Frequently Asked Questions about the IRB Submission Process
The IRB has oversight over human research. Proposed projects or studies must meet both the federal definitions of research and human subjects.
Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.
Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) Data through intervention or interaction with the individual, or (2) Identifiable private information.
Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes.
Interaction includes communication or interpersonal contact between investigator and subject.
Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.
(source 45 CFR 46)
Your project plan should be carefully assessed to determine whether or not it meets these definitions before initiating any activities involving participants. Conducting human research without IRB approval may constitute noncompliance with institutional standards and federal regulations and may be reportable within and outside of the institution. Many sources for sharing and disseminating research results, such as peer-reviewed journals and academic conferences, require documentation of IRB oversight when it is applicable.
Use the HRP-310 WORKSHEET: Human Research Determination to help you determine if your project constitutes Human Research. The HSPP staff can also help you determine whether or not your study or project requires IRB oversight.
For IRB purposes, the term "expedited" refers to a process, not a timeline, where the review is conducted 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. Studies that involve more than minimal risk cannot be reviewed by this expedited process and must be assigned to the next available convened IRB meeting.
Keep in mind, though, that the quality and clarity of your protocol and submission materials will affect the reviewer's 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 according to the regulatory requirements.
Yes. 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. Student-driven research is not held to a lower standard and is evaluated the same by the IRB.
In the development and conduct of human subjects research, students are expected to be appropriately mentored by more experienced researchers. The IRB does NOT review studies submitted solely by student researchers. As a student, your faculty or staff advisor must be designated on the IRB submission as the Principal Investigator. The Principal Investigator should be involved in all aspects of the IRB review process and oversees the conduct of your research. You can engage with the HSPP and IRB to learn about this important process; but, submissions to the IRB and official correspondence must come from the Principal Investigator. Student are not allowed to register with or use IRBNet. This way the IRB is assured that the faculty or staff advisor is not being by-passed in this process and has had the opportunity to review materials being developed by the student.
I collected data for a project that I didn't want to present or publish. My results were great and now I would like to present the study at a conference. Can I get still get IRB approval?
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 may meet that definition of human subjects research, you should seek IRB approval before you begin any project activities. This leaves you the option of presenting or publishing the study results at a later time. If you collect data from individuals for a class project, a quality improvement project, or other non-research purposes, it can be difficult (and in some cases it would not be possible) to gain permission from individuals for use of their data later as research. To receive IRB approval for use of this data in research, you would either need to demonstrate a plan for gaining informed consent or meet the conditions for a waiver. Plan ahead, and consult with the HSPP if you are not sure about the IRB requirements.
I am a researcher from another institution. Can I recruit MSU Denver faculty, staff, and students to participate in my study?
External researchers who wish to recruit study participants from the MSU Denver student, staff, or faculty populations should consult with the HSPP. The HSPP can determine institutional engagement and whether or not MSU Denver's IRB oversight is required in addition to your own institution. In some cases, our IRB can defer to the IRB of record, and we simply need to acknowledge that oversight and protections are appropriate. When MSU Denver IRB review is required, a MSU Denver faculty or staff member should act as a local PI. The local PI assumes responsibility of the ethical conduct of research for those activities conducted at MSU Denver.
Please be advised that even when MSU Denver's IRB review is not required for your research, to access students, faculty, or staff through existing classes, programs, services, listservs, etc. you would need permission from the institutional official overseeing that class, program, service, listserv, etc. AND your proposal will need to be reviewed and approved by MSU Denver's Senior Leadership Group under the direction of the Provost.
The HSPP can help facilitate that process with Senior Leadership. At a minimum, Senior Leadership would expect to see a copy of the IRB approval letter from your institution, copies of the approved study materials (protocol, consent form, etc.), and a cover letter describing the research activities that will take place on our campus and any local permissions you have already obtained.
If you would like to recruit study participants from the MSU Denver community (faculty, staff, or students) please contact the HSPP at 303-352-7330 or firstname.lastname@example.org.
The Institutional Review Board (IRB) is seeing an increase in the request to use specific listservs for recruitment of participants into a research study. The IRB is trained and responsible for assessing the risk to human subjects of all research proposals including research design, recruitment and consent processes, data management and confidentiality according to the three principles contained in the Belmont Report and the Code of Federal Regulations (45 CFR 46). https://www.hhs.gov/ohrp/. Upon review and approval of a research proposal that intends to use any internal or external listservs for recruitment, the IRB requests that the Principal Investigator (PI) obtains permission from the owner of the listerv, to encourage responsible use. This step ensures that the IRB carries out its charge and responsibilities to protect human subjects, and also decreases administrative burden on offices who are not trained in assessing the risk to human subjects of research per federal regulations. PIs will be instructed that it is their responsibility to request permission to use a listserv prior to recruitment. The decision to approve this request is up to the individual unit, office, department, etc. that controls the listserv. Approval to use a listserv to distribute recruitment information does not change the PIs responsibility to the protection of the rights and welfare of subjects in human research, including obtaining informed consent of individual subjects.
What do you call an alligator in a vest? ...an investigator! But, seriously, who is an investigator?
A research study often requires a team of individuals to accomplish its goals, and individuals have a variety of roles in research (funding acquisition, protocol development, data collection, analysis, etc.). To the IRB, investigators are those individuals who interact with participants and/or have access to identifiable private information for the purposes of the research. This means anyone who gains informed consent, administers a survey, conducts an interview or focus group, collects data from individuals by other means, or is involved in data management or analysis where the data is identifiable to individual participants must be listed in your research protocol as an investigator. Individuals who only have access to de-identified data or results do not have to be listed as an investigator.
There are some exceptions. For example, individuals who distribute recruitment materials, interpreters, professional transcriptionists, etc. may not have to be listed as an investigator on your study. Please discuss the details of your proposed research with the HSPP staff to help determine who needs to be listed on the IRB application and, therefore, complete any IRB requirements for investigators.
For every study submitted to the IRB, one individual who is member of the MSU Denver faculty or staff must be designated as the Principal Investigator (PI). The PI has primary responsibility for the development and implementation of a research protocol and has ultimate accountability for the ethical conduct of the research. Investigators may be identified in the initial IRB application or added later to an approved study through an amendment application. It is the PI's responsibility to ensure that no individual on their research team interacts with participants for the study or is given access to identifiable private data until they are approved by the IRB as an investigator.
The Collaborative Institutional Training Initiative (CITI) is an online training program developed and published by the University of Miami. All IRBs are tasked with ensuring that the investigators involved in a proposed study are qualified to conduct the research in an ethical manner. Like many institutions, MSU Denver subscribes to the CITI Program and requires investigators in human subjects research studies to complete training modules designated by our institution.
The HSPP has outlined required training modules for researchers involved in social and behavioral research or in biomedical studies. Every investigator (researchers involved with human subjects) listed in your Initial Review Form must complete the required basic course before the study will be reviewed. This basic course includes information on the history of human subjects research, the development of ethical guidelines, risks to participants, informed consent, and protecting privacy and confidentiality. Completion of the basic course is valid for three (3) years, and researchers have an opportunity to complete a refresher course to maintain their certification. Find out how to register with the CITI Program here.
Collaborating researchers from other institutions may submit an alternate training to the MSU Denver CITI required modules. Alternate training must be equivalent to or exceed the MSU Denver required training and must be approved by the HSPP. MSU Denver faculty, staff, and student researcher should complete our training modules.
Maybe. Read the letter carefully for the specific IRB determinations and instructions, as IRB correspondence can reflect a variety of possible determinations. For new studies under review, an IRB determination letter sent to the Principal Investigator may reflect any of the following decisions:
- Determination of not human subjects research. This letter informs you that the proposed project does not meet the federal definitions of research and/or involve human subjects. Therefore, no IRB oversight is warranted and the project may begin.
- Determination of exempt status. Proposed human subjects research that is determined exempt from the regulatory requirements must meet specific conditions and are still subject to institutional standards. An IRB determination of exempt status has no expiration date and you are free to start your study. Exempt studies do not require IRB continuing review and do not need to be formally closed. Amendments to exempt studies require review and approval before any changes can be implemented. Any unanticipated problems or new information that may impact participants also must be submitted to the IRB for review.
- Approval of proposed human subjects research. If your study is approved by the IRB either through an expedited process or by the convened Board, your determination letter will specify all the materials used to make this determination and any specific approvals, such as a waiver of documentation of consent. Pay attention to the versions of the approved materials (your protocol, consent form, etc.). Only the final approved versions of your study materials should be used. IRB approvals are generally granted for a year at a time and your approval expiration date will be clearly marked in the determination letter. As the PI, you are responsible for either submitting for continuing review or closing out your study with the IRB before your approval expires.
- Request for modifications or clarifications. This letter informs you that the reviewer(s) needs more information about your study or requires some revisions to your submission materials before IRB approval may be granted. This means you cannot start any research activities involving participants, including recruitment. You should read and carefully address each item in the letter. If you do not understand the requests or need assistance on how to respond, contact the HSPP staff for help.
- Referred to the convened Board for review. Some studies begin the review process with only one or two IRB members (i.e. expedited review), but need to be referred to the convened Board. If the initial reviewer(s) determines that risks to participants are greater than minimal (i.e. more than those we encounter in daily life), if subjects may be especially vulnerable, or if more input and expertise is needed, your study can be referred to a convened IRB meeting for review. You cannot start any research activities until the full IRB approves your study. The letter will inform you of the details of this review and if any information is needed from you.
- Tabled. Studies that go to the convened IRB may not be able to be reviewed at the assigned meeting and may be tabled for the next meeting. The IRB may need more information in order to review your study or they may simply have run out of time. If your study is tabled, you will be informed of the date of the next IRB meeting and if any additional information is needed. In some cases, you might be asked to be available at that meeting to answer questions directly about the research. The determination letter will explain any details to you.
- Disapproval of proposed human subjects research. Only the convened IRB can determine to disapprove a proposed study. This decision is not made easily and the IRB usually works with researchers through several rounds of revisions, meetings, and discussions before a disapproval determination will be made. 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 conduct any 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.
You should also note that all official letters from the IRB regarding reviews and determinations are signed by the IRB Chair. However, the IRB Chair acts as the signatory authority for the Board, but may not be individually involved in the review of your study or involved in preparation of the determination letter. Determination letters are provided to the PI via email from the HSPP. If you have questions, concerns, need corrections on, or assistance with any IRB determination letter you receive, please contact the HSPP at email@example.com or 303-352-7330.
When your study undergoes IRB review, the IRB reviewer may ask for additional information or revisions to your submission materials before approval can be granted. When these are needed, the PI is sent a letter detailing the requests. The modification request letter will also specify that revisions must be submitted within 25 days of the date of the letter to remain under IRB consideration. Because of the high volume of submissions, reviews for studies cannot be pending indefinitely and researchers are expected to respond to IRB requests in a timely manner. If you receive a letter requesting clarifications or revisions to your submission and do not respond within 60 days, your study may be administratively withdrawn from the IRB review process and your materials will need to be re-submitted as a new study.
However, there may be circumstances where you need more time to address the IRB requests (for example, if you are collaborating with researchers from multiple institutions or you are awaiting specific documentation from another office or organization). If you anticipate that will need more time than the 25 day limit, please communicate with the HSPP staff to ensure that they are aware of your circumstances, so they can extend the deadline accordingly.
Identifiable information is any information that may reasonably be expected to identify, contact, or locate a single person, or to identify an individual in context. The most common identifier is a name; but, identifiers can also be birthdates, telephone numbers, biometric identifiers (like finger prints or voice prints), and full face photographic or video images. Numbers assigned to individuals are considered identifiers, including social security numbers, medical record numbers, certification/license numbers, and student ID numbers (900 numbers). For research involving the use of the internet to collect data, email addresses, Web Universal Resource Locators (URLs), and Internet Protocol (IP) address numbers are all identifiable information.
An individual's title may be sufficient to identify them depending on how it is used or presented. For example, a quote attributed to the "MSU Denver IRB Chair" would be easily identifiable to an individual; where a quote from "an IRB Chair at a higher education institution" would not.
If you are collecting information about an individual's age, all elements of dates (except year) are identifiable. So, if you ask an individual to provide his/her birthdate on a survey, you are collecting identifiable information. If you ask him/her to provide the year of their birth, their age in years, or to select an age category (e.g. 25 - 35 years of age), this information alone is not generally identifiable.
Information may be identifiable alone or in combination with other available information. When you are collecting detailed demographic information, you should carefully assess whether any combination of that information may be sufficient to identify an individual.
Data or information that is linked to identifiers through a coding system is also considered identifiable.
No. MSU Denver's 900 numbers are considered identifiers and are protected under the Federal Education Right to Privacy Act (FERPA). No part of a 900 number may be used for the purpose of coding or linking research participants with their data.
900 numbers are treated the same as any identifier (names, birthdates, social security numbers, etc.) in a proposed research study. If you collect 900 numbers, the purpose and risks of collecting this information should be clearly explained in both your Investigator Protocol and in your consent information. Students would need to give written, signed permission for collection of this data. And, the researchers would need to put appropriate measures in place to protect the privacy of subjects and the confidentiality of the data.
You can find out more information on FERPA from the Office of the Registrar.
If your study is already approved by the IRB and you decide to make any changes or additions, you will need to complete and submit a modification (using HRP-213: Modification). This application form allows you to inform the IRB as to the current status of your study and to describe any proposed changes for review.
If your proposed changes involve your research protocol, you will need to include an updated protocol. Any revised supporting materials, such as consent forms, recruitment materials, or data collection instruments (e.g. surveys, questionnaires, etc.) should also be included in your amendment submission packet. When you revise your protocol or other materials, be sure that you are modifying the approved version (and not an earlier draft). Use track-changes, highlight revisions, and/or include a cover letter to direct the IRB reviewer to the modifications. No proposed changes can be implemented in your study until IRB approval is granted for the amendments.
This same application form is used if you need to add new investigators to your study. You will need to confirm with the HSSP that any new investigator has completed the required CITI training or you should provide a copy of the CITI completion certificate.
It depends. IRB oversight is required when the existing data (documents, records, specimens, etc.) is "identifiable private information." That is, the dataset is not publically available and subjects (the individual sources of the data) can be identified directly or indirectly by the researchers.
In reviewing a research proposal that involves identifiable private information, the IRB needs to be informed as to how the existing data was originally collected (e.g. for nonresearch purposes, from a previous research study, etc.) and under what conditions, if any, this information was provided. The researchers must demonstrate that they have the appropriate permissions to access and use this data for the proposed study. This can include secondary use of a researcher's own data or specimens. Researchers must carefully outline a data management plan to inform the IRB how the data would be treated (e.g. de-identified, coded, etc.) during the analysis and dissemination of results.
If the existing dataset is publically available or is not identifiable (either directly or indirectly) to individuals, no IRB oversight is required. Please contact the HSPP with any questions on IRB oversight and requirements for research using existing data sets.
The HSPP periodically evaluates the needs of the Institutional Review Board and seeks to add new members as needed. The Institutional Official, as head of the HSPP, is tasked with appointing IRB members and the IRB Chair. When a position becomes available the Institutional Official works with current IRB members and HSPP staff to identify faculty, staff, students, or community members who would meet the needs of the committee.
Federal regulations (45 CFR 46) require an Institutional Review Board 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
- members who are 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 IRB membership by the federal guidelines, the HSSP is also interested in having representation from a variety of disciplines within the University. Members are provided ongoing education and professional development training in human subjects research oversight.
If you are interested in becoming a member of the IRB, please contact HSPP staff at firstname.lastname@example.org or (303) 352-7330.