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Required Ethics Training Overview

Harvard Institutional Requirements

 

Harvard policies require that all individuals who are involved in human subjects research complete training in the ethical conduct of human research. These individuals include:

  • Investigators and all study team members who have contact with human subjects or their identifiable data.
  • Faculty sponsors of non-exempt research.

*NOTE: NIH-Funded Clinical Trials Have Additional Requirements (see below)

 

 

Options for Required Training

Harvard Faculty, Staff, and Non-Undergraduate Researcher Required Training

Harvard Faculty, Staff and Non-Undergraduate Researchers may complete one of the following:

  • CITI (Collaborative Institutional Training Initiative) Social & Behavioral Research online training (instructions below)
  • NIH (National Institutes of Health) Protecting Human Research Participants training (click here to create an account on the NIH website and complete the training)
  • CITI training certificate that is still valid from a previous institution (must be comparable training and at the discretion of the IRB office)

CITI Training Instructions

To complete Harvard's basic social & behavioral course FOR THE FIRST TIME:

NOTE: Harvard University now participates in the "Single Sign On" program.

  • Access the CITI website.
  • Under Select Your Organization Affiliation, select Harvard University from the choices that appear.
  • You will then be directed to the Harvard Key Login page.
  • You will then enter the CITI training portal. At Main Menu > Add a course... > Human Research (Protection of Human Subjects) > Social & Behavioral Research Investigators > Stage 1: Basic
  • Complete the set of seven fundamental modules, as well as three additional modules that you select from a list of choices.

To complete Harvard University Area’s social & behavioral REFRESHER course:

  • Access the CITI website.
  • Under Select Your Organization Affiliation, select Harvard University from the choices that appear.
  • You will then be directed to the Harvard Key Login page.
  • You will then enter the CITI training portal.
  • Complete five modules that you select from a list of options.

Completion of your CITI training will be uploaded to your ESTR profile each Friday.

For technical questions about CITI, contact CITI Support at support@citiprogram.org; U.S. toll-free at 888-529-5929; or international at 1-305-907-3100.

Submitting Certification for Research Ethics Training

Harvard CITI training that was completed as a Harvard affiliate will be uploaded to your ESTR profile on a weekly basis. There is no need to document your training in ESTR.

The following documentation of training should be appended as a “comment” in your ESTR IRB submission:

  • CITI training carried out through another affiliation
  • NIH online training - either basic human subjects protection training or GCP
  • GCP Field Guide for Social Behavioral Researchers (paper-based)

Harvard Undergraduate Researcher Required Training

Harvard Undergraduate Researchers may complete one of the following:

*While online training is available, the in-person training is the preferred option for undergraduate researchers.

 

CITI Training Instructions

To complete Harvard's basic social & behavioral course FOR THE FIRST TIME:

NOTE: Harvard University now participates in the "Single Sign On" program.

  • Access the CITI website.
  • Under Select Your Organization Affiliation, select Harvard University from the choices that appear.
  • You will then be directed to the Harvard Key Login page.
  • You will then enter the CITI training portal. At Main Menu > Add a course... > Human Research (Protection of Human Subjects) > Social & Behavioral Research Investigators > Stage 1: Basic
  • Complete the set of seven fundamental modules, as well as three additional modules that you select from a list of choices.

To complete Harvard University Area’s social & behavioral REFRESHER course:

  • Access the CITI website.
  • Under Select Your Organization Affiliation, select Harvard University from the choices that appear.
  • You will then be directed to the Harvard Key Login page.
  • You will then enter the CITI training portal.
  • Complete five modules that you select from a list of options.

Completion of your CITI training will be uploaded to your ESTR profile each Friday.

For technical questions about CITI, contact CITI Support at support@citiprogram.org; U.S. toll-free at 888-529-5929; or international at 1-305-907-3100.

Submitting Certification for Research Ethics Training

Harvard CITI training that was completed as a Harvard affiliate will be uploaded to your ESTR profile on a weekly basis. There is no need to document your training in ESTR.

CUHS-led undergraduate training does not need to be documented in ESTR. The IRB will enter the information into ESTR.

Non-Harvard Researcher Required Training

Non-Harvard Researchers may complete one of the following:

  • CITI training certificate that is still valid from a previous affiliation (must be comparable training and at the discretion of the IRB office)
  • NIH (National Institutes of Health) Protecting Human Research Participants training (click here to create an account on the NIH website and complete the training).

Documentation of training should be included in the ESTR SmartForm, section “Study Team Members”, section 2, in the listing for those without a HUID for:

  • CITI training that was carried out through another affiliation
  • NIH online training - either Protecting Human Research Participants training or GCP
  • GCP Field Guide for Social Behavioral Researchers (paper-based)

Non-Harvard International Enumerators Required Training

Non-Harvard International Enumerators may complete one of the following:

  • NIH (National Institutes of Health) Protecting Human Research Participants training (click here to create an account on the NIH website and complete the training)
  • The IRB’s paper-based training (instructions below)

International Enumerators Human Subjects Research Training Guide

The IRB office has developed a paper-based human subjects research training guide for use with international enumerators when:

  • They are not affiliated with Harvard University.
  • It is not feasible for them to undertake online human subjects protection training such as the CITI training.
  • As specified in the guide, “The content and language level of this guide is specifically worded to help the investigator convey basic research principles and behavior that accords with those principles to enumerators and/or field workers.” The training:
  • Does not satisfy NIH funded study training requirements for clinical trials (Good Clinical Practice).

This training must be documented by completing a training completion sheet that includes name and signature of those that received the training as well as the person that provided the training. The training completion sheet is found at the end of the guide. The training completion sheet must be appended to the ESTR study record and is valid for three years.

Please click here for a pdf version of the training.

Documentation of training should be included in the ESTR SmartForm, section “Study Team Members”, section 2, in the listing for those without a HUID for:

  • CITI training that was carried out through another affiliation
  • NIH online training - either basic human subjects protection training or GCP
  • Human subjects research training for International Enumerators (paper-based)

*NIH-Funded Clinical Trial Additional Requirements

In effect since January 1, 2017, NIH's Good Clinical Practice (GCP) policy establishes the expectation that all NIH-funded investigators and staff who are involved in the conduct, oversight, or management of NIH clinical trials should be trained in Good Clinical Practice (GCP), consistent with principles of the International Conference on Harmonisation (ICH) E6 (R2).

What is a “clinical trial” according to NIH? If you answer “yes” to all of the following questions, you are conducting a “clinical trial” and GCP training is required.

  1. Is your study funded by the NIH?
  2. Does the study involve human participants?
  3. Are the participants prospectively assigned to an intervention?
  4. Is the study designed to evaluate the effect of the intervention on the participants?
  5. Is the effect that will be evaluated a health-related biomedical or behavioral outcome?

Options to fulfill GCP training requirement

  • Access resources for online trainings via the NIH website.
  • Utilize the Good Clinical Practice Field Guide for Social Behavioral Researchers (paper-based).

The IRB office has developed a paper-based GCP training based on the NIH’s eLearning course to make it more accessible to data collectors and study team members for whom the online CITI or NIH courses are not appropriate or not accessible.

The goal of this course is to introduce good clinical practice (GCP) principles to clinical and/or community-based research investigations involving human subjects as they specifically apply to social and behavioral research.

Please click here for a pdf version of the training.

Included with this training is a quiz, answer sheet for the quiz, as well as a training completion sheet that is to be submitted along with your IRB application to provide documentation of training. Those that take the quiz are expected to attain an 80% passing score.