2:002 Research (Faculty, Staff, and/or Student) involving Human Subjects
|Austin Peay State
|Research (Faculty, Staff and/or Student) Involving Human Subjects
||March 25, 2017
||Provost and Vice President for Academic Affairs
||Office of Research and Sponsored Programs
It is the policy of Austin Peay State University that all faculty, staff, research
associates or students conducting research involving human subjects, shall comply
with the policy for the protection of human subjects participating in activities as
outlined in the Department of Health and Human Services (DHHS) rules and regulations
(codified at 45 CFR 46). Furthermore, all persons conducting human research at or
through Austin Peay State University shall comply with the policies and procedures
regarding the inclusion of women, children, and minorities as participants in research
involving human subjects.
The following policies and procedures for research by faculty, staff, research associates
and/or students involving human subjects have been developed in accordance with the
DHHS regulations. Such regulations provide the minimum standards for policies and
procedures. However, the policies and procedures set forth by the University may surpass
the minimum standards set forth in relevant federal regulations.
This policy applies to all research involving human subjects, and all other activities
which, even in part, involves such research, regardless of sponsorship, if one or
more of the following apply:
1. The research is sponsored by this institution; or
2. The research is conducted by or under the direction of any employee or agent of
the institution in connection with his or her institutional responsibilities; or
3. The research is conducted by or under the direction of any employee or agent of
this institution using any property or facility of this institution; or
4. The research involves the use of this institution’s non-public information to identify
or contact human research subjects or prospective subjects.
-Submission and Review Process
-The Austin Peay Institutional Review Board
-Responsibilities of the University Institutional Review Board
||Refers to a living individual about whom an investigator (whether professional or
student) obtains data, through intervention or interaction with the individual, or
identifiable private information.
||Means a systematic investigation (i.e., the gathering and analysis of information)
designed to develop or contribute to generalizable knowledge.
||Means an individual who either initiates or actually conducts a research investigation,
alone or with others.
||Means that the probability and magnitude of harm or discomfort anticipated in the
research are not greater in and of themselves than those ordinarily encountered in
daily life or during the performance of routine physical or psychological examinations
|Means the knowing consent of an individual or his or her legally authorized representative,
so situated as to be able to exercise free power of choice without undue inducement
or any element of force, fraud, deceit, duress, or other form of constraint or coercion.
The basic elements of information necessary to such consent include:
- a fair and easily understood explanation of the procedures to be followed, and their
purposes, including identification of any procedures that are experimental.
- a description of any attendant discomforts and risks reasonably to be expected.
- a description of any benefits reasonably to be expected.
- a disclosure of any appropriate alternative procedures that might be advantageous
for the subject.
- an offer to answer any inquiries concerning the procedures.
- an instruction that the person is free to withdraw his or her consent and to discontinue
participation in the project or activity at any time without prejudice to the subject.
- with respect to biomedical or behavioral research that may result in physical injury,
an explanation as to whether compensation and medical treatment are available if physical
injury occurs and, if so, what it consists of or where further information may be
- A clear and plain statement of reporting requirements related to disclosure of illegal
|Defined by APSU Policy 2:019 to mean the following: Misconduct in research or other creative or scholarly activities
is defined to include but is not limited to the following acts committed by faculty,
staff, students, and research associates of the University:
- The fabrication or falsification of data or results, the theft of methods or data
from others, plagiarism, or other practices that seriously deviate from those that
are commonly accepted within the academic and research community for proposing, conducting
or reporting research or other scholarly or creative activities. It does not include
error or honest differences in interpretations or judgments of data.
- Failure to comply with Federal and University requirements pertaining to the conduct
of research. This includes but is not limited to: falsification of certifications
and representations pertaining to government compliance requirements, failure to obtain
proper review and approval by the authorized University Board for research that involves
human subjects, animals, radioactive materials or other biohazards, and/or failure
to follow directives made by authorized University Boards concerning research subjects,
materials or procedures.
- Failure to meet legal requirements governing the proposing, conducting, or reporting
- Condoning violations of University research policies. This includes but is not limited
to failure to notify appropriate University authorities whenever it becomes obvious
or apparent that misconduct probably has occurred, or failure to cooperate in an investigation
under the procedures specified by this policy.
- Retaliation of any kind against a person who in good faith reported or provided information
about suspected or alleged misconduct.
The policy stated below is designated to protect the rights and welfare of human subjects
in all research and training programs at Austin Peay State University. This policy
applies to all investigations and training programs that involve the use of human
subjects in any way. The Chairperson of the Graduate and Research Council and the
Austin Peay Institutional Review Board (APIRB) will enforce the policy. This Board
shall be familiar with and guided by the Nuremburg Code, the Belmont Report, the Declaration
of Helsinki, the Ethical Principles in the Conduct of Research with Human Participants
of the American Psychological Association, the Ethical Standards for Research with
Children of the Society for Research in Child Development, 45 CFR 46, and codes developed
by other professional and scientific organizations relevant to specific areas of research.
Copies of relevant codes developed by professional and scientific organizations, as
they apply to specific areas of research, shall be maintained in the College of Graduate
Studies. The Chair of the APIRB shall maintain an additional copy. Further, all members
of the APIRB shall have a copy of such codes for their use.
- Research involving human subjects must conform to the moral and scientific principles
that justify such research and shall be based on established professional and/or scientific
- Research involving human subjects shall be conducted only by qualified persons and
under the supervision of a trained researcher. An individual who does not possess
a graduate degree or other appropriate training that required the conduct of independent
research shall have an appropriately trained and knowledgeable sponsor for all research
involving human subjects.
- Research involving human subjects shall not be carried out unless the sum of the benefit
to the subjects and the importance of the objective substantially outweigh the inherent
risk to the subjects.
- Research involving human subjects must not be undertaken without the legally effective
informed consent of the subjects after being informed of the risks involved. No such
informed consent shall include any exculpatory language through which subjects are
made to waive, or appear to waive, any of their legal rights, including any release
of the institution or its agents from liability for negligence.
- Subjects participating in a research project should be in such a mental, physical,
and legal state as to be able to exercise fully their power of choice and to grant
informed consent. If they are not, then the legally effective informed consent of
the subjects' legally authorized representative(s) must be obtained. Furthermore,
the APIRB may require the investigator to attain the assent of human subjects in cases
including, but not limited to, children and the mentally infirm.
- Consent must, as a rule, be obtained in writing. If written consent is not obtainable,
then full documentation of the reasons must be submitted for approval and retention
by the Board, and must include assurance that risk to the subject is minimal as outlined
in 45 CRF Part 46.10.
- Extreme caution shall be exercised by the investigator in performing research on human
subjects in which the personality of the subjects may be altered or disturbed by experimental
- Research and training programs involving human subjects must respect the rights of
subjects' privacy and assure that maximum confidentiality of personal information
- In the purely scientific application of research carried out on human subjects, it
is the duty of the investigator to protect the life, health, and welfare of the subjects,
within the context of the research situation.
- The nature, purpose, and risk of the research must be explained to the subjects by
the investigator including, but not limited to, the duty to report disclosure of illegal
activities. If, for any reason, the nature and purpose of the research cannot be explained
to the subjects, the investigator must demonstrate the necessity of this approach
to the APIRB, as well as indicate the provisions for safeguards that may be needed.
- A debriefing will be required in all human research which involves deception, except
in such cases where debriefing has the potential to be harmful, such as with young
children. The APIRB shall determine the appropriateness of the debriefing plan. The
principal investigator has the responsibility for providing justification for waiving
the debriefing requirement. Justification for waiving the debriefing requirement shall
be included in the research protocol submitted to the APIRB.
- The responsibility for the care and protection of subjects in research always remains
with the research worker; it never falls on the subjects after consent is obtained.
- The investigator must respect the right of each individual to safeguard his/her personal
integrity, especially if the subject is in a dependent relationship to the investigator.
- The subject or his/her guardian must be informed that he/she is free at any time during
the course of the research to withdraw consent for research to be continued without
prejudice to the subject.
- The investigator or the investigating team shall discontinue the research if it is
judged that an individual has been or will be harmed if the research is continued
and shall notify the Chairperson of the APIRB of such action immediately.
- The University is the agent that assumes official responsibility for the subjects
at risk. Therefore, the University, through the delegation of authority to theAPIRB,
will conduct review of the activities of such research at timely intervals and must
be informed of any changes or unanticipated problems involving the human subjects.
- All research, development, and related activities involving human subjects must be
reviewed and approved by the APIRB prior to conducting any research, and for application
for grants from external agencies prior to submission of proposal. This policy requires
all research protocols involving human subjects to be submitted for either full Board
review or expedited review. No research at Austin Peay will fall under the third review
category (i.e., exempt [from further review]).
- If the type of research to be conducted involves the repeated use of a standard research
protocol, and the nature of the research requires immediate action (e.g., telephone
opinion sampling in response to current events), investigators conducting or supervising
such research shall submit a request for approval of a standing protocol providing
all relevant information pertinent to said research. Once approved, the standing protocol
shall remain valid for no more than one year. In the event of an anticipated departure
from the standing protocol, the research supervisor or sponsor shall submit a new,
specific protocol for the project for approval by the APIRB.
- The investigator submitting the proposal must be a member of the faculty or staff
of Austin Peay State University. In the case of student research, a faculty member
must act as the sponsor. In the case of staff, without research training, a trained
researcher must act as the sponsor. No human subjects research at Austin Peay will
fall under the exempt [from further review] category.
- The proposal shall be submitted to the College of Graduate Studies. If the proposal
is complete, the office, in conjunction with the Chairperson of the APIRB, will determine
whether the proposal requires full or expedited review.
- If research involves no more than minimal risk, and meets the federal criteria to
be eligible for expedited review, the proposal may be reviewed and approved by the
APIRB Chairperson or by his or her designee(s).
- In the case of expedited review, the College of Graduate Studies will review the application
- The reviewer may exercise all of the authority of the APIRB, except that the reviewer
may not disapprove research.
- To approve the research, the reviewer must make the determination that all of the
requirements specified in 45 CFR 46.111 are satisfied.
- All members of the APIRB must be advised, no later than the next regularly scheduled
meeting, of all research proposals approved using expedited procedures.
- Full review must be conducted at a convened meeting.
- Once complete, an application requiring full Board review will be scheduled on the
agenda of the APIRB. The investigator(s) may attend the meeting of the APIRB when
their protocol is on the agenda for consideration. The Board may direct questions
to the investigator regarding the research protocol and make suggestions directly
to the researcher. The investigator may not be present during Board debate and vote
on a protocol.
- The investigator shall receive a written notification of the Board's actions and the
available options. Such notification will be made as timely as possible.
|The Austin Peay
|In order to conduct a full review of a research proposal,the APIRB must have at least
five members with varying backgrounds to promote complete and adequate review research
activities commonly conducted at the University. The Board shall meet at least twice
during each semester of the regular academic year.
- Voting members of the Board shall be appointed by the University President for three-year
renewable terms. The Board will be composed of:
- Chairperson who shall be appointed by the University President in consultation with
the Chair of the Graduate and Research Council.
- One individual from the community-at-large who has no direct affiliation with the
- One student who is currently attending the University;
- A pool of University faculty representing those disciplines involved in research with
- One or more individuals experienced and knowledgeable about working with vulnerable
categories of participants, such as, children, prisoners, pregnant women, mentally
or physically disabled persons, and,
- One individual whose primary concerns are in nonscientific areas.
- Decisions regarding proposals shall be made by a quorum of the Board. A quorum shall
consist of a simple majority of the Board.
- At least one member whose primary concerns are in nonscientific areas must be present
at the meeting.
- To approve research, the APIRB must determine that all of the requirements specified
in 45 CFR 46.111 are satisfied.
- Decisions regarding proposals shall be made on the basis of the opinion of the majority
of those voting members present.
- APIRB members who have a conflicting interest in a research project cannot participate
in the review except to provide information, and shall leave the room when any vote
is taken on the project involving the conflict.
- Formal minutes for the Board meetings shall be kept. The minutes will consist of
- A summary listing members present, the projects reviewed, and the action taken on
- An individual summary for each proposal listing the action taken by the Board, the
listing of any issues on which the Board felt it needed more clarification, and any
recommendations made by the Board.
- Records of the Board shall be maintained, for a minimum of three years, by the Chairperson
of the Graduate and Research Council or the Chairperson's designee. The records shall
- The minutes of the meetings;
- The research proposals; and
- All other substantiating information submitted by investigators, outside experts,
and so forth pertaining to each case considered by the Board.
- A copy of the memorandum sent by the Chairperson to each investigator, informing him/her
of the decision or recommendations of the Board.
- Investigators will submit signed proposals on specially designed forms. The form will
elicit the type of information required by the Board to meet its obligations.
- The Board shall give special consideration with respect of consent involving subjects
partly or totally unable to give consent on their own behalf. Such subjects include,
among others, minors and the mentally infirm. In these cases, the Board shall require
that informed consent be obtained in writing from the parent, legal guardian, or other
appropriate custodian of the subject, and, whenever possible, written consent or assent
of the subject as well.
- After review of the information submitted by the investigator, including the formal
proposal, supporting documents, and any additional taken:
- Approval contingent on requested changes being made;
- Deferral for additional evidence; or
- When actions 11.b or 11.d are taken, the investigator's options are:
- Revise the project in accordance with Board recommendations and communicate in writing
the changes that have been made;
- Discuss the action with the Board; or
- Withdraw the proposal.
- When action 11.c is taken, any further action is contingent on the investigator's
supplying the Board with the appropriate information.
- Subsequent to approval from the Board, the investigator is responsible for the following:
- Obtaining approval from the Board prior to introducing any changes in procedures;
- Keeping signed consent statements for the duration of the project and for a three
year period thereafter; and
- Informing the Board of any unexpected physical or psychological effects on subjects
for re-evaluation of the protocol approval.
- At the conclusion of data collection, and prior to the end of 12 months, investigators
are responsible for submitting a Closed Study Report to the College of Graduate Studies.
If the data collection period is not within the 12 month deadline, investigators much
submit a Request for Continuing Review form.
- Continuing review of approved research must be conducted at intervals appropriate
to the degree of risk. The APIRB cannot approve a project for more than twelve months.
- Continuing review must be conducted using full review procedures unless the original
protocol was otherwise reviewed and approved.
the University Institutional
- Before approving research, the APIRB shall determine that the regulations codified
in 45 CFR 46.111 are met, including the following:
- The risks to subjects are minimized;
- The risks are reasonable in relation to anticipated benefits, if any, to subjects
and to the advancement of knowledge;
- The selection of subjects is equitable;
- Informed consent will be sought;
- Informed consent will be documented unless the requirement for informed consent has
- Where appropriate, the procedures make adequate provision for monitoring data collection
to insure safety of subjects;
- There are adequate provisions to protect the privacy of subjects, and to maintain
the confidentiality of data; and where any of the subjects are likely to be vulnerable
to coercion or undue influence, additional safeguards have been included in the study
to protect the subjects.
- Other review considerations by the Board shall include, but are not limited to:
- acceptability in terms of institutional commitments and regulations;
- applicable law;
- standards of professional conduct and practice; and,
- community attitudes.
- All research investigators must complete ethics training involving research with human
subjects and provide to the College of Graduate Studies evidence of completed training.
- Research investigators are responsible for submitting all research projects for IRB
approval prior to initiation of data collection. This policy applies to all research
conducted at the University. No human subjects research at Austin Peay will fall under
the exempt [from further review] category.
- Research investigators will promptly report proposed changes in previously approved
human research activities to the APIRB. The proposed changes will not be initiated
without IRB review and approval, except where necessary to eliminate apparent immediate
hazards to the subjects.
- Research investigators are responsible for providing a copy of the IRB-approved informed
consent document to each subject at the time of consent, unless the IRB has specifically
waived this requirement. All signed consent documents are to be retained in a manner
approved by the College of Graduate Studies.
- Research investigators are responsible for reporting progress of approved research
to the College of Graduate Studies, as of, and in the manner prescribed by, the approving
IRB on the basis of risks to subjects. In no case shall such progress reports be submitted
in intervals exceeding twelve months.
- Protocols for human subject research shall not be approved for more than twelve (12)
months. To continue human subjects research beyond the twelve (12) month period, the
investigator must submit the Request for Continuing Review form to theAPIRB. A requestfor
reapproval must be accompanied by a progress report that includes, but is not limited
- the number of subjects studied;
- a summary of any and all adverse events that occurred during the approved period;
- the actions taken in response to any and all adverse events; and,
- a clear statement of any modifications of the procedures that will be made.
- Research investigators will promptly report to the IRB any injuries or other problems
involving risks to subjects whether anticipated or not.
||Engaging in research involving human subjects without appropriate IRB approvals and/or
without full compliance with this policy will be considered an act of scholarly misconduct
pursuant to the APSU policy (2:019) governing misconduct in research and other scholarly activities.
APSU Policy 2:002 – Rev.: March 25, 2017
APSU Policy 2:002 – Rev.: August 18, 2011
APSU Policy 2:002 – Issued: November 12, 1999
President: signature on file