Human Subjects Training: A Must For University Students?

The Collaborative Institutional Training Initiative (CITI) is a web-based training platform that offers courses in human subjects research and protection. The CITI program is used by over 1,500 institutions and organisations, and is completed by around 2.8 million people. The courses are intended for anyone involved in research studies with human subjects, including researchers, staff, and students. While the courses are open to anyone, some universities require that students and staff complete the training if they are conducting research that involves human participants. The content is organised into two tracks: Biomedical (Biomed) and Social-Behavioral-Educational (SBE).

Who must complete the CITI human subjects training?

The Collaborative Institutional Training Initiative (CITI) is a web-based training platform that offers courses in the protection of human subjects involved in research. The training is required for researchers and staff who are involved in human subjects research and is offered by many universities.

Any individual involved in human research, including faculty, staff, and students, must complete the CITI human subjects training. This includes researchers and staff who interact, intervene with, or access the private information of subjects for research purposes.

At the University of Connecticut, for example, investigators and research staff must complete the CITI training if they interact or intervene with subjects or access/use subjects' identifiable information or biospecimens for research. Similarly, Montclair State University requires that all faculty, staff, students, and visitors who conduct research involving human participants complete the CITI training.

At the University of California, San Francisco (UCSF), all Key Study Personnel (KSP) must complete the CITI human subjects protection training. This includes the Principal Investigator, other investigators, and research personnel who are directly involved in conducting research with participants or using their identifiable private information.

Iowa State University (ISU) also requires all members of the research team, including the Principal Investigator and study personnel, to complete the CITI human subjects protection training if they are involved in collecting data from participants, administering study interventions, obtaining informed consent, actively recruiting participants, or obtaining/using identifiable private information.

In addition to researchers and staff, some universities may also require certain students to complete the CITI human subjects training. For instance, at Montclair State University, students transitioning to graduate school or a career at another participating institution must complete the training.

It is important to note that the requirement to complete the CITI human subjects training may vary depending on the specific university or institution and their policies. Therefore, it is recommended to check with the relevant university or institution to confirm the specific requirements for completing the CITI human subjects training.

What does the training cover?

The CITI Human Subjects Protection Training covers a range of topics to ensure ethical research practices and protect human subjects. The training is designed for anyone involved in research studies with human subjects or responsible for setting policies and procedures related to such research. Here is an overview of what the training covers:

Historical Development of Human Subject Protections

The training covers the historical context of human subject protections, including the evolution of ethical guidelines and regulations in research. Understanding the historical development helps researchers and institutions apply these principles effectively.

Ethical Issues

A significant focus of the training is on ethical considerations in research involving human subjects. This includes topics such as informed consent, privacy, confidentiality, and the protection of vulnerable populations. Learners will explore the ethical principles outlined in the Belmont Report and their application in various research contexts.

Regulatory and Guidance Information

The CITI program provides comprehensive guidance on current regulatory requirements and standards related to human subject research. This includes information on Institutional Review Boards (IRBs), consent procedures, data safety, and research involving specific populations or methodologies.

Informed Consent

In-depth training is provided on obtaining informed consent from research participants. This includes recognising the elements of consent, understanding the differences between implied and express consent, and addressing any language or cultural barriers that may impact the consent process.

Privacy and Confidentiality

Participants are trained to distinguish between privacy and confidentiality and identify associated risks. They learn about the legal and ethical frameworks surrounding these concepts and how to protect the private information of research subjects.

Vulnerable Populations

The training covers the identification and protection of vulnerable populations in research. This includes children, individuals with impaired decision-making capacity, and individuals from marginalised communities. Special considerations and ethical guidelines for working with these populations are emphasised.

Research Methodologies

The CITI program offers specialised training tracks for different types of research methodologies. The Biomedical (Biomed) track covers topics such as stem cell research, phase I research, and mobile app research. Meanwhile, the Social-Behavioral-Educational (SBE) track focuses on social, behavioural, and educational research contexts.

Institutional Review Boards (IRBs)

The training provides an understanding of the role and responsibilities of IRBs in ensuring the protection of human subjects. It covers the process of IRB approval, including the submission of protocols, consent forms, and other relevant documentation.

Researcher Responsibilities

Participants learn about their responsibilities as researchers or staff involved in human subject research. This includes understanding the definition of research, the definition of a human subject, and the importance of adhering to approved protocols.

Data Safety and Monitoring

Training covers the importance of data safety and monitoring in human subject research. This includes secure data collection, storage, and sharing practices to protect the confidentiality and privacy of research participants.

Refresher Courses

CITI also offers refresher courses to ensure that individuals stay up to date with the latest regulatory changes and ethical guidelines. These courses are typically taken every three years to maintain certification and cover any new developments or updates in the field of human subject research.

How long does the training take?

The length of time it takes to complete the CITI course depends on the modules chosen and the learner's familiarity with the topic. While most users complete all of their required modules in 2 to 4 hours, the course is designed so that learners can easily exit and re-enter modules at their convenience. Each module varies in length, and learners may require different amounts of time to complete it. In general, modules can take about 30 to 45 minutes to complete.

The CITI Human Subjects Protection Training is valid for a three-year period. After this period, investigators and staff must renew their training certification by taking either a refresher course or retaking the full course. Refresher courses are available up to three months after the training expiration date. If the learner does not complete the refresher course during that time, they will be required to take the full course again.

The CITI program offers a variety of course options, including the Social-Behavioral-Educational (SBE) and Biomedical (Biomed) tracks, which are further divided into Comprehensive and Foundation versions. The Foundations course provides a focused introduction to the essential human subjects research topics, while the Comprehensive course offers an expanded curriculum covering additional concepts and topics.

Additionally, the CITI program allows organizations to customize their learner groups and choose the content modules that best fit their organizational needs. This flexibility ensures that learners receive training that is relevant and tailored to their specific requirements.

It is important to note that while there is no uniform standard for how frequently HSR training should occur, most organizations select a three-year cycle of retraining.

How do I register and complete the training?

The Collaborative Institutional Training Initiative (CITI) is a web-based training platform that was founded in 2000 as a collaboration between the University of Miami and the Fred Hutchinson Cancer Research Center.

To register for CITI, go to www.citiprogram.org. On the top right corner of the screen, click on "Register". The registration process will walk you through seven steps.

If you are a returning user, log in to the CITI website and affiliate with your chosen institution. If you have forgotten your login information, click on the "forgot login information" link to recover your login details.

Once you are logged in, you will be given curriculum options. The module called "Human Subjects Research" is the only group required for Institutional Review Board (IRB) certification at some institutions, such as Montclair State University. You may choose the subsection of this module based on what area your research will be in.

Under "My Courses", click on the "Enter" link beside the course for which you have registered. Complete the "Integrity Assurance Statement" and the required modules to finalize your certification. When all modules are completed with an overall score of 80%, CITI will issue you a "completion report".

CITI courses are self-paced and can be completed in your own time. Most users complete all of their required modules in 2-4 hours. You can stop and start the course at any time, but remember to save your work before exiting and keep your username and password safe.

After you finish the course, CITI will issue a completion report. Keep a copy for your records and give a copy to members of your administrative team.

How often do I need to renew my certification?

The Collaborative Institutional Training Initiative (CITI) is a web-based training platform that offers courses on research ethics. The CITI program is designed so that you can easily exit and re-enter modules at your convenience. The estimated time for completion is anywhere from two to four hours.

CITI training must be renewed every three years. You will receive an email notice from CITI 180 days, then 90 days, and then 30 days before the expiration date for your course. You may also log in to the CITI website to see when you are due to take your refresher course. You may complete the Refresher course up to 180 days (six months) prior to the expiration date of your current CITI training. At that time, the Refresher Course will automatically be populated into your Main Menu page under "Course". To renew your CITI training:

• Log in to your CITI account (www.citiprogram.org).
• Click the "My Records" tab on the top.
• You should then see what courses you have completed and what courses are due for renewal.
• Click on the course refresher you'd like to take.

CITI will send you an automatic email reminder with ample time to complete the refresher modules. The refresher modules are significantly shorter than the original modules taken for the initial course.

Frequently asked questions