Community Medical Centers - Preparing for Submission

There are some important steps you need to take prior to submitting your research study.

Does Your Research Require IRB Review?

IRB review is required for any medication or device that is used as part of a Clinical Research trial, regardless of FDA approval status
For medications or devices that are FDA approved, they may be used for Medical Treatment for any indication that is appropriate in the judgment of the prescriber. However, when used for a non-FDA approved indication, insurers may decline payment
FDA approved medications or devices to be used for Medical Treatment alone do not need IRB review regardless of the indication
Medications or devices that have not yet been approved by the FDA cannot be administered to patients for routine Medical Treatment, may only be used in Clinical Research
However, emergency use of unapproved medications or devices may be allowed if the situation meets certain criteria (e.g. life-threatening, no alternatives, not time to obtain FDA approval) and required coordination with the IRB. The Compassionate Use process for individuals or small groups requires FDA and IRB coordination
Humanitarian Use Devices (HUDs) are intended for treatment of rare diseases (<8,000 patients per year) and approved and monitored via alternate processes. The FDA requires IRB oversight for the use of HUDs
IRB review is required for Clinical Research that includes the retrospective review of patient data for any medication or device that may have been used for Medical Treatment
Case studies are not Clinical Research, but a letter of exemption must be obtained from the IRB

Consider what level of review your research might require: full committee review, expedited review or exempt certification

Are you Eligible to Serve as a Principal Investigator (PI)?

Preceptor
Faculty member
Community Medical Centers Licensed Medical professional
Fellows

Note to Residents: Have a mentor review your study proposal prior to submission to the IRB.

PI Responsibilities

By accepting the role as PI, you are responsible to:

Follow Approved Protocol
- Responsible for research team’s adherence as well
Protect Human Subjects
- Ensure informed consent
Control Investigation Product
Document Study Progress
- Submit appropriate reports
- Retain records

FDA Guidelines

Clinical Investigator/Site (21 CFR 312 and 812):

Conduct the study according to the signed agreement, the investigational plan and applicable FDA regulations
Protect the rights, safety, and welfare of subjects under the investigator’s care
Control investigational product
Dispose of/return investigational product
Ensure that an IRB that complies with its requirements (21 CFR 56) will be responsible for initial and continuing review and approval
Obtain Informed Consent per 21 CFR 50.25 prior to study participation
Submit Reports (progress, safety, final, financial disclosure)
Maintain accurate, complete, and current records relating to the investigator’s participation in an investigation
Retain records and make them available for review

FDA/PHS

Clinical Investigator/Site (21 CFR 54 & PHS Regulations):
Disclosure of Conflicts of Interest that affect the design, conduct, reporting, and analysis of the research (Disclosure to Sponsor and Community Medical Centers)

Compensation of equity interest of $5000 or more (publicly traded)
Compensation of $5000 or more, or equity interest of any amount (non-publicly traded)
Intellectual property interests of $5000 or more
Travel expenses paid for in any amount

Form FDA 1572

By signing the form (contract), the Investigator:

Agrees to personally conduct or supervise the study in accordance with the approved, relevant, current protocol

Refer to CyberIRB for more information.

Site Personnel Qualifications

Qualified by education, training and experience in the field being research
Familiar with the investigational product and its proper use
Document that responsibilities are delegated only to qualified personnel

Resources

Sufficient access to the patient population being studied
Sufficient time to properly conduct and complete the study
Adequate number of qualified personnel
Adequate facilities and equipment
Personnel trained on protocol, investigational product, and assigned duties and functions

Medical Care of Subjects

Medical decisions should be made by a qualified physician who is an investigator or sub investigator for the study
Adverse events and other medical issues should be managed adequately
Subject’s Primary Care Physician should be notified of participation, with subject’s approval
Withdrawn subjects should be assessed

Document Study Progress

The PI must ensure proper documentation of the study including, but not limited to:

Consent of subjects (both via the IRB approved form, and research notes in the subject record.)
Research records (including subject charts, medical records, databases where study data is captured, etc.)
Correspondence between the PI and the IRB
Proper storage and retention of records

Interaction with IRB

Written and dated approval should be obtained for the protocol, informed consent form, advertisements, subject literature and amendments prior to being implemented
All documents to be reviewed should be provided in a timely manner and updated as necessary throughout the trial

Protocol Compliance

The investigator should formally agree to comply with the approved protocol and confirm this by signing the protocol
The investigator should not deviated from the protocol without prior knowledge and agreement from the sponsor and the IRB
The investigator should not implement protocol amendments prior to review and approval by the IRB

Control Investigational Product

The investigator must oversee and ensure the appropriate:

Receipt of the investigational product
Storage of the investigational product
Documentation of the accountability of the investigational product
Dispensing of the investigational product
Return or disposal of the investigational product

For More Information

Consult FDA regulations
Consult ICH GCP Guidelines
Complete the Good Clinical Practices Module within the CITI Training Program
Check CyberIRB

Quality Improvement vs Research

What Qualifies as Research?

Research is a systematic investigation of phenomena for the purposes of generalizing findings to a population. Researchers aim to add to the current body of knowledge about a particular subject, and results are often published in academic journals.

Researchers must follow strict policies, obtain consent from subjects, and report any deviation from the protocol. An Institutional Review Board (IRB) must approve the research project before it starts, and a hospital’s administrative personnel must support the project.

What Qualifies as Quality Improvement?

Quality improvement (also called quality assurance) is also systematic, but it aims to improve care, processes, or outcomes within an organization.

The purpose of QI is to test a new process using the plan, do, study, act process. This cycle is repeated, and new changes are made to continue to improve the outcome.

https://www.americannursetoday.com/quality-improvement-research/

CyberIRB Online Application

All IRB submissions to the Community Medical Centers IRB will be completed through the electronic submission software CyberIRB.

Please be aware that CyberIRB has built-in hard-stops, therefore incomplete submission will be automatically returned to Investigators.

Log into CyberIRB: http://www.cyberirb.us/cmc
Ways to log into CyberIRB:
- Contact your study coordinator or IRB for your username and password
- No Study Coordinator – contact the IRB Office

What Needs to be Included in the Submission?

Refer to the checklist on CyberIRB.

The Study Proposal

Your study proposal should include the following components:

Summary
Hypothesis
Specific Aims
Background and Significance
Design of Study
Statistical Analysis
Sample Size
Confidentiality and Privacy
Data Security
References

Research may not be conducted without final written approval from the IRB.