Institutional Review Board (IRB)

What kind of research infrastructure do we have in the Department of Pediatrics?

What kind of research infrastructure do we have in the Department of Pediatrics?

Our research infrastructure is outlined on this website. It consists of the following: 

  • Research Support Services (i.e. help with grant preparation and submission; however, they will not write the grant for you!). Lori Wallin, Jordan Webb and Sue Marshall are incredibly helpful.
  • Clinical Research Services (assist with clinical study preparation, subject recruitment, data collection, and management, etc). This group is led by Amanda Galster.
  • The Department Research Council (manages intramural research funding, research mentoring, addresses research needs and issues). The council is led by Dr. Angela Panoskaltsis-Mortari.

How can the Department Clinical Research Program led by Amanda Galster help me?

How can the Department Clinical Research Program led by Amanda Galster help me?

The Research Program can assist with:

  • Clinical research support-study start up, subject enrollment, data management
  • IRB assistance
  • Assistance with clinical logistics
  • Recruitment/enrollment materials
  • Identifying study coordinators
  • Red Cap Data management

I want to apply for a grant---what do I do and in what order?

I want to apply for a grant---what do I do and in what order?

  1. For your first grant submission, meet with our grant specialists Lori Wallin or Jordan Webb well in advance to discuss grant type, budgets, deadline as an initial introduction to the process.
  2. Then submit the proposal intent form. They will get back to you regarding who has been assigned to assist you and what the deadlines are. It is important to adhere to their deadlines as they are helpful in keeping you on time (the full proposal must be sent to SPA at least 3 days before the NIH deadline). The proposal intent form must be submitted at least 8 weeks before the deadline. When this is not possible (for example, subcontracts from other institutions tend to be late; or the grant announcement did not provide enough time), then permission to apply must be granted by the Department Chair (Dr. Neglia); you can ask for this simply by emailing Dr. Neglia.
  3. If your study requires IRB and/or IACUC approval ahead of submission (some grants do), you need to think well ahead of time as those can take months. However, they are not required to be approved at the time of grant submission for most grants, but it may be required that they are submitted for approval; your assistant will check the “pending” box on the grant application.
  4. The earlier you have your specific aims page and research plan done, the more likely you are to get useful mentoring and advice from your colleagues.
  5. As investigators, we tend to focus on the research plan, but there are countless other parts to a research proposal that must be written so plan enough time.

 

What is SPA?

What is SPA?

Sponsored Projects Administration (SPA) is SPA is the University of Minnesota system-wide office authorized to submit research proposals and receive awards from external sources on behalf of the Board of Regents of the University of Minnesota.  SPA submits and accepts awards and assures they are administered consistently with sponsor and Board of Regents policies, and mediates the grant process.  All sponsored grant submissions must go through SPA.  For a given grant the process is as follows:

  • SPA receives the grant proposal from the investigator and the department grant personnel at least 3 days before the grant due date
  • It reviews the proposal for institutional and external compliance
  • Transmits the proposal to the sponsor
  • Negotiates awards
  • Sets up the account and manages the award through its life cycle
  • Ensures the sponsor is satisfied

They can be contacted at 612-624-5599, or ospa@umn.edu

What is the CTSI?

What is the CTSI?

The Clinical and Translational Science Institute (CTSI), at the University of Minnesota is an academic home and infrastructure to support clinical translational science research at UMN, to foster meaningful relationships and transparent interactions among the UMN and our communities, and to train and reward interdisciplinary clinical translational science teams at the UMN and in our communities.  It has 4 core offices:

The CTSI was originally funded by both UMN and a CTSA award from the National Institutes of Health. This award ended in 2015 and a new grant has been submitted.

What is EGMS?

What is EGMS?

Electronic Grants Management System.  When a grant is being submitted, it must be approved at multiple levels and electronic signatures are required. The Department Research Support Services staff take care of this for the investigator, but the investigator will be asked to electronically sign off on the proposal as the first step. It will then be automatically routed to the next person in line. egms.umn.edu

 

What do I need to know about industry partnerships?

What do I need to know about industry partnerships?

What do I need to know about industry partnerships?
Researchers at the UMN have many types of partnerships with industry:

  • Taking part in a pharma-initiated multi-site trial, and serving as the local Site PI
    • Do not sign any agreements, including initial confidentiality agreements, until after reviewing by UMN staff (SPA or research administration)
    • Work with your research coordinator, or contact Amanda Galster for support
    • Extensive regulatory, financial, and clinical effort is usually needed
    • Pediatrics requires the use of CTSI’s Clinical Trials Finance Services (CTFS) for budget development and contract negotiation. Investigators should not make concessions to sponsors regarding budget and contract.
  • Proposing investigator-initiated clinical research to an industry sponsor for support (funding, free drug, off-label use of a drug/device, etc.)
    • Need to develop a study protocol and schedule
    • Work with your research coordinator, or contact Amanda for support
    • Determine if an IND or IDE is needed (see below)
    • Work with Amanda and CTFS to develop a sufficient budget
  • Service agreement for lab or other technical services---Contact your administrator, accountant, or Lezlie Nordquist

What are INDs and who can help me with them?

What are INDs and who can help me with them?

NDs are Investigational New Drugs and are regulated by the Food and Drug Administration (FDA) per 21 CFR Part 312.  An IND (or FDA approved exception) is required to investigate unapproved drugs or to investigate approved drugs for an unapproved indication. 

There are 3 types of INDs: 

  1. An Investigator IND is submitted by a physician who both initiates and conducts an investigation, and under whose immediate direction the investigational drug is administered or dispensed.  A physician might submit a research IND to propose studying an unapproved drug, or an approved product for a new indication or in a new patient population. (NOTE: collaboration with the drug sponsor must occur first)
  2. An Emergency Use IND  allows the FDA to authorize the use of an experimental drug in an emergency situation that does not allow time for submission of an IND in accordance with  21CFR, Sec. 312.23 or Sec. 312.20.  It is also used for patients who do not meet the criteria of an existing study protocol, or if an approved study protocol does not exist. The FDA Emergency Use Information Sheet and the UMN site describes How to Request Expanded Access (compassionate use).
  3. A Treatment IND is submitted for experimental drugs showing promise in clinical testing for serious or immediately life-threatening conditions while the final clinical work is conducted and the FDA review takes place.  If the criteria are met, may also be utilized for a small number of patients (such as children with a rare disease) for whom a trial is not available. 

Any clinical trial being conducted under an IND must follow strict regulations for study conduct and Adverse Event reporting.  

At the UMN, researchers may be engaged in IND research in two different ways:

  1. We may be a study site for a trial being conducted under an IND, but the IND is sponsored by another entity (such as a drug company, or another institution). 
  2. Researchers may also apply for and sponsor their own IND for their Investigator-Initiated Research. In this case, you are a Sponsor-Investigator, and the research requires significant planning and oversight.  Once you submit your IND you wait 30 days. If you do not hear anything from the FDA it means your IND has been accepted and you can move forward.

Regulatory resources for UMN IND Sponsors:

  • UMN IRB site
  • UMN IND Policy 
  • All correspondence with FDA must be sent to the UMN Central File via regfile@umn.edu, with completed form UM 1813
  • Milana Solganik, IND/IDE Regulatory Director, medreg@umn.edu, 612-626-5654
    • Services available here 
  • Contact Amanda Galster for additional regulatory support as needed

Devices: What are IDEs, HDEs and HUDs?

Devices: What are IDEs, HDEs and HUDs?

All clinical investigations of medical devices must comply with all FDA and IRB regulations for informed consent. The FDA regulations apply to ALL medical device studies, whether the device is marketed or not. 

An Investigational Device Exemptions (IDE) permits the use of an investigational device in human subjects in a clinical investigation. IDEs are regulated by the FDA per 21 CFR Part 812.  

A Humanitarian Use Device (HUD) is a device that is intended to benefit patients by treating or diagnosing a condition that affects or is manifested in fewer than 4,000 individuals in the United States per year. To obtain approval for a HUD, a Humanitarian Device Exemption (HDE) application is submitted to the FDA. See FDA HDE site, and 21 CFR Part 814 Subpart H

NOTE: IDEs, HDEs, and HUDs are complicated. Get help. Resources for UMN Researchers:

  • Insurance coverage and billing: Jill Cordes, research@fairview.org
  • Dr. Gwen Fischer and the PDIC 
  • Contact Amanda Galster for additional regulatory support as needed