To: Deans, Chairs, Directors and Division Heads

From: Judy Matuk, Associate Director, Research Compliance

Subject: IMPORTANT INFORMATION REGARDING HUMAN SUBJECT PROTECTIONS

Date: April 9, 2001

I am pleased to announce that the University's new Federalwide Assurance (FWA), #FWA00000125, has been approved by the Office for Human Research Protections (OHRP). This Assurance replaces our old Multiple Project Assurance, #M1036-01. Please be sure to reference our new FWA # in any documents requiring such certifications (i.e., grant submissions, sponsor inquiries, etc.). The basic requirements of all FWA's, outlined at OHRP's web site, http://ohrp.osophs.dhhs.gov/humansubjects/assurance/filasurt.htm, include both education requirements for investigators and oversight responsibilities for institutional review boards.

The acceptance of our FWA by OHRP necessitates the immediate promulgation of the following new policies:

I. Revised Educational Program in Human Subject Protections:

Effective immediately, successful completion of USB's education training for research involving human subjects is required for all individuals (e.g., faculty, staff, graduate students, undergraduate students, etc.) involved in all categories (exempt, expedited, full review) of human subjects research, regardless of funding source or funding status. As mandated by our FWA, individuals working with human subjects (directly, or with data or biological specimens derived therefrom) under currently approved protocols should complete training as soon as possible, but no later than February 13, 2002. After that date, CORIHS approval will be withheld for new and continuing protocols until all individuals involved in the human subject aspect of the activity have completed training.

The monthly training sessions are currently open for registration to assist you and your staff in meeting this new requirement. In addition, we are currently in negotiation with an outside organization to set up a web-based training curriculum for our investigators. The curriculum is subdivided into modules, and it is our expectation that the number of modules to be completed by an individual will be dependent on the type of contact s/he has with human subjects in the research activity. Full detail will be sent to you once all aspects of this new training mode are secured and we are ready to 'go live'.

For those of you who have not yet undergone training, it is essential that you familiarize yourself with the Belmont Report at http://ohrp.osophs.dhhs.gov/humansubjects/guidance/belmont.htm, which outlines the ethical principles that must govern the conduct of human subject research. The federal regulations that put the principles of the Belmont Report into practice, and with which we are all mandated to comply, are available for review at http://www.access.gpo.gov/nara/cfr/waisidx_00/45cfr46_00.html

Please note that re-certification of human subjects training will be annual. The re-certification process will be web-based. Again, details will be sent to you once available.

II. Oversight Program in Human Subject Protections

The Office of Research Compliance has instituted a formal program to oversee investigator compliance with IRB regulations. Starting June 1, a variable number of protocols will be chosen for review each month. Selection will be made to ensure that a varied mix of expedited vs. full review, and funded vs. non-funded protocols is reviewed. These are not "for-cause" audits. The Principal Investigator of record will receive a questionnaire to complete regarding the protocol in question. Questions will be asked to assess procedural compliance with human subject regulations. Depending on the responses provided, the review team (made up of IRB members, Research Compliance staff, and other administrators as appropriate) will decide what action must be taken, ranging from acceptance of current practice, to need for on-site inspection.

Other Important News from CORIHS:

III. USB is moving to a Two CORIHS System

During the next few months we will be creating a second CORIHS committee to better meet the needs of our investigators conducting research involving human subjects. The addition of a second CORIHS meeting (and, therefore, 2 deadlines available per month) will help reduce delays in the initial reviews of studies. Full details will be posted on the Compliance website (http://www.stonybrook.edu/research/humans/humansubjects.html) as soon as OHRP approves the second committee. We anticipate that the 2 committees will be up and running September 1, 2001.

IV. Issuance of the 'CORIHS Guidelines on the Capacity to Provide Consent for Research (including research involving subjects with diminished capacity)'

The consent process is one of the most important elements of all research studies involving human subjects. If consent is not obtained properly then the rights of the individual research subject will have been violated. An essential part of the consent process is assessing whether the potential subject has the capacity to make a decision about participating in a given research study. The full text of the guidelines is available at http://www.stonybrook.edu/research/humans/capacity.doc

You are reminded that informed consent must be obtained from every subject prior to the initiation of any research activity. The person obtaining consent must sign and date the consent document accurately. Problems that are encountered relative to any phase of the consent process for any subject in a research activity should be reported to me immediately for resolution.

V. Revised Adverse Events (AE) Policy for FDA-regulated Research

The CORIHS policy on AE reporting has been revised to require immediate submission of ALL on-site adverse events.
Off-site adverse events are only to be submitted if they fall under 1 of 3 categories :

CATEGORY A: serious AND unexpected AND associated with the use of the drug
OR
CATEGORY B: Any adverse event occurring in a subject who is participating in a gene therapy research protocol
OR
CATEGORY C: Findings from laboratory animals tests suggesting a significant risk for human subjects including reports of mutagenicity, teratogenicity, or carcinogenicity.

Required AE form and details regarding policy are available at www.research.sunysb.edu/humans/aerguidelines.doc

VI. Obtaining Consent from Non-English Speaking Subjects

An important aspect of the consent process is to provide the information in a language understandable to the subjects. CORIHS recognizes 2 methods for obtaining consent from non-English speaking subjects:

1. CORIHS Guidelines for Investigators, Section II.D states:
"For those consent forms that must be translated into a foreign language, an affidavit of accurate translation must be provided from an appropriate translator who is unaffiliated with the study." The translated consent form and affidavit must be submitted and approved by CORIHS before use of the consent form.

2. The former Office for Protection from Research Risks (OPRR , now OHRP: Office for Human Research Protections) offers guidance on 'Obtaining and Documenting Informed Consent of Subjects Who Do Not Speak English', which CORIHS formally accepted on February 22, 2001, as adequately protecting the rights of non-English speaking subjects. This method involves use of a CORIHS-approved English language consent form, a CORIHS-approved short consent form written in the non-English language, and a witness fluent in both English and the language of the subject. The details are available at:
http://ohrp.osophs.dhhs.gov/humansubjects/guidance/ic-non-e.htm

VII. Banking and/or Use of Biological Specimens

The banking and/or use of biological specimens for research purposes are activities that are covered under the jurisdiction of CORIHS. As such, approval must be obtained from the committee prior to the initiation of such activities. Please refer to the CORIHS Guidelines on the use of Biological Specimens in Clinical (including Genetic) Research available at http://www.stonybrook.edu/research/humans/biospec.doc Where the CORIHS guidelines indicate that consent is required, please be aware that the text found in various University Hospital clinical consent forms regarding research use of tissues is not adequate, and is not consistent with the ethical principle governing respect for persons, as outlined in the Belmont Report (http://ohrp.osophs.dhhs.gov/humansubjects/guidance/belmont.htm). As such, the text in question is in the process of being removed from those clinical consent forms. Separate and distinct consent for research use of biological specimens is required and must be approved by CORIHS. If you propose to, or currently, bank and/or use biological specimens for research purposes, and you are unsure if you are in compliance with CORIHS requirements, please contact me for assistance in obtaining the proper approval for your activity.

VIII. Current Information on the Protection of Human Subjects

The most up to date information available on human subject matters at USB can be obtained from our Compliance Website at http://www.stonybrook.edu/research/humans/humansubjects.html
Please visit this site frequently to help ensure your ongoing compliance with federal, state and local regulations governing human subject research.

Definition of Research: As sent to you in the past, please be aware that the intent to conduct a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge constitutes research. If you are proposing to conduct such an investigation with the involvement of human subjects, or data or tissues derived from them, USB policy requires that you first obtain approval from CORIHS.

Please contact me (e-mail: jmatuk@notes.cc.sunysb.edu, telephone # 631-632-9036) if you have any questions, comments or concerns about the protection of human subjects at Stony Brook.

xc: CORIHS-Approved Investigators