UAMS ADMINISTRATIVE GUIDE
NUMBER: 12.1.06
DATE: 07/15/96
REVISION: 2/23/06
| SECTION: |
ACADEMIC AFFAIRS |
| AREA: |
SPONSORED RESEARCH ADMINISTRATION |
| SUBJECT: |
MANDATORY EDUCATION POLICY FOR INVESTIGATORS/STUDY PERSONNEL PARTICIPATING IN
HUMAN SUBJECT RESEARCH PROJECTS |
PURPOSE
The purpose of this policy is to define the UAMS IRB and Institutional Human Subject Protection and HIPAA
for Research educational requirements and to specify which personnel are
mandated to meet those requirements.
DEFINITIONS
Human Subject Research (HSR):
A systematic investigation, including research development, testing and
evaluation, designed to develop or contribute to generalizable knowledge. HSR activities include; investigational application of drugs, devices, or
interventions, collecting or working with human subject data or specimens
derived from human subjects for research, or dissemination of information from
research activities in humans.
Faculty are employees who hold academic rank of
lecturer, master lecturer, assistant instructor, instructor, assistant
professor, associate professor, professor, distinguished professor, University
professor, or one of the above titles modified by clinical, research, adjunct,
visiting, executive in residence, or emeritus, e.g., clinical professor, adjunct
assistant professor.
Research Staff: those persons whose responsibilities include, but are not limited to, day-to-day
protocol decision-making related to the study conduct; subject interaction,
recruitment, selection and eligibility determination; clarification of the
complexities of the protocol to the subject and others; collecting subject
information or tissue; entering or analyzing data.
Nursing Staff: Hospital inpatient and outpatient nursing,
Research Nurses, and any other staff member who is licensed to practice nursing.
IRB: UAMS Institutional Review Board
POLICY
All persons within the
scope of this policy are required to complete Human Subject Protection and HIPAA
training as described in this policy.
SCOPE
UAMS has adopted the mandatory education
program outlined below for the following personnel:
- all IRB members,
- All UAMS Faculty
- All Investigators
- All Research Staff
- All staff licensed to practice nursing
- All Pharmacists who dispense drugs for research studies
- All Resident Physicians
- Any person reporting findings via publication, presentation or
manuscript from human research activities prior to that disclosure.
PROCEDURE
Mandatory Educational Program
- Human Subject Protection (HSP) initial and recertification Requirements
All persons listed in the “Scope” section of this policy shall complete one of the
web-based Human Subject Protection Training Programs appropriate to their research discipline at
http://www.uams.edu/orc/. These courses are:
Biomedical Course on Human Subject Protection Training
OR
Behavioral and Social Science Course on Human Subject Protection Training
The Biomedical Course is appropriate for persons whose research or potential
research involves drugs, devices, and surgical/invasive procedures. The
Behavioral and Social Science course is relevant to those disciplines and is not
appropriate for fields where research may involve drugs, devices or
surgical/invasive procedures. Both courses integrate UAMS IRB requirements.
Again, persons should complete one of the Human Subject Protection Training
Programs appropriate to their discipline.
Human Subject Protection training must be renewed every two years by returning to the online course.
- HIPAA for Research Training
In addition, the on-line HIPAA for Research Training Course is required of all
persons defined in the scope section of this policy. The HIPAA course is a short overview
of the researcher and key research personnel responsibilities for
confidentiality, use and disclosure of Protected Health Information obtained
during research. UAMS, CAVHS and ACH each have additional policies and
procedures to follow regarding HIPAA. The course can be found at http://www.uams.edu/orc/.
The HIPAA for research course is taken only one time.
HIPAA for Research Training does not require renewal.
On a case-by-case basis, the directors of the UAMS IRB and the Office of Research
compliance may consider other programs with equivalent or better content to meet
the HSP or HIPAA requirements for education.
Documentation of Testing
On-line courses are followed by exams and a record of successful completion is
maintained by the Office of Research Compliance. Certificates will be printed
and retained by the person completing the test. The UAMS IRB will have access
to these completion records. These courses will be updated by the Office of
Research Compliance in conjunction with the IRB.
Persons should save a copy of printed certificates of completion upon finishing any
course other than the UAMS on-line courses.
Responsibilities
Investigators are responsible for assuring that all staff members for each
research study are compliant with the mandatory education policy prior to
beginning a research study. They are also responsible for assuring that any new
staff adheres to the policy, and assuring that each staffer is approved by the
IRB for each study in which s/he may be involved.
Department Chairs, Divisions Heads or Directors are responsible for assuring
that all faculty and others listed in the scope of this policy are in compliance
with educational requirements. Additionally, Chairs, Division heads or Directors
should assure that publications, presentations or manuscripts authors have mandatory education
prior to submission of the information.
Continuing Compliance
Failure to comply with this policy may limit research activities and may result in
disciplinary action.
The Office of Research Compliance will send out reminders for recertification prior to
expiration of the HSP course. Those persons found to be delinquent after two
months, will be reported to the IRB and the appropriate Chair, Division Head or
Director. Monetary penalties may be assessed to the department.
Affiliate Institutions Requirements
Arkansas Children’s Hospital (ACH) and Arkansas Children’s Hospital Research Institute (ACHRI).
ACH and ACHRI consider this policy as the mandatory base requirements for Human
Subject Protection and HIPAA Training on its campus. ACHRI will work with the
Office of Research Compliance Educator to enhance the on-line training courses
to assure the protection of children in research. Additional courses required
by ACH/ACHRI will be announced.
Central Arkansas Veterans Health Care System (CAVHS)
In addition to the UAMS IRB requirements listed above, researchers at CAVHS may have
additional educational requirements. The VA R & D Office should be consulted
for these requirements
For More Information
Questions concerning this policy should be directed to the UAMS Office of Research
Compliance at (501) 526-6876.
Other Contact Numbers:
ACHRI: 501-364-3571
VA R & D: 501-257-4818
UAMS: IRB: 501-686-8062