Institutional Review Board (IRB)

Parkview Institutional Review Board (IRB) Office contacts:

Coordinator: Jennifer Gallagher 719-584-4769 or Jennifer_gallagher@parkviewmc.com

IRB Chair: Kim Arline 719-584-1040 or Kimberly_arline@parkviewmc.com

Email parkview_irb@parkviewmc.com to reach both the Coordinator and Chair

IRB board meets the third Thursday of the month at 7:30 am

IRB submission must be received by IRB Chair and completed by the first day of the month to be placed on the IRB agenda the third Thursday of that month.

Parkview IRB Policy and Procedure Manual

Regulations

• OHRP Regulations, Policy & Posting
• FDA Rules and Regulations
• ICH: Good Clinical Practice
• National Institutes for Health
• Clinical Trials.Gov
• Research Involving Private Information or Biospecimens
• Human Subjects Research

Parkview IRB's Purpose

Parkview IRB’s purpose is to assure the protection of the rights and welfare of research participants in evaluating research. Additionally, we provide prospective, current, and former research participants with the information and support necessary to assist in protecting your rights and welfare allowing you to make an informed decision about whether or not to participate in research.

What is an IRB?

An Institutional Review Board, also called an Independent Review Board (IRB) is a group of people (or a “board”) who review research to assure that it will be done in a way that protects the rights, safety, and welfare of the research participants. IRBs review the informed consent document to ensure it provides enough information about the research in terms you can understand, so that you can decide whether or not you want to participate. If the board feels the research meets the criteria set forth by the FDA or DHHS regulations for IRB approval, they will approve the research. Sometimes they require changes to the research and/or the informed consent document. The IRB continues to provide oversight of the research until its completion.

Three Ethical Principles

In addition to following the federal regulations, industry standards, and internal policies, Parkview IRB employs three basic ethical principles of respect for persons, beneficence, and justice outlined in "The Belmont Report, Ethical Principles and Guidelines for the Protection of Human Subjects in Research," when evaluating research.

IRBManager is a system for IRB submissions & review - use CHROME browser! Extra carriage returns - use CHROME browser each have their own line

All investigators need to create an IRBManager account:

• If you have a Parkview email, use the link with your Parkview username and password.
• If you do not have Parkview credentials, email Jennifer_Gallagher@parkviewmc.com to request an account by providing your first and last name, email address and department or association with Parkview. You will sign in with the lower link "IRBManager issued login."

Update User settings (tips for IRBManager below)

• Update your user setting, contact information
• Upload attachments: add your PHRP or CITI training certificate and your CV
• Complete the Annual Financial Disclosure form: start Xform in left column and select this form. You will receive an email annually to update this form.

Helpful tips and Training for IRBManager:

• Update user settings
• Submit a new study or update a study in IRBManager tips
  • Note additional tips, vocabulary and federal requirements are available throughout the application by clicking "Show Help" on a question.
• Faculty Review of a study in IRBManager tips
• Email parkview_irb@parkviewmc.com if you'd like to schedule an online session to use IRBManager or receive feedback on your study protocol.

The review process in IRBManager: If at any point during the review process changes are requested, the PI will receive an email from IRBManager with the edits required and a link to the application. Make sure you include an email address you routinely check to avoid any delays in the review and approval process.

1. If a Faculty Advisor is involved (if PI is a student, resident or fellow), the faculty advisor must sign off and approve the submission before it goes to the IRB office.
2. IRB office reviews for completeness. May send back to PI for more documentation. IRB protocol number will be assigned that will need to be added to the attached Protocol, Informed consent documents, etc.
3. Senior Leadership may review studies to ensure hospital resources or your funding plan is adequate for the study.
4. IRB Chair will determine if Exempt, Expedited or Full Board review is needed based on the risk, complexity and informed consent required. A primary reviewer from the IRB will be assigned.
5. Primary reviewer will review the study and complete the necessary checklist.
6. If study needs full board IRB meeting: the IRB chair must receive the review by the 1^st day of the month to be placed on the agenda for the 3^rd Thursday meeting that month.
7. If the IRB requires changes to the application for approval, the PI should make the changes within two weeks and resubmit to the IRB Chair/Primary reviewer.
8. Once the IRB approves the study, the IRB Coordinator will send the PI the official approval letter and stamped documents to be used with participants. Research activities may begin once approval letter is received.

Resources For Investigators: tips on navigating the research process, IRB requirements and publishing:

• See IRB Policy and Procedure Manual under IRB Office tab
• Parkview Research & IRBManager Overview presentation
• Research 101 - what is research, links on statistics and study design, definitions of study design from clinicaltrials.gov & more
• Principal Investigator Responsibilities
• Investigator Guide on Recruiting Subjects
• Investigator Guide on Consenting Subjects
  • Exempt Research and Informed Consent
• Overview of documents required for various IRB submissions
• Templates for protocols and informed consent under "Submit your own study to IRB" tab
• Statistical analysis by a statistician at Rocky Vista University of Osteopathic Medicine is available for a very nominal fee for Parkview investigators. Dr. Duffee can help local investigators have their study design pre-reviewed to determine the number of participants needed to reach meaningful conclusions, in addition to statistical analysis after data collection is completed. Email Douglas_Duffee@parkviewmc.com to request and coordinate this. More details on using Statistician in Research as Collaborator vs Consultant.
• Register prospective clinical trials Register the study in this web-based data entry system within 3 weeks of IRB approval, periodically update the enrollment status and submit results for registered studies. Publishers will question why a prospective clinical trial was not registered.
• Free preprint server for clinical research involving humans: several Parkview researchers have published preprints on https://www.medrxiv.org/submit-a-manuscript. This service allows you to share your manuscript publicly prior to peer review. Preprints have been much more common since the Covid-19 pandemic but may impact the decision process of a peer reviewed journal accepting your manuscript for publication. You may submit the manuscript through this service to several peer reviewed journals and services.

1. Protecting Human Research Participant Training: A certificate of completed training is required for all investigators, collaborators, faculty advisors and IRB members. You will need to upload your certificate of training into your IRBManager settings. The IRB office will update expiration dates to be displayed on Xform applications. Training is available from:

• PHRP Training (more affordable) or
• Collaborative Institutional Training Initiative (CITI)

2. All investigators create an IRBManager account: See IRBManager tab for link and helpful tips for updating account, attaching CV, education certificate and completing the Financial Disclosure Xform.

3. Use the resources under Investigator Guides and Tips tab to define your study, understand Informed Consent, recruitment and Principal Investigator Responsibilities.

4. Write a quality study protocol detailing the study. Templates below are for investigators to modify, tips in italics should be deleted. All sections must be completed. A well-written protocol can he handed to a stranger and that person could replicate the study.

• Protocol template - Chart Review
• Protocol template - Prospective Research
• Quality improvement project template

5. Informed Consent must be detailed if there is any contact or intervention with study participants. You will explain the Informed Consent process or justify a Waiver of Informed Consent in the IRBManager Initial application. You will need to attach the written Informed consent or any script or text for a verbal or online consent.

• Written Informed Consent template
• Informed Consent details including samples of verbal/online informed consent
• For more complicated studies, email parkview_irb@parkviewmc.com to discuss more consent details for clinical trials, investigational agents, more than minimal risk or studies involving children or vulnerable populations.

6. Research Committee to review: 1st Tuesday of month at 8 am

• Email your written protocol and consent, survey questions document (if applicable) to both: douglas_duffee@parkviewmc.com and crystal_bravo@parkviewmc.com to be placed on the agenda at least one week prior to the meeting to allow time for committee members to review the protocol.
• You may present a Power Point on your study or screen-share your protocol. The protocol should cover all the details.
• The committee provides feedback on improving the study, how to engage/navigate the hospital system and other departments for assistance, etc.
• Once approved, you can start the IRBManager application to avoid having to make changes to protocol and application based on Research Committee feedback.

7. IRBManager Initial Application:

• Once the study protocol is well defined and approved by the Research Committee, click “Start Xform” in left column and select Initial application Xform.
• You can copy and paste details from the protocol into IRBManager application, attach protocol and other documents such as Informed Consent, recruitment emails/flyers. Investigators may start IRB application, gathering required documents while awaiting Research committee approval.
• Tips for using IRBManager are available under the IRBManager tab above and the right sidebar “Helpful Tips” in the IRBManager dashboard.

8. See IRBManager tab for the Review Process. Please note the IRB Chair must receive the finished application by the first day of the month to go on the IRB agenda the 3^rd Thursday of the month if the review requires Full Board review.

9. Once research is approved by IRB, the study becomes a “Project” in IRBManager, and you can open your Project and click on “Start Xform” in left column to submit an Amendment, Continuing Review, Reportable Event or Study Closure Xform for the IRB to review. See more details on this under "Updating your Study" tab. You may use the search line to find projects by title, IRB number or investigator.

1. Protecting Human Research Participant Training: A certificate of completed training is required for all investigators, collaborators, faculty advisors and IRB members. You will need to upload your certificate of training into your IRBManager settings. Training is available from:

• PHRP Training (more affordable) or
• Collaborative Institutional Training Initiative (CITI)

2. All investigators create an IRBManager account: See IRBManager tab for link and helpful tips for updating account, attaching CV, education certificate and completing the Financial Disclosure Xform.

3. Submit study in IRBManager:

• Select “Start Xform” in left column and select Initial Application Xform and enter details of the study.
• See IRBManager tab for tips on using the system.
• On page two you will provide details and the approval letter from the other IRB for the two IRBs to coordinate.
• You will attach the already approved study protocol, informed consent, recruitment materials and other applicable documents.
• Questions throughout the application help explain how the study will be implemented at the requested Parkview site.
• These studies will be reviewed by Senior Leadership to verify adequate resources are available locally or in your funding plan to fully support the project.
• Email Parkview_irb@parkviewmc.com with any questions or call 719-584-4769.

4. See IRBManager tab for the Review Process. Please not the IRB Chair must receive the finished application by the first day of the month to go on the IRB agenda the 3rd Thursday of the month if the review requires Full Board Review.

5. Once research is approved by IRB, the study becomes a “Project” in IRBManager and you can open your Project and click on “Start Xform” in the left column to submit an Amendment, Continuing Review, Reportable Event or Study Closure Xform for the IRB to review.

Once research is approved by IRB, the study becomes a “Project” in IRBManager and you can open your Project and click on “Start Xform” in the left column to submit an update to the IRB. The following Xforms are available once you are in the correct PROJECT.

• Amendment form: use for any changes needed for protocol or procedures, informed consent, recruitment materials, research personnel changes. Note: exempt studies personnel changes, only submit amendment if PI changes.

• Continuing Review: Investigators must update the IRB a minimum of every 12 months on the study by completing an IRBManager Continuing Review XForm for the study.

1. The purpose is to ensure research is continuing and being conducted in accordance with approved IRB documents. Assess if any change in risk vs benefit by including any Serious Adverse Events or Unanticipated Problems since the last review must be summarized in the report.
2. Notification of Continuing Review due: IRBManager or the IRB staff will notify Investigators at least 6 weeks prior to the study expiration date by email with a link to complete a Continuing Review Xform. If the study meets criteria to close the study instead, the PI may complete a Closure Xform instead. The Xform requires the attachment of the protocol in use, informed consent or other IRB approved documents.
3. Failure to submit the Continuing Review or Closure forms as requested to continue the study on or before the study expiration date, the PI will be notified that the study has lapsed as of the expiration date. See Chapter 8 in IRB Policy for more details.

• Study Closure: when the study has filled enrollment, data gathering, and data analysis of any participant identifiable information are complete, the PI needs to complete a Closure Xform in IRBManager to notify the IRB to close the study. Any serious adverse events or Unanticipated Problems must be summarized in the report. If investigators do not respond to IRB notifications to complete a Continuing Review or Closure form, the IRB can terminate the study as described under Failure to submit Continuing Review chapter 8 of IRB policy under IRB office tab.

• Reportable Events: (Unanticipated Problems (UAP), Serious Adverse Events (SAE), Protocol Deviations and Violations, Investigator non-compliance, Reports from external agencies regarding safety/risks of items or procedures in study):

1. Definitions of Reportable Unanticipated Problems (UAP): an event that is
   1. Unanticipated
   2. Related to or possibly related to participation in the study and
   3. Suggests greater risk to participants than previously known or recognized. An unanticipated problem generally requires a change in policy or procedure, warrants consideration of substantial changes to the protocol/consent or other immediate corrective actions to reduce the risk or eliminate immediate hazard.
   4. Most individual adverse event do not represent unanticipated problems, and therefore, do not need to be reported to the Parkview IRB under the HHS regulations for the protection of human subjects.
2. Reporting timeframe Expectations:
   1. Promptly is within 5 business days from the date the PI first learns of the event.
   2. Immediately is within 24 hours. Any deaths should be reported to IRB chair within 24 hours by emailing Parkview_irb@parkviewmc.com
   3. Periodically is at the study's next Continuing Review time frame.
3. Reporting procedure: Investigators are required to report these issues using the IRBManager Reportable Event Xform. This should include a detailed description of the event, plans to address the concern and if any external sponsor or multi-center study is involved and the guidance they are providing. If applicable to the study, also report to the DSMB (Data Safety Monitoring Board) or any study sponsor. See chapter 8-17 in IRB policy for more details.

RESEARCH PARTICIPANT RESOURCES

As a prospective, current, or past research participant, you may wish to learn more about participating in clinical trials. Visit the websites below for information on a variety of topics that relate to research.

Do not sign the informed consent until you have all your questions answered. You should not feel rushed to participate.

FDA

What you need to know https://www.fda.gov/patients/clinical-trials-what-patients-need-know

NATIONAL INSTITUTES OF HEALTH (NIH)

NIH Glossary of Common Terms https://www.nih.gov This is a list of terms you may hear during your conversations with the researches about participating in a research study.

ClinicalTrials.gov: The government's Clinical Trials site provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.