, including that of
research involving human Subjects. Moral principles express ways of resolving perplexities that
are well established in scientific and medical practice. An examination of these principles may
provide insight into the possibility of making morally sound decisions.
A fundamental principle of morality is that of respect for persons, which embodies the
conviction that persons are to be treated as autonomous agents. In the context of research
involving human Subjects, respect for persons requires that Subjects be given the opportunity to
determine what shall or shall not happen to them. This opportunity is provided by the
requirement of informed consent. Consent is informed when the participant is fully appraised of
the procedures, risks, and benefits s/he may undergo in participating in a particular research
study. Consent is genuine when the participant has the right to refuse participation without
recrimination.
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Student Research in Non-Research and Research Courses and in Research Internships
All human subjects research conducted at Tusculum must be evaluated for its ethical
implications and approved. This can be accomplished in a variety of ways. Approval can be
provided by the professor of a course, by a division review, by another institution’s IRB, or by
Tusculum’s IRB. The following descriptions outline the different means by which ethical
approval may be obtained at Tusculum.
Approval by an individual professor
If a professor obtains consent from all members of a course to collect data as part of the
course, then the professor may collect data only on the students in the course. For example, the
professor may demonstrate how to create and distribute questionnaires, give interviews, collect
observations, or run an experiment by having the students in the course serve as Subjects for one
another. The data collection must pose no risk to the students or Subjects; Subjects must have the
right to refuse to participate without penalty; confidentiality must be maintained to the greatest
extent possible; extra precautions must be taken with vulnerable populations (such as gender or
ethnic minorities); and the data may not be published. The professor of the course, however,
assumes responsibility. If a professor is uncertain whether a project is ethically sound, then the
project should be submitted to Tusculum’s IRB.
Approval by a divisional subcommittee
This option is best for situations where every student in a course will be collecting the
same data outside of the course for the same project and the project is associated with a course
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grade. This option is only appropriate if the data collection poses no risk to either the students or
Subjects, and involves only a few Subjects. The data collected under this option may not be
published. Additionally, this option is not appropriate for theses, capstone projects, etc. For
example, observing a few individuals in public places, interviewing several individuals, holding
a focus group, conducting a completely physically and psychologically harmless experiment, or
providing a harmless intervention within a service learning course with a few individuals all are
acceptable. The divisional subcommittee, however, assumes responsibility. If a division is
uncertain whether a project is ethically sound, then the project should be submitted to
Tusculum’s IRB. The divisional subcommittee for each division will be comprised of members
of the full IRB. The form for submitting a proposal for divisional subcommittee review is
included in the Appendix of this guidebook, and can be submitted at any time.
Approval by the Tusculum IRB
(including research internships, senior research projects, individual student research
projects, as well as faculty and staff research) - This option is required for any student
conducting an individual research project. Additionally, this option is required, regardless of the
setting, where there is any risk to subjects, where there will be more than a few subjects, and/or
where the results of the project may be published. Note that for publication in many peer-
reviewed journals, IRB approval in advance of the project is a prerequisite for consideration, so
if there is any chance a student project may be published, it should be reviewed by the IRB. This
applies to student research conducted at Tusculum or at any other institution (for example,
another college, a university, or a hospital).
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If the project has been approved already by another institution’s IRB, then the student
must submit documentation of approval from that institution to Tusculum’s IRB along with brief
descriptions of the project and the student’s specific role in the project. The documentation may
consist of the approval letter from the other institution’s IRB or of a signature by the principal
investigator of the project on which the student is working indicating that the principal
investigator has received IRB approval from the institution. The name of the institution, the
principal investigator, the student’s name, and the date the IRB approval was obtained must be
included. The IRB Chair then may either waive the requirement that the student submit to
Tusculum’s IRB or require that the student also submit the proposal to Tusculum’s IRB. As long
as the project complies with Tusculum’s policies, other institution’s IRB decisions will be
respected. This information may be submitted electronically to the IRB Chair. The IRB reserves
the right to disapprove of a student’s research. Student projects that require review by the
Tusculum IRB should be prepared following the guidelines presented in Sections VI-VIII,
including submission following the meeting schedule listed in Section VII.
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How Tusculum’s IRB Reviews Research Proposals
Research with Human Subjects Definition?
Research is defined as (1) a systematic investigation (2) whose purpose is to contribute to
generalizable knowledge (Bankert & Amdur, 2006, p. 101). That is, a systematic attempt in
which “the primary goal of the activity must be to develop or contribute to generalizable
knowledge” (Bankert & Amdur, 2006, p. 101). Under this definition some demonstration,
service, and training projects may be considered to include research activities.
A human subject is defined “as a living individual about whom an investigator
conducting research obtains 1) data through intervention or interaction with the individual or 2)
identifiable, private information” (Bankert & Amdur, 2006, p. 101).
Levels of Review
An investigator submits a research proposal for one of three levels of review:
i. Exempt from review
ii. Expedited review
iii. Full review
Whether a research proposal is designated to be exempt from IRB review or will receive
an expedited or full review very much depends on the risk assessment. While researchers may
suggest the level of review they believe is most appropriate based on the criteria listed below, the
Chair of the IRB will make the final decision.
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Assessment of risk
To determine whether the subject will be harmed in any way, the IRB will make a
decision based on common sense and sound professional judgment as to whether or not the
proposed research places the subject at risk. A subject is considered to be at risk if s/he may be
exposed to the possibility of harm, whether physical, psychological, sociological, or other. The
IRB will consider the fact that certain participant populations (e.g., minors, pregnant women,
prisoners, mentally handicapped, workers, culturally or socioeconomically disadvantaged
individuals) may be at greater risk than others.
Certain risks are inherent in life itself, but the IRB is not concerned with the ordinary
risks of public or private living. Risk as applicable to DHHS policy is most obvious in medical
and behavioral science research projects involving procedures that may induce a potentially
harmful altered physical state or psychological condition. There is a wide range of medical,
social and behavioral procedures and projects in which, although there may be no immediate
risk, procedures may be introduced that involve discomfort, anxiety, harassment, invasion of
privacy, or that constitute a threat to the participant's dignity.
If it is judged that the proposed research project will expose a participant to risk, then the
IRB must assure itself that (a) the rights and welfare of the subjects are adequately protected, (b)
the methods used to obtain informed consent are adequate and appropriate, (c) the risks to the
subjects are outweighed by the potential benefit to the subjects or by the importance of the
knowledge to be gained, and (d) risks to subjects are minimized by using procedures which are
consistent with sound research design and which do not unnecessarily expose Subjects to risk.
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Levels of Review in Detail
Exempt from review
a. A research project is exempt from review if it consists of (1) Normal Educational
Practices in Typical Educational Settings, (2) Anonymous Educational Tests,
Surveys, Interviews, or Observations where Subjects cannot be identified and no
disclosure of Subjects’ responses could place them at risk civilly, criminally,
financially, or damage their financial standing or reputation, (3) Public officials or
candidates for public office are involved in #2, (4) Information has been collected
already and subjects cannot be identified (but see medical-HIPPA and
educational-FERPA regulations regarding privacy), (5) Public Department or
Agency Heads are examining Public Services, and (6) Taste and Quality Food
Studies with wholesome foods and contaminants below minimal acceptable levels
(Bankert & Amdur, 2006, pp. 94-95). Because it is difficult to know whether a
research project meets these criteria, an investigator must complete a proposal
submission form, and the IRB Chair will determine whether further review is
warranted.
b. If a submitted proposal is determined by the Chair of the IRB to be exempt from
review, the investigator will be notified rapidly. The investigator may begin the
study after the appropriate forms have been provided to the IRB chair and
approved. If a proposal does not qualify for exempt status, the investigator will be
notified and advised on the level of review required: expedited or full review.
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Expedited review due to minimal risk
a. Research activities involving no more than minimal risk may be reviewed by the
IRB through the expedited review procedure. Continuing research activities that
were approved by the IRB within the past year also may be approved through the
expedited review procedure. Expedited review is appropriate for (1) collection of
biological specimens through non-invasive means excluding x-rays or
microwaves but including collection of bodily tissues or fluids, application of
physical sensors, physiological/neuroscience tests, moderate exercise and
flexibility, (2) research on materials already collected provided privacy is ensured,
(3) collection of data from voice, video, digital recordings, or image recordings
provided confidentiality is ensured and identification of the subjects and/or their
responses would not reasonably place them at risk of criminal or civil liability or
be damaging to the participant's financial standing, employability, insurability,
reputation, or be stigmatizing, (4) research on group characteristics or behavior as
long as the group will not face stigmatization, and (5) continuing review of
research previously approved by a full IRB review as long as no new types of data
are collected that would require a full IRB review (Bankert & Amdur, 2006, pp.
99-100).
b. The expedited review procedure may not be used 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.
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c. The IRB may also use the expedited review procedure to review minor changes in
previously approved research during the period for which approval is authorized.
d. Under an expedited review procedure, the review may be carried out by the Chair
of the IRB, with or without consultation with other IRB members.
Full Review
a. All proposals that do not qualify for exemption or expedited review, including all
research that involves more than “minimal risk,” must be submitted for review by
the full IRB. Under a full review procedure, a majority of the members of the IRB
will be present, including at least one member whose primary concerns are in
non-scientific areas. The investigators may be invited to the meeting to clarify
parts of the proposal. In order for research to be approved, it must receive the
approval of a quorum of IRB members.
Decisions
If a research proposal is determined to exempt by the Chair of the IRB, then the
researcher can begin the study as soon as the paperwork has been submitted.
Decisions regarding expedited and full reviews will be assigned to one of four categories
(below). After all decisions, the investigator can contact either the Chair of the IRB or another
IRB member designated by the Chair to discuss the proposal.
Approved
The investigator may begin the study as soon as the paperwork for the proposal has been
submitted to the IRB and approved.
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Approved with conditions:
The investigator will be notified in writing as to the nature of the required modifications.
The investigator must comply with all required modifications and resubmit a corrected proposal
to the Chair of the IRB incorporating the modifications. Once the Chair of the IRB approves the
research proposal, the investigator may begin the study as soon as the paperwork for the proposal
has been submitted to the chair of the IRB and approved.
Deferred due to serious concerns:
Members of the IRB or the full IRB are uncertain whether the researcher can address
adequately their concerns. The researcher will be notified in writing as to the nature of their
concerns. If the researcher believes s/he can address all the concerns, the researcher may
resubmit a corrected proposal to the Chair of the IRB incorporating the necessary modifications.
Once the Chair of the IRB or the full IRB approves the research proposal, the researcher may
begin the study as soon as the paperwork for the proposal has been submitted to the chair of the
IRB and approved.
Disapproved
The full IRB has decided that the investigator may not proceed with the project.
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Submitting An Application
All IRB inquiries and proposals should be submitted via email to the current chair of the
IRB. The current chair for any given year can be found under the Members of Tusculum IRB
section.
IRB Application Form
All levels of submission require a completed IRB application as well as all relevant
documents to be submitted electronically to the chair of the IRB committee. The application can
be obtained either from the IRB website, the IRB section on Tusculum Governance Moodle site,
or by emailing the chair of the IRB.
Consent, Permission, or Assent Forms
A template of a consent/permission form is available in the appendixes.
The Purpose of Obtaining Informed consent
The informed consent of the individual is a vital element in the protection of human
Subjects. Before a person participates in an investigation involving risk or the likelihood of
substantial stress or discomfort, the nature of these hazards and the procedures to be followed are
to be carefully explained and participant consent obtained.
Three types of acquiescence to participate in a research project can occur.
i. First, those subjects who are over 18 years can consent to participate in research
themselves as long as they understand the research project and can voluntarily
choose whether to participate.
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ii. Second, in cases in which a participant is under 18 or cannot be expected to
understand the research proposal or cannot voluntarily choose whether to
participate (typically a minor or cognitively impaired person), a legal guardian
can provide permission for that person to participate.
iii. Third, in the case when a legal guardian provides permission for a participant to
partake in the research project, the investigator generally should attempt to obtain
the actual subject’s assent, which may occur verbally. This generally requires a
simplified description of the research proposal. Because this is a critical
component of the respect for the dignity of subjects, the IRB will carefully review
the process and documents for consent, permission, and assent forms.
Investigators should seek consent under circumstances that provide the prospective
participant or the representative sufficient opportunity to consider whether or not to participate
and that minimize the possibility of coercion or undue influence. An individual does not give up
any rights by consenting to be a research participant. A participant has the right to withdraw
from a research project at any time or to refuse to participate without loss of benefits to which
the participant would otherwise be entitled. Further, a participant has the right to receive
appropriate professional care, to enjoy privacy and confidentiality in the use of personal
information and to be free from undue embarrassment, discomfort, anxiety, and harassment.
Unless the IRB issues a specific waiver of consent or of documentation of consent (see
below), documented written informed consent of subjects (through the use of a consent form) is
required for all research projects where there is any risk to the human subjects. If a participant is
not legally or physically capable of giving informed consent, a legally authorized representative
may give permission for the participant to partake in the research. Careful consideration will be
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given to the representative's depth of interest in and concern for the participant's rights and
welfare.
The Contents of the Consent/Permission Form
Consent form should convey all of the following information, at a minimum. It should
also be simply written and easily understood. The appendix contains a sample
consent/permission template.
a. A statement that the study involves research, a readily understood explanation of
the purposes of the research and the expected duration of the participant’s
participation, a description of the procedures to be followed, including
identification of any procedures which are experimental
b. A description of how data will be handled (e.g. who will have access for what
purposes).
c. A description of how and to whom data and results will be disseminated (e.g.
intentions to present or publish, share with colleagues, and at what level of
aggregation, etc.)
d. A description of any reasonably foreseeable risks or discomforts to the
participant.
e. A description of any benefits to the participant or to others which may reasonably
be expected from the research and/or findings (e.g. if no direct benefit, this should
be stated).
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f. A statement describing the extent, if any, to which confidentiality of records that
identify the participant will be maintained. (If signed Informed consent forms are
used, regulations require they must be kept for 3 years.)
g. An explanation of whom to contact for answers to pertinent questions about the
research and research subjects’ rights, and whom to contact in the event of a
research-related problem or injury to the participant.
h. For research involving more than minimal risk, an explanation as to whether any
medical or psychological treatments are available if injury occurs and, if so, what
they consist of, or where further information may be obtained.
i. A statement that participation is voluntary, that deciding not to participate will
involve no penalty or loss of benefits to which the participant is otherwise
entitled, and that the participant may discontinue participation at any time without
penalty or loss of benefits to which the participant is otherwise entitled.
j. A statement concerning costs or compensation to the participant, if any.
k. A statement similar to this in the consent document: If you have questions or
concerns about the research, you may contact [name and contact information of
investigator and/or the Chair of the Institutional Review Board at ____________.
Students should also include name of and contact information for their research
advisor or course instructor.
The IRB may require additional information to be included in the consent process and/or
included in the Consent Form.
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What to do with the Consent Form
Researchers must insure that anyone signing a written Consent Form is given a copy of
that form before they participate in the project. Researchers are responsible for safeguarding the
consent documents signed by human research subjects for at least three years following the
termination of the project. Faculty supervisors must maintain the consent documents for student
investigators. In the event that a researcher leaves the institution prior to the three years, they are
required to turn in a copy of all consent forms to the IRB chair. Finally, the IRB committee can
request a copy of the signed consent forms at any time.
Waiving the Requirement for a Consent Form
The IRB may waive the requirement for the investigator to obtain a signed Consent Form
for some or all subjects if it finds that (Bankert & Amdur, 2006, p. 220):
a. The research involves no more than minimal risk to the subjects.
b. The waiver or alteration will not adversely affect the rights and welfare of the
subjects.
c. The research could not practicably be carried out without the waiver or alteration.
d. Whenever appropriate, the subjects will be provided with additional pertinent
information after participation (Bankert & Amdur, 2006, p. 217).
Requirements for Waiving the Documentation of Consent
The IRB may waive the requirement that the investigator document who signed Consent
Forms if it finds that (Bankert & Amdur, 2006, p. 221):
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a. The only record linking the subject and the research would be the consent
document and the principal risk would be potential harm resulting from a breach
of confidentiality. Each participant must be asked whether s/he wants to be linked
with the research OR
b. The research presents no more than minimal risk of harm to subjects and involves
no procedures for which written consent is normally required outside of the
research context OR
c. The participant never signed a consent form, because the consent form
requirement was waived. In that case, the investigator should provide Subjects
with a written description of the project before initiating the project.
Reasons to waive use of a signed consent form should be given in the IRB Application
Form. When the documentation requirement is waived or altered, the IRB still requires an
informed consent process – providing subjects with a written or oral description of the research
and making sure they are freely choosing to participate.
Instructions for Preparing the Consent Form
a. Language - Style: The consent form should be written in the second person. When
combined with conditional language and the invitation to participate, use of the
second person communicates that the investigator believes there is a choice to be
made by the prospective participant. Use of the first person may be interpreted as
presumption of participant consent before consent has been legally obtained.
b. Language – Level: The information that is given to the participant or the
representative shall be in language understandable to the participant or the
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representative. Keep in mind that terms commonly used by members of a
profession are a part of the professional's language, a language many people
outside that profession do not understand. If there is any doubt that a term may
not be understood, a definition should be added. If some of the anticipated
participant population does not understand English, appropriate translation should
be provided. Researchers are commonly advised to write consent materials for
about an 8th grade reading level.
c. Language - Exculpatory: The consent form must not contain any exculpatory
language through which the participant or the participant's representative is made
to waive or appear to waive any of the participant's legal rights, or through which
s/he releases or appears to release the research investigator, the sponsor, the
institution or its agents from liability for negligence.
d. Language – Foreign: If your research study will include individuals with
linguistic backgrounds other than English, the IRB will generally require that you
translate the Informed Consent Form into the appropriate other language. It must
be submitted with the other materials you are sending in your application. An
English “back translation” of the Form should be submitted, as well. In cases
where an individual may be unable to read—whether it is English or another
language—or has impaired vision, appropriate arrangements must be made to
orally convey the contents of the Informed Consent Form. Arrangements must
also be made for the individual to give or withhold their willingness to participate
in the research project. It should be noted that college and university students in
Tusculum IRB Handbook 27
the United States are assumed to have passed the TOFEL exam, and as such, do
not require a consent form in their native language.
e. Length: The consent form should be long enough to explain consent factors
adequately but not so long or detailed as to lose the attention of the participant or
to cause confusion. If a separate project description is given to subjects, the actual
consent form will not need to exceed one page.
f. Submission to the IRB: Researchers must include copies of any proposed consent
form(s) with the proposal. Researchers must also submit copies of any written or
verbal explanation of the project that will be given to Subjects. The approved
Consent Form is valid for a maximum of one year. In cases where a project is
continuing beyond one year, permission to continue use of the Consent Form
must be applied for at least one month in advance of the one-year anniversary
date. Such permission is granted in conjunction with the application for
Continuing Review.
Research with Vulnerable Populations
a. For research with children, the elderly, the disabled, and other vulnerable
populations, additional protections are required. Permission must be obtained
from parents/guardians for all vulnerable subjects as well as assent from subjects
themselves. No subject can provide consent unless they are over 18 years of age
unless they are a college/university student, the research is done on a
college/university, and a waiver for consent has been granted. If subjects are
under 18 years, they will require a family member/guardian to provide permission
Tusculum IRB Handbook 28
for them to participate. Tusculum students under 18 years cannot participate
without parental permission. Pregnant women and prisoners also are considered
vulnerable populations, though not the only ones, so special considerations apply.
Researchers should review the material in the CITI, NIH, or Tusculum’s training
modules and consult with the IRB for further details.
b. Assent and Permission: Be sure to include copies of materials to be sent home to
families/guardians and the Permission Forms they would sign. Be sure that
procedures for gaining and maintaining Assent are clear. For example, teenagers
under 18 require parental permission, but they themselves must also provide
Assent. This can be accomplished by having them read and sign something. For
younger children, the elderly or disabled, ongoing assent must be obtained before
the research commences, then continually determined verbally and behaviorally.
You will need to make it clear how this will be done.
c. For research in institutions (schools, nursing homes, hospitals, prisons):
Researchers will need to provide written documentation to the IRB chair that the
institution approves of your research project before you begin to collect data.
Researchers may also include this information as an appendix if they have
contacted an institution before submitting to the IRB. However, the IRB makes
the final decisions regarding all procedures and instruments, so it is reasonable to
obtain formal IRB approval before obtaining approval from an institution.
Tusculum IRB Handbook 29
Instruments for Data Collection
If used, please include a copy of all instruments that will be used in the research study. If
the instrument is commercially available, please provide a representative sample of questions
from the instrument. Research instruments include, but are not limited to the following: surveys,
interview guides, observation tools, psychometric tests, or any data collection tool.
Recruitment Materials
If used, please include a copy of all recruitment materials used in the research study. If
the research involves cooperating institutions, organizations, or agencies, please include
authorization from those entities to use the recruitment materials as well. Recruitment materials
include such things as flyers, recruitment advertisements, survey monkey descriptions.
IRB Training Verification
IRB training verification is required for Expedited and Full IRB review. Please note that
while IRB training verification is not required for Exempt research, if the IRB determines that
your research is not Exempt or that there are risks to the subjects, the researcher will be required
to provide IRB training verification prior to beginning the study.
All investigators leading or assisting with any phase of a research project (design, data
collection, data analysis, presentation) must complete IRB Training and provide documentation
of completion to the IRB. Researchers may complete Tusculum’s Online IRB Training3. The
IRB Committee also recognizes previously completed “Protecting Human Research Subjects”
3 https://ws.tusculum.edu/survey/index.php/184947
Tusculum IRB Handbook 30
NIH Extramural Research Training course4 or the CITI Program training course5 that was
completed within the last five years. Each investigator is responsible for registering for the
course, reading the content, passing the review quizzes, and printing a copy of the certificate of
completion. The IRB Training must be completed and submitted by the lead investigator and the
faculty supervisor (if applicable) before submitting an IRB application. Certificate(s) of
Completion must be submitted for any additional investigators before the project is approved. All
researchers must provide verification of current IRB training at a frequency no less than every
five years.
4 http://phrp.nihtraining.com/users/login.php 5 https://about.citiprogram.org/en/homepage/
Tusculum IRB Handbook 31
Important Additional Considerations
Safeguarding Information
Safeguarding information about an individual that has been obtained in the course of
investigation is a primary obligation of the researcher. When the researcher is a student,
responsibility for the conduct of the research and the supervision of human subjects lies with the
faculty / staff sponsor. Such information shall not be communicated to others unless explicit
permission for the release of identifying data is provided by the individual. Information about
individuals may be discussed only for professional purposes and only with persons clearly
concerned with the project. Written and oral reports should present only data germane to the
purposes of the project, and every effort should be made to avoid invasion of privacy.
Provisions must also be made for the maintenance of confidentiality in the preservation
and ultimate disposition of any data collected. Adequate security measures must be described to
the IRB and carried out by the principal researcher until the records are destroyed. Records
containing personal information shall be destroyed as soon as possible in keeping with the long-
range goals of the project.
Signed copies of informed consent forms must be maintained by the principal researcher
and be stored in a secure manner. Unless otherwise specified by Federal and/or state regulations,
retention shall be for a period of at least three years beyond the termination of the study. If the
investigator resigns from Tusculum before the end of the designated period, the informed consent
forms must be submitted to the IRB unless otherwise specified.
The one exception to provisions of confidentiality however concerns the federal
government. Unless the researcher files a form with the federal government requesting
Tusculum IRB Handbook 32
confidentiality before data is collected, federal officials concerned with protection of subjects are
allowed to request data collected by an investigator.
Certificate of Confidentiality
A Certificate of Confidentiality may sometimes be required by granting agencies such as
NIH to provide additional protection for vulnerable populations. The following is a summary of
policies from Health and Human Services6.
The Public Health Service Act §301(d), 42 U.S.C. §241(d), "Protection of privacy of
individuals who are research subjects," states:
The Secretary may authorize persons engaged in biomedical, behavioral, clinical, or other
research (including research on mental health, including research on the use and effect of alcohol
and other psychoactive drugs) to protect the privacy of individuals who are the subject of such
research by withholding from all persons not connected with the conduct of such research the
names or other identifying characteristics of such individuals. Persons so authorized to protect
the privacy of such individuals may not be compelled in any Federal, State, or local civil,
criminal, administrative, legislative, or other proceedings to identify such individuals.
The privacy of the research subjects referred to in §301(d) is protected through the
issuance of Certificates of Confidentiality. These certificates of Confidentiality provide
protection against compelled disclosure of identifying information about subjects enrolled in
sensitive biomedical, behavioral, clinical, or other research. This protection is not limited to
federally supported research.
Guidance: OHRP does not issue Certificates of Confidentiality. Certificates of
Confidentiality are issued by the National Institutes of Health (NIH) and other HHS agencies to
6 https://humansubjects.nih.gov/coc/index
Tusculum IRB Handbook 33
protect identifiable research information from forced or compelled disclosure7. They allow the
investigator and others who have access to research records to refuse to disclose identifying
information on research participants in civil, criminal, administrative, legislative, or other
proceedings, whether federal, state, or local. Certificates of Confidentiality may be granted for
studies collecting information that, if disclosed, could have adverse consequences for subjects,
such as damage to their financial standing, employability, insurability, or reputation. By
protecting researchers and institutions from being compelled to disclose information that would
identify research subjects, Certificates of Confidentiality help to minimize risks to subjects by
adding an additional level of protection for maintaining confidentiality of private information.
Certificates of Confidentiality protect subjects from compelled disclosure of identifying
information but do not prevent the voluntary disclosure of identifying characteristics of research
subjects. Researchers, therefore, are not prevented from voluntarily disclosing certain
information about research subjects, such as evidence of child abuse or a subject's threatened
violence to self or others.
However, if a researcher intends to make such voluntary disclosures, the consent form
should clearly indicate this. Furthermore, Certificates of Confidentiality do not prevent other
types of intentional or unintentional breaches of confidentiality. As a result, investigators and
IRBs must ensure that other appropriate mechanisms and procedures are in place to protect the
confidentiality of the identifiable private information to be obtained in the proposed research.
7 CoC Contacts at NIH and Other HHS Agencies that Issue Certificates https://humansubjects.nih.gov/coc/contacts
Tusculum IRB Handbook 34
Changes to the Protocol
If a research procedure changes after a research project has been approved, the researcher
must not proceed with the proposed changes without written approval of the IRB.
In cases where a researcher is seeking approval for a project essentially identical to a
project previously approved by the IRB, renewed approval should be obtained generally through
an expedited review. Full reviews are required when an investigator submits a previously
approved proposal to other funding agencies.
Adverse Effects on Subjects
It is the researcher’s responsibility to notify the IRB in writing of any adverse effects to
research Subjects within one week of such event(s). If a researcher should encounter any
unexpected and serious adverse effects on human Subjects, research should be immediately
discontinued and the IRB must be notified.
Renewed Approval
Any project which exceeds a period of one year in duration must be reviewed and receive
IRB approval prior to the beginning of the second and any successive years of the research project.
Renewed Approval must be sought at least one month prior to the anniversary date of approval for
the research study.
The Consent Form is also valid for a maximum of one year after its approval. In cases
where a project is continuing beyond one year, permission to continue use of the Informed Consent
Form must be applied for at least one month in advance of the one-year anniversary date. Such
permission is granted in conjunction with the application for Continuing Review.
Tusculum IRB Handbook 35
IRB Divisional Tracking for Research Course Assignments
The IRB Divisional Tracking Form for Research Course Assignments is the Appendix.
The form may be copied from the appendix and submitted electronically, along with relevant
documents, to the chair of the IRB committee.
After the IRB Divisional representatives have approved a project, the Tracking Form will
be returned to the faculty person for his/her records and a copy will be submitted to the IRB
chair.
Tusculum IRB Handbook 36
Appendix: Definitions of Terms
Anonymized data — Lacking “identifiers or codes that can link a particular sample to an
identified specimen or a particular human being.” The data is unidentified. (i.e.,
personally identifiable information was not collected, or if collected, identifiers were not
retained and cannot be retrieved). Information or materials (e.g., data or specimens) that
cannot be linked directly or indirectly by anyone to their source(s). Source: 2000.
Research Involving Human Biological Materials: Ethical Issues and Policy Guidance,
Executive Summary. Rockville, MD: National Bioethics Advisory Committee, p. 2.
(http://bioethics.georgetown.edu/nbac/hbm_exec.pdf)
Assent — “...affirmative agreement to participate in research. Mere failure to object should not,
absent affirmative agreement, be construed as assent.”
Source: 45 CFR 46.402(b)
Autonomous person — “An individual capable of deliberation about personal goals and of
acting under the direction of such deliberation.” Source: National Commission for the
Protection of Human Subjects of Biomedical and Behavioral Research. 1979. The
Belmont Report — Ethical Principles and Guidelines for the Protection of Human
Subjects of Research. Washington, D.C.: U.S. Department of Health and Human
Services: Part B, section 1, “Respect for Persons”
(http://ohsr.od.nih.gov/guidelines/belmont.html)
Children — Some federal definitions define all minors as children. Tusculum differentiates
between children and minors. A minor thirteen and under.
Clinical trial — “...a prospective biomedical or behavioral research study of human subjects that
is designed to answer specific questions about biomedical or behavioral interventions
(drugs, treatments, devices, or new ways of using known drugs, treatments, or devices).”
Source: US Department of Health and Human Services Grant Application (PHS 398) Part
II: Supplemental Instructions for Preparing the Human Subjects Section of the Research
Plan (http://grants.nih.gov/grants/funding/phs398/phs398.pdf#page=109)
Tusculum IRB Handbook 37
Coded Data — Direct personal identifiers have been removed (e.g., from data or specimens) and
replaced with words, letters, figures, symbols, or a combination of these (not derived
from or related to the personal information) for purposes of protecting the identity of the
source(s); but the original identifiers are retained in such a way that they can be traced
back to the source(s) by someone with the code. Note: A code is sometimes also referred
to as a “key,” “link,” or “map.”
Coercion — Influencing an individual’s decision about whether or not to do something by using
explicit or implied threats (loss of good standing in a job, poor grades, etc.). Coercion and
be unintentional, (i.e. a supervisor asking a subordinate to participate in a research study).
Source: Faden, RR, and Beauchamp, TL. 1986. A History and Theory of Informed
Consent. New York: Oxford University Press, p. 339.
Compensation — May include money, other material compensation, such as a coupon or gift
certificate, or other non-monetary rewards (e.g. extra credit).
Deception — Misleading research subjects about the research purpose or procedures.
De-identified — All direct personal identifiers are permanently removed (e.g., from data or
specimens), no code or key exists to link the information or materials to their original
source(s), and the remaining information cannot reasonably be used by anyone to identify
the source(s). Note: For purposes of HRPP policy, protected health information is de-
identified when it does not contain any of the 18 identifiers specified by the HIPAA
Privacy Rule at 45 CFR Part 164 (or has been determined to be de-identified by a
statistician in accordance with the standards established by the Privacy Rule). For more
information, including the list of identifiers that must be removed to de-identify health
information, see HIPAA and Human Subjects Research.
Delivery — “Complete separation of the fetus from the woman.” Source: 45 CFR 46.202(b)
Diminished autonomy — An individual with restricted capability of deliberation about personal
goals and of limited ability to act under the direction of their deliberations. Developed in
contrast to the concept of the “autonomous person” in The Belmont Report. Source:
National Commission for the Protection of Human Subjects of Biomedical and
Tusculum IRB Handbook 38
Behavioral Research. 1979. The Belmont Report — Ethical Principles and Guidelines for
the Protection of Human Subjects of Research. Washington, D.C.: U.S. Department of
Health and Human Services: Part B, section 1, “Respect for Persons.”
(http://ohsr.od.nih.gov/guidelines/belmont.html)
Equipoise — Substantial scientific uncertainty about which treatments will benefit subjects
most, or a lack of consensus in the field that one intervention is superior to another.
Fetus — “The product of conception from implantation until delivery.” Source: 45 CFR
46.202(c)
Human Participant — A living individual about whom an investigator (whether professional or
student) conducting research obtains a) data through intervention or interaction with the
individual or b) identifiable, private information. Tusculum utilizes the term subjects and
human participants interchangeably.
Incomplete disclosure — Withholding some information in order to conduct an unbiased study,
with the understanding that the information could be material to a decision by prospective
subjects about whether or not to participate in the study.
Informed consent — A legally-effective, voluntary agreement that is given by a prospective
research subject following comprehension and consideration of all relevant information
pertinent to the decision to participate in a study.
Institutional Review Board — The committee at Tusculum given the authority to approve or
disapprove research projects involving subjects.
Interaction — Communication or interpersonal contact between researcher and subject.
Intervention — Both physical procedures by which data are gathered (for example,
venipuncture) and manipulations of the subject or the subject's environment that are
performed for research purposes.
Investigator — “OHRP considers the term investigator to include anyone involved in
conducting the research. OHRP does not consider the act of solely providing coded
Tusculum IRB Handbook 39
private information or specimens (for example, by a tissue repository) to constitute
involvement in the conduct of the research. Note that if the individuals who provide
coded information or specimens collaborate on other activities related to the conduct of
this research with the investigators who receive such information or specimens, then
OHRP would consider such additional activities to constitute involvement in the conduct
of the research. Examples of such additional activities include, but are not limited to: (1)
the study, interpretation, or analysis of the data resulting from the coded information or
specimens; and (2) authorship of presentations or manuscripts related to the research.”
Source: OHRP, HHS. 2004. Guidance on Research Involving Coded Private Information
or Biological Specimens. (http://www.hhs.gov/ohrp/policy/cdebiol.html). Tusculum
utilizes the term researcher and investigator interchangeably.
Legally Authorized Representative — “An individual or judicial or other body authorized
under applicable law to consent on behalf of a prospective subject to the subject’s
participation in the procedure(s) involved in the research.” Source: 45 CFR 46.102(c)
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.” Source: 45 CFR 46.102(i)
Minor — “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.” Source: 45 CFR 46.402(a)
Neonates — “A newborn.” Source: 45 CFR 46.202(d)
Permission — “The agreement of parent(s) or guardian to the participation of their child or ward
in research.” Source: 45 CFR 46.402(c)
Placebo — An inactive intervention designed to resemble, as much as possible, its active
counterpart in clinical research.
Tusculum IRB Handbook 40
Pregnancy — “Encompasses the period from the implantation until delivery. A woman shall be
assumed to be pregnant if she exhibits any of the pertinent presumptive signs of
pregnancy, such as missed menses, until the results of a pregnancy test are negative or
until delivery.” Source: 45 CFR 46.202(f)
Prisoner — “Any individual involuntarily confined or detained in a penal institution. The term
is intended to encompass individuals sentenced to such an institution under a criminal or
civil statute, individuals detained in other facilities by virtue of statutes or commitment
procedures which provide alternatives to criminal prosecution or incarceration in a penal
institution, and individuals detained pending arraignment, trial, or sentencing.” Source:
45 CFR 46.303
Private Information — information about behavior that occurs in a context in which an
individual can reasonably expect that no observation or recording is taking place, and
information that has been provided for specific purposes by an individual and that the
individual can reasonably expect will not be made public (for example, a medical record).
Private information must be individually identifiable (i.e., the identity of the subject is or
may readily be ascertained by the investigator or associated with the information) in
order for obtaining the information to constitute research involving human Subjects.
Research — systematic investigation designed to develop or contribute to generalizable
knowledge. Under this definition some demonstration, service and training projects may
be considered to include research activities
Researcher — “OHRP considers the term investigator to include anyone involved in conducting
the research. OHRP does not consider the act of solely providing coded private
information or specimens (for example, by a tissue repository) to constitute involvement
in the conduct of the research. Note that if the individuals who provide coded information
or specimens collaborate on other activities related to the conduct of this research with
the investigators who receive such information or specimens, then OHRP would consider
such additional activities to constitute involvement in the conduct of the research.
Examples of such additional activities include, but are not limited to: (1) the study,
interpretation, or analysis of the data resulting from the coded information or specimens;
Tusculum IRB Handbook 41
and (2) authorship of presentations or manuscripts related to the research.”
Source: OHRP, HHS. 2004. Guidance on Research Involving Coded Private Information
or Biological Specimens. (http://www.hhs.gov/ohrp/policy/cdebiol.html). Tusculum
utilizes the term researcher and investigator interchangeably.
Subjects — A living individual about whom an investigator (whether professional or student)
conducting research obtains a) data through intervention or interaction with the individual
or b) identifiable, private information. Tusculum utilizes the term subjects and human
participants interchangeably.
Therapeutic Misconception — The tendency for research subjects to: “downplay or ignore the
risks posed to their own well-being by participation ... [due to] the subjects’ deeply held
and nearly unshakeable conviction that every aspect of their participation in research has
been designed for their own individual benefit.” Source: Emanuel, EJ et al., eds. 2003.
Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary.
Baltimore, MD: The Johns Hopkins University Press, p.194.
Undue Burden — Research populations must not be subject to undue burden, wherein they are
“systematically selected simply because of their easy availability, their compromised
position, or their manipulability, rather than for reasons directly related to the problem
being studied.” Source: National Commission for the Protection of Human Subjects of
Biomedical and Behavioral Research. 1979. The Belmont Report — Ethical Principles
and Guidelines for the Protection of Human Subjects of Research. Washington, DC: U.S.
Department of Health and Human Services: Part B, section 3, “Justice”
(http://ohsr.od.nih.gov/guidelines/belmont.html)
Undue influence — “An offer of an excessive, unwarranted, inappropriate, or improper reward
or other overture in order to obtain compliance.” Source: Emanuel, EJ et al., eds. 2003.
Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary.
Baltimore, MD: The Johns Hopkins University Press, p.37.
Tusculum IRB Handbook 42
Appendix: Template for Consent/Permission Form
The template available on the IRB website as well on the Tusculum IRB Moodle Site
under Tusculum Governance is designed to help Tusculum Faculty, Staff, and Students as they
design the consent process and prepare a consent form. All researchers are STRONGLY
ENCOURAGED to make use of this template. If this template is not appropriate for a particular
study or if you have any consent questions, contact the IRB Chair.
Remember that what is included here relates to consent, designed for adults. For children,
assent needs to be obtained as well as permission from parent or guardian. For the IRB, assent
should be a few simple paragraphs that you include as a separate document in your submission
(outlining what you will tell each child before they take part in your study. It should explain
everything you will be asking them to do and that they can stop at any time. You are expected to
get their personal permission to participate (assent) before you use them as Subjects. If they are
able, they can assent in writing, as well as verbally. When working with young children, you must
describe how on-going assent will be assessed – what behavioral or verbal cues will be used to
determine whether continuing is appropriate or not.
Tusculum IRB Handbook 43
Appendix: IRB Divisional Tracking Form
The template available on the IRB website as well on the Tusculum IRB Moodle Site under
Tusculum Governance is designed to help Tusculum Faculty get research with minimal risk
approved that will only occur within the classroom and is not for publication.
To Be Completed by the Faculty Person Submitting the Research Assignment
Tusculum IRB Handbook 44
General Categories of IRB Submissions
Exempt
Category 1
o Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
o Examples: Evaluating the use of accepted or revised standardized tests Testing or comparing a curriculum or lesson A program evaluation of pharmacy continuing education
Category 2
o Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects’ responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation.
o Examples: Surveying teachers, nurses, or doctors about a technique or an outcome Interviewing managers about a management style or best practice Conducting a focus group about an experience or an opinion of a
community program
Category 3
o Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (2) of this section, if: (i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
o Example: Interviewing public officials about a local or global issue.
Tusculum IRB Handbook 45
Category 4
o Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
o Example: Analyzing existing tissue samples or data set which are recorded by the
investigator without identifiers
Category 5
o Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine: (i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.
o See OHRP’s guidance regarding this category
Category 6
o Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) 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 and Inspection Service of the U.S. Department of Agriculture. (See also FDA’s Exempt Category)
Expedited
Category 1
o Clinical studies of drugs and medical devices only when condition (a) or (b) is met: 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.)
Tusculum IRB Handbook 46
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.
Category 2
o Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows: 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
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.
Category 3
o Prospective collection of biological specimens for research purposes by noninvasive means.
o Examples: hair and nail clippings in a nondisfiguring manner; deciduous teeth at time of exfoliation or if routine patient care indicates a
need for extraction; permanent teeth if routine patient care indicates a need for extraction; excreta and external secretions (including sweat); un-cannulated saliva collected either in an unstimulated fashion or
stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue;
placenta removed at delivery; amniotic fluid obtained at the time of rupture of the membrane prior to or
during labor; 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;
mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings;
sputum collected after saline mist nebulization.
Tusculum IRB Handbook 47
Category 4
o 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.)
o Examples: 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 subjects privacy;
weighing or testing sensory acuity; magnetic resonance imaging; electrocardiography, electroencephalography, thermography, detection of
naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography;
moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.
Category 5
o Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes (such as medical treatment or diagnosis).
o Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(4).
o This category includes materials that were previously collected for either non-research or research purposes, provided that any materials collected for research were not collected for the currently proposed research.
o The phrase “…or will be collected solely for non-research purposes” pertains to the origin of the materials. For example, blood samples that were collected for a clinical test or the results of a course driven exam given in a history class.
Category 6
o Collection of data from voice, video, digital, or image recordings made for research purposes.
o Expedited Review does not apply if identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, insurability,
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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.
Category 7
o 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.
Full Review
• Studies that involve more than minimal risk require full board review at a convened meeting at which a quorum of IRB members is present. For the research to be approved, it must receive the approval of a majority of those members.
• While federal regulations do not specifically list categories that require full board review, studies such as those listed below are normally sent to full board for review when part of the study design involves greater than minimal risk procedures:
o studies involving clinical procedures with drugs, devices, or biologics, or innovative research into new medical or surgery procedures
o studies taking place internationally (particularly countries with little or no provisions for protection of human subjects) where subjects may be at physical, psychological or legal risk
o studies in which disclosed information could require mandatory legal reporting (e.g., child/elder abuse, etc.)
o studies involving deception which raise the risk to subjects or others o studies in which the IRB staff, chair, member, or designee determines risk to
subjects or others to be greater than minimal risk o studies using “vulnerable populations”* and thus requiring extra protections
*Children, prisoner, pregnant women and neonates
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Appendix: Online Resources for IRBs
Office of Human Research Protections; links to other resources http://www.hhs.gov/ohrp/
APA research ethics page, links to other resources http://www.apa.org/ethics/
Office of Research Integrity https://ori.hhs.gov/
https://ori.hhs.gov/human-subject-research-0
45CFR 46
https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html
Nuremberg Code
https://history.nih.gov/research/downloads/nuremberg.pdf
National Research Act of 1974
https://history.nih.gov/research/downloads/PL93-348.pdf
Belmont Report
https://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/index.html
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U.S. Department of Education, Protection of Human Subjects in Research
http://www.ed.gov/about/offices/list/ocfo/humansub.html
American Association for Public Opinion Research http://www.aapor.org/additionalirbresources
IRB Review of the Use of Social Medium in Research
https://www.quorumreview.com/wp-content/uploads/2012/12/IRB-Review-of-the-Use-of-Social-Media-in-Research_Gearhart_Quorum-Review_Monitor_2012_12_01.pdf
ORI Introduction to Responsible Conduct of Research
https://ori.hhs.gov/sites/default/files/rcrintro.pdf