What's the IRB?

IRB stands for “Institutional Review Board”. The IRB is a committee established to review and approve applications for research projects involving human subjects. The primary purpose of the IRB is to protect the rights and welfare of human subjects and to function as a kind of ethics committee.

 

What's a Human Subject?

A human subject is a living individual about whom an investigator or student conducting research obtains data through intervention/interaction with the individual or identifiable private information.

 

Who can be the Principal Investigator (PI) of a Study?

Community Medical Centers' IRB policy requires the Principal Investigator of a study to be a UCSF Fresno faculty member or Community Medical Centers' staff member.

  • 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.

 

What are the Training Requirements for the PI and/or Study Team Members?

  • Refer to CyberIRB in the Reference and Education tabs


Research vs. Quality Improvement

  • Refer to CyberIRB in the Reference and Education tabs


Do I Need IRB Approval to Send Study Data to an Outside Site?

Yes, you need IRB approval to send study data to an outside site. Please contact Community Medical Centers' IRB for more information at (559) 499-6553.

 

What Levels of IRB Review are There?

Levels of IRB review include Convened, Expedited, and Exempt Review. All applications are submitted through CyberIRB, the online electronic application submission system.

 

Exempt Review

Studies with no more than minimal risk that meet the federal exempt review criteria (e.g., research using anonymous surveys) which are reviewed by the IRB chair or experienced IRB reviewer(s) designated by the chair. (45 C.F.R. 46.101(b).)
 

Expedited Review

Studies with no more than minimal risk that meet the federal expedited review criteria (e.g., use of data already collected for non-research purposes) which are reviewed by the IRB chair or experienced IRB reviewer(s) designated by the chair. (45 C.F.R. 46.110.)


Full Board Review

Studies that are not eligible for exempt or expedited review which are reviewed by the full, convened IRB with a recorded vote. (45 C.F.R. 46.109.)
 

How do I Apply?

You can apply in our electronic submission system called CyberIRB.


To Apply:

 

What do I Need to Know about Submitting an Application to the IRB?

For a complete list of required documents, please refer to the Expedited-Exempt Studies and Full Board Studies Checklists located in CyberIRB’s Education sub-tab.

 

What Should I do if I have a Problem with Research Training Requirements?

For assistance with compliance training requirements, please contact Community Medical Centers' IRB for guidance.

 

What's Informed Consent?

Informed Consent is an agreement signed by a participant or the participant’s legal representative in a Research study that describes the purpose of the study and the nature of the participant's involvement. It must provide sufficient information to allow the individual to understand potential risks and determine whether to participate in the study.

For detailed information on types and required elements of informed consents, please refer to Community Medical Centers' IRB Informed Consent for IRB Approved Research policy.

 

What About HIPAA?

The Health Insurance Portability and Accountability Act (HIPAA) of 1996, 42 U.S.C. §1320d-1320d-8, and any applicable rules and regulations issued under its authority.

 

Can HIPAA Authorization be Waived?

In some circumstances, the requirement for a patient authorization may be waived or altered by an IRB.

Community Medical Centers may accept a Waiver of Authorization or a Waiver of Authorization for Prescreening that meets the requirements set forth in this section, in lieu of a patient authorization for the use and disclosure of PHI for Research purposes if the waiver is approved by the IRB.


Community Medical Centers shall ensure that it has obtained the documentation pursuant to a Waiver of Authorization or a Waiver of Authorization for Prescreening which includes:

  1. The identification of the IRB that issued the Waiver and the date the Waiver was approved;

  2. A brief description of the PHI for which the IRB has determined that the use or disclosure is necessary to the Research study;

  3. A statement about whether full board or expedited procedures were used to review and approve the Waiver; and

  4. The signature of the IRB chair or designated reviewer.


What do I Need to Know About Data?

Maintaining confidentiality is essential to any research in order to protect the privacy and well-being of participants. Whenever possible, research should use data that cannot be identified by the recipient of the information. If this is not possible, the amount of personal data stored by researchers should be kept to the minimum necessary to achieve the purpose of the research.

 

What Does it Mean to be “De-identified”?

De-identified data are data that are collected initially with the patient-identifiers, which are subsequently encoded, encrypted or has been stripped of all 18 identifiers as defined by HIPAA so that the information cannot be traced back to an individual.

 

What Happens After Submission?

Your study will undergo verification of submission standards. Followed by a preliminary IRB review. If the application is determined “incomplete”, it will be returned to you to make revisions. Once you submit the completed application, your study will be reviewed at the next available meeting. Additional changes may be requested at any time. You will have the opportunity to accept or reject these changes.

 

How Long Does IRB Review Take?

The PI has a significant influence on the length of time between submission and approval. Well prepared applications result in fewer requests for changes raised as issues by the IRB. Rapid response by the PI to the IRB issues speeds the approval process.

 

What Happens After I Receive Approval?

You may begin your research upon receipt of the written documentation of IRB approval. Please be advised that the IRB reviews the study from an ethical and human subjects protection standpoint. You may need to also obtain operational approval from the facility and/or facility sites where study activities take place.

 

How Long is the Approval Period?

Renewal of all research studies, except studies determined by the IRB to qualify for exempt status, is mandatory.

Studies must receive re-approval no later than 365 days after the previous approval. Mandatory renewal includes research studies in which subject accrual has been closed and the research interventions completed, but data continue to be collected and analyzed.

For detailed information on submission requirements regarding categories of renewal review, please refer to Community Medical Centers' IRB Continuing Review of Research Protocols policy.

 

What if I Have Problems During Research?

Researchers must promptly report to the IRB any serious or continuing noncompliance with federal regulations or Community Medical Centers policies, any injuries to subjects, or unanticipated problems. Please contact Community Medical Centers' IRB for guidance at (559) 499-6553.
 

When do I Need to Submit an Unanticipated Problem/Incident Report/Adverse Event Report?

Researchers must promptly report to the IRB any serious or continuing non-compliance federal regulations or Community Medical Centers' policies, any injuries to subjects, or unanticipated problems.

For detailed information on reporting to the IRB, please refer to the Community Medical Centers' IRB Reporting Adverse Events and Incidents to the IRB policy.

 

What if I Want to Modify the Study?

To modify an approved study, the PI must submit a Post Approval application through CyberIRB. To access the Post Approval application, please log into https://www.cyberirb.us/CMC/index.php.

 

Do I Need to Tell the IRB When my Study is Finished?

Yes. Once all study activities have concluded, or if you decide to end or stop your study, the PI must submit a Renewal/Closure application through CyberIRB. To access the Renewal/Closure application, please log into https://www.cyberirb.us/CMC/index.php.

 

If my Study Approval Lapses, do I Need to Submit a Termination Report?

All studies activities must stop if a study expires. Community Medical Centers' IRB will administratively retire studies that expire. Repeated instances of administratively study retirements may result in continuing non-compliance.

If your study is administratively closed and you wish to continue with your study, the PI will need to submit a new Initial Review application in CyberIRB.

 

If I'm Only Doing Data Analysis, do I Have to Keep my Study Open?

A study must be renewed annually even if the data collection phase has ended.