Frequently Asked Questions About the IRB Protocol Application Process
I collected data for a project I didn't think I wanted to present or publish. My results were great and now I would like to present the study at a conference. Can I get IRB approval now?
Unfortunately, no. The IRB cannot give retrospective approvals for research and can only approve studies before any participant recruiting or data collection has begun. If you are planning a project that you want to have the option to present at a later time, it is advisable to get IRB approval before you begin. This leaves you the option of presenting or publishing the study at a later time.
How do I know whether my project requires review?
My project is under expedited review, what does that mean?
For IRB purposes, the term "expedited" refers to a process, not a timeline, where the review and determination is made by, typically, only one IRB member and not the full board. Studies that involve no more than minimal risk for participants (no greater than the risks we would encounter in our daily lives) generally do not have to be reviewed at a convened IRB meeting. Keep in mind, though, that the quality and clarity of your protocol and submission materials will affect the reviewers ability to assess risks to participants and make a timely determination. Poorly crafted submissions, therefore, will take longer under any review process simply because the reviewers are not given the information they need to make a determination under the regulatory requirements.
I am a student. My old college had a shorter form for student IRB applications. Why does MSU Denver make students go through the exact same process as faculty?
The federal regulations make no distinction between student and faculty research. All researchers are required to abide by the same ethical and regulatory standards, so MSU Denver requires all investigators to follow the same process.
I am a researcher from another institution and I have an approved protocol from the IRB at my university. Can I recruit MSU Denver faculty, staff, and students to participate in my study?
The MSU Denver Human Subjects Protection Program requires researchers who wish to approach potential study participants from the MSU Denver student, staff, or faculty to acquire approval from our administration and from our Institutional Review Board prior to recruitment. Sometimes the MSU Denver IRB cedes to the IRB of record, and sometimes it does not.
If you would like to recruit study participants from the MSU Denver (faculty, staff, or students) please contact the HSPP at 303-352-7330 or email@example.com. If requested, you may need to complete MSU Denver IRB's Request for Review and submit a copy of the approval letter from the IRB of record.
What is the CITI training?
The CITI Program is an online training published by the University of Miami. The vast majority of institutions in the United States and Canada require researchers to show proof of completion of the CITI training before reviewing proposed research. The program will send investigators a certificate of completion that can be sent with the Request for Review. The certificate is good for 3 years. Find more on the CITI Program page. The CITI Course Modules page shows users what modules are included in each course.
What is a Letter of Determination?
A Letter of Determination is sent to the Primary Investigator regarding the decision the IRB has made on his or her research protocol. The possibilities for letters investigators can receive are:
- Determination of not human subjects research,
- Determination of exempt status,
- Approval with continuing review requirement,
- Approval pending revisions not requiring second review,
- Modifications, submission, and second review required,and
Investigators should be aware that they cannot start any research activities involving participants, including recruitment, until a final IRB approval or determination of exempt status is issued. If the IRB disapproves your research proposal, you may appeal their decision or modify your protocol and submit for new IRB review, but you cannot human subjects research activities disapproved by the IRB. No one at the institution, including the administration, deans, department chairs, etc. can override an IRB disapproval determination regarding human subjects research.
Why is a Review of the Literature Required as Part of the Request for Review?
Federal regulations regarding ethical research require that risks to research volunteers be minimized by using procedures which are consistent with sound research design, and which do not unnecessarily expose volunteers to risk (45 CFR 46.111(a)(1). A literature review:
- allows the IRB to know more about your topic,
- demonstrates that you are aware of prior research in this field, including hypotheses, methods, and outcomes of previous research,
- indicates that this knowledge has informed your proposed use of research volunteers,
- should justify and support the purpose of your own study and its importance in your academic field.
What is Identifiable Information?
Identifiable information is either a name, demographic information, or a combination of demographic information that would allow someone working with data to determine the source of the data after it was collected. Identifiers can include birthdates, email addresses, social security numbers, etc. Data that is linked to identifiers through a coding system is also considered identifiable.
Can I Use 900 Numbers for My Coding System
No. 900 Numbers are protected under the Federal Education Right to Privacy Act (FERPA). No part of a 900 Number may be used for the purpose of linking research participants with their data.
How Do I Make Changes to a Study That Has Already Been Approved?
In order to make changes to an approved study, submit a new Request for Review form and check the box at the top of the front page indicating that you are submitting a protocol modification. Please also submit a copy of the previously approved protocol and CITI Program training certificates for everyone who will be recruiting participants, gathering data, or analyzing identifiable data.
I am Conducting a Secondary Analysis of Existing Data. Do I Need to Obtain Approval from the IRB?
Yes. When research is being conducted with existing data sets the IRB is required to confirm that the original data were properly and ethically obtained. Please contact the HSPP with any questions on IRB oversight and requirements for research using existing data sets.
How Can I Become a Member of the IRB?
When the IRB has an opening, the panel evaluates its needs and seeks to fill the open position with someone who meets those needs. 45 CFR 46 requires IRB panels to include:
- at least five members
- persons with varying, race, gender, and sociocultural backgrounds
- at least one member who is not otherwise affiliated with the institution
- at least one member whose interests are in non-scientific areas
- at least one person who is knowledgeable about research with children, pregnant women, neonates, and prisoners
- persons who are sufficiently knowledgeable in
- local, state, and federal laws governing research being proposed
- ethics of research with human subjects
- federal regulations, guidance, and precedent governing research with human subjects
In addition to the requirements for panel membership by the federal guidelines, the MSU Denver IRB is also interested in having representation from each school within the University and a balance of tenured and non-tenured faculty.
When a position becomes available the panel works with the Institutional Official to identify faculty, staff, students, or community members who would meet the needs of the panel based on the criteria listed above.
There are a lot of Acronyms used in human subjects materials. What do they mean?
- CFR — Code of Federal Regulations
- DHHS — US Department of Health and Human Services
- FDA — US Food and Drug Administration
- FWA — Federalwide Assurance
- HSPP — Human Subjects Protection Program (MSU Denver)
- IRB — Institutional Review Board
- OHRP — Office for Human Research Protections
Also find a Glossary of IRB terms here.