Principal investigators and research nurses: These resources provide the tools you need for study activation at the University of Minnesota.
How to get your protocol approved by the Cancer Protocol Review Committee on the first submission:
Certification for the Responsible Conduct of Research
The policy of the Board of Regents, Principal Investigator Eligibility on Sponsored Projects requires training before any award documents can be released by the Office of Sponsored Projects Administration (SPA).
Information about obtaining training is provided by the Office of the Vice President for Research and Dean of Graduate School.
- To get started, go to: www.research.umn.edu/training and complete:
- Responsible Conduct of Research-Part 1
- Responsible Conduct of Research-Part 2
Find information about human subject protection at the IRB website.
Certification for Protecting Human Subjects Training
Human Participant Protections Education for Research Teams (free registration required)
Documentation of Certification Completion
Certification for Responsible Conduct of Research and Protecting Human Subjects Training must be on file in the CTO Investigator Files.
University HIPAA Training
For compliance with HIPAA's privacy standards, every member of the Academic Health Center (all students, staff, faculty, researchers, and volunteers) is required to complete some level of HIPAA training. The training is MANDATORY and required by law.
There are a total of four HIPAA trainings, the first two of which are required by every member of the AHC. The third and fourth trainings deal specifically with work in privacy standards in research.
The following is an outline of HIPAA training:
- HIPAA Awareness (7 minutes)
- Safeguarding PHI on Computers (30-60 minutes)
- Privacy and Confidentiality in Research (30-60 minutes) — Faculty, staff and students who use health information in research must complete this course.
- Privacy and Confidentiality in Clinical Settings (30-60 minutes) — Faculty, staff and students who are in a setting that provides health care and treatment to individuals
- must complete this course.
IND/IDE Assistance Program
FDA regulations define a category of researcher called sponsor-investigator. The FDA regulations for both sponsors and for investigators are complex. Sponsor-investigators expose themselves and the institution to a high degree of risk if they failure to comply with research regulations that govern clinical trials. The IND/IDE Assistance Program is available to assist faculty apply for INDs and IDEs. The University has a policy requiring the use of the IND/IDE Documentation Unit to assist with and ascertain compliance with FDA regulations. This policy requires IND and IDE sponsor-investigators to provide copies of all IND/IDE-related documents, including the original submission and all communications with the FDA, to the IND/IDE Documentation Unit.
The services available from the IND/IDE Assistance program include:
- Explanation of IND and IDE regulations
- Assistance in understanding the obligations of a sponsor-investigator
- Assistance in determining product classification, i.e., drug, device, biologic
- Assistance in determining applicability of an IND or IDE
- Assistance in determining contents of IND or IDE
- Assistance in submitting IND and IDE applications to FDA
- Assistance in scheduling, coordinating, preparing and attending meetings with FDA
- Regulatory support for IRB applications
- Regulatory assistance during FDA inspections of investigator sponsored clinical trials
- Periodic news items from FDA relating to sponsor-investigator clinical trials
The policy can be found at the University policy library at http://www.irb.umn.edu/sponsor.html.
1. Statement of the Investigator (Form 1572)
Form 1572 is is the form that is required by the FDA and is a contract with the FDA to follow Good Clinical Practices. Most pharmaceutical companies will provide a partially completed form but they are also available online.
- Download Form 1572 Statement of the Investigator
- Forward a copy to the Clinical Trials Office.
2. Curriculum Vitae
Typically, the CV must be current within two years and must be signed and dated. However, different funding agencies (i.e. NIH, Pharma, etc) have different expectations for the manner in which they are signed or updated. For instance, some require the date and signature on the cover page while others expect it on the last page. Forward a copy to the Clinical Trials Office Investigator Files.
3. Medical License
Attach a photocopy of your current medical license to your CV. When it expires, retain that copy and include the updated one. NEVER discard prior licenses.
4. Local Conflict of Interest Document
Also known as an AREPA (A Report of External Professional Activities) number. Forward a copy to the CTO Investigator File.
5. Sponsor Conflict of Interest Document
Form will be supplied by sponsor.
6. Local Laboratory Documentation
Pharmaceutical companies require documentation from the local laboratory even if they are using a central laboratory for the clinical trial. Again, it will be sponsor-specific but some of the typical documents are listed below:
- CAP/CLIA Certification
- Laboratory Director's current CV & Medical License
- List of Normal Reference Ranges
- To obtain these items for this institute, go to www.fairview.org/prof/research/lab_accred.asp
7. Request for Taxpayer Identification Number and Certification
Some sponsors require submission of the W-9 Request for Taxpayer Identification Number and Certifcation form. A copy of this form can be obtained at www.ospa.umn.edu/sponsorrequireddocuments/index.html.
Always download the most current form each time an application is submitted for any of the below committees.
1. Human Subjects' Protection Program (IRB)
For more information about the IRB and to download an application, visit their website at www.irb.umn.edu.
- Review the meeting dates and their policy regarding the submission deadlines.
- Ascertain the number of copies of the application, consent form, and protocol that are required for the review process.
- Deliver the application in-person (as opposed to sending via campus mail).
- Note the date the application was submitted for your records.
- Verify the necessity of an outside IRB approval from the sponsor and/or funding agency.
- This institution does not provide such a list of membership but prefers to provide a narrative description of their compliance with federal rules and regulations.
This is the scientific review committee that must review and approve all cancer protocols in addition to the IRB review process. For more information about the CPRC and to download an application, visit the CPRC section of this website.
- Review the meeting dates and their policy regarding the submission deadlines.
- New guidelines have arisen that deal with Data Safety Monitoring Boards (DSMB). It's best to be proactive and obtain documentation of the plan from the sponsor.
3. Academic Health Center (AHC) Office of Research
All research projects by University faculty and staff to be conducted at Fairview performance sites or involving Fairview resources will be routed through the AHC Office of Research. The AHC Office of Research, in conjunction with the Fairview Research Office, will evaluate the project for the extent of use of Fairview resources; ascertain that the research budget properly identifies the use and costs of all such resources; and advise the investigator regarding establishment of the accounts, subcontracts and purchase orders required by University departments, Sponsored Projects Administration, and Fairview Research Office. If issues regarding use of Fairview resources are identified, the AHC Office of Research will work with the investigator and Fairview Research Office to address them before the project is initiated. Visit www.fairview.org/Research/ for more information.
- All research conducted at Fairview and using Fairview resources is covered by the AHC policy.
- Fairview prices for research resources may be obtained through the AHC Office of Research.
- Study budgets should clearly identify Fairview resources and be accounted for using current prices.
- Approval of the AHC Office of Research is required before signature by Department Head, Dean, and SPA submission.
- Documents used in the review: Use of Fairview Resources Approval Checklist, Proposal Routing Form, Research Proposal, Budget (identifying Fairview resources), and
- Research Institutional Account Request Form/Research Project Application for Laboratory Services.
- Allow 72 hours for the review.
Other review committes
- Radiation Committee Review (AURPAC), (See also item #5, "Department of Radiology Review Committee")
- Institutional Biosafety Committee Review
- Investigational Drug Services (IDS)
The IRB review application requests an IDS number. This is the internal number generated by the IDS.
All clinical trials involving investigational agents must be registered with the IDS regardless of whether or not you are going to use their services. If you do not plan on using the investigational pharmacy to dispense the study medications, please complete this form. To download an application, go to www.fairview.org/prof/research/PDF/forms/form4.PDF
The application must have the following items included:
- Form 1572
- Investigational Drug Brochure
- Copy of IRB approval (when available)
- Copy of the IRB-approved consent form (Note: For the BMT Program, this information is supplied automatically by the BMT Administrative Office.)
Department of Radiology Review Committee
All protocols with a radiation therapy component must be submitted to the University's Department of Therapeutic Radiology for review and approval. This approval must be obtained prior to submission to AURPAC.
Research ethics at the University of Minnesota
We are committed to protecting research participants, upholding ethical standards, and improving our practice at every step of our work.