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Frequently Asked Questions
Why is training necessary?
In recent years, reports by the Office of the Inspector Genera (OIG) and enforcement actions taken by the Office for Human Research Protections (OHRP) against a number of prominent universities have called attention to serious problems related to compliance with Food and Drug Administration (FDA) and Department of Health and Human Services (HHS) regulations for the protection of human subjects. Accordingly, national bodies including the National Institutes of Health (NIH), the Association of American Medical Colleges (AAMC) and the Association of American Universities (AAU) have called for formal training of personnel involved in the conduct of human subjects research.
President Smith's June 28, 2000 AAU report states: "Universities must ensure that all personnel (faculty, researchers, management, administrative staff) directly involved in human subjects research understand the applicable laws, regulations, and ethical standards governing the protection of human subjects. All personnel engaged in the direct conduct of such research should be required to receive appropriate education designed for their level of involvement. Upon completion of training, an examination geared to each person's level of involvement should be administered, resulting in a designation (e.g., credentialing or certification) that the individual may engage in human subjects research."
Who must be trained?
"Beginning on October 1, 2000, the NIH will require education on the protection of human research participants for all investigators submitting NIH applications for grants or proposals for contracts or receiving new or non-competing awards for research involving human subjects." [NIH Guide, June 9, 2000].
Each individual identified as key personnel in the application must be trained and certified. Key personnel are defined by NIH as "individuals who contribute in a substantive way to the scientific development or execution of the project, whether or not salaries are requested." A description of training for each of the key personnel must be provided to the NIH in the cover letter at the time of application or, if necessary, this description can be provided in the cover letter accompanying the "Just in Time" materials forwarded to NIH.
In accordance with NIH "Just in Time" procedures, IRB approval is not required prior to NIH peer review. The IRB is not, however, authorized to approve an application linked to an NIH grant/contract until all key personnel are trained and certified. Key personnel are defined as (1) principal investigator(s), (2) secondary investigator(s), (3) participating physicians/health care personnel and research coordinator(s) who are listed by name on the IRB Application.
Will this institution accept certificates of training from other institutions when key personnel include external investigators, or subcontract recipients who have been trained elsewhere?
Yes, provided a description of the training is transmitted to the Office of Regulatory Affairs (ORA).
Will this institution accept certification of training from other institutions for new UNMC/UNOmaha/The Nebraska Medical Center employees?
The only certificates of training which will be accepted are those from institutions who utilize the same training program as this institution. UNMC/UNOmaha/The Nebraska Medical Center must be assured that all personnel involved in human subjects research have at least equivalent training.
Will the IRB review an initial application if all key personnel are not trained and certified?
Yes, the IRB will review the initial application. However, the Board is not authorized to approve the project until all key personnel are trained and certified.
Are training and certification of all key personnel required before the IRB is authorized to approve an IRB application for continuing review?
Yes, this requirement was effective February 1, 2001. As with initial reviews, the IRB cannot reapprove protocols at the time of their continuing review unless all key personnel have been initially certified. HHS and FDA regulations require research projects to be reviewed and reapproved no later than 12 months from date of last review. If the IRB cannot complete the reapproval process because key personnel have not been certified, the protocol will be approval expired and subject accrual must cease immediately. The Principal Investigator should ensure that all key personnel are certified prior to submission of the IRB Application for Continuing Review.
Are training and certification of all key personnel required for IRB approval of requests for change (amendments)?
Yes, this requirement was effective February 1, 2001. Changes in protocol which are needed to minimize risk to subjects will be approved, but all other changes will not be processed until all key personnel are certified.
Does the training requirement apply to research conducted by students or staff?
Yes, research conducted by students or staff must maintain the same high ethical standard as research conducted by faculty.
In what form is the required training available?
This institution is one of the original ten members of the Collaborative IRB Training Initiative (CITI). More than 270 institutions use this training program at the present time.
The CITI has developed a course for investigators and other key personnel involved in human subjects research. This is a web-based course hosted by the University of Miami. The program allows you to download course content and print a hard copy.
The course has 2 parallel training tracks: the Biomedical track and the Social/Behavior Research track. Each track includes core modules that include short quizzes.
The Biomedical Track Core Modules consist of sixteen (16) modules. The following are the modules: (1) History and Ethical Principles, (2) Basic Institutional Review Board (IRB) Regulations and Review Process, (3) Informed Consent, (4) Social Behavioral Research for Bio-Medical Researchers, (5) Records-Based Research, (6) Genetic Research in Human Populations, (7) Research With Protected Populations - Vulnerable Subjects: An Overview, (8) Vulnerable Subjects - Research With Prisoners, (9) Vulnerable Subjects - Research Involving Minors, (10) Vulnerable Subjects - Research Involving Pregnant Women and Fetuses in Utero, (11) Group Harms: Research With Culturally or Medically Vulnerable Groups, (12) FDA-Regulated Research, (13) Human Subjects Research at the VA, (14) HIPAA and Human Subjects Research, (15) Hot Topics, and (16) Conflicts of Interest in Research Involving Human Subjects.
The Social and Behavioral Research Core Modules consist of thirteen (13) modules. The following are the modules: (1) History and Ethical Principles - SBR, (2) Defining Research With Human Subjects - SBR, (3) The Regulations and The Social and Behavioral Sciences - SBR, (4) Assessing Risk in Social and Behavioral Sciences - SBR, (5) Informed Consent - SBR, (6) Privacy and Confidentiality - SBR, (7) Research with Prisoners - SBR, (8) Research with Children - SBR, (9) Research in Public Elementary and Secondary Schools - SBR, (10) International Research - SBR, (11) Internet Research - SBR, (12) HIPAA and Human Subjects Research, (13) Conflicts of Interest in Research Involving Human Subjects.
How long will certification be valid?
Certification will be valid for three (3) years from the date of initial training completion. UNMC employees can check the training expiration date on the Employee Self Service site. A continuing education site is available at www.citiprogram.org. If, however, NIH or HHS should change the training requirements in the interim, individuals may be required to undergo additional or different training.
What are the requirements for re-certification?
All investigators and participating personnel must update their training certification every 3 years.
UNMC/The Nebraska Medical Center investigators and participating personnel and Exercise Science investigators at UNOmaha who previously completed the CITI Biomedical (BioMed) training track should complete the CITI Refresher Course.
All other UNOmaha investigators and participating personnel should complete the Social/Behavioral Science Research (SBR) training track.
How do I access the required CITI training program?
Links are available from the UNMC IRB website (www.unmc.edu/dept/irb). The link at the bottom of the page will take you to a registration page http://www.citiprogram.org and you will enter a user ID, pass word and some contact information. Registered individuals can immediately begin the course or return at any time at http://www.citiprogram.org.
How long will it take to complete the training?
The time required to complete each of the basic modules varies between 10 minutes and 30 minutes. The total time required is estimated to be 2-3 hours. The course does not have to be completed in one sitting, and personnel can enter the course at any time. Units are designed to be taken sequentially.
The time required to complete the refresher course is about 1 hour.
Is it necessary to complete all the units?
- If you are affiliated with The University of Nebraska Medical Center or you are collaborating on a project at The University of Nebraska Medical Center, initially you MUST complete the Biomedical (BIOMED) training track. Complete BIOMED modules 1-16.
- EXERCISE SCIENCE INVESTIGATORS at University of Nebraska at Omaha (UNOmaha) MUST complete the Biomedical (BIOMED) training track. Complete BIOMED modules 1-16.
- ALL OTHER INVESTIGATIORS at University of Nebraska at Omaha (UNOmaha) MUST complete the Social/Behavioral Science (SBR) training track. Complete SBR modules 1-13.
What is the purpose of the quizzes at the end of each unit?
The purpose of the quiz at the end of each module is primarily to provide you with self-evaluation of your understanding and familiarity with the information in the module.
Is there a minimum passing score required in order to be certified?
A passing score of 75% is required.
Where are the test data maintained and what about confidentiality?
Your individual quiz scores are confidential. The webmaster and staff supporting the distance learning software at the University of Miami where the data are processed and stored have access to individually identifiable quiz scores. However, each of these staff members, as well as the IRB administrative staff, have signed confidentiality pledges and will not disclose individually identifiable quiz results nor aggregate institutionally identifiable results. Aggregate, anonymized quiz data will be used by course faculty to help improve course content and quiz questions.
How do I obtain certification?
- Go to the Main Menu (a.k.a. "Learner's Menu")
- Click on "Completion Reports"
- Click on the course that you have completed.
- Click "Print This Report"
- Make a copy for your files
- At the time you complete a course, the University of Miami will automatically email a Completion Report to the Office of Regulatory Affairs.
How will the office of sponsored programs administration be notified that all key personnel are certified?
Training Certification information will become part of the IRB and Sponsored Programs Database. The internal "face page" of the grant applications will be modified to contain a statement of "Certification of Training" just above the signature of the PI. The Sponsored Programs Administration (SPA) staff can confirm certification in the database. The sponsored program application package to the NIH will have a section inserted in the transmission letter which accompanies the grant application. This addition will, depending on the situation, either assure and describe the training and certification of the key personnel in the application, or assure that the training and certification will be in place in time to respond to "Just-in-Time" processing.
If I encounter a problem or have a question, who do I contact?
If you have a question about the CITI Training Program or about any of the material presented in the program, contact:
For UNMC or The Nebraska Medical Center
IRB Administrative Office
irbora@unmc.edu
402-559-6463
For UNO
Office of Sponsored Programs & Researc
sponpro@lists.unomaha.edu
402-554-2286
If you have a problem with Internet access, your Internet Browser, the Adobe Reader, or other technical issues related to your computer, contact the Computing Services Help Desk at 559-7700.
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