IRB Trainings and Resources

Human Subjects Research Training

The Temple University IRB utilizes The Collaborative Institutional Training Initiative (CITI) Program to provide research ethics education to the research community. The CITI program offers both initial and refresher courses covering human subjects research.

Collaborative Institutional Training Initiative (CITI) Program

All key research personnel engaged in Human Research at Temple University or affiliated sites must complete the online CITI program.  IRB approval of any individual application is contingent upon the fulfillment of this requirement. The training requirements are based on the community that the applicant identifies with.  The Minimal training requirement are:

  1. Human Subjects Research (Biomedical or Social/Behavioral)

  2. Biomedical training is required for:

    • Medical (Healthcare Providers, residents, fellows, medical students)Nursing

    • Public Health

    • Nutrition

  3. Practice Runs

  4. Good Clinical Practice (called Good Clinical Practice and ICH under "Add a Course") is required for:

    • Clinical trials (as defined by NIH) regulated by NIH

    • Clinical trials (as defined by the FDA) regulated by the FDA

You can access the CITI training program here:  CITI Training Program

Instructions for creating CITI profile, adding CITI courses, completing Practice Runs training, and updating CITI profile can be found here: CITI instructions
Please contact the IRB Office if you have questions or suggestions for training topics: IRB@temple.edu

Additional information on IRB memos

The following information is meant to provide specifics of the IRB memo sent in early January 2021.

  1. The IRB will no longer be accepting changes to research methods, caused by COVID-19, via the Reportable New Information (RNI) mechanism. Changes to research methods should be submitted via Modifications and reflected in the protocol. The COVID-19 consent addendum is still permitted. This change will be a return to normal and will ensure that approved protocols reflect the methodology currently being used.

    •  Importantly, changes to research methods approved through the RNI submission mechanism are still approved.

    • As per current regulations, changes to research to prevent an immediate hazard can and should still be submitted via a Reportable New Information submission, and the IRB via email or phone call.

  2. The following changes to Exempt research review by the IRB:

    1. The IRB has created additional consent templates for some types of Exempt research. They can be found on the Investigator Quick Links page.

    2. The IRB will no longer stamp consents for studies that are approved as Exempt.

    3. Already approved and stamped Exempt consent forms may still be used, however, stamped consent forms cannot be modified. If an Investigator wishes to make a small change to an Exempt study that would affect an approved consent form, the change must be done to an unstamped consent. This change is only permitted for research approved as Exempt.

    4. In line with this change, the IRB will be ending the requirement for small changes to Exempt research to be submitted as Modifications. The following are examples of changes that would and would not require review.

Examples of changes to Exempt research that do require a Modification to be submitted before implementing:

  1. changes to data collection associated with chart reviews including:

    1. increase in N;

    2. adding variable to be collected;

    3. expanding the date range of data collection, prospectively or retrospectively​​​​​​​​

  2. including new, sensitive questions to a survey or interview;

  3. changing data collection such that de-identified data will now be identifiable;

  4. including an intervention in the methods;

  5. changing variables to be collected from medical charts;

  6. decreasing confidentiality measures;

  7. including minors or adults lacking capacity to consent as subjects when previously only adults capable of consenting were to be enrolled;

  8. no longer collecting signed HIPAA Authorization;

  9. changing data collection method from in person to phone or video call—or vice versa—if the interview contains sensitive questions;

  10. large changes in compensation to subjects

Examples of changes to Exempt research that do not require a Modification to be submitted before implementing:

  1. adding an additional interview or survey—so long as the questions are not sensitive;

  2. adding additional, non-sensitive, questions to a survey or interview;

  3. changing data collection method from in person to phone or video call—or vice versa—if the interview does not contain sensitive questions;

  4. increasing the number of participants to be enrolled;

  5. changing contact information;

  6. changing recruitment material;

  1. The standard letters sent by the IRB have had several important changes. These changes include, but are not limited to: referencing the submission number on applicable letters, creating an Exempt Approval letter, clarifying requirements associated with a Not Human Subjects Research determination, including the determined Risk of an approved study, including a link to a Satisfaction Survey.

  1. CITI is best accessed through our Single Sign On portal. Instructions for how to affiliate with previous institutions can be found here (this should download the Word doc immediately or request a file pathway for the download.

  1. Both the FDA and NIH require researchers on clinical trials—as per each agency’s definitions—require to show proof of Good Clinical Practice (GCP) training.

The NIH definition of a clinical trial is, 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 FDA definition of a clinical trial is, “Clinical trials are voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments.”