- A. Overview
All research carried out by administration, faculty, staff and students associated with Stevenson University (SU) involving human subjects must be conducted using basic ethical principles. These principles include respect for persons, beneficence, and justice. Applications of the basic principles to the conduct of research using human subjects leads to the consideration of the following requirements: informed consent, risk/benefit assessment, the appropriate selection of subjects for research, and confidentiality.
Any human subjects research must comply with federal regulations: Protection of Human Subjects (45 CFR 46) and the Common Federal Rule (Federal Register, June 19, 2018), as amended periodically.
Human subjects research, regardless of funding source, must be reviewed by the Stevenson University Institutional Review Board (IRB) before initiation of a project. The IRB is responsible for monitoring the ethical nature of human subjects experimentation carried out by students and faculty of SU using 45 CFR 46 and the Common Federal Rule (Federal Register, June 19, 2018). Further, this committee has the authority to approve, approve conditionally, require modifications to, or disapprove any human subjects research performed under the auspices of SU. The University will be responsible for maintaining the currency of this document and for providing support to the IRB.
It is the IRB’s responsibility to ensure that researchers follow the guidelines established in 45 CFR 46, especially 45 CFR 46.116 general requirements for informed consent and the Common Federal Rule, and general requirements for informed consent. This applies to research considered to be Exempt from IRB review, as well as research given Expedited and Full Board Reviews. Researchers will make themselves familiar with and agree to abide by 45 CFR 46.116. For proposals offered by student researchers, faculty sponsors must ensure the student has read and understands the federal regulation.
The IRB will strictly follow the definitions for human subjects’ protection found in Article 102 of the Common Federal Rule, 45 CFR 46.
1. Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities. For purposes of this part, the following activities are deemed not to be research:
a. Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.
b. Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).
c. Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.
d. Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.
2. A human subject is a living individual about whom an investigator, whether professional or student, conducting research:
a. Obtains information or biospecimens through intervention or interaction with the individual, and, uses studies, or analyzes the information or biospecimens; or
b. Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
3. Intervention includes both physical procedures by which information or biospecimens are gathered (e.g., venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes.
4. Interaction includes communication or interpersonal contact between investigator and subject.
5. Private information 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 that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record).
6. Identifiable private information is private information for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information.
7. An identifiable biospecimen is a biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.
Purpose, Composition and Authority of the IRB
- Purpose of the IRB
The Institutional Review Board is charged with the responsibility for review and approval of all research involving human subjects conducted by members of the Stevenson University community.
The Board is required to determine that: (a) the rights and welfare of the subjects are adequately protected, (b) the risks to subjects are outweighed by the potential benefits of the research, and (c) appropriate informed consent will be obtained.
The records of the Board, including correspondence and statements of acceptance or rejection, are to be retained for a period of three (3) years after the termination of a project.
- Composition of the IRB
Five (5) voting IRB members will be required for a Full Board Review. They will be appointed by the Executive Vice President for Academic Affairs/Provost or his/her designee and will serve for a period of three (3) years with initial members serving a period of 1, 2, or 3 years. This standing board will meet on an ad hoc basis and will include:
- One member from Sciences or Social Sciences
- One member from a non-scientific area
- One member from outside Stevenson University (no affiliation with the school)
- Two members from any discipline (preferably with some knowledge of scientific research)
* All members of the IRB must complete training on the protection of human participants through the Collaborative Institutional Training Initiative (CITI) Program.
- Authority of the IRB
After requisite review and within thirty (30) days of its submission, the IRB may approve, approve conditionally, require modification to or disapprove a pending proposal.
The IRB has the authority to suspend or terminate approval of research that is not being conducted in accordance with IRB requirements or that has been associated with unexpected harm to subjects. Any suspension or termination of approval shall include a statement of the reasons and be reported promptly to the investigator, appropriate institutional officials, and the funding agency, if applicable.
Should the IRB determine that either unethical behavior or misconduct in research has occurred, the chairperson will initiate action as deemed appropriate by a consensus of the sitting IRB in conjunction with the SU administration.
IRB Review of Proposals
Most research conducted at SU may be exempt from Institutional Review Board (IRB) review. However, this status can only be established by the chairperson of the IRB after reviewing the research proposal. It is suggested that researchers read the following criteria for “exempt” status and, if the research project proposed falls under these criteria, complete and submit the proposal to the committee chairperson. A response can be expected within one (1) month indicating approval, approval with conditions, or disapproval. (If the project does not fall under the criteria for Exempt status, please see the criteria for Expedited Review or Full Board Review and follow the procedures described.)
Faculty members requiring students to conduct research projects for instructional purposes should follow the procedure for “Research for Instructional Purposes” as more fully described in a later section of this document.
- Types of Review
- Exempt. In order to apply for exemption, the principle investigator must summit a form insuring that they meet the standards of exception listed under Exempt Review. Exemption from formal review is granted by the faculty advisor if the principle investigator is a student. If they are not a student, an IRB member will review the form and determine exemption. Before a proposal is determined to be exempt from further IRB review, the chairperson of the IRB may request additional information about the proposal, and/or may require changes in the consent form, subject recruitment methods, or other aspects of the procedure. Research may not proceed until the exemption is given.
- Expedited. The review may be carried out by the IRB chairperson or by one or more experienced reviewers designated by the chairperson. In reviewing the research the reviewers may exercise all of the authorities of the IRB except that the reviewers may not disapprove the research. A research activity may be disapproved only after review and in accordance with the non-expedited procedure
- Full Board Review. All research projects not meeting the criteria for Exempted or Expedited Review must be reviewed by the full IRB. A majority of the IRB members must be present to vote on a proposal requiring Full Board approval. At least one member present must have primary concerns in a nonscientific area. In order to be approved, a majority of the officials present must approve.
See IRB Procedures and Protocols for detailed descriptions of each of the three categories.
- Right to Appeal IRB Decision
If a project is disapproved the principal investigator has the right of reconsideration. The researcher shall send a letter to the Executive Vice President for Academic Affairs/ Provost within ten (10) working days of the receipt of disapproval requesting a meeting of the Full Board. The Executive Vice President for Academic Affairs/Provost or his/her designee shall request that the Chairperson convene the Board in a timely fashion to consider any additional information supporting the proposal. The decision of the IRB regarding the appeal is final.
- Expiration of IRB Approval
- The length of approval for an IRB protocol is one (1) year.
- Researchers may apply for IRB renewal.
Research for Instructional Purposes
Research designed for the purpose of classroom instruction and not designed to contribute to generalized knowledge does not require IRB review, if (1) the instructor educates the class about human subjects’ rights (e.g., informed consent, confidentiality, risks vs. benefit, use of at-risk subjects—children, pregnant women, prisoners, etc., and (2) the instructor assumes ethical and professional responsibility for monitoring the progress of each research project in his or her class, including completion of informed consent documents and student and faculty supervisors’ completion of appropriate online CITI training modules.
Should an instructor choose not to assume the overall responsibility for class projects, then each student must submit an application to the IRB as outlined.
The classroom instructor must send a memo to the chairperson of the IRB, indicating that class projects are on-going and the conditions outlined in this paragraph will be followed.
Research primarily for instructional purposes does not imply that students are exempt from following human subjects protection guidelines. They must, in fact, observe ethical principles as closely as others.
- General Responsibilities
The IRB requires that all investigators, whether faculty members, staff members, graduate students or undergraduate students, comply with both internal and federal regulations regarding the protection of human subjects and the appropriate administration of protocol activities. All researchers are required to complete appropriate Human Research Training (e.g., CITI training). Researchers, in turn, have the responsibility of staying abreast of policies to remain within compliance. Failure to do so will result in the investigator losing his or her capability to perform as the individual responsible for the administration of the research protocol.
See IRB Procedures and Protocols for Specific Investigator Responsibilities.
The principal investigator must maintain a protocol file.
See IRB Procedures and Protocols for Protocol File requirements.
This file will act as the investigator’s documentation regarding the proper performance of the study. Investigators should be aware that this file will be randomly audited on a semi-annual basis by the IRB. The purpose of this audit is to provide internal procedural monitoring to ensure compliance with federal human subject protection regulations. Additionally, it provides a cooperative forum to educate the investigator in correcting problems and to solicit suggestions in improving the IRB process.
The investigator must maintain the protocol file for at least five (5) years past completion of the research activity for adult subjects and, for minor subjects, at least three (3) years after reaching the age of 18, whichever is longer. The investigator must maintain the protocol file for research completed for instructional purposes for one (1) year. An investigator who leaves Stevenson University must notify the IRB chair in writing of the individual taking over the responsibility for maintenance of this protocol (e.g., Department Chair, School Dean, Human Protections Officer). All files must be kept in a secure location.
- Federal Requirements
As stated in the federal regulations (45 CFR 46.113), all protocol deviations and/or instances of non-compliance with IRB regulations must be reported to the IRB by the principal investigator as soon as the violations are discovered. The IRB has the authority to suspend or terminate approval of research not conducted in accordance with the IRB’s requirements or that research has been associated with unexpected serious harm to subjects. The IRB also has the authority to “sanction”, “suspend”, or “terminate” approval if there has been serious or continuing non-compliance with the policies, requirements or determinations of the IRB.
Investigators not in compliance with IRB procedures will not be able to process new protocols or renew current projects until all concerns have been addressed and the investigator sends a letter to the IRB Chair acknowledging the error that was made.
See IRB Procedures and Protocols for specific processes related to IRB Protocol Violations.
- Federal Regulations
The Human Research Protection Officer makes arrangements to meet personally with the investigator and/or research staff to examine the investigator’s protocol file. Investigators should plan to allow for at least one (1) hour for the Human Research Protections Officer to conduct the review; while the investigator’s presence is not required, it will be helpful to be present to answer any questions. Student investigators and faculty advisors should meet prior to the review to make arrangements for a meeting time and access to the protocol files.
See IRB Procedures and Protocols for Stevenson University’s Audit Procedure.
Office of Human Research Protections
- Human Research Protections Officer
The Executive Vice President for Academic Affairs/Provost or his/her designee will designate the Human Research Protections Officer.
The Human Research Protections Officer has the responsibility to implement procedures to fulfill the responsibilities of the Office of Human Research Protections. Investigators have the ultimate responsibility to protect human subjects.
- Responsibilities of the Human Research Protections Officer (HRPO)
- Records Maintenance
a. The HRPO will monitor IRB logs listing research protocols to ensure that they minimally include the investigator’s name, the title of the proposed research, and current IRB status.
- The HRPO will maintain all IRB records relevant to protocol deviations or violations.
- Protocol Audit
a. The HRPO is responsible for the semi-annual internal review (i.e., audit) to ensure that protocol activity remains within compliance with the approved Federal-wide Assurance.
b. Protocol violations identified by the audit will be reported to the Executive Vice President for Academic Affairs/Provost or his/her designee.
Protection of Human Subjects. (2017), 45 C.F.R. § 46, effective 2018.
The Common Rule. (2017). Federal Register, 82(12), 7149-7274.
(Approved May 2020)