Office of Responsible Research
Purpose and Commitment
Baldwin Wallace University is committed to safeguarding the rights and welfare of both human and animal subjects involved in the conduct of research by BW faculty, students, and staff. Baldwin Wallace supports responsible research which promises to increase knowledge and understanding, and encourages the highest ethical standards among BW researchers. To ensure these safeguards and standards are met, the Office of Responsible Research houses an Institutional Review Board (IRB), for the protection of human subjects and, an Institutional Animal Care and Use Committee (IACUC), for the protection of animal subjects.
The Office of Responsible Research views the education of the Baldwin Wallace University community, with regard to the ethical conduct of research, among its primary responsibilities. To that end, instructors of courses that engage students in the research process are strongly encouraged to contact the chair of the IRB at firstname.lastname@example.org, if engaging in human subject research, or the IACUC at email@example.com, if engaging in animal research, to schedule classroom information sessions prior to the submission of project applications. Likewise, primary investigators should contact the appropriate chair in order to obtain information regarding university guidelines or advice regarding the preparation of their application for approval of research involving human or animal subjects.
The Institutional Review Board (IRB) is required to ensure that any research activity funded in whole or in part (e.g. grant, contract, and/or fellowship) by the U.S. Department of Health and Human Services (HHS) remains in compliance with federalwide assurance (i.e. the common rule) regarding the protection of human subjects in research. Further, the IRB is required to report to the Secretary of HHS regarding: 1) serious or continuing non-compliant research activity, 2) the suspension or termination of previously approved research, and/or 3) any unexpected serious harm to participants associated with a research project.
Investigators are responsible for conducting human subject’s research in accordance with all applicable federal and state regulations. Once the IRB has reviewed and approved a research protocol and the various forms (consent, assent, data collection, etc), no changes may be implemented without prospective review and approval by the IRB. The only exception to this rule involves emergency action by an investigator to protect subjects from apparent immediate hazards. During the conduct of the study, investigators must request approval for any changes to the IRB approved protocol and applicable consent forms, questionnaires or other documents prior to implementation.
Noncompliance is defined as any action or activity associated with the conduct or oversight of research involving human subjects that fails to comply with federal or state regulations or institutional policies governing human subject research or the requirements or determinations of the IRB including minor protocol deviations.
Minor protocol deviation is a deviation that does not have a significant impact on the research participant’s rights, safety or welfare; the integrity of the data; nor substantially alter risks to subjects as determined by the IRB. Examples include, but are not limited to, failure to obtain IRB approval, inadequate supervision, failure to follow recommendations made by the IRB, failure to report unanticipated problems or protocol changes, etc.
To report (or self-report) the direct observation of researcher mis-conduct or non-compliant research activity, please complete an IRB Compliance form and submit it to the IRB chair at firstname.lastname@example.org. Your identity will not be shared with anyone outside of the IRB and all information is confidential.