Conducting clinical research in the NIH Clinical Center requires a thorough understanding of the policies and regulations governing human subjects research, as well as the applicable policies of the NIH Clinical Center and NINDS. All staff engaged in clinical research must adhere to the applicable policies. The below trainings will assist you in maintaining compliance when conducting clinical research at the National Institutes of Health.
Annual Ethics Course/Responsible Conduct of Research Training (case studies)
On December 1, 2000, the Office of Research Integrity (ORI) published the final PHS Policy on Instruction in Responsible Conduct of Research (RCR). The policy was updated in 2009, and again in 2011, to provide best practices learned from 20 years of teaching RCR (policy). The NIH Intramural Program, as a federally funded research program, is required to satisfy the requirements of this policy.
NIH has developed a series of Research Ethics Case Studies as a component of RCR training. Research Ethics Cases are a tool for discussing scientific integrity. Cases are designed to confront the readers with a specific problem that does not lend itself to easy answers. By providing a focus for discussion, cases help staff involved in research to define or refine their own standards, to appreciate alternative approaches to identifying and resolving ethical problems, and to develop skills for dealing with hard problems on their own.
To comply with revised Intramural Research Program ethics requirements, every year all investigators are required to attend one discussion session of Research Ethics Case Studies. Sessions are PI-lead and attendees are expected to discuss the cases developed by the OIR. concerning various topics relevant to research.
An email notification is typically generated by the Office of the Scientific Director during October/November that details the dates, times, and locations of the case discussion sessions.
Division of Intramural Research Required Training
All intramural research program (IRP) investigators are required to take the "Responsible Conduct of Research" course including the specific module: "What is Human Subjects Research?" training NIH Research Ethics Course "Responsible Conduct of Research". Visit the Responsible Conduct of Research course.
Human Subjects Protection Training
Per OHSRP Policy 103, Education Program, NIH investigators who are conducting human subjects research (HSR) and non-NIH investigators conducting HSR overseen by the NIH IRB(s) are required to have HSR training as specified in this policy.
IRBs may require additional training for investigators at the IRB's discretion, such as when investigators do not demonstrate understanding of specific areas, when investigators undertake a new type of research, or as part of a corrective action plan. In addition, HRPP or IC leadership may also require investigators to complete additional training.
All NIH investigators conducting Human Subjects Research are responsible for completing the required initial human subjects training and refresher training, as well as maintaining documentation of such certification, as specified in Policy 103. Required training must be completed prior to conducting HSR.
NIH Investigators must complete the following training(s):
- CITI Biomedical 101 (Basic Course) and/or CITI Social-Behavioral-Educational Basic course, and
- CITI Good Clinical Practice (GCP) course (US FDA Focus)
The Collaborative Institutional Training Initiative (CITI), has updated its content related to the revised Common Rule (as of 1/21/2019), and all investigators must complete the revised basic training course. Therefore, if an investigator completed the CITI Basic course prior to 1/21/19, the updated course must be taken. No test out option is available.
Refresher Training
Per Policy 103, NIH investigators will be required to take refresher training for CITI Biomedical 101 or CITI Social-Behavioral-Educational Basic, as applicable, and CITI GCP Course, at the time that their current training expires.
In addition, the OHSRP Director or the IRBO Director may stipulate that additional refresher training is completed.
Non-NIH Investigators conducting non-exempt HSR on protocols overseen by an NIH IRB
These investigators must comply with training as required by their home institution. Unless otherwise specified in an agreement (e.g., a reliance agreement), the non-NIH investigators must provide certification that they have fulfilled the HSR training requirements of their home institution to the NIH PI, and the PI will upload the training certificates into the electronic IRB document section so that they are available for IRB review.
If the non-NIH Investigator is not affiliated with an institution that requires or provides access to human subjects protections training, the investigator must take and provide evidence of human subjects protections training to the NIH PI. The NIH IRB may direct that a GCP course also be completed by individuals who home institution does not offer GCP training.
NINDS Required Training
Obtaining Informed Consent (2-part process)
- Elements of a Successful Consent Training
Required for all individuals who will obtain consent. A completion certificate will be issued. Contact the CTU Research Training and Education Office for the next available ‘live’ training: 301-451-0867 or BonifanS@nih.gov
Elements of a Successful Consent Video (Note: this video is informational only and does not fulfill the ‘live’ training requirement).
- Consent Observation/Monitoring
Following completion of the Elements of a Successful Consent Training, Investigators and Staff must have the first-time obtaining consent monitored by CTU (or HSPU) staff. Completion of this requirement must be documented by inclusion of the signed Objective Structured Clinical Examination (OSCE) rating form with the investigator’s training certificates. Contact the CTU Research Training and Education Office to arrange for observation: 301-451-0867 or BonifanS@nih.gov
Identification and Reporting of Protocol Related Event Training
All research staff are required to take in-person training (Contact the CTU Research Training and Education Office for the next available training: 301-451-0867 or BonifanS@nih.gov) or view the videocast, “Two Years Since Release of the “NEW” OHSRP Research Related Event Reporting Policies: How is the IRP Doing?" May 4, 2021 (previous video "The OHSRP Education Series Presentation 2019: NIH Intramural Research Program New Policies: Reporting Research Events and Non-compliance in Human Subjects Research - 05/20/19” has been retired). The slide set for the video can be found on the OHSRP website (click here(pdf, 2119 KB)). Those who chose to view the video must complete the Investigator Attestation.
Technology Transfer Training (In-Person)
The NINDS Technology Transfer Office supports NINDS investigators by facilitating scientific research; building academic, non-profit, and commercial partnerships; and advancing scientific innovations through the invention evaluation process. The Technology Transfer training identifies common needs within the research process that may involve engagement with the Technology Transfer Office, questions researchers may be asked, and typical solutions. All individuals engaged in research are currently required to take tech transfer training available through LMS, which is covered in this in-person course; it is beneficial for administrative support staff as well. NOTE: You will receive instructions on completing the training in the LMS portal to receive credit after attending the in-person session. Please contact BonifanS@nih.gov to sign up for the training.
IRTA/Non-Credentialed Investigator Training
- IRTA and Non-Credentialed Investigator Training and Competencies Checklist
- Appendix A: Catalog of Activities
- Appendix B: Training Requirements
Contact the Research Training and Education Office for the next available training: 301-451-0867 or BonifanS@nih.gov
Just-In-Time Training
In general, the Just-In-Time training courses are optional. However, the IRB or PIs may require investigators to complete these courses depending on the nature of the investigation or the enrollment population. These courses can be accessed via the CITI courses link on the OHSRP training site. Click on the CITI training link and "add a course" to access the Just-In-Time training options. The options available are:
- Vulnerable Subjects - Research Involving Children
- Vulnerable Subjects - Research Involving Pregnant Women, Fetuses, and Neonates
- Vulnerable Subjects - Research Involving Prisoners
- Vulnerable Subjects - Research Involving Workers/Employees
- Unanticipated Problems and Reporting Requirements in Biomedical Research
- Unanticipated Problems and Reporting Requirements in Social and Behavioral Research
- Genetic Research in Human Populations
- Phase 1 Research
- Social and Behavioral Research
- Stem Cell Research Oversight
NIH Clinical Center/NIH Required Training
To access and launch the following required trainings, follow the link above to the HHS Learning Portal, then log in using either your network credentials, or by inserting your HSPD-12 Access Card and clicking “login” in the corresponding “HSPD-12 Access Cards” box. If you log in using your network credentials, select “NIH” from the list of networks in the drop down box, click “login”, and then enter your NIH username and password in their respective boxes and login. Once, you have successfully navigated to the Learning Portal Page, scroll down to the “Catalog Search” box that will be on the right side of the web page and enter into the search box any of the trainings listed below and click “Search”. Next, find the desired training course within the search results and click on its corresponding link. Once, you are on the training course’s page, find and select the “Launch And Register” box in the top right-hand corner of the page and the course should begin. If it does not, find your profile’s current learning page by clicking the Learning” option under your profile picture on the left side of the Learning Portal page, find the desired training and click “Launch Content”.
- NIH Clinical Center: Emergency Procedures
- NIH Clinical Center: Standard/Universal Precautions
- NIH Clinical Center: Patient Confidentiality and Privacy
- NIH Clinical Center: Infection Control
- NIH Clinical Center: Fire Safety
- NIH Clinical Center: Patient Safety
- NIH Wide: Implicit Bias (must be completed NO LATER than Thursday, April 8, 2021) update: 2/10/21
- CPR Training (every 2 years)
Additional Training (depending on responsibilities)
- CRIS Training
- Falls Risk Prevention Training - Contact the CTU Research Training and Education Office for the next available training: 301-451-0867 or BonifanS@nih.gov
- Medical Records Training for physician dictation (ESA)
- NMR Center Safety Training
- 7SW NeuroTesting Unit Orientation/Safety Training - Contact the CTU Research Training and Education Office for the appropriate Point of Contact: 301-451-0867 or BonifanS@nih.gov