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- A-Z Index and Glossary
Generally a single project or series of closely related projects under the direction of a single investigator.
Potentially legally protectable knowledge, technology, ideas, and information often resulting from performance of sponsored activity.
- U-M Standard Practice Guide 201.30-5
- IPA Process for U-M and Veterans Affairs (Med School Site)
- GSA Form 69 (pdf)
- IPA Form for VA agreements
- Veterans Affairs (VA) Memorandum of Understanding (MOU) - A Memorandum of Understanding (MOU) must be completed when a U-M faculty member with a Veterans Affairs (VA) appointment is identified on a Federal grant or contract application. MOUs are active for one year and must be updated annually.
A copy of the most recent VA MOU must be submitted to ORSP at the time of proposal submission and with each non-competing renewal application and at the time the just-in-time material is requested for NIH applications.
Instituational Review Board - Health Sciences & Behavioral Sciences
- Continuing Review Process
- Data Security Guidelines
- Decision Trees: Exempt Human Subjects Research Decision trees displaying the criteria and potential review paths, including self-determination, for exempt categories 1 - 4, 7 & 8 under the 2018 Common Rule.
- Incident Reporting (AE/ORIO)
- Informed Consent Guidelines & Templates
- IRB Amendment Process
- IRB Application Process
- IRB Health Sciences and Behavioral Sciences (HSBS)
- IRB Repository Application Supplement Template that outlines the information necessary for IRB review of a U-M data/biospecimen repository. Complete and upload to the IRB Repository Application within the eResearch Regulatory Management System (eRRM).
- IRB Repository Application: eResearch Job Aid See "Respository Application" under Proecedure Documents & Tips on the eResearch website for step-by-step instructions to create and submit an REP, amend an REP, file a continuing review, and terminate an REP.
- IRB Review Process
- IRB-HSBS Blue Full Board Roster
- IRB-HSBS Education
- IRB-HSBS Maize Full Board Roster
- IRB-HSBS: Key Changes to the Common Rule IRB-HSBS general session presentation (updated 10/12/2017) explaining key changes in the 2018 Common Rule (Regulations for the Protection of Human Subjects ~ 45 CFR 46)
- OHRP Repository Guidance Issues to Consider in the Research Use of Stored Data or Tissues (1997)
- Tip Sheet: Exemption #1 Provides the full definition and explanation of exemption category #1 (educational exemption) under the 2018 Common Rule, including examples of the types of studies that qualify/do not qualify for this exemption.
- Tip Sheet: Exemption #2 Provides the full definition and explanation of exemption category #2 (surveys, interviews, educational tests, and observations of public behavior exemption) under the 2018 Common Rule, including examples of the types of studies that qualify/do not qualify for this exemption.
- Tip Sheet: Exemption #3 Provides the full definition and explanation of exemption category #3 (benign behavioral intervention) under the 2018 Common Rule, including examples of the types of studies that qualify/do not qualify for this exemption.
Information Technology Management Reform Act
Information and Technology Services is an umbrellla unit of the merged general and administrative computing at the University of Michigan. ITS manages the administrative systems, such as M-Pathways and e-Research. It also provides technology and communications services for U-M Ann Arbor's academic and research needs.
A Limited Submission is a funding opportunity in which the sponsor sets an institutional limit for the number of proposals it will accept. In order to participate, the University must organize to submit our most competitive proposal. This requires an internal competition. The process is critical extra submissions can result in the rejection by the sponsor.
To be informed of the opportunities we have identified, you can sign up for our Weekly Call for Intent and Limited Submission communication. We now communicate both the Calls for Intent to Submit and the Limited Submissions in a single communication.
Interested parties declare their interest for a Call for Intent to Submit and/or submit competition materials for a Limited Submission competition, through our InfoReady Limited Submissions website. For questions, contact firstname.lastname@example.org.
- M-Inform Disclosure Criteria Lists the disclosure criteria with examples (as seen in M-Inform) for an outside interest, activity, or relationship.
- M-Inform Disclosure Questions (Sample) [PDF] Use this resource to assist disclosers in your unit. DO NOT use to submit disclosure information.
- M-Inform Glossary & FAQ
- M-Inform Outside Interest Disclosure Decision Tree
- M-Inform Question #5 Mock-up for July 2017 Draft depiction of Question #5 in the M-Inform system displaying the updated options and text for 2017 (FY18) to describe a person's relationship or role with an external entity when disclosing an outside interest with that entity.
- Maintaining Department Information in M-Inform Instructions to assign M-Inform roles (e.g., unit reviewers of outside interests for the unit or an individual) and send M-Inform reminder emails to disclose to individuals.
- Outside Interest Disclosure Process
- Prepare/Update a Disclosure for Another in M-Inform M-Inform instructions for proxies (i.e., unit assistants) to data enter outside interest disclosures for another U-M discloser.
- Respond to a COI Management Plan (for conflicted individual) M-Inform instructions to access and respond to (i.e., accept) a Management Plan for a COI situation.
- Review an Outside Interest Disclosure in M-Inform M-Inform instructions to review and approve outside interest disclosures on behalf of the discloser's U-M unit.
- Review and Respond to a COI Management Plan (for ombudsperson, monitor, etc.) M-Inform instructions to view and respond to the COI Management Plan as an individual with an oversight role in the unit for the conflict situtation.
- Reviewer Demonstration Video demonstration of the Unit Reviewer workspace, tabs, and functions (e.g., approve disclosure, return disclosure) in M-Inform (2:33)
- Submit an Outside Interest Disclosure in M-Inform Instructions to add new, edit existing, and remove outside interests from your M-Inform disclosure, including restoring previously inactive outside interests.
- Submit Information for a Research Initiated Certification Instructions for a discloser to answer a series of follow-up questions regarding an outside interest disclosure from a COI Office using M-Inform.
- Submit Information for the Annual Review of your COI Management Plan (for conflicted individual) M-Inform instructions to access, answer, and submit the Annual Review questionnaire for a conflict of interest situation.
- Submit the Annual Review Response for a COI Management Plan (for ombudsperson, monitor, etc. M-Inform instructions for individuals in an oversight role (e.g., ombudsperson) to access, answer, and submit the Annual Review of a conflict of interest situation.
- U-M Reviewers: Points to Consider [PDF] U-M guidelines and tips for those who review faculty outside interest disclosures for their unit
- Update Your Company Profile in M-Inform Instructions to enter information about your start-up company in M-Inform. This information is required for the conflict of interest review at U-M when someone options, licenses, distributes, or commercializes intellectual property developed at the university.
Michigan Institute for Clinical & Health Research. http://www.michr.umich.edu/home.
MIchigan Research LibrarY Network. See: http://mirlyn.lib.umich.edu/.
Memorandum of Understanding
Michigan Chapter of Society of Research Administrators
Modified Total Direct Costs. The basis on which most U-M indirect costs are calculated (calculated as total costs minus equipment, tuition, patient care costs, and the portion of a sub-contract in excess of $25,000).
National Institutes of Health. See: http://www.nih.gov/grants.
- U-M NIH Access Policy for Publications (ORSP Link) Information on the NIH Public Access Policy and the use of the My NCBI's My Bibliography for managing eRA Commons and for complying with the Policy.
- NIH electronic Research Administration (eRA) Guides and Documentation Excellent support for eRA Commons resources including: Just-in-Time, ASSIST, IAR, RPPR, FCOI, FFR, iEdison (Invention Reporting).
- Rock Talk Blog Gain a better understanding of NIH grants issues, and weigh in on current happenings that affect the extramural community with Rock Talk (link is external), the blog of Dr. Sally Rockey, NIH Deputy Director for Extramural Research, who directs the Office of Extramural Research.
- U-M FORMS-E Worksheet A fillable PDF worksheet with an extraction of some of the questions in FORMS-E for the SF424 forms set. This worksheet is intended to help Research Administrators (RAs) collect the detailed data and scientific questions they will need from their principal investigators (PIs) to more readily complete FORMS-E in the eResearch Proposal Management System.
- Common Rule & Other Changes
- External sIRB Fee Schedule Depicts a sample budget worksheet outlining the fees for services that may be charged by an external (e.g., commercial) institutional review board (IRB) when that IRB is serving as the single IRB-of-record (sIRB) for a multi-site non-exempt human subjects project.
- FAQ: NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules
- NIH Clinical Trials Requirements - IRB-HSBS Overview Presentation providing an overview of the changes in regulations for NIH funded clinical trials to the IRB-HSBS board (September 2017)
- NIH Guidance on Informed Consent
- NIH Human Gene Transfer Review Process (4/27/16) Link to NIH document (PDF) containing information about the revised (April 27, 2016) NIH review process for HGT trials.
- NIH/OBA Recombinant DNA Advisory Committee, Schedule of Meetings Currently scheduled meetings for the RAC
- U-M Implementation: NIH Single IRB-of-Record (sIRB)
To advance science and improve human health, NIH makes the peer-reviewed articles it funds publicly available on PubMed Central. The NIH public access policy requires scientists to submit final peer-reviewed journal manuscripts that arise from NIH funds to PubMed Central immediately upon acceptance for publication.
- NIH My Bibliography My Bibliography is a reference tool that helps you save your citations directly from PubMed or, if not found there, to manually enter citations using My Bibliography templates.
- NIH Public Access Policy Process Map 101 (U-M Library Research Guides) This downloadable PDF provides a visual step-by-step process map to simplify the compliance process.
- NIH PubMed Central PubMed Central® (PMC) is a free full-text archive of biomedical and life sciences journal literature at the U.S. National Institutes of Health's National Library of Medicine (NIH/NLM).
- Open Letter to Publishers from U0M Medical School (2009)
- U-M Library Research Guides on National Institutes of Health Public Access Policy (NIHPAP)
A request typically to a funding institution, for additional time beyond the originally awarded grant end-date, to finish the scientific portion of a project. Requests for extensions are initiated by a Principal Investigator and are appropriate if additional time beyond the established expiration date is required to assure adequate completion of the original scope of work within the funds already made available. The fact that funds will remain at the expiration date is not in itself justification for an extension.