• Instructions for Registering for CITI training and adding courses to your course list.
  
  
• CITI Program website: https://www.citiprogram.org/
  
  
• FAQs about the CITI training courses (common questions)

Introduction

In compliance with DePaul's Federal Wide Assurance (FWA), all individuals engaged in research on humans must complete an appropriate training program in the protection of human participants.  The FWA is an agreement between DePaul University and the Office for Human Research Protections (OHRP) within the Department of Health and Human Services (DHHS). DePaul requires that all persons engaged in human subject research take the on-line CITI Basic initial training course. Additionally, DePaul will require that all individuals engaged in human subject research complete continuing education once every 3 years.

The educational requirements will help to ensure the safe and ethical conduct of research involving human subjects at DePaul University. Critical to ensuring the safe and ethical conduct of human subject research is ensuring that each person conducting the research have a solid foundation of knowledge and understanding of the historical reasons for IRB review, and the ethical and regulatory requirements to conduct human subject research. We expect all DePaul faculty, staff, and students who wish to participate in the conduct of research involving human subjects to be familiar with and to understand the underlying ethical principles, federal regulations and state laws, and policies and procedures that are incorporated into the DePaul University Human Research Protections Program (HRPP).

This policy applies to all faculty, staff, students (undergraduate or graduate), and other personnel who are engaged in the design, conduct, or data analysis of human subject research that is conducted under the authority of the DePaul University IRB. Faculty sponsors for student researchers must also complete the training, because they are ultimately considered the responsible parties for the legal and ethical conduct of student projects. If there are questions regarding whether a particular activity constitutes human subjects research or if the activity is conducted under DePaul’s authority, researchers should consult with Research Protections staff. This education policy also applies to Local Review Board (LRB) members, Institutional Review Board (IRB) members and staff, and collaborating investigators from other institutions.

This policy applies to all research involving human subjects under the DePaul IRB’s purview regardless of whether or not it is funded, regardless of the source of funding or sponsorship, and regardless of the location where the research is conducted. It applies to both currently active and future research projects, and protocols granted an exemption determination.

The education completed under this policy will meet the training requirements for investigators and key research personnel involved in the conduct of research receiving funds from the Department of Health and Human Services (DHHS). For the purposes of federal funding, “key research personnel” include all individuals responsible for the design, conduct, and reporting of the research and who contribute in a substantive, measurable way (whether or not they receive payment under the grant). This may include consultants if they meet the definition of key personnel.

Individuals are considered to be conducting human subjects research or engaged in research with human subjects if:

• They conduct human subject research eligible for an exemption determination.
• They interact with human subjects for research purposes (for example, they have interpersonal contact with participants, they conduct research interviews, or administer research questionnaires).
• They obtain informed consent from subjects for research purposes.
• They directly receive a grant from a federal agency and the grant involves human subjects.
• They intervene with human subjects for research purposes by conducting invasive or non-invasive study procedures (such as blood drawing, collection of buccal smears, or administering individual or group psychotherapy) or by manipulating their environment (such as altering light, sound or temperature, or adjusting environmental events or social interactions).
• They obtain (from any source) privately identifiable information or biological samples (for example, observing and recording private behavior, obtaining the information from another researcher or institution, or using data previously collected for another use and already in their possession for a new research use).

Initial Basic Education

DePaul University has joined the Collaborative IRB Training Initiative (CITI), which is now the default for satisfying the basic educational requirements at DePaul. CITI is a web-based program that contains educational modules relating to human subjects research. The CITI website is maintained by the University of Miami, with the educational content developed by a national consortium.

CITI contains modules on topics including ethical principles, IRB regulations, informed consent, and vulnerable populations. Each module has a short quiz at the end to assess understanding of the material presented. An overall passing score of 80% (average of all quizzes) must be obtained in order to obtain credit for completion of the training. As the majority of the research at DePaul University is Social and Behavioral related, the basic courses that are required for DePaul researchers include Social and Behavioral modules. If your research includes elements of Biomedical or Health research or other protocol-specific aspects, such as research involving data and specimens or health information protected by the Health Insurance Portability and Accountability Act (HIPAA), additional optional educational modules may be taken, but will not be required.

DePaul has determined that differing levels of education content (number of modules) will be required depending upon the category of the DePaul key research personnel. You must complete the level of training that is appropriate to your status at DePaul University and your role in the conduct of the research. The amount of time required to complete the training will vary based upon the level of training required for your status and the amount of additional reading (available via hyper-links to regulations, guidance, etc.) completed while reviewing the information in each educational module. The estimated time to complete the courses ranges from 3-6 hours.

Basic Course-Students-Class Projects (required for students engaged in human subjects research; recommended for all students taking research courses)

Required Modules

1. DePaul University
2. Students in Research-SBR
3. History & Ethical Principles-SBR
4. Defining Research with Human Subjects-SBR
5. The Regulations and the Social and Behavioral Sciences-SBR
6. Assessing Risk in Social and Behavioral Sciences-SBR
7. Informed Consent-SBR
8. Privacy and Confidentiality-SBR
9. Conflicts of Interest in Research Involving Human Subjects-SBR
10. DePaul University

Additional optional modules may be taken, but will not be required for students.

Basic Course-Faculty/Staff/Outside Collaborators
Required Modules:

1. Students in Research-SBR
2. History & Ethical Principles-SBR
3. Defining Research with Human Subjects-SBR
4. The Regulations and the Social and Behavioral Sciences-SBR
5. Assessing Risk in Social and Behavioral Sciences-SBR
6. Informed Consent-SBR
7. Privacy and Confidentiality-SBR
8. Research with Prisoners-SBR
9. Research with Children-SBR
10. Research in Public Elementary and Secondary Schools-SBR
11. International Research-SBR
12. Internet Research-SBR
13. Conflicts of Interest in Research Involving Human Subjects-SBR
14. DePaul University

Additional optional modules in areas of interest may be taken, but will not be required.

Basic Course-LRB Members
Required Modules:

1. Students in Research-SBR
2. History & Ethical Principles-SBR
3. Defining Research with Human Subjects-SBR
4. The Regulations and the Social and Behavioral Sciences-SBR
5. Assessing Risk in Social and Behavioral Sciences-SBR
6. Informed Consent-SBR
7. Privacy and Confidentiality-SBR
8. Research with Prisoners-SBR
9. Research with Children-SBR
10. Research in Public Elementary and Secondary Schools-SBR
11. International Research-SBR
12. Internet Research-SBR
13. Human Subjects Research at the VA
14. Research and HIPAA Privacy Protections
15. Vulnerable Subjects - Research Involving Workers/Employees
16. Hot Topics
17. Conflicts of Interest in Research Involving Human Subjects
18. DePaul University

Additional optional modules may be taken, but will not be required.

Basic Course-IRB Members and IRB staff
Required Modules:

1. Students in Research-SBR
2. History & Ethical Principles-SBR
3. Defining Research with Human Subjects-SBR
4. The Regulations and the Social and Behavioral Sciences-SBR
5. Assessing Risk in Social and Behavioral Sciences-SBR
6. Informed Consent-SBR
7. Privacy and Confidentiality-SBR
8. Research with Prisoners-SBR
9. Research with Children-SBR
10. Research in Public Elementary and Secondary Schools-SBR
11. International Research-SBR
12. Internet Research-SBR
13. Human Subjects Research at the VA
14. Research and HIPAA Privacy Protections
15. Vulnerable Subjects - Research Involving Workers/Employees
16. Hot Topics
17. Conflicts of Interest in Research Involving Human Subjects
18. The IRB Member Module –“What Every New IRB Member Needs to Know”
19. DePaul University

Additional optional modules may be taken, but will not be required.

The CITI Refresher course does not qualify for initial training. Investigators must make sure to take the correct initial basic training course in order to have their education certified by the Research Protections in Office of Research Services.

Continuing Education

After having completed the initial basic education training requirement in CITI, all personnel who remain engaged in human subjects research are required to complete continuing education once every three years. They must obtain an overall passing score of 80% on the quizzes in order to remain certified to conduct human subject research. The date for having to complete the continuing education is dependent upon the date of completion of the initial basic training. New IRB approvals will not be granted and active protocols may be suspended if the continuing education requirement has not been completed in time. Although Research Protections staff will attempt to send reminder notices regarding the need to complete the required continuing education, it is the responsibility of the researcher and the Principal Investigator (PI) for a specific protocol to ensure that the continuing education requirement has been completed prior to the expiration date. If there is a substantial lapse in education certification (e.g. 6 months) for any reason, the individual researcher may have to retake the initial training course in order to be re-certified.

The continuing education requirement (every 3 years) may be satisfied by one of the following (approximately 1-2 hours to complete)

• Completion of the on-line CITI Refresher Course modules indicated for DePaul University and your use group (Student, Faculty/Staff, Outside Collaborator, LRB Member, IRB Members and Staff).
• Attendance at one seminar, meeting, or conference with the primary focus on human subject research issues and that offers a certificate of completion or attendance or continuing education hours as documentation of attendance or another offering approved by Research Protections staff. Research Protections website will list some offerings that satisfy this continuing education requirement. If you are unsure if an offering would meet this requirement, contact the Director of Research Protections at 312-362-7593 or sloesspe@depaul.edu. In order to aid in determining the acceptability of an offering, please be prepared to provide an outline of the materials covered.

Example of how the Continuing Education (CE) Renewal period will be applied:

For researchers who complete the initial basic education program in order to submit a new protocol, the date of completion of training will be the anniversary date by which they must complete the 3 year continuing education courses (CITI refresher or comparable course). Individual research personnel will have differing CE anniversary dates. Although Research Protections staff will attempt to send reminder emails to research personnel regarding the need to complete continuing education, it is the individual’s responsibility to ensure the training is completed and current every 3 years. Ultimately the PI of a particular study protocol is responsible for ensuring and maintaining study records for initial and continuing education for his/her research personnel. The reminder emails from Research Protections staff will be sent to the individual and if their training affects another PI’s study, the email will be copied to the PI of that study.

Collaborating Investigators or Subcontractors at Other Institutions

Many research projects involve collaborators who are not DePaul students, faculty or staff. These collaborators may be at other academic institutions or other community settings. Any collaborators that would be engaged in the conduct of the research are expected to complete training in human subjects research. If the collaborators work in a setting where they already have local or institutional training/educational requirements, DePaul University will recognize this initial education or training. The training should be current in that it should have been completed in the 3 years prior to their collaboration with a DePaul researcher. If the collaborators work in a setting where they do not already have an institutional training requirement (e.g. persons in private practice, public schools, or community hospitals or organizations), they should fulfill DePaul University’s training requirements at a level appropriate to their involvement in the research (i.e. student level for persons with a minimal role or faculty/staff/outside collaborators for those more involved in the conduct of the research), or an alternative training should be developed and implemented by the PI to satisfy the training requirement (& submitted for approval with the protocol).

International Collaborators

If the DePaul researcher has collaborators from other countries who may benefit from training in other languages, CITI has modules available in Chinese, Portuguese, Spanish, and Russian. Other languages may be made available in the future. Not all CITI modules have been translated for each language, so the number of modules available will differ depending upon the language requested. The completion of the required modules in each language as assigned by DePaul will meet the initial training requirements for foreign collaborators.

Alternative Training for Special Circumstances

Under certain circumstances, Research Protections may approve an alternative human subjects training program to satisfy the DePaul requirements. For example, the CITI training program may be impractical or inappropriate for field workers or staff to complete. In these instances, the PI may create an educational program focused on the specific research protocol and the role of the research staff. The educational program plan for research personnel and the content outline for the training would need to be submitted and approved as part of the initial protocol submission to the IRB.

Verifying Required Education for a Listed Person on an IRB Application

The PI should submit a list of all personnel that will be involved in the conduct of the research using the Co-Investigators and Key Research Personnel Form. When the PI signs the assurance page of the IRB application s/he is certifying that each person listed will complete the required training and that her/his research records will contain copies of the educational training documentation. When the application is received by Research Protections, study personnel training completion will be confirmed by the Office and these persons will be considered certified to conduct human subject research. If someone listed as personnel has not completed training at the time the application is submitted to the IRB, they will be reminded to do so. Final protocol approval will not be granted until all personnel have completed training.  If the PI wishes to add additional research personnel after initial approval of the research protocol, these persons must be added to the research project via an amendment. If Research Protections staff cannot verify training for anyone listed on the protocol, they will not be approved to be part of the conduct of the research study.

Responsible Conduct of Research Training (RCR)

Responsible Conduct of Research Training may be completed in CITI in the event that a funding agency, such as National Science Foundation (NSF) or National Institutes of Health (NIH) requires completion of this training before awarding a grant. Effective January 4, 2010, NSF will require that, at the time of proposal submission to NSF, a proposing institution’s Authorized Organizational Representative certify that the institution has a plan to provide appropriate training and oversight in the responsible and ethical conduct of research to undergraduates, graduate students, and postdoctoral researchers who will be supported by NSF to conduct research. The training plans are not required to be included in proposals submitted to NSF, but they are subject to review upon request. NSF also will modify its standard award conditions to clearly stipulate that institutions are responsible for verifying that undergraduate students, graduate students, and postdoctoral researchers supported by NSF to conduct research have received RCR training.

DePaul University does not currently require that all investigators complete RCR training.

Research Protections web-site

Research Protections (RP), in the Office of Research Services website provides the DePaul community with access to current policies, guidance, forms, and templates. These documents serve as a reference for investigators regarding the regulations and policies that govern human subject research and the requirements for submitting research projects to the DePaul University IRB. Members of the DePaul research community should familiarize themselves with the contents of the website, especially any policies or guidance that pertain to their specific research activities. Since the field of human subject protections is evolving, sections of the website are subject to change. RP updates the website in order to keep the DePaul Research Community apprised of important changes.