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FAQ - Application Submission & IRB Approval Process

 

  • What is the difference between full, expedited and exempt review?
  • What qualifies as research that can go through the expedited review process?
  • Which projects/studies must be reviewed by the IRB?
  • When will I hear from the IRB about my study? 
  • Do IRB review fees need to be submitted with the IRB application? 
  • How much do I pay for IRB review of my study? 

 

What is the difference between full, expedited and exempt review?

 

Full-Committee Review

Studies are reviewed by a fully-convened IRB. The IRB discusses the study and makes a decision about the approval of the study. This type of review is carried out for studies greater than minimal risk to subjects. IRB members also assess risks to decide how frequently the PI must file progress reports for the study.  Depending on risk, IRB members may require the study be reviewed every 3 months or 6 months, but investigators will be required to report on study progress at least once each year. 

Expedited Review

Studies are reviewed by an IRB chair/vice chair or a qualified member of the IRB committee. This member reviews the appropriate materials and consults with the PI if necessary to come to a decision about the approval of the study. This type of review is carried out for studies which involve minimal risk to subjects and fit into an expedited review category of research. If an IRB submission meets the regulations for expedited review, the PI is also required to report on study progress at least once each year. 

Exempt review

Studies are reviewed by an IRB chair/vice chair. If a study fits into an exempt category of research and is low risk to subjects, it will not need to go through expedited or full-committee review. If the study is not found to be exempt, it will need to go through expedited or full-committee review.  Exempt studies do not have a continuing review requirement. 


 

What qualifies as research that can go through the expedited review process?

 

To qualify for expedited review, a research procedure must be limited to the activities that are federally approved (from 63 FR 60364-60367, November 9, 1998.) for expedited review and incur no more than minimal risk for participants, or be a minor change in previously approved research that involves no additional risk to the research subject.
The activities approved in the federal regulations for expedited review are:

  • Clinical studies of drugs and medical devices only when condition (a) or (b) is met.

a.  Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.)

b.  Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.

  • Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture

(a) from healthy, non-pregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week; or (b) from other adults and children considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than 2 times per week.


Children are defined in the HHS regulations as ``persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted.'' 45 CFR 46.402(a).

  • Prospective collection of biological specimens for research purposes by noninvasive means
  • Collection of data through noninvasive procedures, 
  • Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes,
  • Collection of data from voice, video, digital, or image recordings made for research purposes
  • Research on individual or group characteristics or behavior
  • Continuing review of research previously approved by the convened IRB
  • Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.  

 

Which projects/studies must be reviewed by the IRB?

 

The University of Louisville has assured the federal regulatory agencies that the institution will review and approve all research conducted under the auspices of the University involving human subjects before it is initiated.

Federal Definition of Research

a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.

Research requiring IRB review prior to initiation, irrespective of funding:

  1. involving human subjects
    (Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains 1. data through intervention or interaction with the individual, or 2. identifiable private information. – (from 45 CFR 46.102)
  2. using records gathered on human subjects
  3. involving human tissue

This includes research which falls into any of the following categories:

  • The research is conducted by University faculty, staff, or students;
  • The procedures are performed on the premises of the University;
  • The procedures are performed with or involve the use of facilities or equipment belonging to the University;
  • The research involves University patients, students, staff or faculty;
  • The research project satisfies a requirement imposed by the University as the condition for the award of a degree or for completion of a course of study in the University;
  • A Dean or Department Head certifies that the research project satisfies an obligation of the faculty appointment at the University, as consistent with departmental research goals and objectives, including "clinical or adjunct" appointments;
  • The research is conducted by non-University faculty or staff, but is conducted at an affiliated institution where the UofL IRBs are the provider of IRB review and approval (IRB of record).

 

When will I hear from the IRB about my study?

 

If you submit a study to the IRB for review and HSPPO staff schedule the study for full-Committee review, you will receive a letter from the IRB indicating the date your study will be reviewed by the IRB.  The day after the scheduled IRB meeting, you can access the IRB website and see what action was taken on your study.  The HSPP takes pride in preparing meeting correspondence quickly, and sending the results of committee action to investigators usually within 3 working days of the IRB meeting. 


 

Do IRB review fees need to be submitted with the IRB application?

 

No.  When you submit your initial application to the IRB for review, and the study is corporate-sponsored with a budget greater than $10,000, the IRB prepares an invoice for the IRB review fee.  The invoice is sent to the sponsor (or CRO) based on the information you submit in Appendix O – Sponsored Study Billing Information.  The IRB does not release final study approval until initial review fees have been received from the study sponsor.  The PIs department may choose to pay for the IRB review by intra-University transfer in order to get the final approval letter released.  At that point, the department will need to pursue reimbursement of the IRB review fee directly through the study sponsor.



How much do I pay for IRB review of my study?

 

PIs don’t pay for their studies to be reviewed. Corporate sponsors pay for IRB reviews. IRB review fees are only charged on corporate-sponsored research where the total budget is more than $10,000. For all new submissions received after July 1, 2009, the charge for IRB initial review is $2,700. The charge for continuation review submissions for currently active studies is $500 for each continuation review. The new studies submitted after 7/1/2009 will require a continuation review fee of $750. Any questions concerning IRB review fees should be addressed to the Assistant Director of the HSPP Office.


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