Rationale:
Abilene Christian University is comprised of a community of scholars who are committed to the highest level of integrity and ethical conduct in their work. This commitment grows out of the distinctive Christian character of the institution and its members. Respectful of the biblical doctrine of the creation, members of the ACU community are expected to engage in their scholarly activities with due regard for all the created order, both human and non-human. As a teaching institution, the research activities of the faculty and staff serve as exemplars for the students who observe and learn from these activities.
In order to ensure ethical behavior in the conduct of scholarship and research, the University has established this Institutional Review Board policy. This document is meant to that research practices minimize risk to subjects, both human and non-human, and that potential benefits from research activities are maximized. This document articulates procedures that assure the human subject participation is based on equitable selection of subjects, and that participation in human subject research is non-coercive and based on the principle of informed consent. These procedures also provide protections for animal subjects, when used in research by members of the University community.
The procedures described in this document are designed to conform to state and federal requirements for the protection of human and animal subjects. While such conformity is necessary for receiving external funding, the rationale for developing and implementing this document is primarily an expression of the Christian commitment of the institution and its faculty, staff and students. Levels of IRB ReviewLevel 1 - Projects Exempt from Any Review
Projects exempt from any review, departmental or university under Federal Policy for the Protection of Human Subjects (Federal Regulation 46.101b) include:
- Education research projects for instructional purposes and/or class demonstration, provided that the data obtained is not for formal analysis or future publication.
- Research involving the collection or study of existing data from publicly available sources. Any identification of data by subject must be avoided unless the subject studied is a public figure.
- Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), if information taken from these sources is recorded in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
- Aid or services provided by professionals to their clients that are consistent with accepted and established practice, and intended only to meet the clients' own personal needs.
Level 2 - Departmental Research Review (IRB) Panel
A faculty member or student may submit a research proposal (if it is not in one of the four exempt categories) to be reviewed by an Institutional Review Board within the department if the following statements apply:
- The research project is not funded by any federal or state grant.
- The research project poses minimal risk to any human or animal subject.
- The department has an IRB which as been certified by the University. (See document on certifying a departmental research review panel).
Level 3 - University IRB Review
If a research project is funded by federal or state funds or poses more than minimal risk to animal or human subjects, and it does not fall within one of the four exempt categories defined above as Level 1, it must be submitted to the Institutional Review Board.
University IRB Composition and ProceduresComposition
The Assistant Provost for Research and Service will oversee the administration and management of the University's IRB Committee. The University's IRB Committee will be composed of the members of the Cullen Research Committee and/or by the Math/Science Research Committee according to the research subject matter. One member not affiliated with the university will be added to the research councils to review research requests. Rotation onto the University's IRB Committee will reflect the membership rotation of the Cullen and Math Science Research Councils. The above mentioned committees meet the following federal requirements as stated in 45 CFR 46, as amended by CFR 28004.
Procedures
Ten copies of the research proposal and an electronic version on a 3.5" floppy disc, along with an Informed Consent form (or cover letter/questionnaire if survey research) must be submitted to the Grants Administrator in the Office of Research and Sponsored Programs. The Assistant Provost of Research and Service will forward a copy to each committee member within one (1) week of the proposal being received. A committee meeting will be called or organized via electronic means in timely fashion. Committee members will vote to:
- Approve the proposal.
- *Approve the proposal with modifications
- *Request further information/clarification and resubmission of the proposal.
- Reject the proposal for:
-
- Inadequately observing the Standards for Utilizing Human or Animal Subjects in Research.
- Excessive use of specific groups or classes that may have recently participated in other research.
* The proposal must be modified and resubmitted to the Assistant Provost of Research and Service within 10 working days of its return to the investigator.
A simple majority will constitute acceptance of the proposal. No research may be initiated on any proposal that was returned for revisions or has been rejected by the IRB.
The University's IRB Committee will meet a least once (1) a semester and on demand by face to face contact and/or by electronic means. For student research, see Departmental Research Review Board Policies and Procedures.
Standards Regarding Human Subjects in Research (45 CFR 46)
- All procedures must pose no undue risks to life, health, or integrity of the subjects involved.
- Any risks posed to participants must be clearly outweighed by the significance of the proposed outcome of the investigation. Subjects must be notified in writing of potential risks and sign an informed consent form. In addition, the researcher must show that alternative procedures, that better protect subjects, would seriously compromise the nature and integrity of the proposed study.
- The basic elements of the Informed Consent must include:
-
- A concise, yet complete explanation of the procedures to be followed, including the duration of the subjects' participation. Identification of experimental procedures must be revealed.
- A description of any risks or discomfort that can be reasonably expected.
- A description of any benefits that can be reasonably expected.
- A disclosure of alternative procedures, especially therapeutic procedures that may be advantageous for the subject(s).
- A statement explaining the extent of confidentiality of data and records.
- A statement allowing the subject to withdraw consent and/or discontinue participation in the project at anytime without intimidation or prejudice.
- An explanation as to whether compensation or medical treatment is available if physical injury occurs as a direct result of the study.
- The name and telephone number of whom to contact for answers to pertinent questions about the research, research subject's rights, or whom to contact in case of a research-related injury.
- All procedures must show due regard for sensitivities and integrity of participants in order to preserve rights to privacy.
- Procedures must be observed for assuring informed, voluntary consent of all participants. Subjects who have not obtained the legal age of consent must receive permission for participation from their parent or legal guardian.
- The use of all findings must be restricted to purposes for which said consent was obtained. When such purposes have been fulfilled, the research data should be disposed of properly.
- Adequate procedures must be provided such that the collection, processing, storage, retrieval, and disposal of data is in compliance with these standards.
- Any areas or situations not covered by these standards shall be reviewed by the committee.
- Ethical Principles in the Conduct of Research with Human Participants (published by the American Psychological Association, Inc., 1200 Seventeenth St. N.W. Washington, DC 20036) will serve as the guide for the committee's review.
Standards for Utilizing Animal Subjects in Research
(Public Health Service Policy on Humane Care and Use of Laboratory Animals, revised September , 1986 and Reprinted March 1996 & the Health Research Extension Act of 1985 [Public Law 99-158])- When live animals are used in research, there must be a reasonable expectation that such utilization will contribute to the enhancement of human or animal health, the advancement of knowledge, or the good of society. The benefits of the research must clearly outweigh any pain, discomfort, and distress experienced by the animals.
- It is the responsibility of the investigator to consider the source of the animal and to ensure that all animals used for experimental purposes are lawfully acquired.
- The investigator has an ethical obligation to seek the least painful techniques feasible to obtain the protocol objectives. The pain, discomfort and distress should be monitored using behavioral signs based on the normal behavior pattern of the species under study.
- Appropriate anesthetics, analgesics, and tranquilizers must be used if the procedure will cause more than slight momentary pain or distress to the animal. This pertains to pain or discomfort that may be experienced during, as well as after, the procedure, until such time when the pain is either alleviated or reduced to an acceptable tolerance level. If the use of anesthetics and/or analgesics will compromise the scientific validity of the experiment, the deletion of these drugs must be based on scientific fact or experimental data which can be referenced.
- Physical restraints should not be used on awake animals. If such a procedure is necessary, the animal should be conditioned to the restraint prior to beginning the experiment. Prolonged physical restraint of awake animals should be avoided.
- Adequate post surgical/procedural care for the animal is the responsibility of the investigator.
- Any proposed use of Euthanasia must be consistent with recommendations of the American Veterinary Medical Association (AVMA) panel on Euthanasia. Such measures include a quick, painless death for the animal. If the animals will not be euthanized at the completion of the experiment, it is the responsibility of the investigator to assure that the final disposition of the animal is both humane and acceptable.
- The committee shall review any areas or situations not covered by these standards.
The guide for the Care and Use of Laboratory Animals (Institute of Laboratory Animal Resources, National Research Council) will serve as the guide for the committee's review.
Informed Consent Guidelines
"Informed consent" provides the subject the opportunity to exercise free power of choice without undue inducement, as to whether or not he/she chooses to participate in the research project. It is the investigator(s) responsibility to provide a concise, yet complete explanation to the subject concerning what is expected from his/her involvement in the investigation. Each of the following Basic Elements of the Informed Consent must be included:
- A concise, yet complete explanation of the procedures to be followed, including the duration of the subject's participation. Identification of experimental procedures must be revealed.
- A description of any risks or discomfort that can be reasonably expected.
- A description of any benefits that can be reasonably expected.
- A disclosure of alternative procedures, especially therapeutic procedures that may be advantageous for the subjects(s).
- A statement explaining the extent of confidentiality of data and records.
- A statement allowing the subject to withdraw consent and/or discontinue participation in the project at any time without intimidation or prejudice.
- An explanation as to whether compensation or medical treatment is available if physical injury occurs as a direct result of the study.
- The name and telephone number of whom to contact for answers to pertinent questions about the research, research subject's rights, or whom to contact in case of a research-related injury.
Additional elements of the informed consent that may be included are:
- Subject criteria: age, gender, medical conditions, number of subjects needed, etc.
- Circumstances under which the subject's participation may be terminated.
- Financial obligation of the subject that may result from participation in the study.
- Participants should receive a copy of the consent form.
See the following link for examples of an Informed Consent Form.
