4.0 Human Subjects Research Education Program

Drake University has adopted a web-based human subject's research education program to assist investigators and staff in meeting federal regulations and University education requirements.  The human subject's research tutorial and testing program includes initial certification as well as ongoing education and recertification. It satisfies the NIH human subjects training requirement for obtaining Federal Funds. You will have the option of printing a certificate of completion from your computer upon completing the course. (http://cme.cancer.gov/clinicaltrials/learning/humanparticipant-protections.asp)

4.1 Program Objectives
4.2 Initial Certification Requirements
4.3 Who is Required to Complete the Program
4.4 Who is Exempt from Human Subjects Research Education Requirements
4.5 Ongoing Education and Recertification
4.6 Additional Education

4.1 PROGRAM OBJECTIVES
 The program is designed to:

  • Help investigators and staff understand the special requirements associated with the use of human subjects in research
  • Clarify the responsibilities of those involved in human subjects research and of the IRB
  • Increase recognition of the basic ethical principles for the use of human subjects: respect for persons, beneficence and justice
  • Provide education on the protection of human subjects as mandated by DHHS (OHRP) in Title 45 of the Code of Federal Regulations, Section 46 (45CFR46)
  • Provide education on IRB review, informed consent, and policies and procedures applicable to human subjects research
4.2 INITIAL CERTIFICATION REQUIREMENTS
 Initial certification will be provided when investigators and staff have met the following criteria:

4.3 WHO IS REQUIRED TO COMPLETE THE PROGRAM
 Individuals in the following categories must complete the Drake University Human Subject Research Education Program:

  • The Drake University Institutional Official
  • Provost of the University
  • All IRB members
  • Drake University faculty serving as Principal Investigators
  • Any  Drake project staff conducting the informed consent process
  • All Drake project staff designated by the Principal Investigator
  • Drake University faculty serving as teaching faculty to Drake students who are involved in exempt or non-exempt research projects
  • Drake students who are conducting non-exempt research (i.e. research that is subject to either expedited review or full IRB review; See Section 5.2)
  • Principal investigators from non-Drake facilities who do not have certification of education from another institution's IRB and who are conducting research with the consent of the Drake IRB or under the responsibility of the University and
  • Project staff from non-Drake facilities who are conducting the consent process either within Drake or with the consent of the Drake IRB and who do not have certification of education from another institution's IRB

Mandatory education and certification must be completed before IRB approval of any new project, revisions or amendments to existing projects or renewals of existing projects.

4.4      WHO IS EXEMPT FROM HUMAN SUBJECTS RESEARCH EDUCATION REQUIREMENTS
 The following individuals are exempt from human subject's research education requirements:

  • Research staff who perform standard of care procedures in connection with a protocol
  • Research staff who analyze data, if the data do not contain identifying information (e.g. name, social security number)  

4.5 ONGOING EDUCATION AND RECERTIFICATION
 In addition to initial certification, recertification will be required every 3 years.  Drake investigators and staff will be notified that they must be recertified.  The recertification process will include web-based training and renewed certification and periodic updates to inform investigators and staff of changes in federal regulations or University requirements.

4.6 ADDITIONAL EDUCATION The IRB and University may provide additional education as needed, addressing such issues as regulatory changes and issues identified through the current IRB internal monitoring process.

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