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371 Wilson Boulevard
Rochester, Michigan 48309-4486
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(248) 370-2762
(248) 370-4111
research@oakland.edu

Regulatory Compliance

Institutional Animal Care and Use Committee (IACUC)

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 Thursday, October 19, 2017.

The committee reviews the scientific merit of the proposed research as it bears on the humane or proper use of animals. The committee performs program reviews and an inspection of facilities at least once every six months.
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
Training Requirements

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 Guidelines and Policies

Financial Conflict of Interest (FCOI)
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. National Science Foundation (NSF)
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 and Contract Officer, at gonzales@oakland.edu or (248) 370-2753.

Export Control
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 "Submit"
    • Click on "Add a course or update your learner group"
    • Scroll down to Question 6 and select CITI Export Controls

IRB for the Protection of Human Subjects in Research
IMPORTANT IRB UPDATES

As part of an on-going improvement process, the IRB office has revised its forms to make them simpler and shorter. The updated versions of the applications, forms, templates and other IRB related documents have been uploaded into the Forms and Template library in IRBNetAll researchers are requested to download the updated versions from IRBNet before completing any form or application.

Please note the following important changes:

  • The Screening Questions at the beginning of the Exempt Application have been modified (version 7/1/2017). Among the changes, research involving the use of recordings for transcription purposes only and some international research may now be submitted as Exempt
  • The Amendment Form has been divided into three separate forms. Please use only the form(s) that may apply to change(s) you wish to make.
The most current versions of the IRB Applications, Forms, Appendices and Consent Templates are available in the Forms and Templates library in IRBNet.

Rapid Review of Exempt Applications

Exempt application submissions are now eligible for an in-office Rapid Review by Office of Research Administration (ORA) staff.  The purpose of the Rapid Review is to make an Exempt Determination while meeting in the ORA office with a member of the ORA staff.  The IRB Submission Checklist for Exempt Rapid Review MUST be submitted with all Rapid Review requests.  Submission packages should indicate "Rapid Review" in the "Comment" Box.

Commitment to the Highest Ethical Standards in Human Subjects Research
Oakland University (OU) is committed to the highest ethical and legal standards for the protection of human subjects who participate in research.  To comply with these standards, all research conducted by OU researchers, faculty, students, or staff that involves the participation of human subjects must be submitted to the Institutional Review Board (IRB) for review and approval prior to initiation.

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 
Determination of Human Subjects Research Requiring IRB Review
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 and must be submitted through IRBNet.  The most current version of these documents must be used.  Please refer to IRBNet for additional instructions.

Prior to submission of applications to the IRB,
all researchers, faculty, student and staff conducting research involving human subjects 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 evidence of valid CITI training completion for the Principal Investigators, Co-Principal Investigators, Faculty advisors, and all other key personnel on the study.
  • Obtain special permission from the Associate Vice President 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 and Templates 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 by submitting an Event Reporting Form. 
Research projects might be subject to intramural or external inspection or audit.

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 be familiar with Oakland University Office of Research Administration Consent Requirements for Using Education Records in Research For additional questions, contact the IRB administrative staff in the Office of Research Administration or Nancy Schmitz, Dean of Students at (248) 370-3352 or schmitz@oakland.edu

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 haddad@oakland.edu in the Office of Research Administration .

IRB MembersIRB Alternate Members

Christine Stiller, Ph.D., IRB Chair
Scott Pickett, DScPT, Vice Chair

Maria Beam, M.S.W.
Elise Brown, Ph.D.
Stephanie Crockett, Ph.D.
Tomas Giberson, Ph.D.
Margaret (Meghan) Harris, Ph.D.
John Karazim, M.D.
Julie Kruse, Ph.D.
Victoria Lucia, Ph.D.
Tracy Macpherson,
Michele Purdie, Ph.D.
Jean Szura

Laurence Allen
Judette Haddad, Ph.D.
Maria Paino, Ph.D.
Doreen E. Olko, M.L.A.
Allen Silbergleit, M.D., Ph.D.
IRB Staff
Judette Haddad, Ph.D.
Regulatory Compliance Officer
haddad@oakland.edu
(248) 370-4898
Stephanie Edwards, J.D.
IRB Specialist
sedwards@oakland.edu
(248) 370-4329
Kate Wydeven
Regulatory Compliance Specialist
kwydeven@oakland.edu
(248) 370-4306

IRBNet
All research projects to be reviewed by the Institutional Review Board (IRB) MUST be submitted through the online research management system, IRBNet.
  • All new applications, revisions, amendments 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 OU IRB applications, forms, and informed consent templates (adult, parental permission and child assent).  Applications, forms, and templates 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.  To register, go to www.irbnet.org and then click “New User Registration” in the upper right-hand corner and follow the instructions.
Training
IRBNet has an excellent "Researcher Training Resources for Download" webpage that provides instructional videos and step-by-step Training Energizers.  Researchers are highly encouraged to visit the page at  http://www.irbnetresources.org/tresources/training.html, to access the videos.  The login information is:  Username:  oakland and password: training.

Below are copies of the IRBNet Training Energizers: Oakland University Step-by-Step Instructions for the Use of IRBNet

Radiation Safety (RSC)
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.

For questions regarding radiation safety and/or radiation permits contact Domenico Luongo, RSO, at (248) 370-4314, email luongo@oakland.edu or visit Laboratory Safety and Compliance.

Responsible Conduct of Research Training
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.

Human Pluripotent Stem Cell Research Oversight (HPSCRO) Committee

Human Pluripotent Stem Cell Research Oversight (HPSCRO) Committee

Derivation and/or use of human pluripotent stem cells (HPSCs) in research requires review and approval by the Oakland University (OU) HPSCRO Committee prior to initiation.  HPSCs include human embryonic stem cells and human induced pluripotent stem cells.  The HPSCRO committee will ensure that any HPSC research at OU is conducted according to the highest ethical standards and in accordance with all state and federal regulations and other applicable HPSC research guidelines.  The OU HPSCRO Committee guidelines and procedures for derivation and/or research use can be found in Oakland University Human Pluripotent Stem Cell Research Oversight (HPSCRO) Committee Guidelines.

Applications for initial review must be submitted to the Director of Regulatory Support at sandborg@oakland.edu using the HPSCRO Application. Once approved, HPSC research will be registered with the HPSCRO Committee’s internal registry and will be valid for 3 years.  Applications for continuing review should be submitted using the continuing review application. Any modifications in approved research must be approved prior to initiation using the HPSCRO Modification form

For questions, contact the Director of Regulatory Support at Sandborg@oakland.edu or any of the HPSCRO Committee Members listed below.

HPSCRO Committee Members
Judith Venuti, Ph.D., Chair
Rasul Chaudhry, Ph.D.
Gerard Madlambayan, Ph.D.
Luis Villa Diaz, DVM, MAppSc, Ph.D.

Nonvoting Members
Rebecca Sandborg, Ph.D.
Domenic Luongo, MSc, CHMM