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FAQs
An equity interest includes any stock, stock option, or other ownership interest in an outside organization/entity.
You are not required to disclosed to U-M equity from mutual funds, retirement accounts, or similar managed investments where you do not directly control the investment decisions within the portfolios.
Institutional responsibilities are your professional duties/work on behalf of the University of Michigan. These may include, but are not limited to:
- Research
- Teaching
- Conduct of sponsored projects, including administration
- Professional practice
- Service on institutional committees
An outside activity is considered "related" to your institutional role/responsibilities when:
- The outside activity relies on or utilizes your area of expertise, scholarship, employment;
- The outside activity has the potential to influence your U-M duties/responsibilities (research, teaching, clinical, or public service); or
- The external entity associated with your outside activity does business with U-M (e.g., sponsors research, vendor).
In general, an "outside organization" (or an "outside entity") is any entity external to U-M, such as:
- A company (for proft whether publicly traded or not, non-profit);
- An institution, program, or society (academic, professional, or commercial, whether US-based or international)
- U.S. government (federal, state, or local); or
- A foreign institution, government, or company.
U-M applies exceptions for the disclosure of outside activities to some external entities. See the Outside Activity Disclosure Guidance for details.
If you can answer "yes" to the following questions, you need to submit an IRB application in eResearch for IRB review:
1. Is it research?
Research is a systematic investigation (including research development, testing, and evaluation) designed to develop or contribute to generalizable knowledge ~ Federal definition, 45 CFR 46.102(l)
- Systematic investigation is an activity designed to test a hypothesis and to draw conclusions as described in a formal protocol that sets forth an objective and procedures to reach that objective.
- Activities such as the practice of public health, medicine, counseling, or social work are not research.
- Generalizable knowledge is information expressed in theories, principles, and statements of relationships that can be widely applied (e.g, by publishing findings or presenting findings at a professional meeting).
- Studies for internal management purposes (e.g., program evaluation, quality assurance, or quality improvement) are not research because the intent is not to provide generalizable knowledge but to apply findings only to the program or activity.
2. Does the research involve human subjects?
Human subjects research is a project that involves a living individual about whom the investigator (whether student or professional) (i) obtains information or biospecimens through interaction/intervention with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) obtains, uses studies, analyzes, or generates identifiable private information or indentifable biospecimens. ~ Federal definition 45 CFR 46.102(e)(1)
3. Is the university engaged in the conduct of the research?
The university is "engaged" when the research is conducted by U-M faculty, staff, trainee, or other agent acting in connection to their university responsibilities. See OHRP's Guidance on Engagement of Institutions for more information and examples.
Caveats:
- Direct awards from federal sponsors that meet criteria #1 and #2 are always reviewed by a U-M IRB, whether or not the university is engaged in the research.
- If you answer "no" to any of these questions, you may have other obligations than IRB review. See the U-M HRPP Operations Manual Part 4, Section V for more information about regulated/non-regulated research.
If a U-M Principal Investigator leaves the University prior to the end of a sponsored project, leadership arrangements for the duration of the project should be discussed with the unit, ORSP, and the sponsor, in advance of departure.
A full page of definitions of principal investigator (PI) and other key personnel can be found in eResearch Proposal Management System's help text. Also see SPG 500.01.
You can submit article ideas for The Research Administration Post (RAP) as often as you have them. Each will be reviewed. Don't worry if the submission deadline is too far out for your message. If your update is urgent or time-sensitive, we can explore sending it in a RAPid alert. Thank you!
If you would like to revisit articles in a previous issues, or if you missed an issue, you can visit the RAP/RAPid Newsletter Archives. Thank you!
See the Research Study Participant FAQ for basic information.
See Clinical Trials Participant FAQ for Parents for answers to basic questions governing a child's participation in a clinical study.
- Familiar Format - The UFA system functions much like Proposal Approval Forms (PAFs) used to route sponsored research proposals in eRPM. Each type of UFA is an electronic smart form in eRPM (similar to the PAF worksheet) that is used to obtain administrative approval for an unfunded activity.
- Streamlined Workflow - Research Administrators and Principal Investigators no longer need to identify a central office project representative for UFAs. The UFA system routes your agreement based on smart form input.
- Paperless - The UFA system uses a smart form that eliminates the need to route paper. There will be no need to complete a material transfer form nor a need to obtain written signatures from the units or schools before submitting the request via eRPM.
- Broader Visibility and Access - As with PAFs, the approval status, agreement revisions and correspondence will be visible in the record. Track status of approvals, review and monitor negotiation activity, and upload communications and documents directly into the UFA file.
- Downloadable Templates - In an effort to better serve the research community and save them time and effort, ORSP provides downloadable standard agreement templates.
Yes. Due to the fact that U-M research agreements are subject to revisions and updates, templates must be downloaded directly from the website prior to sharing. To avoid potential processing delays, ORSP strongly recommends that all research faculty and staff bookmark the Standard Agreements and Templates page and return frequently to download new agreements or look for updates.
Currently, ORSP is piloting the use of template agreements using non-disclosure agreements. However, ORSP is working with the Office of General Counsel to expand the number of sponsored research agreements that can be made available to Sponsors for review and signature, and will make them available on its website on an ongoing basis. In the meantime, project teams should continue to request ORSP to provide its standard terms and conditions to the Sponsor for review and negotiation.
ORSP will continue to review and negotiate agreements provided by Sponsors. If a Sponsor wishes to use its own template, the project team must request an editable version of the draft agreement and upload it to the UFA. Once the UFA has routed to ORSP, the assigned project representative will review and send an revised version of the agreement to the Sponsor's representative, using the contact information provided by the project team.
External collaborators that opt to sign an unmodified copy of the university's template available will experience significantly expedited processing times. ORSP will be able to process the agreement for U-M signature and return a fully executed agreement without delay, since there will be no need to review terms and conditions or negotiate changes with the Sponsor.
Download template agreements from the ORSP website (please don't save them and re-use, as they may change; we want you to have the latest version).
The project team may insert any additional information requested in brackets throughout the text of the agreement (e.g., Sponsor's name, description of the information to be disclosed, etc.).
Once completed, the project team may email the template to the Sponsor for signature.
Once the Sponsor's authorized representative has signed and returned the unmodified agreement, a scanned PDF must be uploaded to a new UFA file and routed to ORSP through eRPM.
Scroll down to the References and Resources section to find template agreements available to download.
While many research collaborators prefer to negotiate their own template agreements, some sponsors do not have template agreements and prefer to use the university's standard agreements. Sponsors may also be willing to sign a university agreement if there is an urgent need to finalize an agreement prior to a scheduled meeting. The university's template also includes language that ensures the Sponsor's confidential disclosures are protected under statutory safe harbor provisions to minimize risk of unintended disclosures compelled through Michigan Freedom of Information Act requests.
Please use the following link: When Does a Class Assignment Require IRB Approval?
In eRPM:
- For projects that are not a clinical trial, you need only select "Private Sponsor Team" in eRPM from the list of Project Representatives. When you do, ORSP will take on the task of determining the PR.
- For projects that are clinical trials and originate in the Cancer Center, Internal Medicine and Pediatrics, select Lark Haunert for sponsors "A" through "L" or select Tricia Haynes for sponsors "M" through "Z."
- For clinical trials that originate in other departments (other than the Cancer Center, Internal Medicine and Pediatrics) select Debra Dill.
For all other questions:
- Contact Reynaldo Martell (martellr@umich.edu, 936-1353), the Administrative Specialist for the Private Sponsors Team. Just share the name of your project's Principal Investigator (PI), your Department or School, and Sponsor, and they can assist you and connect you to the right PR.
So that we can best serve you, when contacting us, please include:
- Proposal Approval Form (PAF) number
- Project Grant (P/G)
- UFA (Unfunded Agreement) number
- SSP (Special Sponsored Project) number
- PI (Principal Investigator) name
- Sponsor name and detailed contact information (if requesting that a central office contact them)
As always, contact your department administrator first with any questions. For technical questions in eResearch, call 4-HELP.
When on the Research....(see screenshot ) page. Upload the additional Additional Key/Senior Profiles by selecting the button on the lower left.
No, you can't change the order.
No, not through grants.gov.
The Principal Investigator (PI) may be able to access this information using his/her login credentials for NIH eRA Commons or NSF Fastlane (or others). The status information that is available will vary from agency to agency.
eRPM provides status on proposal submission for proposals submitted via system-to-system. To check the content of your electronically submitted proposal for selected agencies including NIH, use eRA Commons. For NSF, submitted proposals can be viewed in FastLane.
Check the Resubmission application (Box 2) and enter the previously submitted NIH grant number (such as GM123456) in Box 4.
No, ORSP project representatives can provide guidance, but your first point-of-contact is your department administrator who can help with system and forms.
ORSP recommends using Grants.gov system-to-system submission (or other agency systems such as NSF's Fastlane or a unique sponsor system) whenever possible. This is integrated in the University of Michigan eResearch system. Note that some agencies specify that paper applications are required, and some will require only Adobe. Those are the only circumstances in which system-to-system should not be used.
Yes, you can find information about the eRPM Proposal Preparation and Unit Review course (taught via Zoom) on the Navigate Program Instructor-Led Courses web page.
In order to give your proposal a full review it is strongly recommended that you deliver it in final form within four (4) business days of the sponsor deadline. We will do what we can given the shortened time frame, but you run the risk of a submission that fails to pass the Grants.gov and agency validations. When a proposal is routed late we make every effort to execute it, but we mark it as "Insufficient Time for Review."
An SF-424 form, or "Standard Form 424," is the application packet used by federal agencies for grant submissions. Most standard information (DUNS, EIN, FWA numbers, etc.) is pre-populated in the required SF-424 forms when completing the application in eResearch (eRPM). If you find your application is not supported by eResearch you can find the standard information on the Frequently Required Proposal Data web page.
No. Individual Principal Investigator registration in Grants.gov is not required. The University is fully registered for the Grants.gov submission process.
ORSP must do the actual submission. The proposal is submitted in a system-to-system process (eResearch >> grants.gov) by ORSP. In some cases, an office with delegated authority can submit directly to grants.gov (e.g., the Medical School Grants Office that can submit to NIH only). To get the proposal submitted, it is the responsibility of the project team to finalize their submission in eResearch. ***We recommend submitting to ORSP four business days prior to the sponsor deadline, but only if it's final.***
To begin using eRA Commons, you must register for a Commons ID. [Requires your U-M uniqname and Kerberos password]
Principal investigators who are not themselves registered for BSL2 work, and who are having this work performed in another investigator's lab, are responsible for ensuring that it is occurring in a laboratory that is registered with the IBC for that type of work and that it is conducted by individuals who have received training for the work they are performing.
In some cases you can. Investigators sharing laboratory space may also share registration and training obligations. The work may be registered either under the investigator in whose lab the work is occurring or under the principal investigator of a project. For example, investigators in charge of labs where work involving potentially hazardous biologics occurs are responsible for ensuring that there is a application with the IBC for all the work involving these potentailly hazardous biological materials that occurs in their lab space. In addition, they must maintain documentation of the training status for all the individuals working in the lab with these potentially hazardous biologics at BL2 containment.
You need to register the work with the IBC if you are cloning the PCR product first, prior to sequencing. The direct sequencing of PCR products does not need to be registered with the IBC - as long as there is no cloning involved.
Follow the steps above, “For Those Who Need a Leave.” Note that an extended leave may be needed for unexpected medical events such as injuries, for a planned maternity leave, or for planned non-medical leaves such as a parental leave for the birth, adoption, or fostering of a child, or another qualified reason. If you have questions, contact UMOR.HR.Team@umich.edu.
No. Tuition refunds are no longer covered by OVPR or ORSP. Tuition refunds for sponsored projects are the responsibility of the employee's unit.
The Office of Research and Sponsored Projects (ORSP) primarily handles pre-award activities and is part of the Office of Research.
Sponsored Programs primarily handles financial post-award activities, and is part of Finance.
Visit our Communications page at orsp.umich.edu/news. You'll be informed of business and system updates, sponsor updates, policies and procedures, professional development opportunities and more that affect work in sponsored projects.
We now have several newsletters and are using MailChimp to manage our emails and lists. MailChimp is a email marketing service provider (similar to Constant Contact or VerticalResponse). It helps organizations to create email newsletters and to manage lists of recipients, including providing them with options to subscribe and unsubscribe. Many in the private and non-profit sector, including other universities and units within the University of Michigan use MailChimp.
Generally, an unfunded agreement refers to a research-related agreement that does not have incoming dollars attached. U-M faculty researchers often engage in activities or collaborations that do not involve funding from Sponsors. These activities may include preliminary confidential discussions with potential research sponsors, requests for research materials from external sources, or data sharing consortiums.
Unfunded research activities are generally carried out under written contracts that set out each of the parties’ expectations and specific responsibilities. Coordination of unfunded research activities can be complex, and some may require University approvals for the use of University property, space, faculty effort, students, or compliance committee approvals for protocols involving human or animal subjects. UFAs are integrated into eRPM to allow the research community to more easily link corresponding agreements, monitor the status of UFA agreements, and communicate with administrative home and central offices.
You might need to maintain effective control over the device with GPS capabilities. If you do not feel you can maintain effective control, you should seek advice as noted above.
It is likely that the export regulations would not require that you maintain effective control of the computer and memory, according to the guidance given above.
It is likely that the export regulations would not require that you maintain effective control of the computer and memory, according to the guidance given above.