Office of Responsible Research
Andy Dohanos, Chair, IRB
Jaimy Dyer, Co-Chair, IRB
Brian Thomas, Chair, IACUC
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 email@example.com, if engaging in human subject research, or the IACUC at firstname.lastname@example.org, 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 Federal Wide Assurance (FWA) (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 email@example.com. Your identity will not be shared with anyone outside of the IRB and all information is confidential.
Institutional Review Board (IRB)
The Institutional Review Board (IRB) is a committee mandated by federal law to protect the rights and welfare of human subjects participating in research activities. The law is specific to research conducted or supported by a federal department or agency. However, a majority of research institutions, including Baldwin Wallace University, voluntarily apply this regulation (45 CFR 46) to all research conducted at their site, regardless of status or source of funding. The IRB achieves its primary function, protecting the rights and welfare of subjects participating in research including their rights to give informed consent and to have their safety protected from undue risk, by educating researchers. An educated investigator makes the IRB's job easier.
Does your project need IRB review?
IRB approval is required if your human subject research consist of the following criteria.
IRB Review Criteria
If any of the following criteria apply to your human subjects’ research then IRB approval prior to initiation is required, irrespective of funding.
- The research is conducted by University faculty, staff, or students
- The procedures are performed on the premises of the University
- The procedures are performed with or involve the use of facilities or equipment belonging to the University
- The research involves University students, staff, or faculty
- The research project satisfies a requirement imposed by the University as the condition for the award of a degree or for completion of a course of study in the University
- The research project satisfies an obligation of the faculty appointment at the University, as consistent with departmental research goals and objectives, including "clinical or adjunct" appointments
Types of IRB Reviews
- Exempt, Expedited and Full Review Descriptions
- Decision Tree: Resources to help determine the correct form of review to request
According to federal regulations IRBs shall consist of at least five members with distinctive backgrounds in order to ensure adequate review of the breadth of research projects conducted at the institution. The members of the IRB should be diverse in terms of race, gender, cultural backgrounds, and sensitivity to community attitudes. No IRB may consist entirely of one gender or profession. Each IRB must include a nonscientist and a person not otherwise affiliated with the institution. At its discretion, an IRB may invite individuals with expertise to assist in the review of proposed research, although these invited experts may not vote with the IRB.
FWA and IRB Registration
The IRB must be registered electronically through http://ohrp.cit.nih.gov/efile. The registration is effective for 3 years at which time it must be renewed. Funding agencies use the government website to verify that an institutional review board (IRB) has an active registration. Baldwin Wallace University’s (IORG0005654) Institutional Review Board IRB00006808 registration is current and will expire on 04/28/2017.
The Federal Wide Assurance (FWA) is an assurance of compliance with the U.S. federal regulations for the protection of human subjects in research. It is approved by the Office for Human Research Protections (OHRP) for all human subjects’ research conducted or supported by the U.S. Department of Health and Human Services (HHS). The FWA is also approved by OHRP for federal wide use, which means that other U.S. federal departments and agencies that have adopted the U.S. Federal Policy for the Protection of Human Subjects (also known as the Common Rule) may rely upon the FWA for the research they conduct or support.
A FWA is the only type of assurance currently accepted and approved by OHRP. It is required whenever an Institution becomes engaged in human subjects research conducted or supported by any U.S. federal department or agency that has adopted the Common Rule, unless the research is otherwise exempt from the requirements of the Common Rule or a U.S. federal department or agency conducting or supporting the research determines that the research shall be conducted under a separate assurance.
Each institution must complete and submit its FWA (new submissions, updates and renewals) using the electronic submission system at http://ohrp.cit.nih.gov/efile/. The FWA must be renewed every 5 years, even if no changes have occurred, in order to maintain an active FWA. Funding agencies use the government website to verify that an institutional review board (IRB) has an active FWA. Baldwin Wallace University has filed an active FWA00014035 which is set to expire 04/29/2019.
IRB Application Submission
- Complete CITI Training prior to application submission
- About CITI Registration
- Complete IRB Application For all new and/or revised or amended projects.
- Revision Applications MUST include strike-through as opposed to deletions of original material. In addition, all new/changed material MUST be highlighted.
- Complete a Continuation Application for previously approved projects expected to continue beyond the approved period of study. NOTE: No project may exceed 365 days between reviews.
- Complete Informed Consent Documentation
- What documents do I need?
- If you requested a waiver of Informed Consent (and justified this) in your IRB Application, proceed to step 4 below.
- If subjects are 18 years or older and capable of offering informed consent, complete the Informed Consent Form.
- If subjects are less than 18 years old, complete the Parental Consent and (when necessary) Child Assent Forms.
- The HHS regulations do not require documentation of assent. The IRB has the discretion to determine the appropriate manner, if any, of documenting child assent. Based on such considerations as the child’s age, maturity, and degree of literacy, the IRB should decide what form of documentation, if any, is most appropriate. If adolescents are involved in research where a consent form would have been used if the subjects were adults, it would generally be appropriate to use a similar form to document an adolescent’s assent. If young children are involved who are as yet unable to read, documentation should take a form that is appropriate for the purpose of recording that assent took place. The IRB may also decide that documentation of assent is not warranted. Please address questions to the IRB chair.
- Gather Supporting Materials
- Recruitment or informational materials: recruitment scripts, e-mail scripts, fliers, debriefing statements, etc.
- Data Instruments: copies of surveys, interview questions, tests, web-surveys, etc.
- Intervention Instruments: any video clips, music clips, photos that subjects will be exposed to as part of your study.
- Grant description, if study is funded.
- Collate All Materials
- All items should be collated into a single Word or PDF document for submission.
- Submit Application to firstname.lastname@example.org
- If the primary investigator is a student, the faculty mentor overseeing the project must be cc’d on the submission e-mail.