- Approval letter for the current Animal Welfare Assurance from the Office of Laboratory Animal Welfare (OLAW)
- Office of Laboratory Animal Welfare (OLAW)
- USDA Animal Welfare Act Regulations (AWAR)
- Guide for the Care and Use of Laboratory Animals
- NIH - Office of Laboratory Animal Welfare - Departures from the Guide
- American Veterinary Medical Association (AVMA) Guidelines for Euthanasia
The use of vertebrate animals in research, teaching, and testing requires the submission and approval of an IACUC application. Applications for the use of vertebrate animals (AUVA), and request for revisions for any previously approved applications, are submitted through RAM 3.0. Please note that use of the most current version of the application is mandatory and is located in RAM 3.0.
Review of Applications
The IACUC committee meets monthly to review applications. If you are preparing an application, please contact the committee chair for the deadline for applications to be reviewed at the next meeting. All applications are due at least 10 days prior to the next meeting.
The next IACUC meeting is scheduled for Monday, September 26, 2016.
- Instructions for Submitting an Application that Requires Modifications (RM)
- Instructions for Revision of Previously Approved Protocols
- IACUC Amendment for Addition of Personnel Form
- IACUC Amendment for Grant Fund Changes
- IACUC Amendment for Animal Source Changes
- IACUC SOP - Continuing Review
- IACUC SOP - Guidance on Reporting Adverse Events
- IACUC SOP - Use of Biomedical Research Support Facility by Outside Users
- IACUC Policy - Appropriate PPE and Apparel
- IACUC Policy - Environmental Enrichment
- IACUC Policy - Social Housing
- IACUC Policy - Use and Preparation of Non-Pharmaceutical Grade Substances and Compounds
The Top 10 Reasons Why Protocol Applications Are Deferred
Pre-Review Checklist - IACUC Protocol
The program for animal care and use is supported by the Biomedical Research Support Facility.
- SOP - Delivery of Inhalant Anesthesia
- SOP - Sharps Injury Prevention
- SOP - Euthanasia by Cervical Dislocation
- SOP - Use of Expired Medical Materials
- SOP - Obtaining Veterinary Care for Sick or Injured Animals
- SOP - Non-Pharmaceutical Grade Substances and Compounds Use and Preparation
The Oakland University Institutional Animal Care and Use Committee (IACUC) requires that all Principal Investigators with an approved IACUC Application for the Use of Vertebrate Animals (AUVA), and any personnel listed on those applications, complete Collaborative Institutional Training Initiative (CITI) Courses before they are allowed to begin working on the project. This requirement is satisfied by the completion of CITI Training.
- Oakland University Training and Information Manual for Animal Care and Use
- Report of Deficiencies in Animal Care and Use
- Policies and Procedures on Anesthesia and Tail Biopsy in Mice - Guidance on the use of anesthesia when performing tail biopsy on mice
- NIH Guidelines for the Genotyping of Rodents
- NIH - What Investigators Need to Know About the Use of Animals
Compliance with Financial Conflict of Interest Regulations
New federal regulations on financial conflicts of interest (FCOI) in PHS-funded research took effect on August 24, 2012. The “Final Rule” replaces the 1995 regulations and applies to all researchers at Oakland University who are planning to apply for, or have received, grant funds from the Public Health Service (e.g., NIH) on or after August 24, 2012. The Final Rule affects the definition, thresholds, disclosure and management of Financial Conflicts of Interest (FCOI).
The Final Rule makes it mandatory for investigators with PHS funding to complete required training. This applies to the Principal Investigator or Program Director and all personnel who are responsible for the design, conduct or reporting of the PHS-funded work. “Investigator” includes sub-grantees, contractors, consortium participants, collaborators, and consultants. OU uses the on-line CITI module on FCOI to comply with this training requirement, but the Office of Research Administration can provide additional in-person training sessions upon request.
- OU’s research policy and operational guidance on compliance with the FCOI Final Rule is now available.
- The FCOI disclosure form is included in the research policy, but a fillable form version is available.
- Disclosures can be e-mailed to FCOI@oakland.edu.
- Other helpful information can be found at the NIH website.
OU's Research Policy and Operational Guidance for National Science Foundation Conflict of Interest (FCOI) is available. This guidance applies to all researchers who are presently funded under an NSF grant or plan to submit an application for NSF funding.
If you are a researcher with Significant Financial Interests related to your NSF-funded research, a fillable form version of the Disclosure Form is available. The form can be emailed to FCOI@oakland.edu.
If you have any questions, please contact Adeline Gonzales, Grant Administrator, at firstname.lastname@example.org or (248) 370-2753.
The purpose of the federal export control regulations is to protect certain national and economic security interests. The regulations may apply to some university activities even though, generally, there are exclusions for fundamental research and education. While Oakland University is committed to academic freedom, the sharing of information and ideas, and public dissemination of knowledge, inclusive of citizens from non-U.S. nations, the university and its members must comply with the export control regulations or face penalties for any violations that occur.
Most of the relevant export control regulations are administered by one of three federal departments—State, Commerce, and Treasury. Each of these departments has its own set of regulations, policies, and procedures, which are changeable and often conflict with each other. Therefore, it is the goal of the Office of the Vice Provost for Research at Oakland University to provide relevant information, guidance, and education to investigators so that they can plan their activities to comply with these complex regulations. In turn, investigators and other personnel must share the responsibility for recognizing the activities under their purview that may require review for compliance with export controls.
The resources on this website are a starting point, but more detailed discussions with Oakland University’s Office of Research Administration staff are welcome and often necessary for reaching an understanding and resolution about specific situations. Click on any of the following resources:
- Online CITI training. To select the correct module:
- Click on "Add a course or update your learner group"
- Scroll down to Question 6 and select CITI Export Controls
Commitment to the Highest Ethical Standards in Human Subjects Research
The IRB applies the ethical principles of respect for persons, beneficence and justice as set forth in the Belmont Report and the regulations codified by the Department of Health and Human Services (DHHS) in 45 CFR 46 and the FDA as applicable in its review of research. The IRB considers additional protections when vulnerable populations are included in the research such as fetuses, pregnant women, prisoners, children, and cognitively impaired subjects.
OU commits to complying with these ethical principles and regulations through its Federal-wide Assurance with OHRP.
- FWA#: FWA00003480
- IRB Registration #: IORG0000063
Not all research conducted at OU must be reviewed by the IRB. Research must meet the DHHS definition of both "research" and "human subject" to come under the purview of the IRB. According to the DHHS regulations, "research" means a systematic investigation, including research development, testing, and evaluation, designed to contribute to generalizable knowledge. The DHHS defines "human subject" as a living individual about whom an investigator conducting research obtains data through intervention or interaction with the individual or identifiable private information. The FDA considers other criteria in the definition of human subjects research. As these determinations are sometimes complicated and take several factors into consideration, researchers must have a nonhuman subjects research determination confirmed by IRB administrative staff in the Office of Research Administration.
Submission Requirements for Human Subjects Research
All research projects meeting the definition of human subjects research must be submitted to and approved by the OU IRB prior to implementation . Research projects are submitted to the IRB through the IRB's online protocol management system, IRBNet. All applications, forms and templates are available in the Forms and Templates Library of IRBNet. Please refer to IRBNet for additional instructions.
Researchers please note: The most current version of these documents must be used or your submission will be returned.
Prior to submission of applications to the IRB, all researchers, faculty, student and staff conducting research involving human subnjects need to comply with the following requirements:
- Become familiar with Oakland University IRB Guidelines.
- Complete mandatory training in human subjects research. The OU IRB uses courses offered by the Collaborative Institutional Training Initiative (CITI) Program to satisfy human subject research training requirements. CITI courses are valid for 3 years with a required minimum aggregate score of 80% to pass. Please see OU IRB's most recent CITI training requirements.
- Submit Conflict of Interest Disclosure Forms and evidence of valid CITI training completion for the Principal Investigators and all other key personnel on the study.
- Obtain special permission from the Vice Provost for Research if you are a non-tenure track faculty or staff seeking to serve as a Principal Investigator or as a Faculty Sponsor or adviser. A copy of the Special Permission Form can be found in the Forms Library of IRBNet. A copy of the fully executed Special Permission Form must be included with the project submission.
After IRB approval, investigators must comply with the following requirements:
- Conduct the research as described in the approved or exempted application.
- Obtain approval prior to implementation of any changes in approved research by submitting an amendment to the IRB. No proposed changes may be implemented prior to IRB approval.
- Obtain continuing review approval at least annually by submitting a Continuing Review Form or if the research is not continuing, submit a Study Closure Form prior to the expiration date of the study.
- Report any unanticipated problems and noncompliance to the IRB within 5 working days of becoming aware of the problem.
The Use of Protected Health Information (PHI) in Research
Researchers using or collecting PHI from medical records or databases in their research must be aware that additional regulations apply. The Health Information Portability and Accountability Act (HIPAA) includes additional provisions for protecting the privacy and security of PHI. PHI includes 18 patient identifiers that are considered individually identifiable. Researchers intending on using PHI in their research must contact one of the IRB administrative staff in the Office of Research Administration and become familiar with the HIPAA regulations in Standards for Privacy of Individually Identifiable Health Information.
The Use of Educational Records in Research
For research involving the use of student educational records, the Family Educational Rights and Privacy Act of 1974 (FERPA) provides additional protections that must be followed. Researchers are advised to contact the IRB administrative staff in the Office of Research Administration or the Office of the Dean of Students with additional questions.
OU Human Subjects Cooperative Research
Investigators involved in projects with other institutions may use joint review arrangements, rely upon the review of another qualified IRB, or make similar arrangements for avoiding duplication of effort. Investigators should be familiar with the OU Human Subjects Cooperative Research Procedures, which involves consultation with OU IRB administrative staff. For additional information, contact Judette Haddad at (248) 370-4898 or email@example.com in the Office of Research Administration .
|IRB Members||IRB Alternate Members|
Christine Stiller, Ph.D., IRB Chair
Judette Haddad, Ph.D.
|Judette Haddad, Ph.D.|
Regulatory Compliance Officer
|Stephanie Edwards, J.D.|
Regulatory Compliance Specialist
IRBNet is the most widely-used research compliance management solution, providing powerful, flexible and cost-effective solutions to more than 1600 organizations in all 50 states and internationally on the National Research Network. Membership includes universities and colleges, community hospitals and hospital networks, and federal and state agencies.
Effective October 15, 2012, IRBNet has been selected to replace RAM2.0 for “research projects” being submitted to the Institutional Review Board (IRB).
- All new applications, modifications to previously approved applications and continuing review applications must be submitted through IRBNet using the appropriate forms.
- All submissions require the use of the most current version of applications, forms, and current versions of the OU informed consent templates (adult, parental permission and child assent) for all human subjects research projects that require documentation of written informed consent. Applications and forms can be found in the Forms and Templates library of IRBNet.
- Researchers including all key personnel must register with IRBNet to access the IRB applications and required forms, which are located in the Document Library and Forms and Templates on IRBNet. To register, go to www.irbnet.org and then click “New User Registration” in the upper right hand corner and follow the instructions.
- Step-by-Step Instructions for the Use of IRBNet
- IRBNet New User Registration and Management of CITI Credentials
- IRBNet Researcher Training Energizers 1: New Project Submission
- IRBNet Researcher Training Energizers 2: Post-Submission Advanced Topics
IRBNet registration for IRB Members is done by the Office of Research Administration. Committee Members are encouraged to take advantage of the training offered by administrative staff as well as the following IRBNet resources for Committee/Board Members and login with username: oakland and password: training
Radioactive material (including machinery producing ionizing radiation) can only be used by authorized Oakland University permit holders or under the supervision of a permit holder. User permits are issued by the Oakland University Radiation Safety Committee (RSC). User permits are issued to the full-time OU faculty members or principal investigators only. All others must work under the supervision of a full-time faculty member.
Full-time faculty members can apply to the RSC for a user permit by submitting a Radiation User Permit Application. Please contact Radiation Safety Officer, Domenico Luongo, to get the electronic copy. The committee will issue a user permit only after reviewing the application. Three-year user permits are issued after an initial probationary one-year user permit. Permit holders are responsible for the proper use of all radioisotopes or radiation producing machinery, proper maintenance of the facilities used for research, and proper maintenance of all required records. The specific, detailed instructions on procedures and requirements for the use of radioactive materials at Oakland is referenced in the Oakland University Safety and Procedures Manual for the Use of Radioisotopes in Laboratories (pdf).
Permit holders are responsible for meeting Oakland University training requirements and standards. Every individual working with, or in the vicinity of radioactive materials, must receive instruction and training commensurate with their duties before beginning any work. In addition, all individuals must be retrained once every three years and/whenever there is a significant change in duties, regulations, or terms of the university’s license of the investigators user permit. A description of these requirements can be found in the Oakland University Safety and Procedures Manual for the Use of Radioisotopes in Laboratories (pdf).
Permit holders should know that federal and state agencies routinely conduct inspections – some unannounced – including inspections of records maintained by permit holders. In addition, periodic audits of laboratories, and inspections of isotope records, are conducted by the Radiation Safety Officer (RSO) or a member of the RSO’s staff. All inspections, including inspections of records, will be done as to minimize the disruption of normal laboratory functions. They will be unannounced.
Researchers must note that several federal funding agencies require training in the Responsible Conduct of Research (RCR). The specific training requirements are agency-dependent.
National Science Foundation
The National Science Foundation (NSF) requires that all student researchers funded by NSF receive training in the RCR. This requirement applies to undergraduates, graduate students, and postdoctoral researchers who are supported by NSF to conduct research. View the relevant regulations.
In order to satisfy this training requirement, which took effect in January 2010, we remind you to have your student researchers take the required training when they begin their NSF-funded research. For this purpose, Oakland University provides on-line RCR training from the Collaborative Institutional Training Initiative (CITI). Instructions for signing on to the required RCR modules are as follows:
- After accessing CITI training, either register as a new user or log in as usual, then click on “Submit”
- Click on “Add a course or update your learner groups.”
- Scroll down to Question 4 and select “RCR for NSF & NIH Researchers.”
National Institutes of Health
Similar training is required for personnel funded on NIH grants that have a training component. For these grants, face-to-face educational sessions are required in addition to the on-line RCR modules from CITI. These NIH requirements were updated in November 2009.
U.S. Department of Agriculture
Recipients of USDA funding requires program directors, faculty, undergraduate students, graduate students, postdoctoral researchers, and any staff participating in the research to undergo training and oversight in the RCR. Completion of the CITI Program training for RCR will satisfy the training requirement. The USDA requirements in the RCR training became effective February 2013.
Please contact our office if you have questions.