CHA is dedicated to the conduct of ethical human subject research. To help ensure those at CHA who conduct such research have appropriate research education training, Principal Investigators (PI) and research team members must complete a mandatory training program prior to beginning research and must undergo continuing education (CE) every three (3) years. To aid in this training, beginning in 2012, CHA introduced the Collaborative Institutional Training Initiative (CITI) online training module.
CHA Research Education Requirements (CITI)
Anyone participating in an on-going human subject research study will need to complete the training and anyone who joins an on-going study team will also need to complete the training. Prospectively, for any new study, all members of a study team will need to complete the training before the IRB can approve the research. To help PIs determine who needs to complete this training, we have included some contextual guidance below.
Registering with CITI
If you have never previously registered with CITI, please follow these instructions
If you have previously registered with CITI it is important that your registration be affiliated with CHA to ensure that you complete the correct required modules in CITI. Please follow these instructions
if you previously registered with CITI to make sure your affiliation is linked to CHA.
Human Subject Training Requirements
We have developed different requirements for those researchers who predominantly conduct biomedical research and those researchers who predominantly conduct social & behavioral research. Based on area of research, in 2012 all researchers participating in research are required to complete the following basic modules in the CITI program
Social and Behavioral Researchers:
1. Belmont Report and CITI Course Introduction
2. History and Ethical Principles – SBE
3. The Regulations and the Social and Behavioral Sciences – SBE
4. Informed Consent – SBE
5. Unanticipated Problems and Reporting Requirements in Social and Behavioral Research
6. Research and HIPAA Privacy Protections
7. Conflicts of Interest in Research Involving Human Subjects
1. Belmont Report and CITI Course Introduction
2. History and Ethical Principles
3. Basic Institutional Review Board (IRB) Regulations and Review Process
4. Informed Consent
5. FDA-Regulated Research
6. Unanticipated Problems and Reporting Requirements in Biomedical Research
7. Research and HIPAA Privacy Protections
8. Conflicts of Interest in Research Involving Human Subjects
These education requirements are to be completed before 31 December 2012.
Each individual is to keep a copy of his/her documentation of completion from the “CITI gradebook.” Principal Investigators are to retain a copy of education certificates for all research team members; these documents are subject to audit. A copy does not need to be submitted to the IRB office.
Anyone who completes the mandatory research education in 2012 does not need to complete any CE for 3 years (2015). However, all researchers are encouraged to avail themselves of on- and off-site research education opportunities, including lectures, seminars, conferences, etc., to stay current on topics in the field.
Guidance for Defining who is a Member of Your Research Team
Principal investigators (PI) and CHA share responsibility for ensuring that PIs, co-investigators, and all other personnel, often referred to as "research team members," involved in the conduct of human subject research fulfill basic education requirements in compliance with applicable laws and regulations, and institutional policies.
CHA defines “research team members” as people who contribute to the design, conduct, or reporting of a research study, have direct contact with study participants1
, contribute to the research in a substantive way, have contact with a study participant’s identifiable data or biological samples (e.g., tissue, blood, urine, plasma, saliva), or uses participants’ personal information.
For example, a nurse who ordinarily works on an in-patient unit, but becomes involved in a research protocol by obtaining informed consent from participants or follows-up with study participants admitted to the unit to collect study data would be considered a research team member. However, a laboratory technician who works only with de-identified data and does not have any direct study participant contact would not necessarily be considered a research team member. On the other hand, a biostatistician working with identifiable or coded data would be considered a member of a research team.
Due to the variability in situations, it is impossible to define everyone2
who could be considered a research team member. Some interpretation by PIs will be needed. CHA expects a PI to make a good faith effort to meet the spirit of the research education training requirement by assuring that all members of a research team receive research-related education and training appropriate to their role in the project.
For additional information to help you determine who constitutes your research team and would therefore need to fulfill the education requirements, please refer to the Office of Human Research Protections “Guidance on Engagement of Institutions in Human Subjects Research
PHS – Funded Research – Mandatory COI Training
In August 2012, US Public Health Services regulations went into effect requiring investigators to meet new requirements for disclosing financial interests. Included in the new Federal regulations is the requirement that conflict of interest (COI) training must be completed.
CHA has developed training materials, including a mandatory quiz. Researchers must complete the training and submit the quiz to the CHA office of Sponsored Research before the PHS - funded grant is awarded, including renewals.
Please refer to the COI information elsewhere on this site for additional details, policy, etc.
Exceptions may exist; there will be individuals whose primary contact with a subject is in the context of clinical care, but who may play a minimal role in the research. An example is a phlebotomist collecting blood for a clinical purpose and collecting an additional sample at the same time for a research project. In this case, provided that someone other than the phlebotomist obtained informed consent, and that the phlebotomist is not playing any further role in the research, s/he would not be considered a research team member; the research education requirement would not apply.
People who may be part of a research team could include administrative assistants, co-investigators, collaborators consultants, contractors, consortium participants, data entry/analysis persons, dieticians, fellows, graduate students, interns, laboratory technicians, nurses, post-docs, recruiters, research coordinators/assistants, residents, students, etc.