The below information and processes are taken directly from or guided by the regulatory requirements, state laws and institutional polices. If you do not find the answer to your question below, please contact an IRB Coordinator.
Getting Started with Institutional Review Board (IRB) Approval
Q. What types of projects require IRB approval?
In order for a project to require oversight by the IRB it must meet the regulatory definitions of research AND human subjects. Policy #3.001, “Investigational Activities Requiring IRB Review and Approval” defines activities that must be reviewed and approved by the IRB before the project begins (including recruitment).
- Research is “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.”
Human subject is a living individual about whom an investigator (whether professional or student) conducting research: (i) obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens. Human subject is a living individual about whom an investigator (whether professional or student) conducting research: (i) obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
Q. Who can make the decision of whether I need to get IRB approval?
The decision of whether or not you are conducting human subjects research can be made by the Principal Investigator and whether or not an application for IRB review must be submitted. According to Policy #3.001 titled, “Investigational Activities Requiring IRB Review and Approval” section 3.3 specifies, “Any individual who is unsure whether or not a proposed activity constitutes “research involving human subjects” should contact the HRPP office for guidance.”
Q. What happens if I make the wrong decision?
If the wrong decision is made and IRB approval is required, it may not be granted if the research has already started or been conducted and the determination of IRB applicability was made incorrectly by the investigator.
If you are unsure whether your project requires approval, please review the definitions above or the Human Subject Regulations Decision Charts available through the Office of Human Research Protections.
If your project does require IRB approval, the decision charts may not be used for exemption determinations, expedited review, or continuing review. Certain state laws and institutional policies, not taken into account within the decision charts, may affect review categories and applicability.
Q. When am I required to submit an IRB application?
All proposed research projects involving the use of human participants conducted under the auspices of the University of Nebraska-Lincoln are to be submitted for IRB review BEFORE the research begins. This includes recruitment of study subjects.
Q. I am just doing a simple survey; do I need to submit to the IRB?
Yes, if the survey meets the definitions discussed above. UNL’s Assurance with the Department of Health and Human Services says all research conducted under the auspices of this institution will undergo the IRB review and approval process.
Q. I believe my protocol is exempt. Does it need to be reviewed?
Yes. It is the policy of the UNL IRB that all proposed exempt research is reviewed by the Human Research Protection Program (HRPP) staff for final determination of review level.
Q. I am not collecting any identifying information from a human subject; do I need to file for approval?
Yes. Federal regulations and UNL regulations require that ALL research obtaining information from human subjects either through interaction and/or intervention regardless of it being identifiable be submitted for review and approval.
Q. What is considered identifiable?
The Office of Human Research Protections provides guidance related to whether or not data or biospecimens are identifiable:
- Identifiable: Identifiers are readily accessible within the research records
- De-identified: No identifiers are accessible by members of the study team AND the link has been destroyed.
- Coded: identifying information (such as name or social security number) that would enable the investigator to readily ascertain the identity of the individual to whom the private information or specimens pertain has been replaced with a number, letter, symbol, or combination thereof (i.e., the code); AND a key to decipher the code exists, enabling linkage of the identifying information to the private information or specimens.
- Private information or specimens are not individually identifiable when they cannot be linked to specific individuals by the investigator(s) either directly or indirectly through coding systems. However, several items must be in place for this to be documented by the UNL IRB before research can begin.
- For example, it must be documented in the IRB application that the private information or specimens were not collected specifically for the currently proposed research project through an interaction or intervention with living individuals; and
- the investigator(s) cannot readily ascertain the identity of the individual(s) to whom the coded private information or specimens pertain because, for example:
- the investigators and the holder of the key enter into an agreement prohibiting the release of the key to the investigators under any circumstances, until the individuals are deceased (note that the HHS regulations do not require the IRB to review and approve this agreement);
- there are IRB-approved written policies and operating procedures for a repository or data management center that prohibit the release of the key to the investigators under any circumstances, until the individuals are deceased; or
- there are other legal requirements prohibiting the release of the key to the investigators, until the individuals are deceased.
Q. I am only working with previously collected data; do I need to file for approval?
It depends. Federal regulations require that if the study will use either existing or to-be-collected data, documents, records, pathological specimens or diagnostic specimens from human subjects, must be submitted for review.
Q. My research is based on de-identified tissue samples; do I need to file for approval?
It depends. Research involving the study of existing pathological specimens from participants who cannot be identified, directly or through identifiers linked to the participants, may qualify for an exemption determination or may not be considered human subjects research. For it qualify for an exemption determination, all of the de-identified specimens must exist prior to the start of the research project for this to apply. These determinations can be complex, we encourage you to contact an IRB Coordinator at the earliest possibility to discuss your project.
Q. I will be collaborating with a researcher at another institution; do I need to file for IRB approval at both UNL and the other institution?
Investigators should contact an IRB staff person whenever collaborative or multi-institutional research is planned. Separate applications may be necessary, or an IRB Authorization Agreement may be reached with the other institution. However, this is the decision of the UNL Institutional Official. The Principal Investigator or study staff do not have the authority to enter into agreements or pledge IRB resources (including review) on behalf of the IRB with other institutions or collaborating researchers. Please review the A-Z Guidance Topic Multi-Site Research for more information.
Q. Should I wait until my research proposal has been funded to submit a protocol for IRB approval?
You can wait, but it is best to submit your IRB application soon after your research proposal is submitted to the sponsor. Some sponsors provide only a small window of opportunity to provide the IRB approval materials and you will want to be as prepared as possible when your proposal is funded.
Before/During the Review Process …
Q. How do I submit my application for IRB approval?
All IRB protocols should be submitted through NUgrant. The NUgrant system is easy to use and leads you through the application process step-by-step. You may be asked to upload certain files to accompany your application, such as measures used in the study (surveys, questionnaires, interview questions, etc), recruitment materials (flyers, e-mails, letters, scripts, etc), informed consent/assent forms, grant proposals, approval letters, follow-up materials, etc.
Q. How long does it take to review an application for IRB approval?
Review times vary. The length of time depends on the quality of the IRB application upon submission, the investigator response times and the review level or complexity of the project. At certain times of the year, a large volume of protocols appear in the reviewing queue. All forms are reviewed on a first-come-first serve basis. More complex protocols often take more time and could involve multiple offices outside of Research Compliance Services increasing additional time for final approval to occur.
Q. Who is required to complete the human participants (CITI) training?
All faculty, students, and staff proposing to use human participants in research under the auspices of UNL are required to complete the human participants training offered through CITI. IRB approvals of a proposed research project will be not be granted until this training has been completed and verified.
Q. What if I am only entering data? Do I have to take the whole CITI training?
A provision in the CITI curriculum allows limited research workers to take an abbreviated version to fulfill the training requirement. Limited research workers must meet ALL of the following conditions to be eligible for abbreviated training: 1) no responsibilities in project design; 2) not enrolled as a graduate student at UNL; 3) not UNL faculty; AND must meet at least ONE of the following conditions: 1) very limited independent decision-making in study implementation and data collection; and 2) no role in data collection, but may have access to participant identity and confidential data.
After Approval is Granted …
Q. When should I submit a request to modify an approved protocol?
Beginning January 19, 2018, for both ongoing research under the Pre-2018 Requirements and new research approved under the 2018 Requirements certain changes may or may not be required to be submitted for review prior to implementation depending on the review level of a project.
- Expedited and Full Board: Any change in protocol must be reviewed and approved by the IRB prior to implementation except when an immediate change is necessary to eliminate a hazard to the participants as required under 45 CFR §46.108(a)(3)(iii).
- Exempt: Only the following changes must be submitted for review prior to implementation:
- A change in the scope of the project
- A change that would increase risk to participants
- A change that may alter the category of the original exemption determination
- The project’s exemption falls under an exempt category requiring limited review
- The addition or removal of a performance site
- Change in Principal or Secondary Investigator
- Exempt project only: All other changes not specified above and within a project that is active and has been certified as Exempt do not require review and approval prior to implementation.
More information about changes and how they are reviewed can be found in Policy #12.001, titled, “Request for Change.”
Q. What do I have to do if I need to amend my approved protocol?
All requests for changes must be made through NUgrant via submission of a change request application.
Q. Does approval of a modification for an approved protocol extend the original approval date?
No. The expiration date of the original approval is not changed by the review and approval of a modification.
Q. How do I renew my project for continued approval?
The principal investigator is responsible for ensuring the continued approval of research projects involving human participants. To remind you of this obligation, approximately two months before the approval expires, you will begin receiving notices via e-mail that you need to file for continuing review if you plan to continue this research beyond the one-year approval period.
Q. In the case of an adverse event, unanticipated problem or non-compliance, when am I expected to report this occurrence to the IRB?
The Principal Investigator should report any adverse events, unanticipated problems or non-compliance within 48 hours of when any of the research team members become aware of the incident. A comprehensive list of examples and definitions can be found in Policy #13.001 titled, “Unanticipated Problems Involving Risk and Adverse Events” and Policy #14.001, titled, “Non-compliance.”
Q. Can the IRB temporarily or permanently discontinue a research project as result of an adverse event, unanticipated problem or noncompliance?
Yes. If an adverse event, unanticipated problem, or non-compliance poses an unexpected risk to the participants, or creates an unmanageable issue related to human subjects protection, the IRB may temporarily discontinue a research project until a thorough investigation has been conducted. Depending on the results of the investigation, the IRB may request changes to a research project or permanently discontinue the research project.
What happens to projects after the revised Common Rule goes into effect on January 19, 2018 when…
Q. I have an Exempt research project approved prior to 2018.
Nothing will change for the project. Project will remain under the Pre-2018 regulations. Once the project reaches the 5 year approval period, a new project application will need to be submitted.
Q. I have a current and ongoing research project that was reviewed using the Expedited review method where data collection is on-going.
Nothing will change for the project. Project will remain under the Pre-2018 regulations. A continuing review will still be required for each year.
Q. An ongoing research project approved under the Pre-2018 regulations has progressed to the point that it only involves data analysis, including analysis of identifiable private information or identifiable biospecimens; and/or accessing follow-up clinical data from procedures that subjects would undergo as part of clinical care?
A continuing review will still be required to be submitted, but while processing the continuing review, IRB staff will ensure the project will be transitioned to the 2018 regulations and documented under the appropriate 2018 category.
Q. I have a project that was approved on or after January 19, 2018, using the Expedited review method. Is a continuing review required?
No. An annual update will be required where the IRB can track the status of the project only.
Q. I have a project that was approved prior to January 19, 2018 using the Full Board method of review and data collection is on-going and the project is not greater than minimal risk.
Nothing will change for the project. Project will remain under the Pre-2018 regulations. A continuing review will still be required for each year.
Q. I have a project that was approved on or after January 19, 2018. Will continuing review be required?
If the IRB votes that the project is minimal risk and can be reviewed using the Expedited method, then an annual update will be required each year. If the IRB votes that the project is greater than minimal risk, a continuing review will be required each year.
Q. My project involves deception. How will this be reviewed?
If the project is ongoing prior to January 19, 2018 no changes will be made to the project’s review. If a project is reviewed on or after January 19, 2018 then if the participants are limited to those 19 and older and you disclose that the project involves deception, the project could be categorized as Exempt Category 3 (benign behavioral intervention).
If the project will involves participants under 19 years of age or you’ve chosen not to disclose that there is deception involved, the project will need to be reviewed at the Expedited or Full Board review level.
Note: The categorization would depend on all of the details of the project. This example is to illustrate how the inclusion of minors will still affect the review level.
Q. I have a currently approved Expedited project that will transition to the 2018 requirements. Do I need to worry about consent/re-consent of subjects?
If the institution chooses to apply the new regulations to research that was approved prior to January 19, 2018, which is closed to enrollment and follow-up, the 2018 Requirements for informed consent and waiver of informed consent would NOT to be implemented retrospectively – i.e. subjects would not need to be re-consented with a revised consent form, and the waiver of consent would not need to be reconsidered under the new criteria.
Q. I have a currently approved Exempt project and I want to pay my participants $10 instead of $5. Do I need to submit a change request?
The revised IRB policies affecting Exempt change requests will be effective January 19, 2018 along with the Revised Common Rule changes. Thus, on or after this date, you would not be required to submit this change request if your project was certified as Exempt.
Q. My project is currently approved to include participants 19 years and older but I want to make a change to include participants 18 years old now. Do I need to submit a change request form?
This would potentially change the project category and the type of participants (minors) involved (consent/assent/waiver impact). You would be required to submit a change request form and receive approval prior to implementing this change regardless of the review level (e.g., Exempt, Expedited or Full Board).
Q. I need approval by the end of January 2018. How will my new project be reviewed?
If the project is submitted prior to January 4th 2018, it could be reviewed using the current form and current regulations. If this is the case, the project would have to be approved by January 18, 2018. It could be submitted on the new form starting December 4th. If submitted on the new form and reviewed under the new regulations, it cannot be approved until January 19, 2018.
Q. My new project form is in process and not approved by January 19, 2018?
If a project is submitted on the current form (pre-2018), IRB staff will do everything possible to make sure it is approved before January 19th; however, depending on circumstances of when review occurs, revisions are submitted, etc. it is possible that the project will need to be resubmitted on the new form and reviewed under the new regulations.