Human Subjects Research

Drexel is now part of the Collaborative Institutional Training Initiative (CITI) along with over 1130 other organizations throughout the world. Drexel chose CITI training because the content is extensively reviewed and critiqued by multiple institutions and updated regularly. In addition, the training is targeted to the user’s needs and is more complete. If key research personnel have taken CITI training elsewhere, the previously completed training will be accepted at Drexel, with the caveat that key research personnel must complete any CITI courses required by Drexel that have not already been completed.

Key research personnel are welcome to take additional non-required modules. ORRC or ORCA staff may occasionally recommend key research personnel complete an additional module.

The minimum required CITI training modules for an applicant to complete are described below. A table has also been provided describing supplemental “As Needed” training modules that may also be required. Your requirement to complete any supplemental training modules is based upon your research design and activities.

Please Note: Members of Learner Group 2 are no longer required to complete the Health Information Privacy and Security (HIPS) training modules. The HIPS modules for Learner Group 2 will only be required if the research activities involve collection or access to Protected Health Information (PHI).

Who must complete the training?

All key research personnel at Drexel or affiliated sites for whom the Drexel IRB has provided approval must complete the online CITI program as well as any other necessary courses. IRB approval of any individual application is contingent upon the fulfillment of this requirement. IRB members, senior administrative officials such as IRB Institutional Officials, Vice Provost for Research, Vice Dean for Research and ORRC staff are also required to complete this training.

CITI Instructional Modules by "Learner Groups"

During CITI registration you will be prompted to select one of three Learner Groups. Select the Learner Group that most closely reflects the main emphasis of your work and IRB committee to which you usually apply.

The Learner Groups are as follows:

Learner Group 1

• Medical (Healthcare Providers, residents, fellows, medical students),
• Biomedical Engineering,
• Nursing,
• Public Health,
• Nutrition and
• Psychology
• Investigators/staff submitting to Medical IRB #1, #4, or to Western IRB (WIRB).

Minimum training requirement:

1. Human Subjects Research
2. Health Information Privacy & Security (HIPS)

Learner Group 2

• Social, Behavioral and Educational Research Investigators (Education, Creative Arts Therapists, IST, Business, Law, Library science)
• Investigators/staff submitting to the Social and Behavioral IRB #3.

Minimum training requirement:

1. Human Subjects Research
   ***Health Information Privacy & Security (HIPS) is only required for Learner Group 2 if you plan to collect or access PHI.

Learner Group 3

• IRB Members,
• ORRC staff and
• Research Administration

Minimum training requirement:

1. Human Subjects Research
2. Health Information Privacy & Security (HIPS)
3. Good Clinical Practice (GCP)
4. Responsible Conduct of Research (RCR) for Administrators

Most users complete the minimum required training in approximately 6-8 hours. You are not required to complete the training all at once. You may stop and start at anytime; however, make sure that you complete the quiz for the module you are working on so your scores are validated.

Will Additional Training be Necessary?

Members of Learner Groups 1 and 2 may be required to complete additional research, privacy and safety training courses. Requirements to complete additional training are based upon the design of the research project. Descriptions and examples of when additional training may be required are listed below.

When Protocol Design Involves:	Additional Training Required:
Evaluation of drugs, devices, biologics or interventional/behavioral treatments	Good Clinical Practice (GCP)
National Science Foundation (NSF) funding	Responsible Conduct of Research (RCR)
Access and review of Protected Health Information (PHI)	Drexel Core Module HIPAA I
Access and review of Protected Health Information (PHI)	Drexel Core Module HIPAA II
Shipping biologic samples off DU/DUCoM campus	Infectious Substances Packaging
Enrollment of subjects unable to provide consent	Substituted (Surrogate) Consent
Use of recombinant materials, manipulation/alteration/modification	Recombinant DNA Molecules Training
Use or processing of high risk controlled chemical/biologic agents	Select Agent Policies and Procedures
Collection and analysis of biologic specimens in a “non” CAP/CLIA certified laboratory	Laboratory Safety and Bloodborne Pathogen Training
Prisoners are engaged in the research protocol	CITI course: ID 506 Research with Prisoners in Social/Behavioral protocols OR CITI course: ID 8 Research with Prisoners in Medical/biomedical protocols

How do I Register

Proceed to www.citiprogram.org and click on the “New Users Register Here” link.

1. Select “Drexel University College of Medicine” as your Participating Institution from a pull-down menu. You are not required to affiliate with any other institution. You will then answer questions 2-7 on this web page.
2. The following page will request your contact and demographics information.
3. On the “Getting Started” page you will be asked to select the desired/required courses; you are given the opportunity to select from Human Subjects Research, HIPS, Good Clinical Practice and Responsible Conduct of Research.
4. You will then be asked to select your Learner Group for each training module selected. Choose the Learner Group that best fits the type of research in which you are most often engaged.
5. The Learning Groups are:
   Group 1: Key research personnel conducting Medical, Biomedical, Nursing, Public Health and Psychology Research Investigations
   Group 2: Key research personnel conducting Social, Behavioral and Educational Research Investigations
   Group 3: IRB Members and ORRC Staff,
6. CITI based HIPAA training, called HIPS, is required for all personnel in Learner Groups 1 & 3. You will select the HIPS training program based upon your specific Learner Group.
7. If you have already indicated you will be taking the GCP or RCR programs you will again be asked to indicate your Learner Group (if you did not sign up for either GCP or RCR these pages will not appear). These two courses are optional for most people; however Principal Investigators and Clinical Research Coordinators conducting clinical trials involving drugs, devices, or interventional/behavioral treatments must complete the GCP course. Also, some federal awards require that grantees undergo education in RCR, and the CITI RCR course is one way to meet this requirement.

How many modules are required?

The Human Subjects Research course for both Learner Group 1 and 2 includes twelve (12) individual training modules, the HIPS course includes a total of four (4) modules. To complete the training you must pass by gaining an 80% average on the module quizzes from your Learner Group. The required modules included within each Learner Group are listed in the link below.

MODULES BY LEARNER GROUPS [PDF]

Frequently Asked Questions

How long does it take to complete the training?

Most users complete all of their minimum required modules in approximately 6-8 hours. Training time for IRB members, Research Administrators and ORRC staff may take between 10 and 12 hours. You are not required to complete the training all at one sitting.

Can I stop and start again later?

Yes, you can stop and begin again at anytime. However, if you are in the middle of a module and taking an exam you must complete the exam before stopping, otherwise your exam results will not be recorded.

How do I obtain a certificate of completion?

After you finish the required modules you will be issued a completion report that is available to print from your learner menu. Please print the report and keep a copy for your records and give a copy to any members of your administrative team who need it for their records. For help printing the report please visit the CITI site. ORRC will be able to confirm that you have taken the training by looking online; however the ORRC will not be able to print off your certificate for you.

How often is recertification required?

Human Subjects Research training recertification is required every three (3) years. This can be accomplished by taking any four (4) modules of your choosing which you have not already completed.

HIPS recertification is required every three (3)years and may be satisfied by completing the same four (4) previously completed CITI HIPS modules.

GCP training recertification is required every three (3) years and involves completing the same 15 modules as initially completed.

Responsible Conduct of Research does not require recertification at this time.

You will receive an automatic reminder from CITI approximately 90 days prior to your anniversary date for courses requiring recertification.

Drexel Core Module recertification guidance is provided in the table below.

Drexel Core Module HIPAA I	Recertification is NOT currently required
Drexel Core Module HIPAA II	Recertification is NOT currently required
Infectious Substances Packaging	Annual recertification
Substituted (Surrogate) Consent	Recertification is NOT currently required
Recombinant DNA Molecules Training	Annual recertification
Select Agent Policies and Procedures	Annual recertification
Laboratory Safety and Bloodborne Pathogen Training	Annual recertification

What do I do if I forget my password?

If you forget your password, follow the instructions on the CITI website.

What if I am transferring my training from another university?

If an investigator has taken CITI training elsewhere, the previously completed training will be accepted at Drexel, with caveat that key research personnel complete any CITI courses required by Drexel that have not already been completed. For personnel whose prior training has expired they would recertify in the same manner as DU/DUCoM personnel. If you are having trouble locating your prior training records please see the CITI Support Center for assistance.

What about collaborators at other sites?

This training would only be required for collaborators for whom Drexel has agreed to act as the IRB of record. If outside collaborators have received their own IRB approval, they do not need to undergo the Drexel training and should defer to their own IRB's training requirements.

Collaborators as co-investigators, key personnel or students from an outside institution who wishes to conduct research at DU/DUCoM must register and complete the appropriate CITI training modules according to their Learner Group and type of research conducted. During registration, if you do not have a Drexelmed.edu or Drexel.edu email address, you may complete your registration with a personal email address of your own choosing. The unaffiliated personnel must “affiliate” with Drexel University College of Medicine during the CITI registration process in order to view and complete the required DUCoM specific modules.

CME Credits

Continuing Medical Education credits may, or may not, be offered by the University of Miami with respect to the CITI program. Questions regarding CME should be directed to the CITI help desk.

Who can I talk to if I have questions?

Contact Jack Medendorp or Marina Bounds at 215.255.7857 if you have questions. The CITI Support Center also provides resources, hints, tips and answers to Frequently Asked Questions about the CITI Program.