Important Updates on SBU's Human Subjects Protection (HSP) Program

There have been many changes to our program since we distributed the revised CORIHS Handbook for Investigators to the campus nearly 2 years ago. Please review these summaries so that you may know the impact of these changes/clarifications on your research endeavors.

I. Substantive Changes/Clarifications to SBU Policies

A. Quality Assurance/Quality Improvement (QA/QI) Activities vs. Research (from Handbook Section I, “Definitions”)

QA/QI activities, which are considered systematic investigations, are not considered research (or under the jurisdiction of CORIHS) if the QA/QI data are not presented or published outside of the University (i.e., not contributing to generalizable knowledge). CORIHS review and approval is required before QA/QI data are prepared for publication and/or presentation outside the University.

B. Unanticipated Problems/Serious Adverse Event Reporting (from Handbook Section 16 “Continuing Review of CORIHS Activities”)

The federal regulations that govern all research at this institution require CORIHS-approved investigators to promptly report to the IRB "any unanticipated problems involving risks to subjects or others…" ( 45CFR46.103 (b) (5) and 21CFR56.108 (b) (1) ). Unanticipated problems are unexpected events that occur during the course of the research activity that can negatively impact the risks to research subjects or others. UPs can take many forms. All investigators are urged to review our revised policy/procedure for satisfying this federal mandate, at http://www.stonybrook.edu/research/HSG/HSGsec16.html#16.E.

C. Data/Tissue Registries (from Handbook Section 18 “Data/Tissue Registries”)
IRB requirements vary depending on the purpose of the registry, and whether or not the registry is mandated by a state or federal agency. Details are provided at http://www.stonybrook.edu/research/HSG/HSGsec18.html.

D. Protocol Deviations (general clarification of policy)
One of the most important responsibilities of a CORIHS-approved investigator is to conduct his/her study as approved by CORIHS. No deviations are permitted without prior IRB approval. This includes deviations of the inclusion/exclusion criteria in order to enroll an otherwise ineligible subject. Obtaining an approval (sometimes referred to as a ‘waiver’) from a study sponsor for such a deviation does not substitute for approval from the IRB. The only situation where deviation from the approved protocol is permitted without prior IRB approval is when it is necessary for subject safety. In that case, the study should be stopped while the deviation is reported and reviewed by the IRB.

E. Recruitment of Subjects (general clarification of policy)
A study’s recruitment plan and all study recruitment materials must be reviewed and approved by CORIHS prior to use. The recruitment plan submitted to CORIHS should be detailed with respect to media to be used (e.g. flyer, newspaper, video, radio etc.), location (e.g., specific sites named, on or off campus) and process (i.e., under what conditions will subjects be approached? etc). When drafting the plan, the investigator must be aware of special approvals that may be required at sites she/he wishes to include in the recruitment plan. These approvals should be submitted for the CORIHS file. As an example, you should be aware that if you wish to recruit (e.g., post flyers etc) at the Northport Veterans Administration Hospital, approval must first be obtained from that site.

II. CRRI: The Central IRB Option

A. For those of you who conduct pharmaceutical (industry) sponsored studies, you will soon have the option of using either our local IRB, or the IRB services of Chesapeake Research Review, Inc. (CRRI). Representatives from CRRI came to our campus on April 26th to introduce their service to our investigators. At this ‘Town Hall’ event, CRRI’s application materials, and general processes and philosophy were discussed. In addition, details concerning the responsibilities that SBU will still retain relative to these studies that undergo IRB review by CRRI were delineated. Please note that the CRRI option will only be available for non-investigator-initiated studies sponsored by pharmaceutical companies.

B. Message from Chesapeake Research Review, Inc (CRRI):

“Chesapeake Research Review, Inc. (CRRI) wishes to thank all of our Stony Brook colleagues who attended the Town Hall meeting on Monday, April 26th. We were pleased to have the opportunity to meet with you and to establish the foundation for a productive partnership between our organizations.

As we approach the beginning of our working relationship with your institution, we’d like to direct your attention to our website – www.chesapeakeirb.com. The website provides an overview of our IRB services, and will also be a resource for obtaining the most current forms needed for project submissions.

The following Chesapeake forms, which have been customized specifically for SBU submissions, will soon be available for use on the SBU website at http://www.stonybrook.edu/research/humans/hsforms.html :

• IRB Submission Form
• IRB Submission Checklist
• SBU/CRRI Informed Consent template

We welcome your questions, comments, and suggestions. Please feel free to communicate with us directly via the contact information provided below. We are sincerely looking forward to working with you and your associates in support of your institution’s research endeavors.

III. IRB/Institutional Fee Recovery from Pharmaceutical Sponsored Research

Pharmaceutical sponsors of clinical trials conducted here at Stony Brook have been charged a fee for local IRB services since May 2001. This one-time fee (valid through initial approval plus 4 renewals of the study) for CORIHS will not change. CRRI (see section II above) charges for various components of their review, should the investigator choose their services.

Beginning July 1, 2004, the pharmaceutical sponsor will also be charged an Institutional fee for studies reviewed by either CORIHS or CRRI .
With the effective date of this revised fee recovery policy (July 1, 2004), all pharmaceutical-sponsored studies submitted to the Office of Research Compliance will need to be accompanied by the SBU IRB/Institutional Fee Invoice Authorization Form, available at:

http://www.stonybrook.edu/research/forms/irbfeeform.doc

IV. Impact on CORIHS Investigators re: Data Sharing Requirement for NIH Grants

Effective February 2003, the National Institutes of Health implemented a requirement that data sharing plans be addressed in certain proposals to that sponsoring agency. Currently, affected grants are defined as those that are “investigator-initiated applications with direct costs greater than $500,000 in any single year”.

NIH’s frequently asked questions on the topic are available at:
http://grants2.nih.gov/grants/policy/data_sharing/data_sharing_faqs.htm

For those affected grants that involve human subjects, questions 25-29 are particularly relevant, and should be considered when applying for IRB approval.

V. Office of Research Compliance’s New Quality Assurance/Quality Improvement Program

The intent behind the federal Office of Human Research Protection’s (OHRP’s) Quality Assurance/Quality Improvement Program is the focus on collegiality and education as a means to promote compliance in human subject protection programs. In July 2002, SBU’s Office of Research Compliance underwent this OHRP assessment for its IRB processes and found the experience to be enlightening and extremely helpful. In fact, some ORC staff were trained by OHRP so that they could conduct the QA/QI assessment at other SUNY campuses.

With this federal program in mind, ORC is in the process of developing a comprehensive QA/QI program specifically for investigators. Over the next few weeks, members of the ORC staff will begin contacting some of you to set up a block of time where we can come and speak with you and your staff, go over your processes for conducting your protocols and review some of your research records. This will allow us to assess strengths and weaknesses with respect to compliance with SBU’s policies for conducting human subjects research, and more importantly, to assess where improvements can be made. Opening up the lines of communication between ORC and investigators can only help to result in the further protection of subjects in studies conducted at our Institution; this is our ultimate goal.

VI. The ORC Website has all the current information and current applications you need:

http://www.stonybrook.edu/research/humans/humansubjects.html

Our HSP program is always undergoing review to ensure that SBU is following the best possible practices in protecting our subjects. The best way to stay up to date with changes made to our HSP Program is to visit the website often. When you need to complete an application or form, always download it directly from the web, to ensure you are using the most current version.

If you have any questions about any of the information above, please feel free to contact me at jmatuk@notes.cc.sunysb.edu , phone 632-9036.