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FAQs

 

The eResearch Proposal Management (eRPM) team, along with leaders and consultants around campus, helped enhance eRPM with new Award Management functionality in August of 2018.

To start an Award Change Request (ACR), use the Request Action/Modification activity in the eRPM Award record and upload a signed copy of the Post Award Change Request (PACR) form to request changes to the award. Subsequent changes in terms and conditions, additional funding, time extensions, and other modifications may require ORSP staff to complete a Modification (MOD) to the AWD record in eRPM. Completed  ACRs and MODs can be reviewed and accessed through the Modifications tab in the AWD record.

Every award is different. You must read the Award, and any details in the Sponsor Guidelines to understand how and when you will receive the funds. You need a P/G number set up to start spending. After you’ve reviewed the award you can contact your assigned Finance - Sponsored Programs Customer Service Representative with questions.

Should the PI want to modify the budget distribution, the proposed changes may be made on a Budget Reallocation Form, which should then be routed through the normal approval process.

The AWD record in eRPM contains attachments and details including the terms and conditions, key personnel, and other items that the project team can review.

At the time of award activation, a system-generated email notification is sent to all investigators and administrative personnel listed on the award and identified email contacts for all departments participating in the award informing them that the AWD has been created in eRPM. That notice provides the AWD number and the Project/Grant (P/G) number for the project. 

If you have already consulted the helpful NIH Public Access site, and are still unable to come into compliance, the U-M Library staff may be able to assist. Send an email request for assistance to: nihms-library-support@umich.edu.

Yes, it will show up as Hardship. The Project/Grant will not have an award ID until it is awarded.

Today, ORSP adds commitment lines in the PAF. In Award Management, ORSP will complete an award modification to add new funding information to an award. The new budget line information will appear on the $$$ tab in the Award workspace.

A link to M-Reports is available on the Main tab in Award Management. You can use it to locate more detailed information about the Project/Grant, including any subs under the parent.

PANs and PACs are available on legacy (pre-Award Management) PAFs under Manage Data > View All Award Notices on the PAF workspace.

No. PAF comments will not be migrated over to the Award.

Post-award hardship requests will be submitted through a new award change request type available both on the PAC-R form and the online Award Change Request.

When Award Management goes live in August, fully automated routing of unit requests will not be in place but is planned for a future system upgrade.

Until then, the PI/Project Team will have two options to request an award change:

  • Complete the current PACR form, obtain ink signatures, and upload the form using the new Request Action/Modification activity available in the Award workspace 
    Or
  • Use the new online Request Action/Modification activity
    • Fill out the online Request Action/Modification form, print the form, and obtain ink signatures
    • Upload the signed form to your change request and click Submit

No. The PAF exists for historical purposes. Once a PAF is funded, it is for reference only.

All modifications are handled on the award. When a modification is made to the award, the PAF will not change. Links to modifications display on the Modifications tab in the Award workspace.

All PAFs tied to a single award will show up on the Related Records tab. From this tab, you can link back to the PAF if needed.

eRPM will be unavailable during the weekend of the system upgrade and data conversion. Tentatively, the temporary system outage will run from 5:30 p.m. on Friday, August 17 through 6:00 a.m. on Monday, August 20.

eRPM system users (unit and central offices) will be notified in advance of the weekend for the upgrade once the dates are confirmed to allow for planning.

Accelerated Clinical Trial Agreement logoUniversity of Michigan Supports Adoption of Accelerated Clinical Trial Agreement (ACTA). For those industry partners that agree to use the agreement (and the sponsor must agree to use it), it will decrease contract negotiation time. The other steps, such as budget negotiation, proposal approval form (PAF) processing, and IRB review and approval are still required. And U-M is committed to exploring process improvements and working toward the goal of reducing the total time to opening a clinical trial in all of these areas.

The ACTA is a straightforward and unambiguous document that clearly sets forth the contractual obligations of both parties, and presents language which — while perhaps not ideal for either party — is acceptable to both. Adoption and use of the ACTA will expedite the contract negotiation process and reduce the time it takes to start up industry-sponsored, multicenter clinical trials.  

HOW TO USE THIS AT U-M

screen shot of Clinical Trials Routing Form

We are ready and fully setup at U-M to support and encourage the use of the ACTA for industry sponsored multi-center clinical trials! Here is what you can do to take advantage: 

  1. There is a new question in the eResearch Proposal Management System (eRPM) for the PI added to the "Sign UFA" activity where you may indicate that you would like to attempt the use of the ACTA during the UFA process.
    • Answering “Yes” allows ORSP to approach the sponsor to propose the use of the ACTA. 
  2. Additionally, on the Clinical Trials Routing Form (CTRF), the UFA answer will carry over from the NDA. If not answered, ORSP project representatives can help you later pursue the ACTA. 
  3. Project Award Notices (PANs) will also carry language to indicate if the ACTA was accepted.
  4. Contact one of the following ORSP PRs directly when you have questions,  if a Sponsor indicates an interest in using the ACTA, or if a Sponsor would like a template agreement to review.

You can review the language in the agreement from the ACTA Website(link is external). The ACTA is not the promise of a full solution to industry-initiated clinical trial contracting, but it can help reduce one part of the process.

The CTSUs are trans-departmental business units aligned around common thematics of research. The CTSUs are business units that partner with investigators, their teams, and their departments to ensure the timely and efficient activation and execution of clinical trials at the Medical School. The CTSUs provide the administrative support to allow investigators to focus on the science. More information about the CTSUs is available at the Clinical Trials Support Office website.

The first step is to fill out the CTSU Intake Form. The CTSU will then process your CTA and shepherd your trial through the pre-award processes. The CTSU works closely with the ORSP project representatives (Debra DillLark HaunertTricia Haynes, and Mike McAllister) who specialize in clinical trials.  

A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include a placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.1


(1)  U-M has adopted NIH's definition of clinical trials to track and monitor organizational metrics.  See full NIH definition with detailed footnotes(link is external).

The Awards tab (for PI & Project Teams) is where you find awards awaiting action (similar to the PAFs tab). Awards on this tab are grouped by:

  • Awards Awaiting PI Signature
  • Modifications Awaiting PI Signature
  • Change Requests with Required Action
  • Awards on Hold

You can find a list of active awards on the Active tab.

Research development activities are coordinated by offices and staff, both centrally and within academic units, many of which are listed below. For schools or colleges without assigned contacts below, please contact the relevant Associate Dean for Research here or the U-M Office of Research.

For staff wishing to stay apprised of research development activities, connect with other U-M research development professionals or for general questions, please contact umresearchdev@umich.edu.

Research development "encompasses a set of strategic, proactive, catalytic and capacity-building activities designed to facilitate individual faculty members, teams of researchers and central research administrations in attracting extramural research funding, creating relationships, and developing and implementing strategies that increase institutional competitiveness," according to the National Organization of Research Development Professionals.

No. PAF comments will not be migrated over to the Award.

IRB approval is required for the study, but the IRB does not additionally review and make a determination regarding the registration record in ClinicalTrials.gov. 

Required Informed Consent Language for Applicable Clinical Trials:

Applicable Clinical Trilas must use the unaltered consent template language provided below in the informed consent document:

  • "A description of this clinical trial will be available on http://www.clinicaltrials.gov/, as required by U.S. Law. This Web site will not include information that can identify you. At most, the Web site will include a summary of the results. You can search this Web site at any time."

Required Informed Consent Languaage for NIH and other Sponsor Requirements for Registration and Reporting

NIH funded clinical trials that began on or after 1/18/2017 must refer to ClinicalTrials.gov in their informed consent document (unless they are conducted under a grant submitted prior to that date, with no competing renewals on or after 1/18/2017).   Use the below language:

  •  “This trial will be registered and may report results on www.ClinicalTrials.gov, a publicly available registry of clinical trials.” 

 

Yes, it will show up as Hardship. The Project/Grant will not have an award ID until it is awarded.

Post-award hardship requests will be submitted through a new award change request type available both on the PAC-R form and the online Award Change Request.

You can enter the new end date in the Comments/Instructions for ORSP box. Refer to Award Change Request.

When Award Management goes live in August, fully automated routing of unit requests will not be in place but is planned for a future system upgrade.

Until then, the PI/Project Team will have two options to request an award change:

  • Complete the current PACR form, obtain ink signatures, and upload the form using the new Request Action/Modification activity available in the Award workspace 
    Or
  • Use the new online Request Action/Modification activity
    • Fill out the online Request Action/Modification form, print the form, and obtain ink signatures
    • Upload the signed form to your change request and click Submit

Today, ORSP adds commitment lines in the PAF. In Award Management, ORSP will complete an award modification to add new funding information to an award. The new budget line information will appear on the $$$ tab in the Award workspace.

A link to M-Reports is available on the Main tab in Award Management. You can use it to locate more detailed information about the Project/Grant, including any subs under the parent.

No. The PAF exists for historical purposes. Once a PAF is funded, it is for reference only.

All modifications are handled on the award. When a modification is made to the award, the PAF will not change. Links to modifications display on the Modifications tab in the Award workspace.

All PAFs tied to a single award will show up on the Related Records tab. From this tab, you can link back to the PAF if needed.

No. If you update personnel (Investigators or Administrative) on the Award, the related PAF is not updated.

Yes. Click on the Name of the item to edit. Refer to Manage Deliverables.

Both units and ORSP have the ability to create Deliverables.

Units are not required to use Deliverables. You are encouraged to check with your unit about any guidelines or requirements in place regarding the use of Deliverables.

  • The Attachments tab lists associated award, modification, change request, supporting and other documents, and security plans.
  • On the Unit Documents tab, you will see documents uploaded by you or others in your unit with access to the award (e.g., PI). Documents stored here are also visible to central offices.
  • The Activity History tab holds documents added through the Post a Comment activity.

Yes, a "snapshot" of the closed PAFs will be available in a single table in the data warehouse for running queries.

What is getting converted?

  • PAFs with Active P/Gs
    • Single PAF = New Award/Single P/G
    • Multiple PAFs with same P/G = New Award/Single P/G
    • (Includes PAFs that are expended but related to an active P/G)
    • Includes projects that are complete, but not yet Closed)
  • A list of historical PANs and PACs will display on the Modifications tab of the Award record.  
    • An award modification reference will be created for each historical PAN/PAC. 
      • All modifications of a project will have a Modification ID in order of the PAN or PAC create date.  
      • The name of the modification will be the PAF ID on which it was created followed by the PAN/PAC ID (e.g., 18-PAF012345-F055555-01).
      • The modification type will start with "Legacy" (e.g., Legacy - PAC Financial, Legacy - Administrative, etc.) to indicate that it is a converted record
      • These records are intended for reference only and will not contain any content. The original PAN/PACs, including detailed content, can be found on their respective PAFs. 

What is NOT getting converted?

  • Closed Projects. PAFs will remain in the system in a Closed state.
  • Documents - No documents will be moved from the PAF to the Award record. Documents will remain on the PAF for historical reference.

For more details, please see Data Conversion on the ITS website.

The following training resources will be available the week of July 23, 2018, on the eRPM Training and Reference Materials web page:

  • Narrated training video with system demonstrations
  • Step by step job aids and other helpful documentation

In addition, eRPM users have access today to the eRPM “sandbox”, where you can practice using real dataPlease note that data entered in the sandbox will not be reviewed, processed, or approved.

We are also planning to hold two interchanges (one on central campus, one on North Campus) just prior to the go live. Details will be shared once the schedule and locations are confirmed.

  1. We cannot guarantee we will find and announce every limited funding opportunity.
  2. We sometimes learn of a limited opportunity belatedly. We will do our best to announce it within a reasonable time.
  3. If you find a funding opportunity of interest and believe it is limited, but do not see it here or in our archived emails, you still must follow our process. Let us know the opportunity you have found. This process is critical: extra submissions can result in the sponsor's rejection of all from the University of Michigan.
  4. If the sponsor deadline has not expired, you may be able to still apply. Contact UMORlimitedsubmissions@umich.edu.
  5. We will try to work with all interested parties to achieve a satisfactory outcome.

Conflicts of Interest (COI) represent financial or other situations where an individual has an outside interest (e.g., equity in a company, intellectual property, consultant activity with a company) that could affect the design, conduct or reporting of their research.  Also refered to as personal or individual COI.

 

Institutional conflicts of interest (ICOI) represent financial or other situations where the University, as an institution, has an outside interest (e.g., equity in a company doing business with the University) that could affect the design, conduct, reporting, review or oversight of research conducted by its employees or students.

A Covered Official of the University is an executive officer, dean, or institute/center director with day-to-day responsibility for the supervision of faculty and staff participating in research conducted at or under the auspices of the University.

The initial award notification will come in an email, and all information that we currently know as PAN (Project Award Notice) or PAC (Project Award Change) will reside in the AWD system. If you wish to have a hard copy printed, your best course of action would be to save the email notification as a PDF. 

User Acceptance Testing (UAT). During the UAT process, representatives from the schools/colleges/institutes and central offices  (who were involved in the working groups) will be asked to preview the online workflow. Additionally, this is a time to redefine or identify any remaining "offline" business processes. No new functionality is expected to be added during UAT. The UAT process simply ensures that requirements have been met.

 

The eRA Commons (electronic research administration commons) website, by the National Institutes of Health (NIH), that provides principal investigators and their research staff with online features and tools including the abilities to:

  • View a full application
  • Review current status of an application
  • Check for errors
  • View application assignment information
  • Obtain PDF copies of applications
  • Access copies of previous Notices of Grant Award

Get current information on the program official and the grants management specialist

More information from ORSP about using Grants.gov through the U-M eResearch Proposal System

  1. Extended definition for federal exemption #2 [pre-2018 Common Rule] (proposed by IRB-HSBS, 2013; adopted by all U-M IRBs)
    Federal exemption category 2 applies to projects involving educational tests, surveys, interviews, or observation of public behavior.  It does not allow for any other research intervention in conjunction with the durvey, etc., regardless of the risk.  U-M exemption #2a expands the federal definition to minimal-risk research with adults that involves a non-invasive intervention followed by data collection vai survey, interview (including focus groups) or observation.  Examples of non-invasive interventions include, but are not limited to:
    • Reading a story or vignette
    • Playing an electronic game
    • Using a computer program or website
    • Watching a video
    • Using a robot arm or device
    • Being exposed to stimuli, such as color, light or sound (within safe limits)

  2. Two-year approval periods (proposed by IRB-HSBS, 2007; adopted by IRB-Flint, 2014, IRBMED, 2015)
    Federal regulations require continuing review of research at least annually, depending on the degree of risk to the subjects.  For research projects posing no more than minimal risk to subjects, U-M postulated that lengthening the review period beyone one year was unlikely to increase risks to subjects.

  3. Exemption for analysis of identifiable data:  U-M Exemption #7 [pre-2018 Common Rule] (proposed by IRB-HSBS, 2007; adopted by all U-M IRBs) Federal regulations require annual continuing review for all studies, including minimal risk studies where research activity is limited to analysis of identifiable data.  U-M proposed that for research involving no direct interaction or intervention with human subjects, the requirement to submit annual continuing reviews doesn not enhance subject safety.  A new exemption category was created to provide appropriate review and subsequent exemption from regulatory oversight.  Anticipated benefits included:
    • Reduction of administrative workload for investigators
    • Reduction of application volume for IRB staff and reviewers
    • Reduced turn-around time for application review of U-M Exemption #7 studies

HRPP's criteria for demonstration projects includes:

  1. The research must be determined to pose no more then minimal risk to subjects.

  2. The research must not include:
    • Federal sponsorship, including federal training grants
    • FDA regulated components
    • Sponsor or other contractual restrictions requiring adherence to federal regulations for clinical interventions (including clinical behavioral interventions)
    • Prisoners as subjects
    • NIH-issued Certificates of Confidentiality

  3. The project must evaluate the impact of procedural improvements, including the:
    • Compatibility with the current electronic IRB application
    • Ease of training and informing investigators, study teams, and the IRB staff
    • Ability to monitor the projects.

  4. The project must signify the impact of procedural improvements on the research community, such as:
    • Elimination of regulatory excess that is not protective of human subjects
    • Enhanced regulatory outcomes for minimal risk research
    • No increase in effort required for investigators.

Innovations U-M has implemented to date include:

  1. Streamlining the IRB application paths (i.e., types of applications) in eResearch for:
    • Secondary use of existing data/records/specimens
    • Exempt human subjects research
    • Activities not regulated as human subjects research
    • Requests for review by a non-UM IRB.

  2. Updating IRB policies regarding staff roles for:
    • Exempt reviews - authorization for IRB staff to make exempt determinations
    • Scheduled Continuing Review (SCR) - authorization for qualified IRB-HSBS staff to conduct expedited review of non-federally funded research.

  3. Implementing U-M guidelines regarding:

  4. Expanding the interpretation of federal exemption category #5 to cover public benefit and service programs sponsored by the State of Michigan.

The U-M Office of Research (UMOR) offers support for research, scholarship, and creative activities in all fields.

The intent is to:

Help support areas of research and scholarship where external funds are scarce or unavailable

  • Assist in maintaining the base activities of high-quality projects between funding cycles
  • Support for equipment and infrastructure on sponsored activity
  • Seed novel, high-risk, innovative, inter-unit projects
  • Assist with colloquia, symposia, and other events that promote the evolution of new research ideas and collaborations
  • Assist junior faculty in establishing new research programs

Applications are reviewed by faculty peers. Please consult the specific funding opportunities for detailed application procedures and other pertinent information.

Eligibility

Eligible Not Eligible
Instructional and Research Faculty Research Investigators
Librarians Lecturers
Curators Postdoctoral, Graduate and Undergraduate Students
Archivists  

Review Procedures, Award Terms, & Other Information

Signatures

The U-M Office of Research (UMOR) requires the signatures of the department or unit head, and the dean or director of the school/college/unit. The dean/director may delegate this authority to an associate dean/director. Please route the application to the appropriate office for signatures well in advance of any deadlines. Your school/college/unit may have internal processing requirements that must be completed prior to submission. Contact those offices for clarification.

Applications will not be processed by UMOR until all appropriate signatures are obtained.

Matching Funds

For all UMOR funding opportunities, securing matching funds or cost sharing from the unit, school/college, department, or outside sources is viewed as an important sign of commitment to and support of the application. As such, a match on a portion of the total project cost is required. The specific required minimum % varies by funding opportunity and can be found in the program description. Non-allowable costs listed under Funding Restrictions (below) are not to be included in matching funds. Joint UMOR and BMRC applicants for maintenance support must follow BMRC's requirement of 1:1 matching funds from the PI's department.

Peer Reviews

Applications will be reviewed by faculty peers. This step may be waived in the case of proposals with comparable external review.

Key considerations during review include:

  • Scholarly merit and potential impact on the field
  • Value for the applicant's own research potential and progress
  • Productivity and qualifications of the applicant, as indicated by record of research achievement or potential
  • Likely impact of this work on the field and its potential to enhance the scholarly distinction of the University
  • Appropriateness of the budget to the project proposed
  • Extent of unit support as indicated by matching funds
  • Any special review requirements as noted in the individual program description

Priority

Priority is typically provided to faculty who have not received or have received little funding from UMOR previously.

Frequency of Application

To equitably distribute research and scholarship funds across the campuses, UMOR limits faculty to one award per fiscal year. Exceptions may be granted under special/unique circumstances with prior approval.

Funding Restrictions

In general, UMOR support is NOT available for:

  • Travel to present at conferences
  • Regular salary of faculty except as specifically indicated in program guidelines
  • Computer/hardware/software for routine use
  • Office equipment, telephone installations, photocopy machines
  • Equipment maintenance costs
  • Tuition support
  • Requests for small amounts more appropriately handled at the unit level
  • Projects that are primarily instructional
  • Funds covering reduced external awards
  • Retroactive funding, costs overruns, or disallowances on other sponsored projects
  • Faculty recruitment and start-up packages
  • Page or reprint costs of articles in professional journals

Award Notification

UMOR is committed to responding to faculty requests for support as quickly as possible. Notification of funding decisions is typically made within 12 weeks of the program’s deadline.  Late applications will not be processed until the next deadline for that program.

Applicants can facilitate expeditious review by providing complete information, all required signatures, and by suggesting qualified, independent reviewers.

Award Administration

For most awards of $5,000 or more, a project/grant will be established in the recipient's academic unit for a specified amount, duration, and purpose. The recipient is responsible for ensuring good stewardship of the funds received. All applicable university policies and procedures must be followed.

Award amounts are final. Overruns and disallowances are the responsibility of the individual recipient and academic unit. Each award stipulates an expiration date, after which it is expected that the remaining balance will be returned to UMOR.

Faculty may not retain the award if they leave the University of Michigan.

Any changes in budget items or project period must first be approved by UMOR. Contact UMOR-FGA-Submissions@umich.edu for questions.  To request a No Cost Time Extension (NCTX) for an existing UMOR Faculty Grants & Awards program award, click here.

 

 

32 CFR Part 2002 identifies three control levels that guide the safeguarding or dissemination of CUI:

  • CUI Basic - requires or permits the agencies to control or protect the information, but provides no specific information security controls
  • CUI Specified - requires or permits the agencies to control or protect the information, and provides specific information security controls
  • CUI Specified, but with CUI Basic Controls - requires or permits the agencies to control or protect the information, and provides only some of the controls

When the university accepts a contract that includes CUI, the Research Information Security Liaison determines the level of CUI (basic or specified) control required and works with the research team to ensure that the appropriate controls are implemented for the life of the project.

An external (i.e., commercial or other academic) IRB may charge for services when designated as the single IRB-of-Record (sIRB) for a multi-site, non-exempt human subjects research project.  Estimated expenses are negotiated on a case-by-case basis in the service agreement between U-M and the external IRB, and budgeted for as direct costs in the sponsor's (e.g., NIH) funding proposal and award.

Common IRB services include, but are not limited to:

  • IRB Reviews
    • Initial review of the research protocol, investigator/site qualifications, informed consent plan and documentation, and subject recruitment materials
    • Continuing/annual protocol review (regulatory requirement) for subsequent years of the project
    • "Periodic" review of any incident reports (e.g., Adverse Events or ORIOs), as they are filed
    • Amendments/modifications -  changes to the study that require IRB review
  • Administrative Services - letters, study changes not requiring IRB review, etc.
  • Site/Project Closeout - review of the final status report, resolution of outstanding issues 
  • Other - services as applicable to the project, e.g., foreign language translation, etc.

Factors that impact the budget for sIRB services include the number of performance sites, level of risk to the subjects and/or institution, duration of the study, and more.  See the External sIRB fee schedule -sample for an example.

Warning iconThe principal investigator is not authorized to sign the negotiated service agreement with the external IRB.  As a financial transaction, the agreement must be signed by an authorized official from U-M Procurement Services and may require approval from the U-M Regents.

Always contact your U-M IRB to determine sIRB requirements prior to submitting funding proposals for multi-site, non-exempt human subjects research.

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