Provider Resources / Clinical Research Resource Center
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Clinical Research Resource Center

Your centralized hub for information, support, and tools related to clinical research at North Memorial Health.

Clinical research is a vital part of our mission to deliver high-quality, patient-centered care. As a community-based health system, we have a unique opportunity to contribute to research that reflects and serves the real-world needs of our diverse patient population.

This resource page is designed to support physicians, nurses, advanced practice providers, medical assistants, pharmacists, and administrative staff who are directly or indirectly involved in research activities.

Close up of North Memorial N logo

Whether you are:

  • Referring patients to active clinical trials,
  • Supporting study-related care at the bedside or in the clinic,
  • Coordinating study visits and documentation,
  • Serving as a Principal Investigator or Sub-Investigator,
  • Or simply learning more about how clinical trials function in our setting—

This webpage provides easy access to educational materials, institutional policies, compliance guidance, documentation tools, research submission forms, and training resources to help you navigate the research process with confidence.

Together, we advance medicine, improve patient outcomes, and ensure that research opportunities are equitable and accessible within our own community.

If you have questions or need direct support, our Research Office is here to help. Contact us at Research.Office@northmemorial.com

Clinical Research Resources

North Memorial Health Human Subjects Research Program

Office of Research

The North Memorial Health Human Research Protections Program (HRPP) is responsible for protecting the rights, safety, and welfare of patients participating in research occurring at North Memorial Health and ensuring compliance with applicable regulations and policies. The North Memorial Health Research Office guides and supports the offices and programs that make up the HRPP and serves as the point of contact for investigators or sponsors conducting research at North Memorial Health. North Memorial Health does not maintain its own Institutional Review Board (IRB) and relies on external IRBs for all non-exempt research.

The Research Office will work with investigators to facilitate institutional reviews, execution of clinical research, IRB reliance, and data use agreements and ensure that required human subjects research education and conflict of interest information is complete and update to date.

If you have questions about clinical research at North Memorial Health or want to schedule a research consultation, please contact the Research Office at Research.Office@northmemorial.com.

North Memorial Health Research Committees

North Memorial Health Institutional Research Review Committee

North Memorial Health is committed to conducting research that is feasible, scientifically meritorious, compliant, ethically sound, and in alignment with local standards and institutional values. The success of a protocol is contingent upon performance of a thorough local context review and feasibility assessment prior to activation of clinical research.

The goal of the Institutional Research Review Committee is to ensure investigators have adequate department and institutional support, and resources (e.g., funding, staff, equipment) to implement the research. It is an opportunity to confirm that the recruitment, study management, and data security plans are sufficient. It also allows members of the committee to use their individual expertise during the review process to provide additional guidance to researchers.

The Institutional Research Review Committee is not an Institutional Review Board (IRB). All activities requiring IRB review will seek approval from an external IRB (e.g., the Advarra IRB) and have the appropriate reliance agreements executed.

Privacy & Security Review Board

The North Memorial Health Privacy & Security Board reviews requests for Waivers or Alterations of HIPAA Authorization to use and/or disclose organization Protected Health Information (PHI) for research purposes. The Privacy Board is not an Institutional Review Board (IRB) and is not authorized to review and/or approve human subjects research regulated under the federal Policy for the Protection of Human Subjects (45 CFR 46).

MMCORC Activation Committee

North Memorial Health Cancer Center is a member of the Metro Minnesota Community Oncology Research Consortium (MMCORC). MMCORC regularly joins clinical trials. MMCORC member institutions then activate those trials for local enrollment. The purpose of the monthly MMCORC Activation Committee Meeting is to discuss protocol priorities and operational considerations to open specific studies for enrollment at NMH.  It is an opportunity to ensure that there are sufficient resources (e.g. staff, equipment, chemo order builds) to implement the research.

Research Review Workflow
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Office for Human Research Protections (OHRP)

Federal Wide Assurance

Assurance: FWA00001572 North Memorial Health Care
Located at: Robbinsdale, Minnesota
Expires: 11/22/2029

Visit OHRP Database
Advarra as the IRB of Record

North Memorial Health will rely on external IRB to review and approve non-exempt research. NMH has an agreement with Advarra to serve as the IRB of record. Below is helpful information for your application submission.

Submission Information

Required Training & Forms
Templates
Unique Research

Single Patient IND for Compassionate or Emergency Use

Humanitarian Use Device

Policies and Standard Operating Procedures (SOP)
Agreements

Often human subjects research requires collaboration with other institutions, sponsors, and external investigators. Access, use, and disclosure of data to and from North Memorial Health requires specific agreements to be in place prior to engaging in research activities. Please reach out to the North Memorial Health Research Office for guidance to help with facilitating the appropriate agreements for your research. Please note that these agreements cannot be signed by the investigator and must be reviewed with North Memorial Health legal for official execution.

  • Confidential Disclosure Agreement
  • Clinical Trial Agreements
  • IRB Reliance Agreements
  • Individual Investigator Agreements
  • Data Use and Transfer Agreements
Research Reporting

Please contact the Research Office for additional information.

  • Annual Administrative Check In
  • Participant Complaints
  • Unanticipated Problems to Subjects or Others
  • Research Misconduct Concerns
  • Research Noncompliance
Post Approval Monitoring and Audit Readiness

Please contact the Research Office for additional training, education, and support for the following:

  • External Monitoring Support
  • FDA Inspections
  • Institutional Post Approval Monitoring
  • Corrective and Preventive Action Plans
Research Resources

Human Subjects Research Protection Program

FDA Regulated Research

HIPAA Privacy & Security

Clinicaltrials.gov

Financial Conflict of Interest

National Institutes of Health (NIH)

Frequently Asked Questions

General Overview

Clinical research refers to studies that involve people and aim to answer specific questions about health, treatments, or procedures. These studies can involve testing new drugs, devices, diagnostic tools, or behavioral interventions. Research can be interventional (e.g., testing a new medication) or observational (e.g., tracking outcomes from standard care over time).

Community-based research ensures that our patient population is represented in medical discoveries. It offers patients access to innovative therapies and allows providers to contribute to advancing medicine. It also supports equity in research by including diverse and underserved populations who are often underrepresented in studies.

The clinical research program is overseen by our Research Office in partnership with the Institutional Review Board (IRB), Institutional Oversight Committee, and the HIPAA Privacy & Security department. These teams ensure that studies comply with ethical standards, federal regulations, and hospital policies.

For Providers & Clinical Staff

As a provider or staff member, your role may include:

  • Identifying and referring potentially eligible patients
  • Supporting the informed consent process
  • Performing protocol-specific assessments or procedures
  • Documenting study activities properly in the EMR and source documents
  • Communicating with the research team to ensure patient safety and protocol adherence

You are a critical link between research and clinical care.

Yes, and we encourage it. If you know a patient who might benefit from or be interested in a clinical trial, notify the research team. Do not tell the patient they are eligible until the study team has conducted proper screening.

No. Patients who join trials still receive high-quality standard care. The trial may offer an additional treatment or schedule of visits, but participation is voluntary, and all patients can withdraw at any time. Your clinical judgment remains central to care decisions.

Operational Support

Only studies that have appropriate approval and are institutionally authorized can be conducted.

You can also contact the Research Office to verify study status.

Clinical activities tied to a research protocol must be documented in two places:

  1. The Electronic Medical Record (EMR) – using designated templates or notes to track what the patient received.
  2. The study source documents – such as visit worksheets, case report forms, or binders maintained by the research team.


This dual documentation helps ensure transparency and supports audits or sponsor monitoring.

Treat the patient first based on medical need. Then notify the Principal Investigator (PI) and research team as soon as possible. Some events may need to be reported to the sponsor, Research Office, and/or IRB within specific timeframes, so prompt communication is essential.

Compliance & Ethics

Only trained, IRB-approved, and delegated personnel can obtain informed consent from a participant. The process must be conducted in a private setting, with ample time for questions, and documented thoroughly. Consent must always be obtained before any research-related activity occurs.

Yes. All staff engaged in research must complete:

  • CITI Program training in Human Subjects Protection
  • Any role-specific or study-specific training as needed

Training ensures that all staff understand the ethical, legal, and operational aspects of research.

You can:

All reports are taken seriously and investigated confidentially. Retaliation is strictly prohibited.

Getting Involved

If you’re interested in research—whether as a study coordinator, sub-investigator, or support staff—reach out to the Research Office. Opportunities are available based on your background, interest, and departmental needs. We provide guidance, mentorship, and onboarding for those new to clinical research.