FAQs

Yes, if you are:

• An IT Manager and are listed on a Technology Control Plan (TCP), you need to take the PEERRS Export Controls course.
• A Study Coordinator for a U-M human subjects study, you need to take the PEERRS Human Subjects Research Protections course.
• In a Research Staff role on a U-M biomedical human subjects study, you need to take the PEERRS Human Subjects Research Protections course.

No.  Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording, and reporting clinical research that involves human participants in research.  A sponsor (e.g., National Institutes of Health) may require that research involving a clinical trial and/or utilizing an FDA-approved protocol follow the International Conference on Harmonization (ICH) Good Clinical Practice guidelines, including ICH-GCP training for investigators.  The biomedical version of GCP focuses on FDA requirements and the application of the informed consent processes for clinical research.  The social-behavioral version of GCP training focuses on the informed consent process for clinical research.

GCP training is not offered through PEERRS.  For U-M GCP training options, see:  HRPP Education Resources.

Human Subjects Protections (HSP) training focuses on the U.S. Common Rule regulations and requirements, including the ethical principles associated with protecting the human particpants in research and the codified protection methods such as Institutional Review Board (IRB) oversight and criteria for an appropriate informed consent process.  HSP training is required by federal sponsors for human subjects research, including research that qualifies for an IRB exemption.

Yes.

A new faculty, staff, or temporary employee (e.g., paid summer-term researcher) whose appointment/job has yet to officially begin can obtain access to PEERRS to proactively complete required regultory training.

1. Work with your U-M department to obtain a U-M Sponsored Affiliate Account.  This is a temporary U-M uniqname and email address.


2. After you have the Sponsored Affiliate Account, complete the PEERRS Access Request webform.


3. Go to the PEERRS home page to register for and complete the applicable PEERRS courses using your sponsored U-M uniqname and account password.

My LINC/PEERRS accounts are typically limited to U-M employees and students and granted automatically using your U-M network credentials.  If you receive a "no account found" error upon logging in to My LINC, one of the following actions may apply:

• If you are a U-M Flint employee or student, log into My LINC/PEERRS using your U-M uniqname and UMICH (Kerberos, Level 1) password.  This password is different than your LAN password for the U-M Flint systems.


• If you are an external (non-UM) researcher who is/will be collaborating on a UM-based human subjects study and who does not hold current certification in a qualifying human subjects protections course, request PEERRS Guest Access.  
  • If you have completed human subjects protections training at your institution, request a Training Waiver instead.

If neither applies to you, email the U-M PEERRS group at peerrs@umich.edu for assistance.

PEERRS certification in any one course is valid for a period of three years from the date of course completion. 

Automated renewal notices are sent from the My LINC system for most courses prior to the expiration date to alert you of the potential need to renew your certification depending on your current research activity.

For each PEERRS course* you previously completed, you may receive up to three "reminder" emails to renew your certification:

1. First email  - 30 days prior to certification expiration.
2. Second email - upon certification expiration, only if renewal has not occurred.
3. Third email - 30 days after certification expiration, only if renewal has not occurred.

These emails are automated from the My LINC system and cannot be "turned off."  The volume you receive at any one time is dependent on how many courses you previously completed on the same day.  

These emails are notifications of the need to potentially renew certification only.  With each notification, you should determine whether or not you need to renew certification in any one PEERRS course based on your current research activity and/or current affiliation with U-M.

* Human Subjects Research Protections, Research Administration, and Responsible Conduct of Research courses only.

As a U-M student, you may be assigned to complete a PEERRS course by an instructor as a class assignment or by the leads (e.g., principal investigator, study coordinator) on a research project on which you are/will be working.  Which course(s) you complete will be up to your school/college and/or the project leads. 

Which PEERRS courses you need to complete is dependent on your research activity and the type of research you do.

1. If you are/will be an investigator (whether "principal" or "participating") on a U-M sponsored award, you are required to hold a current certification in the following PEERRS courses:
   • Responsible Conduct of Research
   • Research Administration


2. If your research involves human participants as subjects, you are required to hold a current certification in the PEERRS Human Subjects Research Protections course or provide proof of equivalent training from another source to PEERRS.


3. If your research involves the use of export control technology, you are required to hold a current certification in the PEERRS Export Controls course.

If possible should provide a supporting reference demonstrated the production and validation of the research tool. This delivers value to scientists who wish to use your reagent in their own experiments by providing a method for experimental reproducibility.

Anytime if it is a finished material to disseminate regardless of publication status.

Because research tools do not necessarily need to be protected by patents to be licensed to commercialize and generate royalties for the laboratory.

Yes, depending on what dissemination strategy is chosen either licensing revenue or production cost (material fee) can be reimbursed to the laboratory.

Your research tool will be promoted to the U-M research tool portfolio and to a third-party marketing site with a one-click purchase option. Webpage links will be shared with you so that you can reference them on your laboratory website and provide it to any requestor. The rest will be taken care of by U-M Innovation Partnerships. If there are questions, you will be contacted by the assigned licensing specialist to discuss the invention and its potential commercial applications. 

Yes, as long as the quality is regulated while stored an extended period of time.

It is a written description of your invention or development provided to IP. The report refers to all sources of support and includes information necessary to begin pursuing dissemination and commercialization activities.

To initiate the process, submit the report online at https://innovationpartnerships.umich.edu/for-inventors/submit-your-innov....

Yes. Under the terms of most funding agreements, researchers have an obligation to promptly disclose whether a patent is being sought or not. A Biological Material/Research Tool Report is required for all research tool inventions and developments. These may accelerate someone else’s research, therefore, promote scientific innovation.

Typically, research tools are materials such as antibodies, vectors, plasmids, cell lines, mice, and other materials used as “tools” in the research process. These are sometimes referred to as research resources, research materials, or tangible research property.

If you have research tools that you believe to be valuable or wish to provide for others (including research collaborators), IP will work with you to develop the appropriate protection, licensing, and distribution strategy.

Any research materials created in the performance of the project is an Invention.

No. ORSP may still submit your proposal after conducting a Limited (Institutional Only) Review, but there might not be enough time for "At Risk" proposals to ensure they meet the Submission Deadline.

No. The new U-M policy is meant to create a fair and level playing field for everyone who prepares a proposal for external funding. Proposals that are submitted timely to ORSP should not be penalized for doing so.

For the purposes of disclosing international research activity to U-M and federal sponsors, the words "collaboration", "interest", and "affiliation" seem to be used interchangeably to describe or qualify the relationship an individual has with a foreign entity or individual.  The terms are often associated with a specific activity or process, such as disclosing outside interests or reporting foreign affiliations on a biosketch.

• "Collaboration" tends to used to describe formal or contractual agreements between two parties, such as a research collaboration between investigators/study teams where both parties are working toward a common research goal.


• "Interest" tends to be used to describe external activity, especially financial-related activity (e.g., financial interests).  


• "Affiliation" tends to be used to describe an association with an organization, such as employment appointments, honorary positions, and visiting scholar opportunities.

If you are unsure whether you have correctly made the Required Changes identified by ORSP, please contact the ORSP Project Representative assigned to your PAF.

Yes. The new U-M policy is meant to create a clear, fair and level playing field for everyone who prepares a proposal for external funding.

Recommended Changes refer to sponsor requirements, and the item is disallowed by the sponsor. Required Changes refer to U-M institutional requirements. In this case, failure to make the Recommended Change may result in the proposal not being funded, being funded for an amount that is lower than requested, or being fully funded but restricted by U-M to prevent a disallowed cost.

No exceptions will be made. That said, ORSP will endeavor to submit "At Risk" proposals. The absence of an exception mechanism is a recognition of the fact that there is simply not enough time to guarantee that late-arriving proposals will be submitted by the sponsor's deadline.

Yes. ORSP is prepared to staff the office as needed during peak volumes to process proposals that meet the internal deadline for Full and Limited Reviews.

Yes. The cross-campus deadline policy working group designed the eRPM workflow to have a number of trigger points in the PAF lifecycle that automatically generate a warning email.

The Executive Director of ORSP,  the Associate Deans for Research, and the chief research administrators of the various schools and colleges will inform the faculty who submit "outside the system" that such practices are against U-M policy. Individuals who show a pattern of disregard for the internal deadline policy may be brought to the attention of the Vice President for Research, who may impose additional administrative measures in consultation with the appropriate Associate Dean for Research.

No, but ORSP will endeavor to submit your proposal if it is "At Risk." The reality is that there is simply not enough time to guarantee that "At Risk" proposals will be submitted by the Submission Deadline.

Proposals arriving in ORSP after the 15 business hour deadline will be “At Risk.” The deadline policy applies the same to collaborative proposals as it does to all proposals. ORSP will endeavor to submit an "At Risk" proposal, as long as there are no timely proposals already in the queue and there is sufficient time to conduct a Limited (Institutional Only) Review.

Your school or college may allow you to submit an administrative shell for their review. However, ORSP will not review a proposal until it has been "finalized" in eRPM. An administrative shell that made its way to ORSP would be returned as Incomplete.

Yes.

The state of the PAF will change to "Sponsor Deadline Missed" and a system-generated email notification will be automatically sent to the Principal Investigator and Project Team.

If the PAF never arrived in ORSP for review, the PAF state will change to "Sponsor Deadline Missed" for 30 days, during which time the Project Team may update the Submission Deadline field to enable further processing. If after 30 days the Submission Deadline has not been updated or the PAF has not been forwarded to ORSP, the PAF state will change to "Cancelled."

If the PAF arrived in ORSP as an “At Risk” proposal, the PAF state will again change to "Sponsor Deadline Missed" for 30 days, during which time the Project Team may update the Submission Deadline field to enable further processing. If after 30 days the Submission Deadline has not been updated or the PAF is not forwarded to ORSP, the PAF state will change to "Cancelled."

If the PAF arrived in ORSP and qualified for a Full or Limited Review, but was not submitted by the sponsor deadline, ORSP leadership will reach out to the PI to discuss next steps.

It depends on multiple factors outside ORSP’s control, including how many other proposals are in the queue and staff availability. The proposal will be classified as "At Risk" and it might not be submitted to the sponsor in time. To fairly support all U-M faculty, ORSP will not prioritize “At Risk” proposals over proposals in the queue that have met U-M’s internal deadline.

In handling such a significant proposal, it is critical that your team mitigate risk at every level, and this includes building in time to adhere to internal and external deadlines.

The Submission Deadline may be updated as needed until such time as the PAF is finalized. Alternatively, a Target Date may be provided in lieu of a Submission Deadline.

The University of Michigan business day ends at 5:00 p.m., ET. Therefore, you may need to adjust the Submission Deadline to ensure it gets to the sponsor in time. 

If the sponsor deadline is later than 5:00 p.m. ET., the deadline policy will calculate the review type in relation to 5:00 p.m. ET of the Submission Deadline entered on the PAF.

If the sponsor deadline is earlier than 5:00 p.m. ET., then (1) the earlier time must be noted on the PAF, and (2) the deadline policy will still calculate the review type in relation to the later 5:00 p.m. ET of the Submission Deadline entered on the PAF.

Note that many sponsors often consider the local applicant institution time as the deadline, even if they are in a different time zone.

The schools, colleges, institutes, and centers must meet the U-M deadline. Your school/college/unit has most likely worked through its own internal policies to ensure alignment with the new proposal submission deadline policy. You should engage with your unit leadership to learn more about their requirements and deadlines.

If the PI/Project Team chooses to ignore the Recommended Changes ORSP has identified, the proposal might not comply with the sponsor’s guidelines and could be rejected without review.

ORSP recommends changes to help proposals meet sponsor guidelines. ORSP requires changes when they are needed to ensure compliance with U-M institutional requirements.

Proposals needing Required Changes will not be submitted.

A Required Change is requested whenever an item on either the PAF or the Final Proposal must be corrected in order to be compliant with U-M policies or other U-M requirements. Required Changes must be made before a proposal may be submitted.

Required Changes relate to compliance with U-M policies or other U-M requirements. A proposal will not be submitted until these Required Changes are made. Recommended Changes are offered to make the proposal compliant with a sponsor requirement. Recommended Changes are optional.

Yes, but that guarantee is conditioned on the PI/Project Team submitting to ORSP the changes that ORSP identified in a timely fashion. If the PI/Project Team submits changes too close to the sponsor's deadline, then ORSP cannot guarantee the proposal will be submitted.

An approved PAF and Final proposal are deemed "At Risk" if they arrive in ORSP fewer than 15 business hours prior to the Submission Deadline. "At Risk" proposals may not be submitted to the sponsor in time, and they won’t be reviewed for completeness or correctness or compliance with any sponsor guidelines. To fairly support all U-M faculty, ORSP gives priority to the proposals in the queue that have met U-M’s internal deadline for Full and Limited Reviews.

ORSP will endeavor to submit an “At Risk” proposal by the sponsor’s deadline provided no timely proposals are in the queue ahead of it, and there is sufficient time for ORSP to conduct a Limited Review. ORSP cannot, however, guarantee “At Risk” proposals will be submitted by the sponsor’s deadline or will be complete or correct upon submission.

In a Limited (Institutional Only) Review, ORSP only ensures compliance with U-M policies or other U-M requirements. This review will only result in Required Changes, if any. The proposal will not be submitted unless Required Changes are made. A Limited (Institutional Only) Review is provided if the approved PAF and Final proposal arrive in ORSP fewer than 32 business hours, but at least 15 business hours, prior to the Submission Deadline. 

Remember that your school/college/unit may have its own internal deadline proposal submission policy.

No. The deadline policy will apply to limited submissions as it does to all proposals. ORSP will endeavor to submit your proposal if it is "At Risk," but ORSP cannot guarantee that it will be submitted by the Submission Deadline.

As a foreign collaboration may touch upon multiple areas related to research activity - from funding to travel to invention reporting - U-M has established a cross-unit Committee on International Engagement to align the institutional knowledge across missions of the university to ensure continued academic excellence amid increasing concerns of undue foreign influence. Learn more about the International Engagement Committee charge.

In addition, U-M is collaborating with advocacy groups, such as the Council on Government Relations (COGR), the National Council of University Research Administrators (NCURA), to encourage federal agencies to clarify their foreign collaboration disclosure requirements and to provide guidance on how to meet these requirements.

1. National Institutes of Health (NIH) - "Investigators, including subrecipient investigators, must disclose all financial interests received from a foreign institution of higher education or government of another country..."


2. Department of Defense:  National Defense Authorization Act - "work with academic institutions who perform defense research and engineering activities...to limit undue influence, including through foreign talents programs, by countries to exploit United States technology..."


3. National Science Foundation (NSF) - U.S. universities must "embrace transparency and rigorously adhere to conflict of interest and conflict of commitment policies."


4. Department of Energy (DoE) - "...federal and contractor personnel fully disclose and, as necessary, terminate affiliations with foreign government-supported talent recruitment programs.

No.  Per the National Institutes of Health (NIH), as long as the fully or partially foreign-funded student, postdoc, researcher, or visiting scholar is working exclusively within the United States, the participation is not considered a reportable foreign component.  

However, any work that such an individual continues to perform under an NIH grant after leaving the U.S. would need to be disclosed and approved by the NIH as a foreign component.  In addition, any support that such an individual, if key personnel on the project, receives from a foreign organization would be reportable to NIH as Other Support.

When a PAF is returned as Incomplete, that means the proposal is not “submission-ready” or Final in some significant way. For example, it may be missing some required component or the PI/Project Team has not granted ORSP access to the proposal in the sponsor’s electronic system (when ORSP is responsible for submission). In these cases, ORSP will return the PAF for the Project Team to complete its work, an action that strips the assigned review type and "resets the clock" for determining the level of review (Full or Limited) the proposal will receive.

When a PAF is returned for Changes, that means the proposal is Final (e.g. all required components are complete) but ORSP has identified for the PI/Project Team some aspect of the proposal that must or should be changed (i.e., a Required or Recommended change). When a PAF is returned as needing Required or Recommended changes, the action does not "reset the clock" for determining which level of review the proposal will receive.

 “Final” means ready for ORSP submission at any time (i.e., ORSP could submit to sponsor within 2 minutes or 2 days after it’s routed to ORSP). ORSP may need to provide additional documentation or signatures, but everything else is in its final form.

In a Full Review, ORSP ensures compliance with U-M policies, other U-M requirements, and sponsor requirements. A Full Review may result in ORSP requesting Required and/or Recommended Changes. Required Changes must be made in order for ORSP to submit by the sponsor’s deadline. Recommended Changes are optional, though considered to be best practice. A Full Review is provided if the approved PAF and Final proposal arrive in ORSP 32 or more business hours prior to the Submission Deadline.

Remember that your school/college/unit may have its own internal deadline proposal submission policy.

ORSP uses a single PAF and Proposal Review Checklist. See: http://orsp.umich.edu/paf-proposal-checklist.