The Research Office

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

Other Helpful Resources:

Regulatory Compliance

At Oakland University, we adhere to laws, regulations, guidelines and specifications relevant to research processes. The Research Office will help you navigate through these processes. 

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
Financial Conflict of Interest (FCOI)

Oakland University’s Research Financial Conflict of Interest (FCOI) Policy and Procedures

Oakland University (OU) maintains the highest ethical standards in research and other scholarly activity.  To promote objectivity and transparency in research and other sponsored program activities and to ensure compliance with federal funding agency requirements, OU has implemented the policy, Research Policy and Operational Guidance on Financial Conflicts of Interest.  This policy supersedes Oakland University’s former research policies on Financial Conflict of Interest specific to NSF- and PHS-funded research. The effective date of Oakland University’s new Research Policy and Operational Guidance on Financial Conflicts of Interest is May 1, 2020 and applies to all sponsored proposals submitted on or after that date including those funded by the National Science Foundation and PHS-funding agencies.

What is the new requirement?

Under OU’s new FCOI policy, any “investigator” participating in or planning to participate in a project submitted for funding by any external sponsor must disclosure any significant financial interests (SFI), relationships or other outside interests related to their University responsibilities. 

For research that is funded by PHS funding agencies or agencies that have adopted the Final Rule, investigators must also disclose the occurrence of any sponsored or reimbursed travel that meets the de minimus threshold prescribed by OU’s Policy. 

These disclosure requirements not only apply to each investigator on a project, but also to the investigator’s spouse and dependent children.

Investigators are reminded of their responsibility to report all financial interests and reimbursed or sponsored travel from a foreign institution or government of another country.  See recent reminders by the National Institutes of Health.

NOT NOT-OD-19-114
Reminders of NIH Policies on Other Support and on Policies related to Financial Conflicts of Interest and Foreign Components

NOT-OD-18-160
Financial Conflict of Interest: Investigator Disclosures of Foreign Financial Interests

Who is an investigator?

An investigator is defined as the project director or principal investigator and any other person, regardless of title or position, who is responsible for the design, conduct, or reporting of the sponsored project. Investigators may include sub-grantees, contractors, consortium participants, collaborators, consultants, graduate students and postdocs.   The determination of who is an investigator on a sponsored project must be made by the Principal Investigator taking into consideration the significance of the contributions to the project and the degree of independence with which that individual works.

Institutional responsibilities include the investigator’s professional responsibilities conducted on behalf of OU including but not limited to research, research consultation, teaching, professional practice, and service on OU committees.

When and how are Investigator Disclosure Forms submitted?

Investigator Disclosure Forms must be submitted to the Research Office through InfoReady REVIEW at the following times and under the following circumstances:

  • No later than at the time of proposal submission
  • At least annually, regardless of any changes, during the award
  • No later than 30 days after discovering or acquiring a new SFI or other conflict
  • At the time a new investigator is added to the project
  • Within 30 days of new reimbursed or sponsored travel that meets the de minimus threshold prescribed by OU’s Research FCOI Policy

Investigators should log in to InfoReady REVIEW using their NetID, download and complete an Investigator Disclosure Form and then upload it to the system.

All investigators must have an up to date Investigator Disclosure Form on file in the Research Office within 12 months of submission of a new sponsored project.  The Research Office will accept previously submitted paper disclosure forms provided they are up to date.  However, for new proposals submitted on or after May 1, 2020, investigators must submit Investigator Disclosure Forms to the Research Office using InfoReady Review. 

Note that investigators with significant financial, travel or other interests will be prompted to submit additional information regarding the amount and nature of these interests. This additional information will be collected through separate “opportunities” in InfoReady REVIEW using the following forms:

  • Significant Financial Interest Disclosure Form (Appendix A)
  • Reimbursed or Sponsored Travel Disclosure Form (Appendix B)

How are disclosures reviewed?

Disclosures will be reviewed in accordance with OU’s Research Policy and Operational Guidance on Financial Conflicts of Interest to ensure all conflicts are reduced, managed or eliminated prior to expenditure of funds.  Investigators may be asked to submit additional information to assist in this review.  This information will be collected through separate opportunities in InfoReady REVIEW.  Forms to capture pertinent information can be found in InfoReady REVIEW.

What training is required?

All investigators must complete training on conflict of interest prior to expenditure of funds on new awards and every 4 years thereafter.  The training requirement may be satisfied by completion of the Conflict of Interest Course offered through the Collaborative Institutional Training Initiative (CITI) Program or the interactive NIH Financial Conflict of Interest training module. Training certificates should be uploaded as a proposal attachment in cayuse.  Investigators should note that funds will not be released for a project until training has been completed.

The Research Office also provides face-to-face training in FCOI periodically throughout the academic year or by special request.  Investigators are encouraged to attend one of the training sessions and should contact the Director of Research Integrity for more information at mwlong@oakland.edu or 248-370-2708.

References

Oakland University Research Policy and Operational Guidance on Financial Conflicts of Interest

Final Rule on financial conflicts of interest in PHS-funded research.

The Public Health Service funding agencies include:

  • Agency of Healthcare Research and Quality (AHRQ)
  • Agency for Toxic Substances and Disease Registry (ATSDR)
  • Centers for Disease Control (CDC)
  • Food and Drug Administration (FDA)
  • Human Resources and Services Administration (HRS)
  • Indian Health Service (HIS)
  • National Institutes of Health (NIH)
  • Office of Global Affairs (OG)
  • Office of the Assistant Secretary for Health (OASH)
  • Office of the Assistant Secretary for Planning and Evaluation
  • Office of the Assistant Secretary for Preparedness and Response (ASPR)
  • Office of Public Health and Science
  • Substance Abuse and Mental Health Services Administration (SAMHSA)

National Science Foundation conflict of interest policies

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, which can be found on the Research Office e-space, under Regulatory Compliance, HPSCRO Committee: https://espace.oakland.edu/mod/page/view.php?id=103361.

Applications for initial review must be submitted to the Director of Regulatory Support at mwlong@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 HPRSCRO Continuing Review Form.  Any modifications in approved research must be approved prior to initiation using the HPSCRO Modification Form. 

These forms:

  • HPSCRO Application
  • HPRSCRO Continuing Review Form
  • HPSCRO Modification Form

can all be found on the Research Office e-space, under Regulatory Compliance, HPSCRO Committee: https://espace.oakland.edu/mod/page/view.php?id=103361.

Resources:

1. The National Institutes of Health Guidelines for Human Stem Cell Research -  https://stemcells.nih.gov/policy/2009-guidelines.htm

2. Final Report of the National Academies' Human Embryonic Stem Cell Research Advisory Committee and 2010 Amendments to the National Academies' Guidelines for Human Embryonic Stem Cell Research -  https://www.nap.edu/catalog/12923/final-report-of-the-national-academies-human-embryonic-stem-cell-research-advisory-committee-and-2010-amendments-to-the-national-academies-guidelines-for-human-embryonic-stem-cell-research

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

HPSCRO Committee Members
Paul Megee, Ph.D., Chair
Rasul Chaudhry, Ph.D.
Kyeorda Kemp, Ph.D.
Gerard Madlambayan, Ph.D.
Gustavo Patino, M.D., Ph.D.
Varna Taranikanti, M.D., Ph.D.
Luis Villa Diaz, DVM, MAppSc, Ph.D.

Nonvoting Members
Michael Long, Ph.D.
Domenic Luongo, MSc, CHMM

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.

More information can be found on the IACUC e-space.  For access to this e-space, email conley@oakland.edu.

Institutional Biosafety Committee (IBC)

All research, teaching, and studies at Oakland University that involve recombinant DNA, infectious agents, and/or cultured cell lines must be approved by the  Institutional Biosafety Committee (IBC)  prior to any work performed in the laboratory.

  • Human/Primate derived materials
  • Bloodborne Pathogens
  • Recombinant DNA
  • Infection agents including:
    • Bacteria
    • Virus
    • Fungi
    • Prion
  • Biologically-derived toxins
  • Cultured cell lines

Project Application and Revision Via RAM 3.0

  • IBC scheduled to meet monthly
  • Applications must be submitted 2 weeks prior to scheduled meetings. 
  • Access to the Research Application Manager:    RAM 3.0.
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), which can be found on the Research Office e-space under Regulatory Compliance, Radiation Safety Committee: https://espace.oakland.edu/mod/page/view.php?id=103364.

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), which can be found on the Research Office e-space under Regulatory Compliance, Radiation Safety Committee: https://espace.oakland.edu/mod/page/view.php?id=103364.

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.