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- A-Z Index and Glossary
HRPP CoC Process and Guidance
See also Representations & Certification.
Code of Federal Regulations
The class chartfield is used to denote the functional nature of an expense, which is essential for external and internal financial reporting. Codes should be used appropriately and consistently among like transactions. See this list prepared by Cost Reimbursement for the codes relevant to research and sponsored projects. Learn more about this topic and download class code definitions on the Finance website.
Clinical Trials is a type of "Other Sponsored Activity."
Clinical Trials fill a key role not only at the U-M Medical School, but with the entire University research enterprise. To streamline the initiation of clinical trials, the UMMS Office of Research and the Office of Research and Sponsored Projects (ORSP) have developed a program where several steps in the trial contracting process have been clarified and made more efficient.
A major component of the program is a Nondisclosure Agreement (NDA) template that can be signed by the school without routing to ORSP for negotiations if the sponsor agrees to the terms. This NDA is intended to expedite the process for exchanging and protecting a sponsor's confidential information prior to entering into a sponsored clinical trial agreement. Often the parties are simply exploring the possibility of a clinical trial that may or may not result in the University and sponsor establishing an agreement. The goal is to provide a fair and balanced NDA that protects the sponsor's information and also meets the needs of the University as a public body.
Another important component of the program is the use of the Clinical Trial Routing Form (CTRF) which allows study teams to send draft agreements for the trial to ORSP for contract terms review prior to the routing of a PAF with final financial arrangements. Further information on the CTRF is available.
Below you will find related resources. If you have further questions, please contact the ORSP at 734-764-5500 and ask for a "ORSP Project Representative for Clinical Trial Agreements and Medical School Non-Disclosure Agreements."
Clinical Studies health research at the University of Michigan: https://umclinicalstudies.org/
- 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.
At the end of a project there are important considerations to make sure the project comes to an orderly close. The University has an obligation to sponsors to submit a final technical and financial report. The necessary closing procedures may vary, depending on the policies of the sponsoring agency and whether the support was in the form of a grant or contract. The requirements may vary from a one-page form to a multi-page document. Perhaps inventions or patents are necessary. Learn more in the Close Out Project section of our website.
The "Common Rule" is the popular term for the Federal (U.S.) Policy for the Protection of Human Subjects, 45 CFR part 46, which outlines the criteria and mechanisms for IRB review of human subjects research.
- Common Rule & Other Changes
- 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.
- eRRM Overview of Changes - Flexibility Initiative ITS eResearch document outlining the changes to eRRM system to implement flexibility initiative to pilot the 2018 Common Rule for non-federally funded human subjects research.
- 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)
- IRBMED: Changes to the Common Rule Link to IRBMED's Seminar Series webpage containing two presentations explaining the changes to the 2018 Common Rule. The presentations differ in content based on information known as of the presentation date.
- 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.
- U-M Implementation: Continuing Review
- U-M Implementation: Exemption Changes
- U-M Implementation: Informed Consent Changes
A Michigan law that complements FOIA in exempting proprietary information held by university personnel if certain conditions are met.
- CRIIA Excerpt - MCL Section 390.1553
- Michigan Confidential Research and Investment Information Act (CRIIA) - Act 55 of 1994
- Michigan Freedom of Information Act (FOIA) - Act 442 of 1976 (MCL 15.231, et seq.) Full text of the Michigan Freedom of Information Act (FOIA) - Act 442 of 1976 (MCL 15.231, et seq.)
A conflict of interest is when a University employee is in a position to influence the conduct of a project for personal gain due to responsibilities or to arrangements with an outside entity. A conflict of interest (COI) is a situation created by the combination of an external entity, your activity/relationship with that external entity, and your University of Michigan employment/job responsibilites and activities. For further definitions, see SPG 201.65-1.
- Agencies/Organization Following PHS COI Regulations
- COI Annual Review Process
- COI Initial Review Process
- COI Management Examples
- COI Policies
- COI Review: Committee Determination Process
- Conflict of Interest (COI)
- Outside Interest Disclosure form (Word) used by individuals who are external (i.e., not affiliated with, employed by) to the U-M, but are participating on a project (e.g., investigators from a subcontracting organization; investigators on a human subjects study).
- How to determine if you need COI review and approval How to Determine if Your Project or Technology Transfer Activity Needs COI Committee Review and Approval
- Institutional Conflicts of Interest (ICOI)
- M-Inform Disclosure Criteria Lists the disclosure criteria with examples (as seen in M-Inform) for an outside interest, activity, or relationship.
- M-Inform Glossary & FAQ
- M-Inform Outside Interest Disclosure Decision Tree Use this visual diagram to walk through the considerations to determine whether to disclose an outside interest/activity in M-Inform. Last updated: 06/18/2018.
- 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.
- NIH COI Policy (PHS)
- NIH Conflict of Interest resources page Public Health Service (PHS) regulations, which apply to the National Institute of Health (NIH)C and other PHS agencies
- Non-U-M Investigator Disclosure Process
- NSF COI Policy
- Outside Interest Disclosure Process
- Policy for Institutional Conflicts of Interest in Research Effective July 1, 2018. Office of the President policy outlining the criteria and processes for the identification, review, and management of conflicts of interest arising when U-M, as an institution, has financial interests that may affect or appear to affect the design, conduct, reporting, review, or oversight of research.
- 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.
- Principles & Concepts
- Regental Action Requests (RARs) & COI Review
- 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.
- Sample M-Inform System Email to Disclosers Sample (Word) of the system email sent from M-Inform to those at U-M required to disclose per unit procedures or PHS regulations.
- 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 Feedback to COI Office Instructions to submit additional feedback and inforamtion to a COI Office regarding an outside interest disclosure when the COI Office has identified a potential conflict of interest.
- 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.
- The Michigan Conflict of Interest Statute (Public Act 317 of 1968)
- U-M Policy for Identification and Management of Conflicts of Interest in Research and Technology Transfer U-M policy outlining the outside interest disclosure requirements and COI review processes for research and technology transfer activity
- U-M Reviewers: Points to Consider [PDF] U-M guidelines and tips for those who review faculty outside interest disclosures for their unit
- U-M Standard Practice Guide (SPG) - 201.65-1
- U-M Standard Practice Guide (SPG) - 201.65-1
- U-M Start-Up Company Disclosure Process
- UMORCOI Review Committee & Schedule
- Unit COI/COC Plans Unit plans (e.g., LSA, Engineering, UMOR) for Faculty & Staff, posted to Provost web site.
- 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.
Generally an agreement between university and corporate partners entered into for a specific research project or program.
A participant, either internal or external to the University, whose participation does not require a sub-account or sub-contract, and who is paid via a personal service agreement.
A contract or an agreement involves a promise, or set of promises, for which the performance of is recognized as a legal obligation.
Each contract document contains a statement of work or a description of the services to be provided. This work statement should be drafted with great care, for failure by the University or contractor to deliver the results anticipated, or to perform what is defined in the statement of work, is a breach of contract.
An agreement where a specific work statement is supported by funds from a sponsor who exercises more control than in the case of a grant.
Parent tag for the Controlled Substances in Research compliance program
- Annual Inventory Example Sample of a completed State of Michigan Annual Inventory
- Apply for or Renew a Controlled Substance Research License/Registration Instructions for both the SOM license and DEA registration
- Article 7: Controlled Substances Index of links to the controlled substance policy sections of the Public Health Code Act 368 of 1978
- Authorized Personnel Log Template (Word) to track the individuals, other than the licensee/registrant, who are authorized to handle controlled substances for research use and/or access to the storage location.
- Board of Pharmacy Controlled Substances (R 338.3101 - 338.3199q) Controlled substance policy, including definitions and schedules, from the Department of Licensing and Regulatory Affairs (LARA)
- Controlled Substance Compliance Checklist Checklist (Word) to use to prepare your laboratory and/or the controlled substance storage location for a U.S. Drug Enforcement Administration (DEA) inspection.
- Controlled Substance DEA Inventory Template Template (Word) used to perform a biennial inventory of the controlled substances currently stored at the DEA registered location.
- Controlled Substance Diluted Solution Log Log (Word) used to document the usage details for a controlled substance that has been withdrawn from its original container and mixed with a solution to dilute the concentration.
- Controlled Substance Initial & Closing Inventory Template Template (Word) used to record controlled substances at a new storage location immediately upon receipt of a DEA registration or used to list the controlled substances stored at a registered location upon the closing of that location.
- Controlled Substance Inspection Guidelines Instructions for researchers and lab staff to follow when the U.S Drug Enforcement Administration (DEA) arrives for a controlled substance inspection.
- Controlled Substance Multiple Dose Log Log (Word) to document the details for each use of any controlled substance amount removed from its original container.
- Controlled Substance Research Policies
- Controlled Substance SOM Inventory Template Template (Word) used to perform the State of Michigan (SOM) annual inventory of all controlled substances stored at the licensed location.
- Controlled Substances General Inventory Template Template (Word) used to summarize the usage of a controlled substance from the time of acquisition to the end of use (e.g., administration and/or disposal). Also called a “perpetual inventory.”
- Controlled Substances in Research
- DEA Form 106 - Report Theft/Loss Link to the online DEA form for use by the DEA Registrant only
- DEA Form 222 - Example Annotated PDF showing how to complete a DEA Order Form 222
- DEA Registration Application & Renewal
- DEA Research Application Instructions Guide to completing the DEA research application.
- DEA Theft/Loss Procedures & Information Link to the DEA website for additional procedural information regarding the reporting of a controlled substance theft or loss
- DEA Update Request Online form to request modifications to an existing DEA controlled substance registration. For use by the registrant only.
- Diluted Solution Log Example Sample of the information that can be found on the controlled substances Diluted Solution Log
- Dispose of Controlled Substances Printable version of the procedure (PDF). Updated 01/20/17 to include the new Schedule I & II disposal steps.
- Dispose of Controlled Substances
- Form 225 Instructions Link to the DEA website for instructions to complete the Controlled Substance Registration Form 225 (all Schedules)
- General Inventory Example Sample of a completed general inventory log
- Initial and Closing Inventory Example Sample of the type of information that could be found on a closing inventory using the Intitial & Closing Inventory template.
- Inspection Preparation
- Maintain Controlled Substance Records
- Maintain Security & Storage Controls for Controlled Substances Used in Resarch Printable version of the procedure (PDF)
- Modify a Controlled Substance License/Registration Printable version of this procedure (PDF)
- Modify a License/Registration
- Multiple Dose Log Example Sample of the information that can be found on the controlled substance Multiple Dose Log
- Online Form 225 Link to the online DEA Controlled Substance Registration Form 225 for Schedules II - V only
- Order & Receive Controlled Substances for Research Printable version of the instructions (PDF)
- Order & Receive Controlled Substances for Research
- PDF Form 225 Link to the DEA Controlled Substance Registration Form 225 (PDF) for Schedule I substances only
- Report Theft/Significant Loss of Controlled Substances Printable version of this procedure (PDF)
- Report Theft/Significant Loss of Controlled Substances
- Researcher Controlled Substance Request Form Form (PDF) required to order controlled substances for research use from the Michigan Medicine B2 Pharmacy.
- Reverse Distributor Inventory Instructions Instructions to complete the Reverse Distributor Inventory List, also known as the DLD Controlled Substance Inventory List.
- Reverse Distributor Inventory List Inventory template to use when disposing of controlled substances through EHS - Hazardous Materials using U-M's contracted reverse distributor (Drug, & Laboratory, Inc. or DLD.) Also known as the DLD Controlled Substance Inventory List.
- Schedule I and II Controlled Substance Disposal Process Detailed instructions with examples of completed forms for disposing of Schedule I and II controlled substances utilizing the required reverse distributor process offered via Drug & Laboratory Disposal, Inc. (DLD) by U-M Environment, Health & Safety (EHS)
- SOM Data Request Change Form Online form from the State of Michigan (SOM) used to request modifications or updates to an existing controlled substance license. For use by the licensee only.
- SOM License Application (fillable PDF) - enter the data, then print, and mail to the address listed in the application form
- SOM License Application & Renewal
- State of Michigan Application Instructions Guide to preparing State of Michigan application for controlled substances research license.
- Title 21 Code of Federal Regulations, Part 1300-End Index listing the links to the sections of DEA policy for controlled substance registration
- Title 21 United States Code (USC) Controlled Substance Act U.S. Department of Justice - Drug Enforcement Administration (DEA) outline of the federal Controlled Substance Act
- U-M Authorized Personnel Screening Statement Form Internal attestation form (PDF) for personnel who will handle controlled substances for research purposes and/or have access to the storage location.
- U-M Policy on the Use of Controlled Substances in Research and Education Outlines the investigator and/or department roles and responsibilities when utilizing controlled substances in research at the University of Michigan (revised 12/14/15)
- Use of Buprenorphine SR is NOT Approved for Use in Research at U-M Statement indicating that Buprenorphine SR is not currently approved for use in research at U-M
Controlled Unclassified Information (CUI) is federal non-classified information (i.e. information the Government creates or possesses, or that an entity creates or possesses for or on behalf of the government) that requires safeguarding or dissemination controls compliant with law, regulations, and government-wide policies.
The CUI Program is a government-wide approach to creating a uniform set of requirements and information security controls directed at securing sensitive government information
- Controlled Unclassified Information (CUI)
- National Archives Website on Controlled Unclassified Information Link to the agency that oversees the federal CUI Program. This website contains the CUI Registry, links to policies, guidelines, and more.
A funding mechanism like a grant, except there is substantial programmatic involvement of the sponsor.
CAS. Cost Accounting Standards. Specific rules promulgated by the federal government to achieve consistent accounting practices for sponsored projects. See 48 § CFR 9905.501, 9905.502, 9905.505, and 9905.506.
Cost sharing is the financial support contributed by universities to sponsored projects. Compliance with federal cost accounting standards requires that cost-shared expenses be treated in a consistent and uniform manner in proposal preparation, award negotiation and the accounting of these expenses in the financial reports to both federal and non-federal sponsors.
Cost sharing is subject to audit and is a condition of the award when included in a proposal or an award budget. It is most important, therefore, that any cost-sharing commitments be reflected in the project accounts once an award is received.
Center For Statistical Consultation and Research (CSCAR). U-M unit that offers an integrated, comprehensive statistical consulting service, covering all aspects of a quantitative research project ranging from the initial study design through to the presentation of the final research conclusions. A service and research unit of the University of Michigan, administratively located in the Office of Research. Its staff provides statistical services to faculty, primary researchers, graduate students and staff of the University. See http://www.cscar.research.umich.edu.
Current and pending support is a term generally used by all other federal sponsors and other types of funding entities to request the submission of information for key personnel's active and pending review or award research funding. This information is submitted at the time of proposal. The format varies by sponsor. NSF and other sponsors tend to call this "Current and Pending" Support. NIH tends to refer to it as "Other Support."
- Current and Pending Template 1 (Blank) Download an Excel file to help you manage current and pending support for ongoing projects. The file you will download contains an Excel spreadsheet. This is the version that is clean and ready for fresh use. Please note: This won't work well on a Mac; you' need to use a PC to utilize the forms. It won't solve the world's problems, but it's a start! This resource is provided by the RAAC Metrics Subcommittee.
- Current and Pending Template 2 (Sample version with Data) This Excel spreadsheet has some sample current and pending data in it so you can open it for examples of forms and/or to view output without having to enter data. Please note: This won't work well on a Mac; you' need to use a PC to utilize the forms. It won't solve the world's problems, but it's a start! This resource is provided by the RAAC Metrics Subcommittee.