Human Subjects Protection Training

Researchers and staff who are research personnel on any human subjects project must complete human subjects protection training (HSPT) within the last 3 years. If an extensive HSPT training has been completed more than 3 years ago, a refresher training will be required.

Human Subjects Protection Training

Initial training requirement can be met by completing CITI Basic Training. Important: other types of training from CITI such as GCP or Responsible Conduct of Research will NOT satisfy Human Subjects Protection Training requirement.

• If you have completed training through another institution, please, send your certificate to irb.training@yale.edu;
• If you need to complete the training, ensure that you do so through Yale Workday Learning website so that your completion in CITI is automatically recorded in Workday, which will then show in IRES IRB system.

Instructions on how to complete the initial training via CITI

Overview

Step A: Ensure that you have a requirement assigned to you

1. Log into your Learning Homepage in Workday.
2. Verify that the Human Subjects Protection Training – Initial appears under Required Training section
3. If it does not, do one of the following:
   • a. Add your name in IRES IRB to a pending study or submission – overnight, IRES IRB will send your name to Workday to ensure you have the training required assigned; OR
   • b. Ask your manager to manually assign you the Human Subjects Protection Training – Initial requirement in Workday; OR
   • c. Email learning@yale.edu to ask for the manual assignment; OR
   • d. Email irb.training@yale.edu to request a manual assignment; OR
   • e. If available to you, complete Compliance Assessment to indicate that you are conducting human subjects research.

Step B: Confirm the training requirement by ‘enrolling in’ it

1. Click on the Human Subjects Protection Training - Initial that was assigned to you;
2. Look at the blue radio button on the right, under a photo:
   • a. If it states ‘Enroll’, click on it and then Submit in the window that will appear - the status should change to Start Program;
3. Click Start Program under the photo. Note that if you’ve taken the training before, the button may instead say ‘Retake Program’.

Step C: Log into CITI

1. In the description of the program, locate a link to CITI and click on it;
2. You will be redirected to CITI webpage and may need to log into it using YCAS;

Step D: Complete the training in CITI

1. Select “Add a Course” (scroll down to the bottom of the page) and choose one initial/basic CITI HSP Training under the Human Subjects Research heading. We accept the CITI Biomedical Research Basic or the CITI Social Behavioral Educational Researchers Basic as an initial HSP training.
2. Choose: “Yes, I want to take courses on Human Subject Research”
3. Choose “Biomedical Research” or “Social Behavioral Educational Researchers”
4. Choose; “Yes”: “Please give me the basic course”
5. Choose “Yes” (I want to take modules for Biomedical Research-Basic Course)
6. The course will appear on your dashboard. Click start and complete the course. Your Workday Learning transcript will then auto-update within 2 business days.

Note: If you are NOT employed by Yale University but you must complete CITI training, you can access the training by logging into CITI directly. The completion record of the training will need to be provided to Yale IRB in IRES IRB system at the time of protocol submission.

Refresher Training Requirements

Refresher training requirement can be met by completing any Human Subjects Protection Training module from CITI Basic Training. Important: other types of training from CITI such as GCP or Responsible Conduct of Research will NOT satisfy Human Subjects Protection Training requirement.

• If you have completed training through another institution, please, send your certificate to irb.training@yale.edu;
• If you need to complete the refresher training, ensure that you do so through Yale Workday Learning website so that your completion in CITI is automatically recorded in Workday, which will then show in IRES IRB system.

Instructions on how to complete the refresher training via CITI

Overview

Step A: Ensure that you have a requirement assigned to you

1. Log into your Learning Homepage in Workday
2. Verify that the Human Subject Protection Training - Refresher appears under Required Training section
3. If it does not, do one of the following:
   • a. Ask your manager to manually assign you the requirement in Workday; OR
   • b. Email learning@yale.edu to ask for the manual assignment; OR
   • c. Email irb.training@yale.edu to request a manual assignment.

Step B: Confirm the training requirement by ‘enrolling in’ it

1. Click on the Human Subjects Protection Training- Refresher that was assigned to you;
2. Look at the blue radio button on the right, under a photo:
   • a. If it states ‘Enroll’, click on it and then Submit in the window that will appear - the status should change to Start Program;
3. Click Start Program under the photo. Note that if you’ve taken the refresher training before, the button may instead say ‘Retake Program’.

Step C: Log into CITI

1. In the description of the program, locate a link to CITI and click on it;
2. You will be redirected to CITI webpage and may need to log into it using YCAS;

Step D: Complete the training in CITI

1. “Select “Add a Course” (scroll down to the bottom of the page), select either the CITI Biomedical Research Refresher or the CITI Social Behavioral Educational Researchers Refresher. You will have the option of selecting the “refreshers” option so you can complete one refresher to update your training for three years.
2. Choose: “Yes, I want to take courses on Human Subject Research”
3. Choose “Social Behavioral Educational Researchers” or “Biomedical Research Refresher”
4. Choose: “No, I need a refresher”
5. Choose: “Yes” (I want to take modules for Social Behavioral Educational or Biomedical Research Refresher)
6. Choose any modules from the list.
7. The module will appear on your dashboard. Click start and complete the selected modules. Your Workday Learning transcript will then auto-update within 2 business days.

Good Clinical Practice Training

Individuals engaged in the conduct of a clinical trial (following the NIH definition) must complete a Good Clinical Practice (GCP) training. The training must be refreshed every three years. Any of the following will satisfy the initial and/or continuing education GCP training requirement:

• Attendance at the instructor-led GCP training offered by Yale Center for Clinical Investigation (YCCI) or Yale HRPP. The sessions are offered several times a year. Registration is available through the Yale Workday Learning website. Sign up for the HRPP newsletter to be notified about the upcoming sessions.
• Completion of the GCP training conducted by the TransCelerate identified provider. The certificates should be emailed to irb.training@yale.edu for data entry.
• Completion of the CITI training. The links to the online training sessions are available in the Yale Workday Learning website.

Instructions on how to complete Good Clinical Practice training via CITI (both initial and refresher)

Overview

Step A: Ensure that you have a requirement assigned to you

1. Log into your Learning Homepage in Workday
2. Verify that the Good Clinical Practice Training appears under Required Training section
3. If it does not, do one of the following:
   • a. Add your name in IRES IRB to a pending study or submission – overnight, IRES IRB will send your name to Workday to ensure you have the training required assigned; OR
   • b. Ask your manager to manually assign you the Good Clinical Practice Training requirement in Workday; OR
   • c. Email learning@yale.edu to ask for the manual assignment; OR
   • d. Email irb.training@yale.edu to request a manual assignment; OR
   • e. If available to you, complete Compliance Assessment to indicate that you are conducting clinical trials.

Step B: Confirm the training requirement by ‘enrolling in’ it

1. Click on the Good Clinical Practice Training that was assigned to you;
2. Look at the blue radio button on the right, under a photo:
   • a. If it states ‘Enroll’, click on it and then Submit in the window that will appear, the status should change to Start Program;
3. Click Start Program under the photo. Note that if you’ve taken the training before, the button may instead say ‘Retake Program’.

Step C: Log into CITI

1. In the description of the program, locate a link to CITI and click on it; You will be redirected to CITI webpage and may need to log into it using YCAS;

Step D: Complete the training in CITI

1. Select “Add a Course” (scroll down to the bottom of the page) and choose Good Clinical Practice.
2. You will be provided with options for different types of GCP training e.g., social-behavioral clinical trials, device trials, etc. Select the course that best fits the type of clinical trials you are engaged in.
3. Selected course will appear on your dashboard. Click start and complete all modules. Your Workday Learning transcript will then auto-update within 2 business days.

Note: If you are NOT employed by Yale University but you must complete CITI training, you can access the training by logging into CITI directly. The completion record of the training will need to be provided to Yale IRB in IRES IRB system at the time of protocol submission.

Additional Training Opportunities

Investigators may feel that additional training should be provided to their research staff in addition to the required training through CITI. One option is to contact the HRPP office and request a specific training for the research team (e.g., one that is focused specifically on obtaining informed consent). You can also review training sessions that have been previously presented by the HRPP and can also take advantage of training opportunities provided by other institutions or federal agencies such as the ones listed below.

Human Subjects Protection Training for Community Partners

CIRTification: Community Involvement in Research Training is a human research protection training program designed especially for community partners. If your research involves community members recruiting research participants, obtaining informed consent, or collecting data, this training is appropriate for you study team members. Visit the Center for Clinical and Translational Science (CCTS) Training Center website to access the training.

OHRP Human Research Protection Training

If you complete all 5 modules of the OHRP Human Research Protection Training, it may be accepted to satisfy the initial training requirements. Email the 5 certificates you will receive at the end of each module to irb.training@yale.edu. Be sure to save screengrabs or printed PDFs of each certificate as you complete the modules. The OHRP site does not maintain records of completed trainings and HRPP cannot give you credit for this course without all 5 certificates.

Educational Sessions offered by the HRPP

Videos and PowerPoint Presentations forthcoming

ESCRO Training Requirements

All Yale University and affiliate individuals, including faculty, staff, postdoctoral scholars, students, visiting scholars and other researchers who plan to engage in Human Embryonic Stem Cell (hESC) research or Induced Pluripotent Stem Cell (iPSC) research that requires Embryonic Stem Cell Research Oversight (ESCRO) are required to satisfactorily complete training regarding the ethical considerations and the policies and regulations pertaining to hESC Research or covered iPS research before beginning preparatory work on any project involving hESCs or iPS cells.

Initial training requirements can be met by completing the following CITI course and related modules:

• Biomedical Research – Basic/Refresher Course (which includes the two required modules below):
  • Stem Cell Research Oversight (Part I)
  • Stem Cell Research Oversight (Part II)

Please email your Completion Report (transcript showing the completion of the two stem cell research modules) to irb.training@yale.edu.