GUIDELINES FOR HUMAN SUBJECTS RESEARCH AT UW–STEVENS POINT
Statement of Principles, Summary of General
Institutional Policies and Applicability
Guiding Principles
The University of Wisconsin–Stevens Point is guided by the ethical principles 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,” also known as "The Belmont Report."
To fulfill this commitment, the University has developed and submitted to the HHS Office of Human Research Protections (OHRP) a Federalwide Assurance (FWA) for the Protection of Human Subjects, following the Terms of the Federalwide Assurance specified by HHS. In addition, the University has registered with OHRP an Institutional Review Board (IRB), established in accord with and for the purposes expressed in 45 CFR 46.
Human research involves risks that may be social, psychological, financial, or physical. Others, in addition to the research subject, also may be at risk, including persons discussed in the study, the investigator, society at large, and UW–Stevens Point. The IRB does not expect research to be free from risk, but does expect the investigator to be aware of the risks, to minimize risk when possible, and to take appropriate precautions whenever necessary.
Research Requiring IRB Approval
Research is defined as a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.The IRB requires completion of a research protocol form. The form contains explanatory information about the specific requirements. IRB approval is required for all research involving human subjects. In addition, the IRB requires that everyone dealing with subjects must receive training in research ethics. This requirement can be met by completing the Human Subjects Protection Training.
The regulatory requirements are applicable to all University authorized activities which in whole or in part involve research with human subjects if one or more of the following apply:
The research is sponsored by UWSP.
The research is conducted by or under the direction of any employee or agent of UWSP in connection with his or her institutional responsibilities.
The research is conducted by or under the direction of any employee or agent of UWSP using any property or facility of UWSP.
The research involves the use of UWSP’s non-public information to identify or contact human research subjects or prospective subjects.
In accordance with federal regulations, all research involving human subjects must be reviewed by the Institutional Review Board for the Protection of Human Subjects (IRB), except for those categories specifically exempted or waived by Federal Regulation as outlined in 45 CFR, Section 46.101. The determination of exempt research must be made by the IRB, not the principle investigator. Exempt determinations must be renewed at least every five years.
The IRB has the authority to review, approve, disapprove, or require changes for approval in research activities involving human subjects. Initial IRB approval is effective for one year. Research extending beyond one year may be approved through continuing review annually for up to three additional years. Research extending beyond four years from the original approval date requires resubmission of the research protocol to the IRB.
If the protocol is for a sponsored project, IRB approval must be provided to the office of Grant Support Services prior to the expenditure of project funds. Protocols may be submitted as part of an application for external funding, which may require IRB approval at the time of submission of the grant proposal. Approval must be indicated on the UWSP Extramural Support Transmittal Form.
If a project does not initially include human subjects, but human subject participation is needed at later time, the principal investigator must submit a protocol and obtain IRB approval prior to initiating the research activities involving human subjects. For such projects that have extramural support, the office of Grant Support Services must be notified of IRB approval. The office of Grant Support Services will notify the sponsor of the IRB’s approval and human subject participation will not be permitted until this certification of IRB review and approval is received by the sponsor.
IRB Review Processes
The IRB conducts three types of reviews: exempt, expedited, and full-board review. The type of review is determined by the IRB Chair or their designee as protocols are received.
Exempt research categories, as outlined in 45 CFR, section 46.101, require review by the IRB Chair or their designee to ensure that the research qualifies under one of the exempt categories. The most common types of exempt research at UWSP involve Scholarship of Teaching and Learning research and anonymous surveys involving minimal risk to participants. Researchers should typically expect to receive either exempt approval or request for changes or additional information within two weeks.
Most research conducted at UWSP is subject to expedited review by the IRB. Expedited protocols are distributed to two IRB reviewers upon receipt of the protocol. Researchers should typically expect either approval or request for changes or additional information within two weeks.
Research involving relatively high risk or vulnerable populations requires full-board review by the IRB. Vulnerable populations include, but are not limited to: minor children, pregnant women, incarcerated individuals, and those with diminished cognitive functioning. Full board reviews are conducted at monthly IRB meetings which take place on the first Thursday of each month during the regular Fall and Spring semesters of the academic year. The IRB does not meet in January or during the summer (June through August). Protocols requiring full-board review must be received by the IRB no later than one week prior to a scheduled meeting in order to be placed on the agenda. Researchers are encouraged to attend the IRB meetings to address any questions or concerns posed by the IRB.
Changes in research protocols, which may alter the risks to the research subjects and occur during the period for which IRB approval has already been given, must not be initiated by the principal investigator until the proposed changes are approved by the IRB. An exception is made for changes necessary to eliminate apparent immediate hazards to the subjects.
Unexpected Risk and Noncompliance
In accordance with federal regulations, the IRB is authorized to suspend or terminate approval of research in violation of IRB decisions, conditions, and requirements, or research resulting in unexpected serious harm to subjects.
Principle Investigators must report any instances of unanticipated risk to participants and any instances of noncompliance to the IRB Chair. Informed consent documents must also provide participants with contact information for the IRB Chair.
The IRB may also require periodic audits of research data and methods to monitor risk and compliance with approved protocol procedures. The need for audits will be determined either at the time of review or in response to information provided by investigators, participants, or others with knowledge of the research.
In the event of unanticipated risk to participants or noncompliance, the IRB may require further review which could result in modification, suspension or termination of IRB approval.
Questions?
For more information contact one of the following persons:
Dr. Jason Davis Or Dr. Katherine (Katie) Jore
IRB Chair Associate Vice Chancellor
715-346-4598 Academic Affairs/202A Main
715-346-3710
jdavis@uwsp.edu kjore@uwsp.edu
Protocols should be addressed to IRB/Grants Office and sent to 204 Old Main Building.