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: PROCEDURE
Mandatory Educational Program
  1. 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. 

     

  2. 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