Additional Requirments for Obtaining HSIRB Approval

Education/Training Requirement for protocols submitted to the HSIRB
In its ongoing efforts to improve the protection of human research subjects and to comply with regulatory requirements, the University at Buffalo’s Human Research Protection Program (HRPP) has revised its education requirements.  The major change to the education program is that the Collaborative IRB Training Initiative’s (CITI) courses in the Protection of Human Research Subjects are replacing the currently required NIH human research protections training. CITI courses have become recognized as the national standard for human research education.

 Effective September 1, 2007, the Initial Education Requirements will be to:

1) Complete the biomedical track of the Collaborative IRB Training Initiative (CITI) course with a passing grade of 80% or higher.
2) Read the “Belmont Report – Ethical Principles and Guidelines for the Protection of Human Subjects Research.”
3) Read the “Protection of Human Subjects Policy and Procedure manual (UB SOP).
4) Read the UB HRPP Investigator’s FAQ’s.
(Please note that the above items - 2, 3, and 4, are incorporated into the CITI course).
 
The continuing education requirement will need to be fulfilled every three years after completion of the initial program. For those who have previously completed the NIH human research protections training tutorial, completing the initial CITI Biomedical course fulfills the continuing education requirement for the HSIRB. Researchers will be notified when “refresher” continuing education courses are available.
 
As of September 1, 2007, the HSIRB, as well as the Social and Behavioral Sciences IRB (SBSIRB) and the Children and Youth IRB (CYIRB), will only accept the CITI certificate of completion as fulfillment of the education requirements for all personnel regardless of having completed the NIH tutorial. All submissions at that time will require that all key research personnel have completed CITI training appropriate to their particular type of research:
  • For protocols submitted and reviewed by either the HSIRB or the CYIRB all project key study personnel must complete the Biomedical CITI course.
  • For protocols submitted and reviewed by the SBSIRB all project key study personnel must complete the Behavioral CITI course. 
(Please note that if you conduct biomedical research and social behavioral research, key study personnel may need to complete both courses).
 
Completion of biomedical track of the CITI course will take about 2½ - 4 hrs depending on your experience and knowledge about human subjects research. When logging in be sure to indicate SUNY – the University at Buffalo as your affiliated institution (not Buffalo State). Because the CITI site limits the number of individuals who can access it at the same time, be sure you save each module as you complete it. Do not leave it idle for any period of time while you’re logged in, you will lose what you have done and it will freeze you out. Finally, when you have completed the course, be sure to print out a copy of your completed modules for your own records.
 
Access the CITI Course at https://www.citiprogram.org/default.asp

 

Financial Disclosure/Conflict of Interest Requirement

All protocols involving human research subjects must be evaluated to ascertain whether any financial conflicts of interest exist.  UB policy requires all investigators and co-investigators (but not key study personnel) complete and forward the SUNY-2-UB Financial Disclosure to their cognizant dean prior to submission of the proposal for review.  Final HSIRB approval is contingent upon the decision by the dean's office whether there is no conflict or whether the conflict of interest can be managed. Annual Financial Disclosure Form (formerly SUNY-2-UB) . (Found under "University Forms - Pre-Award")

 

REVISED - EFFECTIVE MAY 1, 2007

FEES - IRB Review Fee for Commerically Sponsored Research

Fee Collection Procedure

The following fees will be assessed for IRB review for commercially sponsored research protocols involving human subjects. For initial reviews the fee will be $2000 for minimal risk (expedited) protocols and $2,500 for greater than minimal risk (full review) protocols.

These fees are based upon the results of a recent nationwide survey and are undertaken after consultation with the University community. The IRB review fee is a charge for service rendered. The fee is collectable regardless of whether the IRB approves the protocol or whether the protocol is funded.

A one-page authorization form is required and must accompany all commercially sponsored research protocols. The authorization form will provide the information needed to carry out the fee collection process more effectively. All revenues received are being used to enhance UB's human research subject protection program in response to ever increasing federal expectations with regard to education, compliance and quality assurance activities in the research subjects protection field.

 

Guidelines for Advertising for Research Participants

Advertisements used to recruit subjects/participants are reviewed as an extension of the informed consent process. Review of advertisements is necessary to ensure that the information is not misleading to the subjects. This includes, but is not limited to:  flyers, letters, newspaper ads, TV ads/announcements, posters, and bulletins.

The HSIRB must approve the advertisement before it can be used. Copies of all recruitment materials must be included as part of the request for protocol approval or submitted as a change/revision to the protocol. It is recommended that Principal Investigator obtain HSIRB approval of message text prior to video or audio taping in order to avoid the necessity of re-taping because of unacceptable language/wording.

Advertisements can be submitted electronically and should include:

  • title of project (optional)
  • purpose of the research and eligibility criteria (in lay terms and summary form)
  • name and address of the Principal Investigator
  • straightforward and truthful description of incentives, e.g., payments, a no-cost health exam
  • time or other commitments required
  • location of the research and the person to contact for further information

If the study involves investigational drugs or devices:

  • no claim should be made either explicitly or implicitly that the drug/device is safe or effective for the purpose under investigation
  • no claim should be made that the drug/device is in any way equivalent or superior to any other drug/device

Investigational drugs and/or devices

To ensure proposals involving the use of FDA investigational drugs and/or devices comply with FDA requirements, PIs should seek guidance from the HSIRB office prior to submission of protocols to avert any delays in the approval process. Or visit the FDA web site: www.fda.gov

Emergency/Compassionate Use

For emergency or compassionate use of a test article contact the HSIRB Chair.

Repository

All files of the PI containing human subject documentation, (e.g., IRB correspondence, consent documents, etc.) must be kept a minimum of 3 years upon completion of the project in the repository stated on the HS-1A form.


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