Frequently Asked Questions and Special Topics
Special Topics
Research Involving External Organizations and Communities
FAQ Page Contents:
Can we list multiple Principal Investigators on an IRB application?
Can an Adjunct or Affiliate Faculty member serve as Principal Investigator?
Can students serve as a Principal Investigator (PI)?
Who should be listed on an application?
Human Subjects Research Training
Why do I need to complete IRB training? What if my project is exempt?
Is it important to keep the certificate proving that I have taken this or another training course?
When does my CITI human subjects research training certificate expire?
Does the 老澳门六合彩开奖记录 CITI IRB training course include information about HIPAA?
Is it possible to have an IRB member review my application prior to submission?
What are the procedures for a review by the Full IRB?
How long do I have to respond to a request for information or modification?
What type of IRB records should I keep and for how long?
What if I want to include children in my research?
Does the IRB review participant incentive documentation?
What is the IRB鈥檚 review of a Data Use Agreement (DUA)?
Who should I contact if I have any questions or comments about training or any other IRB matter?
Which IRB do I use?
- The 老澳门六合彩开奖记录 IRB is the primary Institutional Review Board for all 老澳门六合彩开奖记录 faculty, staff, and students. If a faculty or staff member is the principal investigator on a project, a 老澳门六合彩开奖记录 IRB/ORIC application must be filed before submission to any other relevant IRBs. The 老澳门六合彩开奖记录 IRB will help you determine the need to engage other IRBs, and ORIC staff will facilitate institutional and individual investigator authorization agreements as needed. In cases where 老澳门六合彩开奖记录 is a subcontractor or in extenuating circumstances, the 老澳门六合彩开奖记录 IRB will cede oversight and approval to the primary organization鈥檚 IRB to reduce administrative burden for investigators.
Investigators
Can we list multiple Principal Investigators on an IRB application?
- No. A Principal Investigator (PI) is the contact person who is responsible for all project operations and oversight of human subject research. Being listed as a PI on an IRB/ORIC application is not the same as on a grant application. If you do wish to include more than one person as a PI, then all persons listed as PIs will need to electronically sign all submissions, amendments, reports, updates, and any other documents required for the research. Because of this, it is often more efficient to designate one person as the PI for the application.
Can an Adjunct or Affiliate Faculty member serve as Principal Investigator?
- Only full-time faculty (clinical, term, tenure track, research) or staff may serve as the PI. Anyone who holds an Adjunct or Affiliate Faculty position should secure a project sponsor, who must be full-time faculty or staff as defined above. The PI will be required to sign off on the proposal and assist the Adjunct or Affiliate Faculty member to navigate the 老澳门六合彩开奖记录 infrastructure, policies, and procedures as needed.
Can students serve as a Principal Investigator (PI)?
- The IRB does not support the idea that students serve as the Principal Investigator on a project. PI responsibilities should be assumed by the Faculty Advisor. An IRB designation as PI has no bearing on funding, publication, or other measures and the PI is the person who is responsible for all project operations. Students should not be placed in a position to assume overall responsibilities of research.
Who should be listed on an application?
- Anyone who will work with the data, recruitment, interact with participants (consent, collect information, contact, etc) should be listed under project personnel/staff. Their organizational affiliation should be included.
Human Subjects Research Training
Why do I need to complete IRB training? What if my project is exempt?
- It is a federal requirement that all institutions conducting federally-funded Human Subjects Research (HSR) provide proof of HSR trainings. Anyone submitting an HSR proposal to the 老澳门六合彩开奖记录 IRB/ORIC must include a certificate of completion of training, regardless of the level of review. See the page for further information on this topic.
Do all 老澳门六合彩开奖记录 faculty, students and staff need to take an IRB training course even if they are not the Principal Investigator?
- All persons directly involved with human subjects research should take this training course, regardless of whether they are faculty, students, staff or if they are directly affiliated with 老澳门六合彩开奖记录. If you are working on a human subject research project in which some of the other investigators are not affiliated with 老澳门六合彩开奖记录, the other individuals are still required to have taken training in human subjects research protections, and there are other considerations involved when non-老澳门六合彩开奖记录 individuals are helping to conduct 老澳门六合彩开奖记录 research.
Are there other ways to meet HSR training requirement besides the CITI training course 老澳门六合彩开奖记录 offers?
- Yes. There are a number of other courses that meet this requirement. If you have already taken a training course from another institution within the last three years, then you do not need to take the 老澳门六合彩开奖记录 recommended course. However, you do need a certificate proving that you have completed the training within the last three years, and the content of the training may need to be evaluated.
Is it important to keep the certificate proving that I have taken this or another training course?
- Yes. You should attach a copy of the certificate to any proposal that is submitted to the 老澳门六合彩开奖记录 IRB/ORIC for review. If you took a course from another institution, then you would need to attach that certificate the same way. If you do not provide proof that you have received training in human subjects research protections, then your proposal will not be reviewed by the 老澳门六合彩开奖记录 IRB.
When does my CITI human subjects research training certificate expire?
- The training certificate is good for three years. You need to complete a CITI refresher course after three years. For more information on training, go to our IRB Training & Certification page
Does the 老澳门六合彩开奖记录 CITI IRB training course include information about HIPAA?
- Yes, there are modules about the HIPAA regulations, as well as a specific course focused on HIPAA compliance for researchers. If you would like to view more information about HIPAA, please refer to the .
IRB/ORIC Reviews
Is it possible to have an IRB member review my application prior to submission?
- Depending on your turnaround time needs and available IRB/ORIC personnel, we can often help with the application or answer questions. However, this will not constitute a formal review, and formal reviews鈥攁nd approvals鈥� are only given over
- Once a project is submitted via we respond as quickly as possible and will work closely with the PI to ensure that any needed changes are communicated clearly and subsequent re-submissions are reviewed in a timely manner. Timelines are outlined on our Submitting a Proposal page.
What are the procedures for a review by the Full IRB?
- For complete information about IRB review procedures of each kind, please refer to the IRB's SOPs, found on in the 老澳门六合彩开奖记录 IRB Forms & Templates library for researchers. You must create an account and affiliate with 老澳门六合彩开奖记录 in order to access this library.
How long do I have to respond to a request for information or modification?
- Responses to a request for information or modification should be provided within 30 calendar days from the date of the IRB/ORIC correspondence. In most cases, new application and amendment modification requests will be closed if the response exceeds 30 days, which would require resubmission. In cases where the required information makes this not feasible, please notify the IRB in advance.
What type of IRB records should I keep and for how long?
- Per , IRB records, including consent forms, should be kept for at least three years. If you are a student and do not plan on being at 老澳门六合彩开奖记录 for three years, the materials should be stored securely on campus with your faculty advisor. The retention period may be longer depending on the study.
What if I want to include children in my research?
- There can be additional considerations for research with minors. Please see the
Does the IRB review participant incentive documentation?
- No. While the IRB/ORIC requires a statement of compliance with Accounts Payable (AP) requirements, the review only assesses the presence or absence of such a statement, and whether the stated incentives are not so large as to provide undue influence and are distributed in an egalitarian manner. Ensuring compliance with 老澳门六合彩开奖记录 AP policies should be navigated between the PI and 老澳门六合彩开奖记录 AP.
What is the IRB鈥檚 review of a Data Use Agreement (DUA)?
- The IRB is not the party responsible for approving DUAs. While the IRB requires a DUA be submitted with a proposal review (as warranted), the IRB鈥檚 review only assesses the alignment with the data specified in the IRB application, including the presence of personally identifying information (PII) and protected health information (PHI), and verification the DUA has been duly completed.
Who should I contact if I have any questions or comments about training or any other IRB matter?
- For questions about human subjects research, please contact the 老澳门六合彩开奖记录 Office of Research Integrity and Compliance at (907)-786-1099 or uaa_oric@alaska.edu.