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 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.
Andy Dohanos, Chair, IRB
Jaimy Dyer, Co-Chair, IRB
Brian Thomas, Chair, IACUC
Basic Human Subject Research (HSR) modules are suitable for all persons involved in research studies involving human subjects, or who have responsibilities for setting policies and procedures with respect to such research, including institutional review boards. These modules are typically assembled into a basic course, which is the learner's first exposure to the content. Refresher modules, which can be assembled into refresher courses presented to learners at intervals defined by the institution, are designed to provide continuing education in human subjects research issues.
BW requires all investigators to register a Collaborative Institutional Training Initiative (CITI) account in order to complete the Basic Social-Behavioral Educational modules. The steps below will assist you in the registration process. The details below highlight REQUIRED information for participants registering as Investigators for Basic Human Subject Research, which applies to MOST students and faculty on this campus. Please read all prompts as you register and only provide information that is applicable to your situation.
Go to the website https://www.citiprogram.org to register and complete the training.
- Click the link and choose to Register
- In step 1 under "Participating Institutions" type in Baldwin Wallace University
- Select Continue to Step 2
- Complete the rest of the registration information in steps 2-5
- In step 6 of “Learner Registration” for "Role in human subjects research:" choose Principal Investigator
- In step 6 of “Learner Registration” for "Which course do you plan to take?:" choose Basic Human Subjects - Social & Behavioral Focus
- In step 7 “Select Curriculum — Baldwin Wallace University” Screen, choose the Social & Behavioral Research Investigators option
- Click the “Complete Registration” button at the bottom of the screen
- On the Main Menu Screen, you can see the course you are enrolled in under the Baldwin Wallace University Courses tab. Click on the name of the course to ENTER and begin completing the course modules.
Does your project need IRB review?
IRB approval is required if your human subject research consist of the following criteria.
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.
Types of IRB Reviews
In accordance with Department of Health and Human Services regulations, Baldwin Wallace University recognizes three categories of review for research involving human participants: Exempt, Expedited and Full. It is anticipated that most research activities carried out at BW will fall under the exempt and expedited review categories in that they involve relatively low-risk procedures. To determine which category applies to your research please use the decision charts provided by the Department of Health and Human Services.
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.
Does your project need IRB review?
IRB approval is required if your human subject research consist of the following criteria.
IRB Application Submission
- Complete CITI Training
- Must be completed prior to submission
- 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 theInformed 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 email@example.com
- If the primary investigator is a student, the faculty mentor overseeing the project must be cc’d on the submission e-mail.
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 Federalwide 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 federalwide 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 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
In accordance with 45 CFR 46.101, the following research activities may be may be reviewed through an exempt review procedure by the IRB:
- Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
- Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:
- information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.
- Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph(b)(2) of this section, if:
- (i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
- Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
- Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine:
- (i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.
- Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
- Research activities that (1) present no more than minimal risk to human subjects, and (2) involve only procedures listed in one or more of the following categories, may be reviewed by the IRB through the expedited review procedure authorized by 45 CFR 46.110 and 21 CFR 56.110. The activities listed should not be deemed to be of minimal risk simply because they are included on this list. Inclusion on this list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects.
- The expedited review procedure may not be used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects= financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.
- The expedited review procedure may not be used for classified research involving human subjects.
- IRBs are reminded that the standard requirements for informed consent (or its waiver, alteration, or exception) apply regardless of the type of review--expedited or convened--utilized by the IRB.
- Categories one (1) through seven (7) pertain to both initial and continuing IRB review.
- Clinical studies of drugs and medical devices only when condition (a) or (b) is met.
- Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.)
- Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.
- Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
- from healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week; or
- from other adults and children, considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than 2 times per week.
- Prospective collection of biological specimens for research purposes by noninvasive means.
- Examples: (a) hair and nail clippings in a nondisfiguring manner; (b) deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; (c) permanent teeth if routine patient care indicates a need for extraction; (d) excreta and external secretions (including sweat); (e) uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue; (f) placenta removed at delivery; (g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; (h) supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques; (i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; (j) sputum collected after saline mist nebulization.
- Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications.)
- Examples: (a) physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subject=s privacy; (b) weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; (e) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.
- Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis). (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects.45 CFR 46.101(b)(4). This listing refers only to research that is not exempt.)
- Collection of data from voice, video, digital, or image recordings made for research purposes.
- Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(2)and (b)(3). This listing refers only to research that is not exempt.)
- Continuing review of research previously approved by the convened IRB as follows:
- where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects; or
- where no subjects have been enrolled and no additional risks have been identified; or
- where the remaining research activities are limited to data analysis.
- Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.
Full Board Review
Unless expedited or exempt review is specifically requested, all research proposals will undergo full review by the IRB. The investigator will complete the Application to the IRB. A quorum of the members of the IRB will review the proposal and supply written recommendations. When necessary, the opinions of an outside consultant expert (i.e., medical, legal, etc.) may be sought. At any time during the review process, the IRB may request further information. By a majority vote of all its members, the IRB will take one of the following actions:
- Approve the research
- Conditionally approve the research
- Disapprove the research with a request for resubmission
A written decision, with explanation where necessary, will be sent to the investigator and to the Office of Academic Affairs. The review process typically will require at least two to four weeks.