Yes. ORCR will consider requests for study start-up consultations. Please contact us at orcr-deptemail@umich.edu.
An external entity conducts business with U-M when that entity and U-M enter into a transaction, including, but not limited to:
- Sponsoring/funding research, testing, or training,
- Subcontractor on a research project,
- Vendor/supplier for procurement (e.g., purchasing) purposes,
- Giving a gift to the University, or
- Providing goods or services (e.g., equipment, drugs, devices) for research purposes or other U-M business purposes.
Historically, RCR training has included instruction related to the conduct of research only. U-M recognizes the importance of scholarship and scholarly activities to the academic endeavor and therefore has chosen to prepare our current and future scholars with the same standards of integrity delivered to researchers. Additionally, as the U-M SPG 303.03 (Policy Statement on the Integrity of Scholarship) applies to allegations of misconduct in both research and scholarship, U-M believes it is vital that all individuals be trained in the ethical and responsible standards held by U-M.
No, NIH requires that RCR training be conducted in-person for a minimum of eight (8) contact hours and include instructor-led discussions. Online instruction, such as the PEERRS-RCRS course, is not sufficient.
Please contact UMOR.RCRS@umich.edu with your contact information and job description. UMOR will request you complete an attestation that you are not engaged in research and scholarship and will remove the PEERRS-RCRS course from your required training in My LINC.
For questions regarding instructor-led RCRS training, please contact your unit/school. Please contact UMOR.RCRS@umich.edu for questions regarding general or PEERRS-RCRS training requirements. Please contact peerrs@umich.edu if an alternative training option is needed due to visual impairment or other ADA compliance reasons.
For help with My LINC navigation or browser pop-up blockers, contact the ITS Service Center at 734-764-HELP [4357] or 4HELP@umich.edu.
While some of the material in GCP and PEERRS Human Subjects Research Protections is similar to some material covered in a RCRS course, they are completely different training requirements. Completion of CGP and PEERRS Human Subjects Research Protections does not replace the requirement to complete the RCRS training course. Likewise, the RCRS training course does not replace CGP and PEERRS Human Subjects Research Protection.
Per NOT-OD-10-019, the instructor-led RCR requirement applies to “D43, D71, F05, F30, F31, F32, F33, F34, F37, F38, K01, K02, K05, K07, K08, K12, K18, K22, K23, K24, K25, K26, K30, K99/R00, KL1, KL2, R25, R36, T15, T32, T34, T35, T36, T37, T90/R90, TL1, TU2, and U2R. This policy also applies to any other NIH-funded programs supporting research training, career development, or research education that require instruction in responsible conduct of research as stated in the relevant funding opportunity announcements.”
You are completing the PAF for U-M’s portion of the project.
Same as above. (See answer to “What if the sponsor is a foreign entity.”)
Any U-M faculty member, staff member, or student listed in one of the following investigator roles on a Proposal Approval Form (PAF) for sponsored funding or a sponsored award (AWD) is responsible for disclosing their outside activities in M-Inform and complying with the U-M COI in Research policy:
- U-M Principal Investigator
- U-M Sponsor Principal Investigator
- Participating Investigator with Specified Effort
- Participating Investigator without Specified Effort
- Other Non-Faculty Investigator
Per U-M SPG 201.65-1, the U-M "COI in Research" policy, and the Public Health Service (PHS) financial conflict of interest regulations, a "family member" is defined as a spouse, domestic partner, and/or dependent children.
If a family member has an outside activity with an external entity that is doing business with your U-M department, you should disclose this activity in M-Inform if you are in a position to direct business to that entity.
The recipient institution should evaluate the element of the project that is being conducted outside of the United States within the context of the project as a whole when making determinations about significance. Some examples of activities that may be considered a significant element of the project include, but are not limited to:
- collaborations with investigators at a foreign site anticipated to result in co-authorship
- use of facilities or instrumentation at a foreign site
- receipt of financial support or resources from a foreign entity
Per NIH: "The recipient institution should evaluate the element of the project that is being conducted outside of the United States within the context of the project as a whole when making determinations about significance. Some examples of activities that may be considered a significant element of the project include, but are not limited to:
- collaborations with investigators at a foreign site anticipated to result in co-authorship
- use of facilities or instrumentation at a foreign site
- receipt of financial support or resources from a foreign entity"
This is not performance of a portion of the project and you should answer "no" unless the work is performed in a foreign country.
No, this is not performance of the project.
Just because your sponsor is a foreign entity doesn’t mean your project has a foreign component. It’s where the work is performed that determines whether there’s a foreign component.
Please reach out to your NIH Grants Management Specialist or Program Officer to confirm whether or not these individuals need to be listed. When required, disclosure of foreign co-authors to the NIH should occur prior to publication. Other sponsors have not specifically commented on this. Should you have questions, please consult your ORSP Project Representative.
The NIH definition of “foreign component” states that “extensive foreign travel by recipient project staff for the purpose of data collection, surveying, sampling, and similar activities” is a “foreign component.”
Yes. You may not perform a significant scientific element or segment of an NIH-funded project outside the U.S. without prior NIH approval. Per NIH Grants Policy Statement 8.1.2.10 “Adding a foreign component under a grant to a domestic or foreign organization requires NIH prior approval.”
Yes. There are three potential reporting requirements in this scenario:
- Foreign Component: For proposals and progress reports, you will need to account for this visitor as a “Foreign Component” if (a) s/he is performing a significant element of the project and (b) s/he is performing at least some portion of the project outside of the United States.
- Other Support: For proposals and progress reports, the visitor should be disclosed as a source of non-monetary Other Support.
- Project Personnel: For progress reports, the visitor should be identified as a participant if s/he has worked at least one person month per year on the project during the reporting period, regardless of funding source.
To receive funding opportunities sign up to Research Blueprint. Additionally, find internal funding opportunities at the Research Commons webpage.
Your Unit Administrator takes care of that through eResearch. If you find the information here is not up to date, your unit liaison can update it in the Reviewer and Unit Liaison Workspace of eRPM. Here are links to ITS's step-by-step guides:
The start/initial date of an outside activity occurs at the point that a written or verbal agreement is established with the outside entity, or you begin work/activities with the outside entity.
Professional effort, as it relates to outside interest disclosure, is the expenditure of time (measured in days) to perform or support an outside activity.
For example, if you spend 8 hours in a given day on a professional activity (e.g., research) and 4 hours of that day is spent on behalf of your outside activity, you would calculate 0.5 days of professional effort spent on that outside activity. If you spent 0.5 days six times per year on that outside activity, you would enter 3 days of professional effort when disclosing the outside activity in M-Inform.
If the outside activity involves no spent time (e.g., royalties, stock ownership) or if you disclose an outside activity of your spouse or dependent, enter 0 days for professional effort.
Yes. If needed, here is a link to our "legacy" Blue pages.
We are requesting that you review your Other Support for any needed updates, specifically looking back to July 2019. Your updated Other Support must include all resources in support of and/or related to all of your research endeavors since July 2019.
Specifically, your updated Other Support must include any previously undisclosed resources that were received over the course of your current active NIH grants and over the course of any NIH grants that were active since July 2019. Examples:
i) Currently active grant: If your current NIH grant began in August 2017, your updated Other Support should include any resources received August 2017-present.
(ii) July 2019 active grant: If you also had an NIH grant that began in June 2016 and ended in October 2019, your updated Other Support should also include any resources that were received June 2016 to October 2019.
(iii) Pre-July 2019 grant: If you also had an NIH grant that began in April 2015 and ended in January 2019, that grant falls outside the scope of this request.
Proposals that arrive at ORSP fewer than 15 business hours prior to the Submission Deadline will be assigned “at risk” status. ORSP will give first priority to the proposals in the queue that have met U-M’s internal deadline for the two service levels described above. ORSP will endeavor to submit an “at risk” proposal by the Submission Deadline entered on the PAF provided no timely proposals are in the queue ahead of it, and there is sufficient time for ORSP to conduct a limited review. Ultimately, ORSP cannot guarantee “at risk” proposals will be submitted by the Submission Deadline or will be complete or correct upon submission.
Once the policy has been implemented on January 6, 2020, the U-M Office of Research will review data on the impact of the policy in order to assess whether any changes are needed. As part of the assessment, the U-M Office of Research will determine whether a formal waiver should also be required to send a proposal to ORSP with fewer than 15 business hours lead time.
We are requesting that you review your Other Support for any needed updates, specifically looking back to July 2019. Your updated Other Support must include all resources in support of and/or related to all of your research endeavors since July 2019.
Specifically, your updated Other Support must include any previously undisclosed resources that were received over the course of your current active NIH grants and over the course of any NIH grants that were active since July 2019. Examples:
i) Currently active grant: If your current NIH grant began in August 2017, your updated Other Support should include any resources received August 2017-present.
(ii) July 2019 active grant: If you also had an NIH grant that began in June 2016 and ended in October 2019, your updated Other Support should also include any resources that were received June 2016 to October 2019.
(iii) Pre-July 2019 grant: If you also had an NIH grant that began in April 2015 and ended in January 2019, that grant falls outside the scope of this request.
Proposals that arrive at ORSP fewer than 15 business hours prior to the Submission Deadline will be assigned “at risk” status. ORSP will give first priority to the proposals in the queue that have met U-M’s internal deadline for the two service levels described above. ORSP will endeavor to submit an “at risk” proposal by the Submission Deadline entered on the PAF provided no timely proposals are in the queue ahead of it, and there is sufficient time for ORSP to conduct a limited review. Ultimately, ORSP cannot guarantee “at risk” proposals will be submitted by the Submission Deadline or will be complete or correct upon submission.
Once the policy has been implemented on January 6, 2020, the U-M Office of Research will review data on the impact of the policy in order to assess whether any changes are needed. As part of the assessment, the U-M Office of Research will determine whether a formal waiver should also be required to send a proposal to ORSP with fewer than 15 business hours lead time.
Each individual submits his/her own Other Support.
One form per PI will suffice, as long as the NIH-funded projects to which the Other Support applies are identified.
We are requesting that you review your Other Support for any needed updates, specifically looking back to July 2019. Your updated Other Support must include all resources in support of and/or related to all of your research endeavors since July 2019.
Preferably Word, but any standard format will be accepted.
Please submit your updated Other Support by January 20, 2020.
Please submit your updated Other Support to other-support-reporting@umich.edu.
Most likely. 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. Consult with your unit leadership to learn more about their requirements and deadlines.
An administrative shell that made its way to ORSP would be returned as Incomplete. ORSP will not review a proposal until it has been "finalized" in eRPM.
However, Your school/college/institute/center may have a policy to allow or require you to submit an administrative shell for their review.
ORSP requires a Final Proposal no later than 32 hours before the Submission Deadline. Your school/college/institute/center may require additional reviews and lead time. You should engage with your unit leadership to learn more about their requirements and deadlines.
There is no U-M wide deadline policy calculator as school/college/unit deadline requirements vary to align with U-M’s overall policy.
Section 6 of the PAF, tiled “Submission Information,” will display the times and dates by which the PAF and final proposal must arrive in ORSP in order to qualify for a Full or Limited Review, calculated from the Submission Deadline you enter on the PAF.
Yes, but not without risk. Your request will not be prioritized over other proposals that have yet to be reviewed. It’s also important to recognize that resubmitting your proposal first requires that the original proposal be withdrawn, or assessed as Incomplete. Depending on the number of unreviewed proposals ahead of your request, your resubmission may be delayed so close to the sponsor’s deadline that it would be highly inadvisable to withdraw an otherwise high quality proposal on the chance that the resubmission will be successful and on time.
No. Consistent with ORSP's mission to both enable and safeguard the conduct of research at U-M, ORSP will always review a proposal for institutional compliance before submitting it to the sponsor.
You must use the earlier date as the Submission Deadline.
As described, ORSP will not begin its review because ORSP has not been granted access to submit your proposal in the sponsor's system. Your proposal should not have been finalized since you are still working on the Project Description. Instead of being reviewed, your proposal will be returned as Incomplete and your PAF returned to the state of "Awaiting Final Proposal." You must grant ORSP access and re-finalize your PAF in order to qualify for a review.
The sponsor's deadline is the date by which the sponsor has stated proposals must be received in order to be considered for funding.
The “Submission Deadline” (a.k.a., the "Send By" date) is the last date that a proposal can be submitted in order to be received by the sponsor’s deadline.
In the case of an electronic proposal submission, the Submission Deadline and the sponsor's deadline are the same. In the case of a hardcopy proposal submission to a sponsor where overnight courier service is available, the Submission Deadline is at least one day before the sponsor's deadline. In the case of a hardcopy proposal submission to a sponsor where courier service may take an extended period of time, the Submission Deadline is at least several days (or more) prior to the sponsor's deadline.
The Target Date is the date by which you would like ORSP to submit a proposal or negotiate an agreement. It is optional and considered to be a non-binding request that ORSP will attempt to accommodate when reasonable time is given, but ORSP can make no guarantees that it will be able to do so.
A Target Date can be provided alone (i.e., there is no Submission Deadline), in combination with a Submission Deadline, or not at all.
For example, you may wish to enter a Target Date for when you would like a contract to be negotiated and there is no sponsor deadline. Another use of a Target Date is when you would like for your proposal to be submitted earlier than the Submission Deadline, i.e., earlier than is necessary to meet the sponsor's published deadline.
No. If you leave the Submission Deadline field blank, and there is a sponsor deadline, ORSP will return it as Incomplete for correction. If there is no sponsor deadline, the deadline policy does not apply.
No. Sixty percent (60%) or more of ORSP staff members' time is dedicated to other mission-critical activities unrelated to proposal submission (e.g., award setup, management and closeout, unfunded agreement negotiation, etc.) and they need every free moment to attend to this other work.
During a Limited Review, ORSP only checks certain items for compliance with institutional policy and other U-M requirements. Any corrections must be made prior to submission and thus fall in the category of Required Changes. The suggested "grantspersonship" changes that would otherwise be caught during a Full Review are not checked during a Limited Review.
No. Certain funding sponsors (e.g, NSF, NIH) may require a description of the principal investigator's plan/program to train students and post-doctoral researchers in the nine components of Responsible Conduct of Research as part of the grant/contract proposal.
Per federal sponsor guidelines, an online course cannot be the sole method of instruction, so the PEERRS Responsible Conduct of Research & Scholarship course and/or other PEERRS courses are not sufficient in themselves. However, the PEERRS course may be recommended by your unit as a pre-requisite to in-person, discipline-specific training.
Check with your unit to determine the applicable RCR training options offered through your School/College.
Yes, if the project lead (principal investigator or "PI") or the project's study coordinator asks you to complete the PEERRS Human Subjects Protections course, you will need to:
- Obtain a U-M Friend Account (guest computing) using a valid email address.
- Request My LINC/PEERRS access using the same email address as your Friend Account.
Likely not, though you are welcome to take all the courses for educational purposes. To review who is required to (or might) take a particular PEERRS course, see:
Controlled Unclassified Information (CUI) Protections - training requirements
Export Controls - training requirements
Human Subjects Research Protections - training requirements