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To: BIDMC Employees
From: Randy Mason, Vice President, Research Operations and
Alan Lisbon, IRB Chair
Subject: New Human Subjects Research Education Requirement
EFFECTIVE JANUARY 15, 2008
Date: November 1, 2007
BIDMC has a long history of excellence in clinical research. Protection of its human research subjects through
education of research faculty and staff is one key to that excellence. Towards that end, and in order to comply with the
federal education mandate for
key research personnel involved in clinical research, a new web-based research education program is being put into place. The new education training will be offered through the Collaborative IRB Training Initiative (CITI) program.
The CITI program offers a more robust Human Subjects Protection training course than our
current in-house program and also provides courses in Good Clinical Practice (GCP). This educational requirement will make us more consistent with the other Harvard Medical School institutions and
help us move towards accreditation from the Association for the Accreditation of Human Subject Protection Programs (AAHRPP).
Starting January 15, 2008,
human subject research study
staff, (i.e.
Key Research Personnel)
on all new research protocol submissions, continuing review of existing protocols and individuals added to study staff must complete the CITI training exam in order to participate in clinical research. Final IRB approval will not be granted
until the requirement has been met.
In addition to completing the Basic Required Training, Principal Investigators that hold an IND
or IDE must also complete the Good Clinical Practice exam.
These exams are web-based and will take approximately 4-6 hours to complete. However, you may leave and come
back to the site using your CITI username and password and are encouraged to use multiple log-on sessions. A
passing grade of at least 80% is required to receive credit for the exam. Certification for this examination is good for three years after which time a Continuing Education course will be required. Completion of the training by the
Investigator and study staff will automatically be recorded in the Research Information Tracking System, so you are not required to submit any paperwork.
If you currently hold a certification from the CITI exam please refer to the
FAQ’s
for further information.
Please see the FAQ’s on the BIDMC Human Subject
Protections website for additional information and instructions as to how to complete the exam. For any questions or concerns, please contact
Barbara Ferguson, Human Subject Protections Office, Research Education Administrator at CITIexam@bidmc.harvard.edu.
Please ensure that the appropriate
members of your staff are aware of this new Human Subjects research education requirement.
Definitions for terms used in memo
Key Research Personnel: include those who are involved in the design and/or conduct of the research, have access to human participants, and/or confidential and identifying information,
including principal investigators, co-investigators (sub-investigators), research nurses, study coordinators, associates/ assistants, students and other support staff or persons assisting with the research. (Principle investigators may want
to also check for sponsor or grantor specific requirements.)
Research:
Research is defined as a systematic investigation, including Research development, testing and evaluation, designed to develop or contribute to generalizeable knowledge.
Human Subject: A Human
Subject is a living individual about whom an Investigator conducting Research obtains data through intervention or interaction with the individual or through
Identifiable Private Information (45 CFR 46.102(f)). As required by 45 CFR 46.102(f), an intervention
includes all physical procedures by which data is gathered and all physical, psychological, or environmental manipulations that are performed for Research purposes. Interaction includes communication or interpersonal contact between the
investigator and subject.
Identifiable Private Information:
includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and
information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). |
