Review Board (IRB) - Frequently Asked Questions (F.A.Q.)
1. Is my project research?
Research is the careful study, investigation or inquiry of a scholarly or scientific subject. It is different in practice, even though research and practice are often carried out at the same time. Research can include the following: the testing of a hypothesis and then drawing conclusions from data; interaction with individuals whereby information is gathered through interviews and/or questionnaires or private information sources; investigation, research development, testing and evaluation; and finally, the use of bench or laboratory specimens. Further, research is described in a protocol (or plan) that names certain objectives and procedures used to achieve these objectives.
2. Does my research require IRB approval?
All projects that involve human subject research require review and approval from the IRB.
3. What is considered a "human subject"?
A human subject is any living individual from whom an investigator collects data by either direct intervention or through interaction, or private sources like clinical databases, medical records, billing and/or pathologic or diagnostic specimens. Private data collected shows identifiable information about this person. These people may include patients, families, classmates, staff, etc.
4. What is the IRB process?
First, an eprotocol access request form must be completed through webcentral:
Electronic Access Request Form
If you are new to the eprotocol system (IRB, IACUC, IBC electronc application submissions), you must request access via webcentral.
Logon to webcentral:Go to the Student/Employee tabUnder my web (banner self service) select Student and Financial Aid forms or Employee formsClick on DU protocol access form, complete and submit
All required education must be completed prior to submission of this form. See section 19 for more details.
Once entered into the system, you will receive information by email including login, default password and links to eprotocol. Eprotocol workshops are available throughout the year and a PI guide is also posted on our website for the creation of research protocols/IRB applications. Once the application is electronically submitted, it will be reviewed by the IRB.
5. Where do I submit my e-protocol access form?
We no longer accept paper copies of the e-protocol access request form. Please login to Webcentral and apply for e-protocol access electronically.
6. Who can answer questions about the protocol/ IRB application?
Research Compliance staff: 303.871.4050/4052 or email@example.com
7. When and how often are the IRB meetings?
The IRB meetings take place monthly; see the updated calendar on the website for the most accurate date information available at http://www.du.edu/orsp/meetingdates.html.
8. How long will the review process for my IRB take?
During November, March, May and the summer months reviews may take longer due to the administration of final exams and the summer holiday• For the full review process, the committee meets two weeks after the due date, and the PI will be informed of the decision approximately 5-7 working days after the meeting.For the expedited review process, two members of the IRB will be given your application two days after the monthly due date. The PI will be informed of the decision approximately three weeks after the due date.For revisions and addendums, the process takes about two weeks from the time of submission.For the exempt applications, the process takes about two weeks from the time of submission.
9. What is the process for notification of protocol status?
The investigator and any PI and/or key personnel will be notified by an official letter that they have been approved, approved with revisions, deferred, or denied. Additionally, one to five days after the meeting the investigator should receive an email notifying him or her to the status of their protocol.
10. How is the level of review for my protocol determined?
The level of risk is determines the type of review needed for the protocol. If the protocol has more than minimal risk a full-committee review will be necessary. If a protocol is determined to have only minimal risk, it will then be reviewed under the expedited or exempt certification. Researchers are not qualified to determine the level of IRB review needed for their protocol review. The DU OSP can however give you information about the review your protocol might receive. For questions, please contact us at 303.871.4050/4052 or by email: firstname.lastname@example.org.
11. What can I do to help the IRB process move quickly?
To help the IRB process move quickly, we at OSP strongly recommend that researchers consult with an IRB staff member before submitting their protocol application. Pre-review helps to identify any potential questions or other issues that might otherwise arise during the review process. To set up a pre-review appointment, please contact us at 303.871.4050/4052 or email at email@example.com.
12. What happens after I submit my IRB application?
Once the application is received in the ORSP office, it is reviewed for completeness before submission to the IRB reviewers. If additional information is needed a staff member of the IRB may contact the researcher before the meeting date. Once the completed protocol application is received, it is assigned a status (full, expedited, or exempt), and is then submitted to the IRB for review.
13. May I pay study participants?
Yes. However, payment depends on several factors such as available funds, and the effort on the part of study participants. Researchers should keep in mind the possible side effects that monetary compensation could cause for both the research results and the study participant (for example, monetary incentive may make it difficult for a participant to make and informed and voluntary choice about taking part in the research). A great alternative to payment would be non-monetary incentives such as gift certificates or meals at fast-food restaurants. If compensation of any kind is part of the study, it is important to include specific information in the about payment and terms in the informed consent of the protocol application. All information should be given before the recruiting of any participant.
14. What if there are changes to my study after I receive IRB approval?
Before implementing any changes to an already approved study, you are required to obtain IRB approval. One exception to this rule is if an immediate change is necessary to eliminate a risk or hazard to a human subject. In this case, the change needs to be submitted to the IRB as soon as possible for review. Further, any minor change(s) which does not involve more than minimal risk often undergoes an expedited review often by a subcommittee of the IRB. Any major change must undergo a full IRB review.
15. How do I renew or close a study?
• Federal regulations require the IRB to review any ongoing study on a yearly basis. The IRB may choose in some instances to review a study more frequently. To renew a study it is necessary to submit a continuing application. This application will be sent out about three months before the expiration date of the previous study. To close a study it is necessary to contact an IRB staff member or submit a close out report, now also available through eprotocol.
16. What is minimal risk?
Minimal risk as defined by federal regulations is the probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
17. What is informed consent and when is it needed?
In almost all cases before participation in research begins, researchers must obtain consent from research participants or their legally authorized guardians (if under 18). The informed consent consists of providing the potential participant with information regarding the study, allowing the potential participant the opportunity to consider what the researcher is asking, and then responding to any questions the potential participant might have so that the potential participant or his/her guardian fully understands the information. This process includes obtaining the potential participants agreement to take place in the research through his or her signature on a written consent document.
18. What if my study qualifies for exemption? Do I still need IRB approval?
What if my study qualifies for exemption? Do I still need IRB approval? Although the IRB currently reviews all research involving human subjects, the regulations provide that certain human research activities may be eligible for a determination of "exempt" status by the IRB. A Principal Investigator may request exemption from review by submitting an Application for Exemption from Review. A Principal Investigator must obtain such a determination from the IRB prior to initiating the study. An exemption from IRB review does not equate to an exemption from the HIPAA requirement for authorization or waiver of authorization when the research involves a covered entity's protected health information. Researchers who receive an exemption determination but whose research involves protected health information must still submit a HIPAA authorization form (or a request for waiver of HIPAA authorization), or, if applicable, HIPAA forms for conducting research involving decedents' information or research using a limited data set. Researchers who wish to review protected health information (e.g., medical records) to prepare a research protocol must submit the appropriate HIPAA form for IRB approval. For further information on exemption status, please contact us at firstname.lastname@example.org or 303.871.4050/4052.
19. Do I need to complete training before conducting human subject research?
All researchers involved in human subjects' research must complete training. At this time there is only one option. Researchers must complete the Human Subject Protection in Research exam found on the University of Denver CITI website. Below are the instructions for enrolling for the online Human Subject Protection Certification exam. You may find printing these instructions helpful in order to refer to them while enrolling.
Go toEnroll as new userEnter the University of Denver as your affiliated institution and fill out the information requestedUnder the (1) Human Subject Research, register in the Social Behavioral Educational Research Group (SBER)Complete the modules included listed
Additional course modules are offered depending on your research interests, such as International Research, Internet Research, Research with Minors, etc.
If you have previously completed the Blackboard training you will not need to recertify via CITI. This only applies to new DU investigators. However, we highly encourage you to visit the website and explore some of the other course modules. For general courses, please select the "general group".
Course Completion is required before submitting to the IRB
* Register on both SBR and General if you would like access to other research resources.
Note: You may stop and resume at any time. You may print a completion report for your records. You do not need to submit documentation to the Office of Research and Sponsored Programs.
20. Who can be a Principal Investigator?
The Principal Investigator (PI) must be a full-time staff or faculty member. In the event that the responsible researcher is an undergraduate or graduate student, then they act as PI and the supervisory faculty member/faculty advisor must act as faculty sponsor.
21. What are the responsibilities of the Principal Investigator?
- the compliance of all co-investigators, student investigators, and research associates with the IRB decisions, conditions, and requirements
- reporting to the IRB any changes to the research protocol (e.g., research design of the study, recruitment procedures)
- requesting re-approval when contact with subjects will extend beyond the approval termination date
- reporting to the IRB chair any unanticipated adverse reactions or unanticipated events associated with the conduct of this research
- seeking clarification and advice from the IRB regarding ethical aspects of the research
22. Can I do a study for more than one year?
In accordance with federal policy, research can be approved for up to one year. It is necessary to submit a continuing application form if a project is to last longer than the approval period, which is typically one year. A continuation application will be mailed out three months prior to the project expiration date. The continuation application must be completed and returned to OSP if the project is continuing. If the application is not reviewed, all work on the project must be stopped on the expiration date. This includes data analysis, even if no contact with subjects is occurring. The review process continues for the duration of the project. In certain cases approval may be for less than one year. For more information about continuing a study, please contact us at 303.871.4050/4052 or email@example.com.
23. If my research has been approved by another university's IRB, do I need to submit this protocol to the DU IRB too?
If you are an affiliated member of the University of Denver you will need DU IRB approval also. Please contact the Office of Research and Sponsored Programs to see if certain exceptions apply.