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Research Education & Training Program

Research Education and Training Program

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.

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. Please follow these instructions if you previously registered with CITI 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
1. Belmont Report and CITI Course Introduction
2. History and Ethical Principles – SBR
3. The Regulations and the Social and Behavioral Sciences – SBR
4. Informed Consent – SBR
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

New Biomedical Research Investigators
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

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.

2015 Continuing Education Requirements

​If your research education training has or will soon expire, and you will need to undergo research CE in 2015, the following modules are to be completed in CITI:

Social & Behavioral Research Investigators 2015 Continuing Education:
1. SBE Refresher 1 – Informed Consent
2. SBE Refresher 1 – Privacy and Confidentiality
3. SBE Refresher 1 – Research in Educational Settings 
4. Cultural Competence in Research
5. External IRB Review
6. Students in Research
7. Research with Persons who are Socially or Economically Disadvantaged 
8. Illegal Activities or Undocumented Status in Human Research

Biomedical Research Investigators 2015 Continuing Education:
1. Biomed Refresher 1 – Informed Consent 
2. Biomed Refresher 1 – Populations in Research Requiring Additional Considerations and/or Protections 
3. Biomed Refresher 1 – FDA-Regulated Research 
4. Cultural Competence in Research 
5. External IRB Review
6. Students in Research 
7. Research with Persons who are Socially or Economically Disadvantaged
8. Illegal Activities or Undocumented Status in Human Research

Each individual is to keep a copy of his/her completion report 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.

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.”

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.


IRB Office Contact
Ida Rego
           
IRB office: (617) 806-8702
IRB office fax: (617) 806-8710

IRB office physical location:
1035 Cambridge Street, Suite 27A
Cambridge, MA 02141

IRB office mailing address:
Cambridge Health Alliance
Institutional Review Board Office
1493 Cambridge Street
Cambridge, MA 02139
IRB Leadership Contact
We can be reached through the IRB office at (617) 806-8702:

J. Glover Taylor
Institutional Official
Chief Compliance Officer

Jennifer A. Graf
Manager, Human Research Protection Program and Research Integrity

Lior Givon, MD, PhD
IRB Chair

Sarah E. Nelson, PhD
IRB Vice-Chair