I'm Writing My IRB Application

The IRB is the decision-making body governing research approvals; it consists of ≥ five individuals from diverse backgrounds (some with technical expertise in research regulatory affairs, content experts, lay community members). The full group meets periodically (usually monthly) and votes on approvals for studies that require Full Board Review. A smaller group may meet more often to review Exempt and Expedited studies. 

Three types of Institutional Review Board (IRB) review exist, based on the level of risk involved: Exempt, Expedited, and Full Board Review. Please see the Levels of IRB Review on CMH Institutional Review Board website on the intranet.

Which type of IRB review your study receives is a technical decision made by trained professionals. The Expedited category involves the same application requirements as a Full Board Review. The Exempt category still requires an application within the eIRB system. Below you can find additional detail on Levels of Review.

Exempt Review

• You may discuss with GME Research staff whether your study, particularly those involving minimal risk, may be eligible for Exempt status. Only the IRB can grant your project Exempt status. Note that research done with prisoners or minors, FDA-regulated studies, and studies conducted with the VA will not meet criteria to be Exempt.
  • Studies that may be given Exempt status must:
    • a) involve no more than minimal risk AND
    •  b) fit one of six specific categories: 1) Research conducted in an educational setting that does not impact a student’s ability or opportunity to learn; 2) Educational tests, surveys, interviews, observations (if certain criteria are met); 3) Benign Behavioral Interventions (if certain criteria are met); 4) Secondary Research using PHI or biospecimen (if certain criteria are met); 5) Educational tests, surveys, interviews, observations of Public Officials (conducted or supported by a federal agency); 6) Taste and Food Quality and Consumer Acceptance (if certain criteria are met). Some useful examples of each category can be seen here.

Expedited Review

• Expedited Review is conducted by the IRB Administrator plus the IRB Board Chair. Some common examples of resident research projects that qualify for Expedited Review include retrospective chart review and patient surveys. Expedited studies:
  • a)  involve no more than minimal risk, AND
    • The phrase “no more than minimal risk” is a (very technical) mouthful. The Code of Federal Regulations defines “minimal risk” as “the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examination or tests.”
  • b) do not primarily recruit from a vulnerable population, AND
    • Vulnerable populations may have a lack of autonomy or ability to understand research procedures; these can include: children and fetuses; prisoners; pregnant people; individuals with limited or impaired decision-making capacity (can be temporary); undocumented individuals; economically-, socially-, or educationally- disadvantaged individuals; veterans; patients with stigmatizing disease. This does not mean you cannot do research with these populations, but rather that there must be a plan in place to mitigate this risk and the study will be given a Full Review.
  • c) are not listed as one of the six categories that qualify a study for Exempt status (see below).

Full Board Review

• Full Board Review refers to review by the Full Institutional Review Board; examples include randomized control trials testing new treatments and research involving children. Full Board review is needed if your study involves:
  • participants:
    • under the age of 18 years
    • who are prisoners
    • with impaired decision-making capacity
    • (and may be needed for those who are economically- , socially-, or educationally- disadvantaged, pregnant, or experiencing health disparities)
  • procedures that might cause:
    • physical harm
    • significant psychological/emotional distress
  • data collection about:
    • highly sensitive topics
    • illegal behavior
    • information that could seriously harm the participant (legally, socially, financially, etc.) if identified

If you find yourself surrounded by IRB- or research-speak and are in need of a translator, you are not alone. To quickly look up a term, check out this Glossary (with an A-Z navigation + an entire section on HIPAA terms), this guide or this shorter but more targeted list of definitions.

Broadly, the six categories of research that may be eligible for Exempt status include: 

1.  Research conducted in an educational setting that does not impact a student’s ability or opportunity to learn; 
2.  Educational tests, surveys, interviews, observations (if certain criteria are met); 
3.  Benign Behavioral Interventions (if certain criteria are met); 
4.  Secondary Research using PHI or biospecimen (if certain criteria are met); 
5.  Educational tests, surveys, interviews, observations of Public Officials (conducted or supported by a federal agency); 
6.  Taste and Food Quality and Consumer Acceptance (if certain criteria are met). Some useful examples can be seen here. 

Some studies (involving no more than minimal risk) may receive documentation from the IRB of Exempt status from specific regulations. If you believe Exempt status might be an option for your study, be sure to read a bit more here about risk before speaking with GME Research Staff to verify applicability and apply. Only the IRB can grant your project Exempt status. Note that research done with prisoners or minors can most likely not be Exempt, nor can FDA-regulated studies nor studies conducted with the VA. 

As a general rule, if you believe you may want to publish the findings of your project, IRB approval can be vital as some publishers require IRB approval. Because an IRB cannot retroactively give approval for a study already conducted, it is best to cover your bases from the start. 

• Pro Tip: portions of a well-written IRB protocol may be useful in jumpstarting the manuscript writing process. Future You will thank you. 

Please reference the CMH Institutional Review Board website on the intranet to review how long it typically takes for your protocol to be reviewed. Case reports, case series, and retrospective analysis are usually considered expedited and have the fastest turnaround time. 

The IRB meets the first Tuesday of every month except August and January. Completed applications need to be submitted according to the IRB schedule. Partial applications will not be considered. 

You should not contact the IRB for research specific questions; instead speak to the GME Research Staff. 

Consult this sample timeline or this estimation of how long various steps take to plan your study submission. To avoid a delay due to preventable resubmission, please review the document Common Challenges with IRB Apps. 

GME Research Staff will review all IRB applications prior to submission to ensure accuracy and completeness. They can help anticipate any preventable issues to avoid a bounceback from the IRB (see: Common Challenges with IRB Apps). They will discuss your idea, read a draft of your protocol, and answer general questions about the process or methodology and statistical plan behind your study. For nonexempt study, the IRB will ask you to appear at their IRB meeting to answer any questions about your proposal. 

The “Common IRB Forms Explained” guide can help you peek at what paperwork may be needed.

If you plan to recruit participants who speak languages other than English, you will need to have study materials translated. For translation assistance, please consult All Languages Interpreting and Translating, Inc.

• Phone (805) 654-0509 | Facsimile (805) 293-8524 
• Email language@translateventura.com
•  

IRB application materials are located on the CMH Institutional Review Board website on the intranet. GME research staff need to approve all IRB applications before submission.

Probably. If your study involves one of the 18 HIPAA identifiers known as Protected Health Information (PHI), you may need to obtain HIPAA authorization from research participants. A helpful primer on HIPAA in Research can be found here. A more comprehensive resource, as well as the necessary documents, can be found on the CMH Institutional Review Board website on the intranet. There are limited times when a Waiver or Alteration of HIPAA Authorization may be appropriate. (This often includes chart or database reviews or studies that obtain informed consent verbally.) To apply, all 3 criteria below must be met:

1.The use or disclosure of protected health information (PHI) involves not more than minimal risk to the privacy of individuals based on:

• • • An adequate plan to protect the identifiers from improper use and disclosure; 
    • An adequate plan to destroy the identifiers at the earliest opportunity consistent with conduct of the research, unless there is a health or research justification for retaining the identifiers, or such retention is otherwise required by law; 
    • Adequate written assurances that the PHI will not be reused or disclosed to any other person or entity, except as required by law, for authorized oversight of the research project, or for other research which the use or disclosure of PHI would be permitted by the Privacy Rule.

2. The research could not be practicably conducted without the waiver or alteration, AND

3. The research could not be practicably conducted without access to and use of the protected health information.   

If consent for your research will be obtained verbally, you must also complete a Waiver of Documentation (Signature) of Informed Consent; for more information, review the “I’m designing my study” section of this document under “Consenting.”

You can find the case report forms on CMH Institutional Review Board website on the intranet.

A great place to start is reviewing the Common IRB Forms Explained doc.

The level of risk involved in your study will dictate the documents needed. Utilizing this Risk Assessment document will help guide you toward the right set of documents.

This Common Challenges with IRB Apps document may prove helpful in avoiding unnecessary delays in study approval.