Required training programs at the Broad Institute are designed to promote awareness of ethical issues in research and the rights of the people who have generously provided us with the research samples and information that make our biological insights here possible.
Everyone at the Broad (including all members of the administrative staff) must complete and regularly renew a course on the ethical treatment of human subjects.
All Broad employees and affiliates must complete a Human Subjects Protection (HSP) course. The Broad utilizes the Collaborative Institutional Training Initiative known as (CITI Program) to satisfy this training requirement among others. If you are new to the Broad please first register a new account via www.CITIProgram.org. Please refer to the HST page for further instruction.
Upon logging into your CITI account you may become prompted to answer CITI's Course Enrollment questions, a series of questions that will allow you to self determine which trainings you need to complete. Broad offers two HSP course-trainings, the “Introduction to Human Research Protections" course and "Biomedical Research" course. You will be prompted to select one of these two courses upon answering the CITI enrollment questions. Please choose the appropriate course based on your professional role and involvement in human subjects research.
**If you are a Principal Investigator, work directly with human subjects OR their identifiable information, or need to be listed as study staff on an IRB protocol application, you are required to take the "Biomedical Research" course. (Note: those required to complete this course must renew their training every three years.)
**If you do not fit into any of these categories described above, please “complete the “Introduction to Human Research Protections" course to satisfy this one-time training requirement.
If you have previously taken an equivalent HSP training at another institution please send your CITI certificate to Kelly Flannigan for review. HSP training taken at other affiliated institutions may be applied to satisfy Broad's training requirement. If you have further questions and/or concerns regarding meeting our HSP requirement, please contact Kelly Flannigan in tthe Office of Research Subject Protection (ORSP).
CITI HIPAA and Health Information Security training
If you work in certain departments at the Broad, or if you work with identifiable information about human research subjects, you are required to take the CITI HIPAA and Health Information Security course training. If you work in the Broad's Genomics Platform (GP) or the Data Science Platform (DSP), OR work directly with human subjects and/or have access to their identifiable information (at Broad or another institution) please enroll and complete this course.
This training program consists of online training modules and workshops designed to promote discussion. Please visit the RCR page for more information.This course can be accessed on the CITI Program website (www.citiprogram.org).
All postdoctoral scholars whose primary appointment is at the Broad and all principal investigators with less than five years of experience as a PI are also required to complete training in Responsible Conduct of Research (RCR).
Investigators who are conducting or involved in a clinical trial are required to complete Good Clinical Practice (GCP) training. A clinical trial is defined by NIH as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.
The Dana-Farber IRB also requires that investigators who are listed on federally funded IRB protocols complete the Good Clinical Practice (GCP) training course whether or not the study meets the definition of a clinical trial.
*Investigators who are listed on Dana-Farber IRB protocols with no participating sites other than the Broad Institute and no federal funding are not required to complete GCP training.
You can complete the online course through your Broad or DFCI CITI accounts:
1. Log in to the CITI Program Website (www.citiprogram.org).
2. Under "Broad Institute Course" (or DFCI Course), click "Add a Course" from the My Learner Tools for Broad Institute/DFCI.
3. This will bring you to the Curriculum page. Select the "GCP for Clinical Trials with Investigational Drugs or Medical Devices (U.S. FDA Focus)" course. Please note that you will need to click "not at this time" next to the additional courses if you are only fulfilling the GCP requirement at this time. Click submit.
4. You will then return to the home page. When you are ready to complete the course, click on the course and complete the modules.
Upon completion a copy of your training record will be automatically routed to the Broad's Office of Research Subject Protection.
If you have any questions, please contact Kelly Flannigan at email@example.com
Data Safety Training
All employees and appointees who have access to raw sequence data must complete Data Safety Training. Data Safety training is now offered/assigned to individuals through MyLearning. Please click on this link to log into MyLearning. If the Data Safety training has not yet been assigned to you and/or if you have any technical issues with accessing the course, please contact ORSP and the MyLearning team at firstname.lastname@example.org and email@example.com.
Conflict of Interest Training
Principal investigators and key personnel must complete financial conflict of interest training before engaging in NIH-funded research at least every four years. Instructions to access the CITI training module can be found in this presentation.