For Researchers

Phronetik Institutional Review Boards (IRBs) are the committees designated by Phronetik to review the conduct of research involving human subjects that is conducted by Phronetik™ staff (conducting studies involving human subjects within the course and scope of their duties).

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The Phronetik Office of Human Studies Research (OHSR) is the office that supports Phronetik™ IRBs. Each IRB specializes in certain types of research. See the description of their specialties.

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The OHSR staff serve as liaisons between the IRBs and researchers and are a resource to support researchers in their applications to and communications with the IRBs.

First, determine if the activities meet the federal definition of "research" involving "human subjects". Any research that involves either the participation of human subjects or the use of human biological specimens, medical charts, or databases with identifying information about humans is considered to be human subject research and requires review.

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These guidance documents will help you to determine whether your activity meets the definition of research involving human subjects:

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• Determining Which Activities Require Phronetik OHSR/IRB Review 
   

• Determining When Collection or Use of Data and Specimens for Research Requires IRB Review

IMPORTANT NOTE: IRB review and approval or certification of exemption must be obtained prior to any contact with human subjects or any use of their specimens, records, or data.

Once you have determined that the activities are research involving human subjects, complete the training courses:

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Human Subjects Ethics and Regulations:

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• All key research personnel who will work with human subjects must complete the Collaborative Institutional Training Initiative (CITI) Online Human Subjects Protection Training before submission to the IRB. See a definition of Key Personnel.
   

IRB application system:

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• For current information on our IRB application system, please see Electronic Submission Systems.

The risk level and types of research procedures will determine which level of review is required. To determine the risk level of your research, see "Conducting Risk-Benefit Assessments".

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Exempt Certification:

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• Technically exempt from the need for IRB review, but requires submission of an application, and OHRPP confirmation of the certification of exempt status.
   

• OHRPP Guidance on Certification of Exemption from IRB review including details of Exemption categories.
   

IRB Review - See Level of IRB Review - Expedited Review and Full Committee Review
 

• Expedited

  • No more than minimal risk: "Minimal risk means that 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 examinations or tests."

  • Reviewed by a representative or subcommittee of the IRBs.

  • List of the Expedited Review categories.

  • EXAMPLES: Standard quality of life survey, in-person interview about non-sensitive topics.
     

• Full Committee:

  • More than minimal risks to subjects.

  • Reviewed by one of five convened IRBs.

  • EXAMPLES: Randomized double blind clinical trial of investigational drug to treat terminal disease; behavioral intervention to reduce drug use; one-on-one interviews with a vulnerable population about sensitive topic where privacy and confidentiality cannot be guaranteed.
     

IMPORTANT NOTE: This determination will help you allow for sufficient time for review of your protocol.

The length of time for review and approval depends on the type of human research, the level of risk, and the complexity of ethical or technical questions that arise during review.

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Full committee review:
 

• Allow 6-8 weeks for Full Committee approvals of initial submissions and modifications.

• Allow 4 weeks for Full Committee approval of continuing review submissions.

• Each of the 5 IRBs meet twice monthly: IRB meeting dates and application deadlines.
   

Expedited and Exempt review:
 

• Allow 2-3 weeks for Expedited approvals.

• Allow 1 week for Exempt certifications.

• Allow 1 week for renewals and modifications to expedited and exempt studies.

• Exempt and expedited applications are reviewed in the order received and do not have application deadlines.
   

Allow extra time during holiday and vacation periods.

All levels of review use the same webIRB application; the application is designed to branch in response to the information provided about the study procedures.

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Develop or collect the following Materials Required for IRB Review before completing the IRB application:

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• Funding application (if funded)

• Recruitment and screening materials (flyers, letters) (See Guidance and Procedure: Recruitment and Screening Methods and Materials)

• Consent and assent forms (See Consent, Assent, and Screening Templates)

• Study measures

• If applicable: Investigational Drug/Device Brochures, Package Inserts, Sponsor’s protocol

Pre-Review:

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• OHSR staff perform an administrative pre-review of submissions to ensure that the information and materials required for the Board to complete their review are included.

• OHSR staff may send requests to obtain the necessary information. (EXAMPLES: Consent forms are missing; a recruitment process is not described)
   

IMPORTANT NOTE: Administrative pre-review does not include scientific or scholarly review.

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Review:

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• IRB members review all information and materials provided in the IRB application. Investigators are not routinely invited to attend IRB meetings for the review process.
   

Post Review:

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• During the IRB review, you will likely be asked to discuss different aspects of your research, or add information to your application.

• OHSR staff will communicate the IRB’s decisions and requests to researchers.

• Researchers need to provide the requested information and materials and complete the requested revisions in order to complete the IRB review process.

See detailed explanation of the process of Communication of IRB Actions

• Obtain prospective IRB approval for modifications to previously approved research.

• Obtain IRB continuing review annually, if applicable, or complete annual PI assurance.

• Submit post-approval reports of events that are unanticipated problems that may adversely affect the safety of participants or the conduct of the research, and any information relevant to the conduct of the approved research.

• Submit closure report when research is complete.

• Please ask questions at any stage of the process. The OHSR is available and can help facilitate the review.

• You may reach us at:
  IRB@phronetik.com

• Each IRB specializes in certain types of research. See the description of their specialties.

• Staff who support each IRB can be identified in the OHSR Staff Directory.