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)

  • Intellectually 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.


What Needs to be Included in the Submission?

Refer to 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.