Frequently Asked Questions
General - Approval - Consent - Post-Approval
What is an Institutional Review Board (IRB)?
Under FDA regulations, an IRB is an appropriately constituted group that has been formally designated to review and monitor research involving human subjects. In accordance with FDA regulations, an IRB has the authority to approve, require modifications in (to secure approval), or disapprove research. This group review serves an important role in the protection of the rights and welfare of human research subjects.
The purpose of IRB review is to assure, both in advance and by periodic review, that appropriate steps are taken to protect the rights and welfare of humans participating as subjects in the research. To accomplish this purpose, IRBs use a group process to review research protocols and related materials to ensure protection of the rights and welfare of human subjects of research. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/institutional-review-boards-frequently-asked-questions
Who serves on the IRB commitee at UD?
Current Committee membership includes Adam Kleinschmit (Chair), Angela Brandel (Secretary), Matthew Schlimm, Cortney Kueter, Lalith Jayawickrama, and Mark Stevens. Election and appointment of new committee members will occur in the Fall of 2021.
What are the IRB requirements for training?
Investigators who are informed that their applications will require Full-Committee Review will be required to successfully complete the CITI program for training in the ethical conduct of research with human participants. While investigators whose applications qualify for Expedited Review are not required to complete CITI (or other) training by the UD IRB, it is highly recommended.
May an independent IRB review a study to be conducted in an institution with an IRB?
Generally, no. Most institutional IRB have jurisdictions over all studies conducted within that institution. An independent IRB may become the IRB of record for such studies only upon written agreement with the admnistration of the institution or the in-house IRB.
How do I know if I need IRB approval for my research?
Begin by reviewing the following decision tree put together by Iowas State University for determing if your project constitutes "research" and if your project requires IRB approval.
When do I need to apply for IRB approval for research involving human subjects?
Investigators must apply for and receive written IRB approval BEFORE any subject recruitment, data collection, or data analysis can take place. Submitting an application to the IRB committee does NOT grant investigators the right to begin contacting human subjects regarding the study.
The IRB meets once a month in fall and spring semesters, and does not meet over the summer. Applicants should allow at least two weeks for the committee to review their materials, respond to questions, and provide additional items as needed. See the Home page for committee meeting dates.
What if I already started recruiting human subjects, collecting data from them, and/or analyzing that data?
Per federal regulations, IRB approval can NOT be granted retroactively. Any data collected prior to IRB approval cannot be used in the study. Attempts to hide, disguise, or otherwise use data collected prior to IRB approval will be reported to relevant UD administration.
If I am teaching a course in which students may do research involving human subjects, what should I do?
If the research involving human subjects is specific to the outcomes of the course and not intended for further dissemination, does not involve sensitive topics, will not involve vulnerable populations, and involves minimal risk to participants, the instructor should apply to the IRB for course certification. See Forms, Template, Samples / UD IRB - Course Certification Form.
What is the difference between Full and Expedited Review?
A full-committee review is carried out for studies greater than minimal risk to subjects. In a full-committee review, the fully-convened IRB committee reviews the application materials individually, discusses the study as a group, and votes to approve or deny the application.
An expedited review is carried out for studies that involve minimal risk to subjects and fits into an expedited category of research. In an expedited review, the application materials are reviewed by a qualified member of the IRB committee. This member consults with the Primary Investigator if necessary to come to a decision about the approval of the study.
I’m fairly certain my research study is considered Exempt based on some things I’ve read online. Do I still have to submit an application to the IRB?
In order for a research study with human participants to be deemed “exempt”, the investigator will still need to submit an application to the IRB, along with study-related materials. Primary Investigators and/or Faculty Advisors can NOT “self-exempt” a research study.
What is informed consent relative to research involving human subjects?
Informed consent involves providing potential human research subjects the information needed to make an informed decision whether or not to voluntarily participate in the research activitites.
As an investigator, you must make sure that the way in which you seek consent from a human research subject gives them sufficient opportunity to decide if they wish to participate in your study. You should minimize the possibility of explicit coercion, as well as more implicit undue influence.
An informed consent document provides a potential participant with the purpose, procedures, risks and benefits, time commitment, how their information related to the study will be maintained, the degree to which their information will be confidential and/or anonymous, and their rights to both agree to and decline participation. This document should provide a potential participant information on where to direct questions and/or concerns, provide contact information for the primary investigator, IRB Committee, and any other relevant individuals and/or organizations. Informed consent is valid for one year after it is signed and the subject should receive a copy of their informed consent.
Do I have to get signed consent from all of my study participants?
The standard expectation is that all subjects will sign a document containing all the elements of informed consent. The informed consent process gives potential subjects a description of the study that is clear and complete enough for the individual to judge whether they wants to participate. The consent form should provide readily understandable information about the type(s) and level(s) of risk potential for participants. See the UD IRB Informed Consent Form Template.
Can minors give consent to participate in research studies?
In research involving minors, a parent or legal guardian must give permission to allow the child to participate in the research. Children who are able to understand information about participation are asked to “assent” to their participation as well. See Forms, Templates, Samples / UD IRB - Assent Form Template.
Do I still have to get signed consent if I'm not collecting any identifying information?
If the study is of minimal risk and there are no individual identifiers (e.g., name, rank, address, username, identification number, etc.) collected, the investigator should still provide all elements of the consent form, with a statement informing the subject that completion and return of the survey is considered implied consent. See Forms, Templates, Samples / UD IRB - Implied Consent Form Template.
What if I want to do research in a primary or secondary school?
In addition to following all state and local guidelines, you must obtain consent from the following individuals (See Forms, Templates, Samples for relevant template items):
- The Administrator of the school district where the research is to be performed.
- The Principal of the school where the research is to be performed.
- The Teacher of the class in which the research is to be performed.
- The Parent(s)/Legal Guardian(s) of the Minor child from whom data is to be collected.
- The Minor child from whom data is to be collected.
Are there special considerations for online surveys?
Sensitive data must be protected as it moves along communication pathways. If using a commercial site (e.g., Survey Monkey), the research should review the site’s security measures for protecting respondent privacy and data confidentiality, as well as provisions about how, and for how long, it will store the data.
Online surveys should allow “no response” as an option for every question. A survey design where one cannot proceed without answering the question is in violation of the respondent’s right to withhold information.
Besides minor children, are there other types of human subjects who require special attention when obtaining informed consent?
Yes. Whenever the potential subjects of research have special features or circumstances that might alter their ability to render informed and voluntary consent to participate in research, the researcher has special responsibilities. These types of potential subjects include, but are not limited to, prisoners, individuals with mental disabilities, individuals with physical disabilities, pregnant women and fetuses, the elderly, the economically disadvantaged, and members of groups whose language skills may pose a barrier to informed consent. The relevance of each of these types and the safeguards required depends on the nature of the research proposed. If you are considering research involving human subjects who will or may be members of these groups, please contact the IRB to discuss.
If my study is approved, but modifications are needed while the study is underway, do I need to file an amendment to the original application?
Any and all changes to an approved research study must be submitted for review and approval prior to implementing the changes in the research study. See the UD IRB Approved Project Modification Form.
If my study is approved, but unanticipated problems involving risks to participants or others occur, when and how must I notify the IRB?
Serious adverse events (such as injury to or death of human subjects) must be reported to the IRB immediately, with a written report by the Primary Investigator within 24 hours of the Primary Investigator becoming aware of the event. Modifications to or discontinuation of the study may be required as a result of said events.