Frequently Asked Questions (FAQs)
The University of Arizona Human Subjects Protection Program
Frequently Asked Questions (FAQs)
· HSPP – Human Subjects Protection Program
· BIO – Biomedical Committee (IRB-04)
· CRC – Continuing Review Committee (IRB-03)
· BSC – Behavioral Science Committee (IRB-02)
· HSC – Human Subjects Committee (IRB-01)
· IBC – Institutional Biosafety Committee
· IRB – Institutional Review Board
· R&D Committee – Research and Development Committee (SAVAHCS)
· SAVAHCS - Southern Arizona Veteran’s Affairs Health Care System
· UMC – University Medical Center
· UPH – University Physician’s Healthcare
· VPR – Vice President for Research
Forms· CRF – Continuing Review Form
· CRR – Continuing Review Report
· PAF – Project Approval Form
· PRF – Project Review Form
· VOTF – Verification of Training Form
Research Roles· PI – Principal Investigator
· Co-PI – Co-Principal Investigator
· Co-I – Co-Investigator
· Sub-I – Sub-Investigator
Other Entities/Agencies· AAHRPP – Association for the Accreditation of Human Research Protection Programs, Inc.
· CIRB – Central IRB
· CITI – Collaborative Institutional Training Initiative
· DHHS – Department of Health and Human Services
· FDA – Food and Drug Administration
· NIH – National Institutes of Health
· OHRP – Office of Human Research Protections
· WIRB – Western IRB
Industry Terminology· COI – Conflict of Interest
· CRF – Case Report Form
· DSMC – Data Safety Monitoring Committee
· DSMB - Data Safety Monitoring Board
· FWA – Federalwide Assurance
· HIPAA - Health Insurance Portability and Accountability Act
· ICF – Informed Consent Form
· IDE – Investigational Device Exemption
· IND – Investigational New Drug
· PHI – Protected Health Information
Q1. What is the difference between the Human Subjects Protection Program (HSPP) and the Institutional Review Board (IRB)?
A1. The Institutional Review Board is the committee that reviews new projects involving human subjects and other items related to existing projects that are considered to be “greater than minimal risk”. The Human Subjects Protection Program is the overall program that houses the Institutional Review Boards. This includes the director and office staff who support the review boards.
Q2. How many review boards are there?
A2. The University of Arizona has four Institutional Review Boards:
IRB-01 (Human Subjects Committee): This board was the first Institutional Review Board at The University of Arizona. All projects prior to 2001 were reviewed by this board. This board currently performs initial review of non-oncology, biomedical projects, and amendment reviews for any project initially reviewed by IRB-01.
IRB-03 (Continuing Review Committee): This board was created in 2003 when the number of projects became too great for the Human Subjects Committee to perform all the necessary reviews. This committee handles the continuing review and unanticipated problems involving risk to subjects or others for the Human Subjects Committee. In addition, this board reviews all single-patient use and humanitarian use device protocols.
IRB-02 (Social and Behavioral Sciences Committee): This board was created in 2001 in response to requests from behavioral researchers for a board specially geared to behavioral/social science research. This board performs initial review, continuing review, major amendment review, and review of unanticipated problems involving risks to subjects or others.
IRB-04 (Biomedical Committee): This board was created in 2006 as an additional biomedical board that reviews mainly oncology projects. This board performs initial review, continuing review, major amendment review, and review of unanticipated problems involving risks to subjects or others of oncology and nursing projects.
Q3. What institutions depend on The University of Arizona Human Subjects Protection Program for review of research projects?
A3. We are the “IRB of Record” for The University of Arizona, University Medical Center, University Physicians Healthcare, and the Southern Arizona VA Health Care System (SAVAHCS).
Q4. I am new to research. Where can I get information regarding human subjects research?
A4. Available on our website is an Investigator Information page that has links to information regarding the approval process, HIPAA, tips, articles printed in monthly newsletters Additionally, there are two Investigator Handbooks (one geared toward behavioral research and one for biomedical research) that provide detailed information regarding research and human subjects.
Q5. My department says that my project is exempt. Do I still need to submit paperwork to the Human Subjects Protection Program?
A5. Yes, paperwork must be submitted. While the departmental review chair makes a recommendation regarding the level ofreview required for the research, the final deciaion is made by the HSPP office. A determination of "exempt" does not mean that it does not need review by our office, but that it is exempt fro mthe requirements of 45CFR46.
Q6. Much of my research is very similar. Can I get an umbrella approval for my research that covers the general methods but allows flexibility in the research question?
A6. The IRB is required to consider each protocol separately rather than provide a general approval for similar research projects.
Q7. I did not know about the regulations regarding research with human subjects and have already performed my research. Can I submit my Project Review Form now?
A7. Approval is always granted prospectively. In other words, you must submit your Project Review Form/Project Approval Form and receive IRB approval before you begin to gather any data. To discuss individual situations/circumstances, contact the Director at 626-5925.
Q8. Who should be listed on the Verification of Training Form (VOTF)?
A8. Any person who will be “engaged” in research should be listed on the VOTF. These individuals 1) intervene or interact with living individuals for research purposes, or 2) obtain individually identifiable private information for research purposes. A person is not engaged if they do not: 1) intervene or interact with living individuals for research purposes, or 2) obtain individually identifiable private information for research purposes (for Human Subjects Protection Program Policy regarding engagement in research, see Policies and Procedures, Section I: http://www.irb.arizona.edu/system/files/Copy_of_Policies_and_Procedures_Section_I_april+2008.pdf). Additionally, students must list their advisors on the Verification training form since advisors are mentoring their students through the research process.
Q9. How many Principal Investigators (PI/Co-PI) can be
listed on the application?
A9. The number of PI/Co-PIs on a project depends on the type of study. A Co-PI has all the rights and responsibilities on the study as the PI; so if that person needs access to make executive decisions on a project, they should be listed as a Co-PI.
Q10. Can a project list Co-PIs only and not a PI?
A10. Yes, a project can list only Co-PIs. However, if this is done, the Human Subjects Protection Program requests that you delegate a “contact” Co-PI that will receive all paperwork from our office. This is to help minimize any potential breakdown in communication between researchers and our office.
Q11. Does my entire dissertation/thesis committee have to be listed on the VOTF?
A11. Unless the committee members are engaged in research, the Human Subjects Protection Program does not require a student’s dissertation committee members to be listed on the VOTF. A student must have an advisor listed on the VOTF; however, this advisor does not need to be a member of the student’s committee.
Q12. I am a student performing research for my thesis/dissertation but am listed on the Verification of Training Form (VOTF) of my advisor’s project. Is that sufficient?
A12. If you will be authoring a paper or if this is your thesis/dissertation, the best practice is to submit your own project with yourself as the PI. This is preferable when the project is secondary data analysis or a separate analysis of biological samples. However, if the work truly is a portion of the advisor’s research (e.g. one of the specific aims of the grant), then it may be appropriate to remain under the advisor’s project only. In that case, the advisor should add you onto the project as a Student Principal Investigator. The Advisor must submit a Request for Amendment Form, an updated Verification of Human Subjects Training Form, and an abstract (outlining your portion of the project) for review and approval. The abstract must include the title of your project. The Student PI designation does not include oversight of the larger research project, but does include the authority to submit modifications and other documentation pertaining to your designated portion of the project (reference: Page 8 of the Investigator’s Handbook – Behavioral).
Q13. Why does the entire grant have to be submitted with my application?
A13. According to Department of Health and Human Services, Office of Human Research Protections, regulation 45CFR46.103(f) requires that research supported by a federal department or agency that involves human subjects be reviewed by an IRB. In order for an appropriate review of the proposed research to take place, the entire grant must be submitted.
Q14. Can I use passive consent in my project? In other words, I would like to be able to assume that if a parent does not send back the informed consent document that they are giving permission for their child to participate in research.
A14. What you are requesting is a waiver of informed consent. According to 45CFR46.116(d), the only time informed consent can be waived is if the following criteria are met (reasons for each of these should be documented by the Principal Investigator in the request):
(1) The research involves no more than minimal risk to the subjects;
(2) The waiver or alteration will not adversely affect the rights and welfare of the subjects;
(3) The research could not practicably be carried out without the waiver or alteration; and
(4) Whenever appropriate, the subjects will be provided with additional pertinent information after participation.
Q15. When can a waiver of documentation of authorization to use and disclose Protected Health Information be obtained?
A15. According to 45 CFR 164.512(i)(2), the use of an authorization form can be waived if the following criteria are met (reasons for each of these should be documented by the Principal Investigator in the request):
(1) The risk to the privacy of individuals is minimal;
(2) The investigator will protect the identifiers from improper use or disclosure;
(3) Destruction of the identifiers will be performed at the earliest opportunity consistent with the research;
(4) The PHI will not be reused or disclosed outside the study except as detailed in the request of waiver of authorization; and
(5) The research could not be practicably conducted without the waiver or without the PHI.
Q16. If I want to do research with identifiable data/specimens previously collected for research purposes, what do I need to do?
A16. In addition to the initial application (either the Project Review Form or the Project Approval Form for Research Involving Human Biological and/or Genetic Materials), include the original IRB approval for the data/specimens that you will be using, the consent form that was used to collect the samples, a permission letter from the owner of the data/samples to use them in the proposed research. Additionally, if you are requesting a waiver of consent, see Q14 regarding the criteria for a waiver of consent. If a waiver of HIPAA is requested, please see Q15.
Q17. If I want to do research with de-identified data/specimens previously collected for either research/non research purposes, what do I need to do?
A17. In addition to the initial application (either the Project Review Form or the Project Approval Form for Research Involving Human Biological and/or Genetic Materials), if the specimens were originally collected for research purposes and are now de-identified, include the original IRB approval for the data/specimens that you will be using, the consent form that was used to collect the samples, and a permission letter from the owner of the data/samples to use them in the proposed research.
If you are proposing the use of de-identified data obtained for nonresearch purposes, include only a data abstraction sheet with what information will be abstracted and used for research purposes.
Q18. I have a change to a project, but it is not an amendment. What form do I submit it on?
A18. Any change to a project is considered an amendment. Many sponsoring agencies use the term “amendment” for major protocol changes, but any change to a project is considered an amendment. Submit your request on a Request for Amendment Form. A template for this form can be found at http://www.irb.arizona.edu/forms/Supplemental.
Q19. I submitted an amendment a week ago, but have not heard anything yet. What do I do?
A19. Feel free to call or email us and ask for an update on your amendment. Our contact information is located at http://www.irb.arizona.edu/contactus. If you do not know who to call, contact Leslie at the front desk (626-6721) and she can direct your call to the appropriate person.
Q20. What IRB agenda will my project go on?
A20. Go to our online calendar at http://www.irb.arizona.edu/meeting-calendar. This calendar has the upcoming IRB meeting dates, the last date for project submission, and if the meeting is still open for project submission. Also, feel free to call our office. We are happy to let you know on which agenda your project has been scheduled. Please see Q2 regarding the types of review each committee performs.
· Office of Human Research Protections (OHRP) Frequently Asked Questions and Answers
http://www.hhs.gov/ohrp/faq.html
· Food and Drug Administration (FDA) Frequently Asked Questions
http://www.fda.gov/opacom/faqs/faqs.html
· National Institutes of Health (NIH) Frequently Asked Questions
http://www.nih.gov/about/FAQ.htm
· CITI – Collaborative Institutional Training Initiative (The University of Miami)
http://www.citiprogram.org