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.
Anyone participating in a new or on-going human subject research study and anyone who joins an on-going study must have an up-to-date certificate of completion. Education requirements are tailored for those researchers who predominantly conduct social & behavioral research and those who predominantly conduct biomedical research; details are below.
Research Participant Education Materials
Harvard Catalyst has created a variety of Research Participant Brochures (available in more than 15 languages) that provide useful information to prospective participants on a range of research topics, including:
- Should I be a research subject?
- Research Subject Bill of Rights
- Social and Behavioral Research
- CT Scans for Research
- MRI Scans for Research
- PET Scans for Research
- Surrogate Decision-Making in Health Research
Researchers are encouraged to review the brochures and consider providing them to prospective study participants. The brochures can be downloaded and printed free of charge. The IRB office has some printed copies available for distribution; please contact the chairboffice@challiance.org for more information.
New Resource!
The Research Clinic, a Web-based interactive training video aimed at teaching clinical and social researchers how to better protect research subjects and avoid research misconduct, was recently released by the U.S. Department of Health and Human Services’ Office of Research Integrity (ORI) and Office for Human Research Protections (OHRP).
The video allows viewers to assume the role of one of four characters and determine the outcome of the storyline by selecting decision-making choices for each character. Please take a few minutes to watch the video and experience the unique situations encountered by different members of the research enterprise.
CHA Research Education Requirements - CITI Training
In October 2012, the Collaborative Institutional Training Initiative (CITI) online training module was introduced at CHA. For those participating in an on-going human subject research study and anyone who joins an on-going study, you will need to have an up-to-date certificate of completion before the IRB can approve new or-reapprove on-going research. Individuals are responsible for keeping track of when they need to complete CE.
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. If you previously registered with CITI please follow these directions to make sure your affiliation is linked to CHA.
Initial Human Subject Training Requirements
The education requirements have been tailored for those researchers who predominantly conduct social & behavioral research and those who predominantly conduct biomedical research. 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. Based on area of research, the following are the initial basic modules to be completed in CITI:
New Social & Behavioral Research Investigators:
- History and Ethical Principles – SBR
- The Regulations and the Social and Behavioral Sciences – SBR
- Informed Consent – SBR
- Unanticipated Problems and Reporting Requirements in Social and Behavioral Research
- 5. Research and HIPAA Privacy Protections
- 6. Conflicts of Interest in Research Involving Human Subjects
New Biomedical Research Investigators:
- History and Ethical Principles
- Basic Institutional Review Board (IRB) Regulations and Review Process
- Informed Consent
4. FDA-Regulated Research
- Unanticipated Problems and Reporting Requirements in Biomedical Research
- Research and HIPAA Privacy Protections
- Conflicts of Interest in Research Involving Human Subjects
Each individual is to keep a copy of his/her completion report from the “CITI gradebook.” PIs 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.
Summary Reference & Guidance Documents
We have created several summary reference and guidance documents for researchers to help educate on various topics:
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.
1 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.
2 People who may be part of a research team could include administrative assistants, co-investigators, collaborators consultants, contractors, consortium participants, data entry/analysis persons, dietitians, fellows, graduate students, interns, laboratory technicians, nurses, post-docs, recruiters, research coordinators/assistants, residents, students, etc.