Owner: Vice President of Academic Affairs
Author: CSS IRB
Contact: irb@css.edu
Policy Number: 37
Effective Date:  10/8/2021

Policy

The College of St. Scholastica IRB has pledged a commitment to the protection of all human subjects in research.  In keeping with this commitment, completion of the CSS IRB approved human subjects training is required for all individuals involved in the conduct of research involving human subjects, regardless of funding source.  The IRB will not release the approvals for new protocols until all individuals involved with human subjects on the project (i.e., direct contact with subjects or access to data) have completed the required training.  Additionally, no new personnel will be added to the protocol until the required training is complete.

Purpose

The CSS IRB requires that all individuals working with human subjects in either medical or nonmedical research complete an instructional program in the protection of human subjects. Training must be completed before the IRB will approve a project protocol. This requirement reflects the CSS IRB’s commitment to the protection of the rights and welfare of human subjects in research.

The educational training requirement applies to all IRB Members, IRB Administrator, faculty, staff, students, visitors, or any other individuals who pursue research projects with human subjects or their identifiable data. Some examples include: individuals who obtain informed consent, administer interventions or conduct procedures that contribute to the research in a substantive way, collect/analyze subjects’ identifiable data or biological samples (e.g., tissue, blood, urine, plasma, saliva), or use subjects’ personal information. All research staff including, but not limited to, Principal Investigators, Co-Investigators, Study Coordinators, Research Assistants, and Data Analysts must undergo the education process.

Definitions

Key Personnel - The National Institute of Health (NIH) defines key personnel as, The PD/PI and other individuals who contribute to the scientific development or execution of a project in a substantive, measurable way, whether or not they receive salaries or compensation under the grant. This includes, but is not limited to, individuals involved in conducting the research with human subjects through an interaction or intervention for research purposes, including participating in the consent process by either leading it or contributing to it; and those who are directly involved with recording or processing identifiable private information, including protected health information, related to those subjects for the purpose of conducting the research study. Some examples are investigators, research assistants, statistical analysts, and faculty advisors.

Procedures

The CSS IRB’s online research compliance education provider is the Collaborative Institutional Training Initiative (CITI), whose Human Subjects Research (HSR) course offers multiple learning tracks.

IRB Members

New IRB Members are required to complete initial CITI training which includes modules covering the history and purpose of IRB regulations, ethical principles related to human subject research, and regulations that apply to studies enrolling certain vulnerable populations and to various types of studies. Before a new IRB Committee member can be added to the roster and vote at a convened meeting, they must complete the following two items:

• Completion of the Human Subjects in Research Training Module through CITI:
  • Social Behavioral Educational Basic
  • Biomedical Basic
  • IRB Members
  • Conflict of Interest (COI) Basic
• An initial orientation meeting with the Chair.  The initial orientation meeting includes review of human subject protection documentation including the IRB Standard Operating Policies, the COLLEGE OF ST. SCHOLASTICA MANUAL GOVERNING RESEARCH INVOLVING HUMAN SUBJECTS, and the IRBNet electronic submissions and reviewer software.

All IRB Members are required to maintain on-going human subjects research protections training via CITI.

Principal Investigator and Key Personnel

The principal investigator is also responsible for ensuring that the research team has appropriate protocol specific training prior to and during the conduct of the study.  External PI’s and Co-PI’s are not required to complete the CSS CITI training course but must have proof of IRB training (CITI, NIH, etc.) from their own institution. It is required that their institution has a policy compliant with federal regulations for human subject research education. (See also, CSS IRB SOP #19 Cooperative Research Authorization Agreements and Sample Agreements.)

The CSS IRB requires one of the following tracks for IRB applicants, co-pi’s, student workers/research assistants, and faculty advisors:

• Social Behavioral Educational Basic, or
• Biomedical Basic, and
• Conflict of Interest (COI) Basic

A majority of investigators at CSS usually complete the social and behavioral track.

CITI Courses Offered:

        1.   Social Behavioral Educational Research (SBER) Course Content

• History and Ethical Principles
• Defining Research with Human Subjects
• The Federal Regulations
• Assessing Risk
• Informed Consent
• Privacy and Confidentiality
• Research with Prisoners
• Research with Children
• Research in Public Elementary and Secondary Schools
• International Research
• Internet-Based Research
• Unanticipated Problems and Reporting Requirements in Social and Behavioral Research
• Vulnerable Subjects - Research Involving Workers/Employees
• Populations in Research Requiring Additional Considerations and/or Protections
• Conflicts of Interest in Human Subjects Research

✓ Additional CITI Select a Course  – FERPA for Researchers and Health Privacy (HIPAA)

✓ All modules

2. Biomedical Basic Research Basic Course Content

✓	History and Ethics of Human Subjects Research
✓	Basic Institutional Review Board (IRB) Regulations and Review Process
✓	Informed Consent
✓	Social and Behavioral Research (SBR) for Biomedical Researchers
✓	Records-Based Research
✓	Genetic Research in Human Populations
✓	Populations in Research Requiring Additional Considerations and/or Protections
✓	Research Involving Prisoners
✓	Research Involving Children
✓	Research Involving Pregnant Women, Fetuses, and Neonates
✓	Avoiding Group Harms - U.S. Research Perspectives
✓	Avoiding Group Harms – International Research Perspectives
✓	FDA-Regulated Research
✓	Recognizing and Reporting Unanticipated Problems Involving Risks to Subjects or Others in Biomedical Research
✓	Research and HIPAA Privacy Protections
✓	Vulnerable Subjects - Research Involving Workers/Employees
✓	Conflicts of Interest in Human Subjects Research

3. Conflict of Interest (COI) Basic

• Financial Conflicts of Interest: Overview, Investigator Responsibilities, and COI Rules (COI Basic)
• Institutional Responsibilities as they Affect Investigators (COI Basic)
• Conflicts of Commitment and Conscience (COI Basic)
• Institutional Conflicts of Interest (COI Basic)
• Organization Specific Policies (Basic)

Documentation of Completion

Each individual has an opportunity to print a completion certification. Upon completion of CITI training, users download and save their certificate. Under the user profile in IRBNet, the certificate is attached and submitted by the user as a training and credentials record. The CITI training certificate is reviewed and accepted by the IRB Chair.

After completing all the modules in the course, individuals will download and save a copy of their certificate of completion to include with the other materials when applying to the IRB. Individuals will then reference the CITI Program Training page on the CSS IRB website for additional information about required human subjects in research training.  Refreshers are required every three years.

Training Expiration

Applicable training requirements must be renewed every three years. Expiration reminders are sent automatically.  If a PI’s training expires, notice of this lapse in completion will be forwarded to the CSS IRB Chair.  Protocol related research activities must stop until training is complete. In order to maintain CITI certification, a refresher course must be completed every three years. The refresher course can usually be completed in less than two hours.

Resources

NIH Grants and Funding - Key Personnel (Definition) https://grants.nih.gov/grants/glossary.htm#Senior/KeyPersonnel

Tufts Health Science IRB Human Subjects Research Protection Education Requirements https://viceprovost.tufts.edu/HSIRB/research-education/

Wisconsin Medical College

https://www.mcw.edu/departments/human-research-protection-program/irb-committees-and-member s/irb-member-education

Stanford University Training in the Protection of Human Subjects in Research

https://doresearch.stanford.edu/policies/research-policy-handbook/human-subjects-and-stem-cells-res earch/training-protection-human-subjects-research

The College of St. Catherine Human Subjects Research Education Requirements Policy https://www.stkate.edu/academics/research/spree/policy-compliance

University of NorthernIowa IRB Manual Institutional Roles https://rsp.uni.edu/irb-manual-institutional-roles

This is a new policy per the 2018 Common Rule Requirements.