Policy on Education

ARKANSAS CHILDREN’S HOSPITAL RESEARCH INSTITUTE
LITTLE ROCK, ARKANSAS

SUBJECT: Training in the Protection of Human Subjects in Research

DATE: July 29, 2003 Pages: 2
APPLICATION: ACHRI

DISTRIBUTION: Interdepartmental
Policies and Procedures

APPROVED BY:ACHRI Executive Committee

RECOMMENDED: ACHRI Administration

SUPERSEDES: Version Dated: 5/14/02, 12/4/01, 6/7/01, 12/15/00

PURPOSE
The purpose of this policy is to define the Human Subject Protection educational requirements for investigators and key personnel involved in human subject research overseen by the UAMS IRB.

POLICY
Recognizing the complexity of the federal, state, and campus policies and regulations created to adequately protect the rights of human subjects in research, ACHRI and UAMS have adopted the mandatory education program outlined below for all IRB members, Principal Investigators, and all key research staff having contact with human subjects, human subject data, or biological specimens. Key research staff may be defined as those persons whose responsibilities may include, but are not limited to, day-to-day protocol decision-making related to the study conduct; subject recruitment, selection and eligibility; clarification of the complexities of the protocol to the subject and others; collecting subject information; and entering data.
Re-certification is required every two years after completion of the initial educational program requirement.

Accepted Educational Programs

Completion of one of the following educational programs will meet mandatory ACHRI and UAMS requirements for investigators and key personnel involved in human subject research.

1. Successful completion of one of the UAMS web-based tutorial programs on Human Subject Protection AND the HIPAA training course at http://www.uams.edu/orc/ . Researchers should complete one of the Human Subject Protection Training Programs appropriate to their research discipline:

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 involves drugs, devices, and surgical/ invasive procedures. The Behavioral and Social Science course is relevant to those disciplines and is not appropriate for investigators whose research involves drugs, devices or surgical/invasive procedures. Both courses integrate UAMS IRB requirements.

In addition, the on-line HIPAA for Research Training Course is required of all researchers. The HIPAA course is a short overview of the researcher and key research personnel responsibilities for confidentiality, use and disclosure of Public Protected Health Information obtained during research. UAMS, and ACH each have additional policies and procedures to follow regarding HIPAA.

On-line courses are followed by exams and a record of successful completion is maintained by the UAMS Office of Research Compliance. The UAMS IRB will have access to these completion records. This course will be updated quarterly and, if regulatory changes dictate, more frequently by the Office of Research Compliance.

2. Attendance and successful completion of the seminar "Conduct of Human Subjects Studies" sponsored by UAMS and/or ACHRI will also fulfill the Human Subject Protections Training Requirement. This seminar is scheduled to be taught yearly and includes history, ethics, federal regulations, UAMS IRB procedures, and discussions pertinent to the group's interests. There is an exam and certificates of training are distributed to attendees if a successful score (80%) is achieved. If an attendee does not achieve an 80% on the initial attempt, the on-line course and test must be taken and passed.

3. On a case-by-case basis, the UAMS IRB Director and the Office of Research Compliance Director will consider other programs with equivalent or better content to meet this requirement.

Persons should save a copy of printed certificates of completion upon finishing any course other than the UAMS on-line courses.

Who Must Comply With This Policy

The requirement of mandatory completion of the Human Subject Protections Training applies to the following individuals:

1. Investigators (including faculty, residents, and students) submitting a human subjects protocol to the HRAC for review and approval.
2. Investigators and persons participating in human subject research, including faculty, residents, and students.
3. Faculty Supervisor of investigator submitting a human subjects protocol to the HRAC for review and approval (if the investigator is a student).
4. Persons responsible for, but not limited to, day-to-day protocol decision-making related to the study conduct; subject recruitment, selection and eligibility; clarification of the complexities of the protocol to the subject and others; collecting subject information; and entering data.
5. Research Coordinators, Research Nurses, and Research Assistants/Associates
6. Members of the UAMS IRB

Deadline for Compliance

Effective January 31, 2004, all persons to whom this policy applies must have documentation of one of the acceptable courses listed above for Human Subject Protection. Mandatory HIPAA training for researchers was due 4/14/03. Persons without appropriate training are subject but not limited to the following the disciplinary actions:

1. ACHRI will not submit to the Human Research Advisory Committee (HRAC) on the Principal Investigator's behalf or provide the HRAC required ACHRI sign-off letter.
2. All research accounts will be frozen.
3. Research support services will be suspended
4. Suspension of investigational drug dispensing, which would require HRAC notification.
5. Notification sent to the Investigator's department chair regarding non-compliance
6. And, any additional actions taken by UAMS, for non-compliance to this policy.

Continuing Education

Re-certification will be required every two years through one of the methods below:
· Re-completion of the web-based tutorial programs at http://www.uams.edu/orc/.
· Re-attendance of the seminar "Conduct of Human Subject Studies"
· Other programs (e.g. Association of Clinical Research Professionals Seminar in Investigator Training) may be an acceptable alternative to the above courses. Please contact the Office of Research Compliance if this is chosen as an option.

Affiliate Institutions Requirements

University Arkansas for Medical Sciences (UAMS)
UAMS consider this policy as the mandatory base requirements for Human Subject
Protection and HIPAA Training on its campus. Additional courses required by UAMS will be announced.

For More Information

Questions concerning this policy should be directed to the ACHRI Human Protections Administrator at 501-364-7373.

Other Contact Numbers:

UAMS: IRB Director: 501-686-8845 .