Policies and Procedures for the Protection of Human Subjects in
Approved December 1994; modified December 2001, May
2009, July 2011 and January 2012
Application Form for Accepting Approval of another Institution's
Summary and Introduction ~ View Details
Human Subjects Research
Research for the purpose of the human subjects policy is defined
as "A systematic investigation designed to develop or contribute to
generalizable knowledge". Research includes questionnaires,
interviews, tests, observations, surveys and other experiments.
All faculty, staff and students conducting research involving
human subjects under the auspices of Butler University.
The Provost and Vice President of Academic Affairs is
responsible for the administration of the human subjects policy and
procedures. The Provost and Vice President of Academic Affairs may
disallow approvals of the IRB, but cannot change disapprovals or
impose restrictions. The oversight of the policy and management of
the procedures is delegated to the Director of the Institute for
Research and Scholarship.
Institutional Review Board (IRB)
The IRB is the institutional body that approves the procedures
to be used in research with humans. The IRB may suspend or
terminate approvals. The IRB is appointed by the Provost and Vice
President of Academic Affairs for three year staggered terms and is
composed of at least five individuals, including at least four
faculty members, one outside member and the Director of the
Institute for Research and Scholarship who is ex-officio
The individual researcher is responsible for knowledge about the
human subjects policy and procedures. The academic or thesis
advisor of a student is responsible for familiarizing the student
with the policy and procedures.
Application and Approval Process
Researchers complete the Application for Approval and submit it
to the Director of the Institute for Research and Scholarship. The
Director will ascertain if the application is complete and forward
it to the appropriate reviewer. The IRB will decide if a human
subjects protocol is approved, conditionally approved with required
revisions or denied for those reviews where such review is
The IRB must conduct a minimum of one review of approved
research activities every 12 months. The IRB may request an update
or periodic review from any investigator at any time. The IRB may,
from time to time, conduct such additional reviews as may be
necessary to assure that compliance with policies, guidelines, and
pertinent law is satisfactory. Examples of studies that
may require more frequent review include transplant protocols
and gene therapy studies. The IRB may consider whether involvement
of vulnerable populations merits more frequent review. In addition,
if a protocol has a number of protocol-related adverse events which
cause concern, or if there are compliance or other problems
associated with the protocol, the approval interval may be reduced
so that re-review frequency is increased.
Protocol reviews are monitored by the Institute for Research and
Scholarship (BIRS). The BIRS forwards continuing review notices to
the Principal Investigator 30-60 days in advance of the due date,
and an overdue notice the day after the due date. This review is
due each year in the same month the protocol was originally
approved; if the review has not been completed and turned in to the
BIRS by the due date, accrual on that protocol is suspended until
the review is completed. The PI must complete and sign a continuing
review form regarding protocol progress to date and addressing any
adverse events, both expected and unexpected, any unanticipated
problems involving risks to subjects or others, and a summary of
any reports or complaints about the research since the last IRB
Continuing review forms remain in the same category in
which the original protocol was approved (expedited or
full), unless circumstances dictate a change in category.
Following approval of the continuing review form submitted by the
PI, the PI will be notified of final approval through receipt of a
letter from the BIRS. If there are stipulations and/or
recommendations, the review will be returned to the PI for
revisions. These revisions must be made within 10 days of
notification of the IRB stipulations/recommendations in
Informed consent is required for most expedited and full review
projects unless the investigator specifically requests a waiver
from informed consent (45 CFR 46.116). Informed consent is
recommended for exempt projects but is at the discretion of the
Research involving prisoners, children, people with
disabilities, pregnant women and other vulnerable groups has
Maintenance of Records
The University, the IRB and the Researcher must maintain
appropriate records for three years after the termination of the
A written description of the involvement of humans in the
research project and the measures to protect them from risk.
Butler University recognizes the responsibility to protect the
rights and welfare of individuals involved as subjects of research
conducted under the auspices of the institution or under the
direction of any employee or agent of the institution. The IRB's
Policies and Procedures reflect the institutions commitment to the
protection of human subjects in research. These policies and
procedures are in compliance with the Department of Health and
Human Services (DHHS) regulations for the Protection of Human
Research Subjects (Title 45, Code of Federal Regulations, Part 46,
Revised June 18, 1991). Butler University is also guided by the
ethical principles regarding the use of human subjects in research
as set forth in the report of the National Commission for the
Protection of Human Subjects of Biomedical and Behavioral Research
entitled "Ethical Principles and Guidelines for the Protection of
Human Subjects of Research (Belmont Report)".
Applicability ~ View Details
This policy applies to research under the auspices of the
University involving the use of human subjects conducted by Butler
University faculty, staff or students regardless of the source of
funding. "Under the auspices of the University" is defined as: The
research is funded externally by way of a grant, contract or
similar agreement between the sponsor (public or private) and the
University, the University by way of grant, contract or similar
agreement funds the research internally, the research is conducted
upon assignment by the University, or the research is actively
assisted by the use of University facilities, resources, supplies,
equipment or personnel. Any research involving human participants
that is conducted by faculty, staff or students at Butler
University must be submitted for review to the IRB. Similarly, any
research conducted on the property of Butler University, regardless
of the affiliation of the researcher, must be submitted for review.
Review and approval by an IRB at another institution does not
constitute an exemption from review by the Butler IRB, although the
Butler IRB may elect to rely upon the review of another qualified
Definitions ~ View Details
Butler University has adopted the following definitions included
in the federal regulations to guide researchers and other
interested parties in determining the necessity for review:
"A systematic investigation designed to develop or contribute to
generalizable knowledge." Research encompasses work that is
conducted on or off campus and includes questionnaires, interviews,
tests, observations, surveys, and other experiments, regardless of
the content or routine nature of the research. The policy applies
to research that is preliminary in nature as well as fully
developed study. Research extends, but is not limited, to any
systematic collection of data from human subjects that occurs in
conjunction with classroom projects, "demonstration" and "service"
"A living individual about whom an investigator, whether
professional or student, conducting research obtains
- data through intervention or interaction with the individual,
- identifiable private information."
Includes 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.
Includes communication or interpersonal contact between
investigator and subject.
Includes 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 which has been provided
for specific purposes by an individual and which the individual can
reasonably expect will not be made public (for example, a medical
Means that the risks or harm anticipated in the proposed
research are not greater, considering probability and magnitude,
than those ordinarily encountered in daily life or during the
performance of routine physical or psychological examination or
A subject's affirmative agreement, oral or written, to
participate in research. Failure to object cannot be construed as
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
The procedures and rules for dealing with the subject and the
records derived from the subject.
Administration ~ View Details
The Butler University official responsible for overseeing the
Policy and Procedures for the Protection of Human Subjects in
Research is the Provost and Vice President of Academic Affairs. The
functions to be performed by the University include: the
development of an institutional policy, the establishment of
procedures to insure protection for human subjects in research, the
continuing education of personnel with respect to the policy, the
modification of the policy to maintain its conformity with laws and
regulations, and the provisions of appropriate administrative
support and legal assistance for the IRB. The Provost and Vice
President of Academic Affairs has delegated the oversight of the
policy and procedures, the management of support services required
by the Institutional Review Board (IRB) and the maintenance of
records to the Director of the Institute for Research and
Institutional Review Board ~ View Details
The IRB is responsible for the review, approval or disapproval
of all research subject to this policy.
- The IRB shall be composed of at least five individuals,
including at least four faculty members and one member who is not
otherwise affiliated with the University and who is not part of the
immediate family of a person affiliated with the University. The
University IRB shall include at least one faculty member whose
primary concerns are in a non-scientific area. The Director of the
Institute for Research and Scholarship will be an ex-officio
non-voting member of the IRB.
- The Provost and Vice President of Academic Affairs will appoint
all members for terms of three (3) years. Membership on the IRB
shall be staggered so that the terms of no more than two members
will expire in any given year. Members may be reappointed.
- The IRB shall elect two officers, a Chair and a Vice Chair, to
serve two-year terms. Officers may be re-elected. The Director of
the Institute for Research and Scholarship will be the Secretary to
- No member who has a conflicting interest in a particular
research project may participate in the IRB's initial or continuing
review of that research except to provide information requested by
- The IRB, at its discretion, may invite individuals with
competence in special areas to assist in the review of complex
issues which require expertise beyond, or in addition to that
available on the IRB. These individuals may not vote with the
Responsibilities of the IRB
- Be responsible for the review of proposed research projects
involving human subjects and the approval, required modifications
for approval or the disapproval of the proposed research.
- Determine the most appropriate type of review (i.e. Exempt,
expedited or full) for a proposed research project. In cases of an
Exempt review, the IRB chairperson or one member of the
IRB will evaluate the proposal. An Exemption Reviewer has the
authority to approve a study, ask for clarification to ensure the
procedures meet the Exempt criteria, or disapprove the research for
exemption. The chairperson shall provide oversight to the Exemption
review process to ensure compliance with the policies and
procedures of this Board.
- A proposed study that is disapproved for exemption is eligible
for submission to the IRB as a Full or Expedited application. In
cases of an Expedited review, the IRB chairperson or one or two
members of the IRB designated by the IRB chairperson will evaluate
the proposal. In cases of a Full Review, (1) the review must be
conducted at a convened meeting (2) a majority of members must be
present, (3) at least one member whose primary concerns are in
nonscientific areas must be present at the meeting, and (4) the
study must receive approval of a majority of the members present at
- Notify the investigator and the Provost and Vice President of
Academic Affairs in writing, of its decision. If the IRB decides to
disapprove a research activity, it shall include in its written
notification a statement of the reasons for its decision and give
the investigator an opportunity to respond in person or in
- Conduct continuing reviews of approved research in accordance
with this policy and report all findings and actions to the Provost
and Vice President of Academic Affairs.
- Require that information given to subjects as part of informed
consent is in accordance with this policy and applicable law.
Require documentation of informed consent or waive documentation in
accordance with this policy.
- Establish written policies for conducting the initial review,
monitoring and approving of continuing projects for annual review
or any changes in procedure.
- Require prompt reporting to the IRB of unanticipated problems
involving risks to subjects or others.
- Be responsible for reporting to the Provost and Vice President
of Academic Affairs and the appropriate government agency any
serious or continuing non-compliance by investigators.
The IRB will meet on a monthly basis unless there is
no business to be conducted. At a minimum, the Board will
meet once each semester. The IRB will have other meetings as
needed. These meetings will be called by the Chair or at the
request of a majority of the members on the IRB. A quorum is
a majority of the voting members. A majority vote of the
members present is required to approve research protocols.
Researcher Responsibilities ~ View Details
It is the responsibility of the researcher to know and comply
with the Butler University Policy and Procedures for the Protection
of Human Subjects and the requirements of the IRB. Research
investigators shall make a determination as to whether research
will involve human subjects using the definitions on this website.
When it is not clear whether the research involves human subjects,
researchers should seek assistance from the Chair of the IRB or the
Director of the Institute for Research and Scholarship.
- Comply with the policy and procedures to obtain approval for
- Complete the Application for Approval describing the research
to ensure the protection of human subjects and submit it to the
Director of the Institute for Research and Scholarship.
- Ensure that required compliance with the policy on informed
consent is followed.
- Inform the IRB and the Director of the Institute for Research
and Scholarship of any problems related to human subjects as part
of the research.
- Ensure that the IRB is informed and approval is obtained for
any changes in the research involving human subjects.
- Ensure that the IRB is informed and approval is obtained for
projects continuing beyond the yearly anniversary date of
- Provide to the IRB and the Director of the Institute for
Research and Scholarship a brief description of the results of
the research and benefits to and problems for the subjects.
- Maintain all appropriate records related to the research and
the measures to protect human subjects.
Training Requirements - Updated August 2011 ~
All personnel involved in Human Subjects Research that is
under the purview of the Butler University IRB must demonstrate
completion of an education program on the use of human participants
in research. In the fall of 2010 the university began using
an on-line education program through the Collaborative
Institutional Training Initiative (CITI). One advantage
of this program is that it includes material for both
social and behavioral researchers and biomedical
As of October 1, 2011, anyone from Butler University who has not
completed human subjects education and will be involved in human
subjects research must complete a CITI course. People
who have previously completed the CITI education do not need to
repeat the CITI course.
To complete the required education go to CITI's
- Select Butler University as your "participating institution"
and create an account.
- When you have created an account you will be directed to a page
titled "Select Curriculum" which displays a list of courses on
Human Subjects Research: Biomedical Research Investigators; Social
& Behavioral Investigators, and IRB Members. Choose the human
subject research module most appropriate to the type of research
- The course may take a few hours to complete but can be done
over a period of time. When you complete the course, CITI will
e-mail your completion record to the BIRS office.
If you have done CITI education for another organization,
add Butler to your profile. You will be given credit for your
previous courses to the extent they overlap with Butler's
Should the researcher be a student, the student's academic or
thesis advisor assumes primary responsibility for the proposed
activity. The advisor is to familiarize the student with his/her
obligation for the protection of the subject from risks incurred as
a result of participating in the research. Student researchers must
abide by the above training requirements (CITI Training).
Application and Protocol Guidelines ~ View Details
Any Butler employee or student planning to conduct research
involving human subjects should proceed as follows:
- Read the Policy and Procedures for the Protection of Human
Subjects in research as provided in 45 CFR 46.
- Contact firstname.lastname@example.org for
- Complete and submit the application form to the Institute for
Research and Scholarship in JH 109.
Guidelines for Completing Faculty Research Protocols
- Describe the purpose of the study, and in non-technical terms,
what will happen to your subjects.
- Describe any potential risks to the subjects.
- Give the ages, sex, and number of subjects, and explain how
they will be recruited.
- Describe the procedures for obtaining informed consent as
provided for in the Code of Federal Regulation section 46.116.
- Provide copies of questionnaires, letters, stories or other
documents to be used in the investigation.
- If minors are involved, describe the procedures for obtaining
individual assent to participate from minors capable of giving
assent, as well as the procedures to obtain parental or guardian
- Explain fully the knowledge to be gained and/or the benefits to
the subjects from the proposed research. Justify the risks that the
subjects may incur.
- Explain what, if any, support services will be provided in the
event of harm to a subject.
Types of Reviews ~ View Details
Exempt ~ determined by an Exempt IRB Reviewer
designated by the IRB chairperson; View Details
Exemption from Review
Research involving human subjects is exempt from review if it
satisfies one or more of the conditions listed below.
- Research conducted in established or commonly accepted
educational settings, involving normal education practices, such as
- research on regular and special educational instructional
- research on the effectiveness of or the comparison among,
instructional techniques, curricula, or classroom management
- Research involving the use of educational tests (cognitive,
diagnostic, aptitude, achievement), survey procedures, interview
procedures or observation of public behavior, unless:
- information obtained is recorded in such a manner that human
subjects can be identified, directly or through identifiers linked
to the subjects.
- any disclosure of the human subjects' responses outside of 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.
- Research involving survey or interview procedures, except where
all of the following conditions exist:
- responses are recorded in such a manner that the human subjects
can be identified, directly or through identifiers linked to the
- responses if known outside the research, could reasonably place
the subject or respondent at risk of criminal or civil liability or
be damaging to the subjects' financial standing or
- the research deals with sensitive aspects of the subject's own
behavior, such as illegal conduct, drug use, sexual behavior, or
use of alcohol.
NOTE: All research involving survey or interview procedures is
considered "exempt" when the respondents are elected or appointed
public officials or candidates for public office.
- Research involving the observation (including observation by
participants) of public behavior.
- 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 manner that
subjects cannot be identified directly or through identifiers
linked to the subjects.
- 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:
- public benefit or service programs,
- procedures for obtaining benefits or services under those
- possible changes in or alternatives to those programs or
- possible changes in methods or levels of payment for benefits
or services under those programs
- Taste and food quality evaluation and consumer acceptance
- if wholesome foods without additives are consumed,
- 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.
- Any other category specifically added to this list by the
Department of Health and Human Services and published in the
Expedited Review ~ conducted by the chairperson
or the chairperson and one reviewer designated by the chairperson,
or two reviewers designated by the chairperson; View Details
The IRB may use an expedited review procedure for research that
involves no more than minimal risk to the subjects and in which the
only involvement of human subjects will be in one or more of the
categories listed below. The review may be carried out by the
chairperson or the chairperson and one reviewer designated by the
chairperson, or two reviewers designated by the chairperson. 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. The expedited review conditions are:
- Collection of hair and nail clippings, in a non-disfiguring
manner; deciduous teeth; and permanent teeth if patient care
indicates a need for extraction.
- Collection of excreta and external secretions including sweat,
un-cannulated saliva, placenta removed at delivery, and amniotic
fluid at the time of rupture of the membrane prior to or during
- Recording of data from subjects 18 years of age or older using
noninvasive procedures routinely employed in clinical practice,
which involves no deception. This includes the use of physical
sensors that are applied either to the surface of the body or at a
distance and do not involve input of matter or significant amounts
of energy into the subject or an invasion of the subject's privacy.
It also includes such procedures as weighing, testing sensory
acuity, electrocardiography, electroencephalography, thermography,
detection of naturally occurring radioactivity, diagnostic
echography and electroretinography. It does not include exposure to
electromagnetic radiation outside the visible range (for example,
- Collection of blood samples by venipuncture, in amounts not
exceeding 450 milliliters in an eight week period and no more often
than two times per week, from subjects 18 years of age or older and
who are in good health and not pregnant.
- Collection of both supra and sub gingival dental plaque and
calculus, provided the procedure is not more invasive than routine
prophylactic scaling of the teeth and the process is accomplished
in accordance with accepted prophylactic techniques.
- Video/audio recordings made for research purposes such as
investigations of speech defects.
- Moderate exercise by healthy volunteers.
- The study of existing data, documents, records, pathological
specimens, or diagnostic specimens.
- Research on individual or group behavior or characteristics of
individuals, such as studies of perception, cognition, game theory,
or test development, where the research investigator does not
manipulate subjects' behavior and the research will not involve
stress to subjects.
- Research on drugs or devices for which an investigational new
drugs exemption or an investigational device exemption is not
- Any other category specifically added to this list by the
Department of Health and Human Services and published in the
Expedited Review Follow-up
When the expedited review procedure is used, the IRB chairperson
shall inform the IRB members of the research protocols which have
been approved under the procedure. At a convened IRB meeting, any
member may request that an activity that has been approved under
the expedited procedure be reviewed by the IRB in accordance with
non-expedited procedures. A vote of the members shall be taken
concerning the request and the majority shall decide the issue. The
determination of the IRB will be conveyed to the researcher
following the meeting.
Full Review ~ review by a quorum of IRB members
at a convened meeting. Except as may otherwise be provided by law,
the IRB has final authority to determine whether particular
research is subject to this policy or exempt. Only the full IRB
Board can disapprove a project.
When one other member of the IRB determines a research proposal
involves more than a minimal risk to the subjects and it does not
fall with in the expedited review category, the proposal is
referred to the IRB for full review. In such cases, the researcher
may be required to submit additional information necessary to
perform the risk/benefit analysis outlined below. The full review
- Risks to subjects are minimized:
- by using procedures which are consistent with sound research
design and which do not unnecessarily expose subjects to risk,
- whenever appropriate, by using procedures already being
performed on the subjects for diagnostic or treatment
- Risks to subjects are reasonable in relation to anticipated
benefits, if any, to subjects, and the importance of knowledge that
may reasonably be expected to result. In evaluating risks and
benefits, the IRB shall consider only those risks and benefits that
may result from the research (as distinguished from risks and
benefits of therapies subjects would receive even if not
participating in the research).
- Selection of subjects is equitable. In making this assessment
the IRB shall take into account the purposes of the research, the
setting in which the research will be conducted, and the population
from which subjects will be recruited.
- Informed consent will be sought from each prospective subject
or the subject's legally authorized representative, in accordance
with applicable regulations.
- Informed consent will be appropriately documented in accordance
with applicable regulations.
- Where appropriate, the research plan makes adequate provision
for monitoring the data collected to insure the safety of
- Where appropriate, there are adequate provisions to protect the
privacy of subjects and to maintain the confidentiality of
Cooperative Research Review ~ As
permitted and encouraged by applicable federal regulations to
eliminate duplicative efforts the Butler IRB has approved
a Procedure for Accepting Approval
of Another Institution's IRB. Read full text
Informed Consent Procedures ~ View Details
Unless exempted or specifically waived by the IRB in accordance
with federal regulations, it is the researcher's obligation to
obtain the legally effective informed consent of the subject or the
subject's legally authorized representative prior to the start of
data collection. In addition, the researcher must solicit the
assent of any minor subject capable of assenting. To be legally
effective, informed consent should: be in language understandable
to the subject or the representative; be obtained under
circumstances that offer the subject or the representative
sufficient opportunity to consider whether the subject should or
should not participate; and not include exculpatory language
through which the subject or the representative is made to waive or
appear to waive any of the subject's legal rights, or releases or
appears to release the research investigator, the sponsor, the
institution or its agents from liability for negligence.
Basic Elements of Informed Consent
- Statement that study involves research; explanation of purposes
of research and expected duration of subject's participation;
description of procedures to be followed and identification of any
- Description of risks or discomforts to subject.
- Description of benefit to subject or to others.
- Disclosure of alternative procedures, if appropriate.
- Description of the extent to which confidentiality will be
- For research involving more than minimal risk, explanation as
to whether compensation and medical treatments are available if
- Explanation of whom to contact if questions arise about the
research, the subject's rights or whom to contact if
research-related injury occurs.
- Statement that participation is voluntary, refusal to
participate involves no penalty or loss of benefits, and the
subject may discontinue at any time.
- If minors are involved, a specific section for the
parent/guardian to indicate refusal to allow participation.
Video/Audio Taping Procedures
Unless exemptible, projects involving the use of videotaping or
audiotaping, must make specific mention of these practices in the
consent documents. The subject must have the choice of whether to
participate in the electronic recording procedures. This consent is
separate and distinct from consent to participate in the project,
therefore a separate signature and date line is required.
Videotapes must be appropriately secured during a project and
destroyed after the project to protect the anonymity of the
Additional Consent Requirements
When called for by the IRB, the research investigator must
provide additional elements of information to the subject,
including the possibility of currently unforeseeable risks; any
additional costs to the subject that may result from participation
in the research; the consequences of a subject's decision to
withdraw from the research; procedures; informing subjects of
significant new findings developed during the course of the
research which may relate to the subject's willingness to continue
participation and the approximate number of subjects involved in
Documentation of Informed Consent
The researcher shall be responsible for insuring that informed
consent is documented by the use of a written consent form approved
by the IRB and signed by the subject or the subject's legally
authorized representative, unless this requirement is specifically
waived by the IRB. Each person signing the written consent form is
given a copy of that form. A written consent form should include
those standard elements listed above, and contain the subject's
signature and date lines. This form may be read to the subject or
the subject's legally authorized representative. In any event, the
research investigator shall give either the subject or the
representative adequate opportunity to read the form before signing
it. A convenient way to document informed consent is to have a
tear-off form at the bottom of a page describing the subject's
participation in the project. The subject can read the description,
sign the form and give it to the project director.
A "short form" may also be used in which the elements of
informed consent have been presented orally to the subject or the
subject's legally authorized representative. When the "short form"
is used, researchers should insure that a copy of the short form is
given to the subject or the representative and that a written
summary of what is to be said to the subject or the representative
receives prior approval by the IRB. Furthermore, a witness should
be present at the oral presentation, and the subject (or
representative), the witness, and the researcher (or person
obtaining consent) must sign the short form. Research investigators
are responsible for placing the consent documents signed by human
research subjects in a repository approved by the IRB chair.
Waiver of Informed Consent
In cases where the research would be jeopardized by full consent
procedures, full or partial consent may be waived by the IRB if it
is found that:
- the research involves no more than minimal risk to the
- the waiver or alteration will not adversely affect the rights
and welfare of the subjects;
- the research could not practicably be carried out without the
waiver or alteration; and
- whenever appropriate, the subjects will be provided with
additional pertinent information after participation. Also, the IRB
may waive the requirement for signed consent forms if 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. Requests for a full or partial
waiver of informed consent procedures must be accompanied by
sufficient justification. In cases where the documentation
requirement is waived, the IRB may require the investigator to
provide subjects with a written statement regarding the
Special Populations ~ View Details
The IRB, in compliance with federal regulations, gives special
consideration to proposed research involving: prisoners, children,
persons with physical or mental handicaps, fetuses, pregnant women,
in-vitro fertilized human ova, and other potentially vulnerable
groups. Of particular concern is research involving children as
subjects. Parental consent (as well as IRB approval) must be
obtained prior to any research project that alters a child's
routine or behavior. This includes research conducted in classroom
settings, such as educational tests, and surveys. Parental consent
may be waived only when the child is legally designated an
emancipated minor or when it is determined by the IRB that parental
permission is not a reasonable requirement to protect the subjects
(for example, neglected or abused children). Furthermore, assent of
the children must be obtained unless the IRB determines that the
capability of the children is so limited that they cannot
reasonably give assent. For research conducted in settings in which
general blanket participation forms have been signed by guardians,
(e.g., schools, classrooms), specific consent of the guardian and
assent of the child must still be obtained for each project
conducted with these subjects unless there will be no manipulation
of the subject's behavior or disruption of the normal routine of
the individuals in these settings.
Suspension or Termination of Approval ~ View Details
The IRB shall have authority to suspend or terminate approval of
research that is not being conducted in accordance with the IRB's
requirements or that has been associated with unexpected serious
harm to subjects. Any suspension or termination of approval shall
include a statement of the reasons for the IRB's action and shall
be reported promptly to the investigator, the Provost and Vice
President of Academic Affairs, and if the research is externally
funded, to the sponsor.
Review by Provost and Vice President of Academic
Affairs ~ View
Institutional Review Board approvals, actions and
recommendations are subject to review and to disapproval or further
restrictions by the Provost and Vice President of Academic Affairs.
Such disapprovals or further restrictions shall then be returned to
the IRB and the investigator. However, IRB disapprovals,
restrictions or conditions cannot be rescinded or removed except by
further action of the IRB or in the case of federally funded
research, by appeal to the Department of Health and Human Services
or other federal agency with appropriate jurisdiction.
Maintenance of Records ~ View Details
The IRB in cooperation with the Director of the Institute for
Research and Scholarship shall prepare and maintain documentation
of its activities.
- Copies of all research protocols reviewed, scientific
evaluations, if any, that accompany the protocols, approved sample
consent documents, progress reports submitted by investigators, and
reports of injuries to subjects.
- Minutes of IRB meetings shall be in sufficient detail to show
attendance at the meetings; actions taken by the IRB; the vote on
these actions including the number of members voting for, against
and abstaining; the basis for requiring changes in or disapproving
research; and a written summary of the discussion of controversial
issues and their resolution.
- Records of continuing review activities.
- Copies of all correspondence between IRB and the
- A list of IRB members as required by the United States
Department of Health and Human Services.
- Written procedures for the IRB as required by this policy.
- Statements of significant new findings provided to
Maintenance Time Limit
The records required by this policy shall be retained for three
years after the termination of the study.