North Texas Regional IRB: Question and Answer

Frequently Asked Questions for Human Subject Research Investigators

IRB Review Process

Who are considered key personnel?

Can a student be the Principal Investigator?

How long does a review take?

What can I do to help the IRB process move quickly?

Will notification of approval come back to me?

Will Principal Investigators receive notification of upcoming Continuing Reviews?

When do I need to submit Conflict of Interest (COI) statements?

I have a Conflict of Interest. Does this mean I will have trouble getting my study IRB approved?

External IRB Review Process

What if I am involved in a research study requiring multi-site IRB review (e.g., Cook Children’s IRB as well as NTR IRB)?

Do I need North Texas Regional IRB approval if my project has received approval at another IRB where I am conducting some of my research?

What type of documentation do you need from me related to an external IRB’s review and approval?

Consent Process

Is it always necessary to give an informed consent document to study participants?

How do I know when to submit a HIPAA waiver with my IRB application?

Do I always have to use an IRB-stamped Informed Consent?

Protocol Modifications

How do I request a change/addition to research/key personnel?

What is the review process for protocol modifications of already IRB-approved study?

How do I submit protocol modifications after IRB approval?

Do modifications to an already approved Exempt category protocol need to be reported to the IRB?

Reportable Events

How do I report a protocol deviation or violation to the IRB?

How do I report a Serious Adverse Event (SAE) to the IRB?

Human Subject Educational Training Requirement

What is CITI training?

Does CITI training expire?

How do I register on the CITI website to complete CITI training (for first time users)?

What documentation of human subject education training do I need to submit for collaborating non-North Texas Regional IRB investigators?

IRB Submission

How do I submit a protocol to the North Texas Regional IRB?

Continuing Review (of Full Board and Expedited studies)

Minor Modifications to Protocol (not Full Board Amendment)

Full Board Amendment

Final Report

IRB Submission Deadline

When are new Full Board Protocols due?

Are there submission deadlines for new Expedited and Exempt category protocols?

Who Can I Contact for General IRB Questions?

IRB Review Process

Who are considered key personnel?
Key personnel encompass those individuals directly involved in designing the research protocol, conducting informed consent, executing study interventions or procedures, or handling or analyzing data and/or specimens involving human subjects. This list will include the Principal Investigator as well as Co-Investigators, collaborating investigators, study coordinators, etc. back to top

Can a student be the Principal Investigator?
No…Student investigators are required to have a faculty member as the principal investigator of record. back to top

How long does a review take?
The length of protocol review depends on adequacy of the information given to the North Texas Regional IRB. Incomplete or unclear information or research documents may delay the review process. The IRB must have sufficient time to carry out an effective and accurate review to ensure subject safety and compliance with federal regulations.

Expedited and Exempt category research may be submitted to the IRB at any time. Although an exact review time cannot be given (as review times may often depend on the complexity and clearness of the protocol, in addition to the volume of IRB submissions/tasks received), our goal is to ensure we provide review/approval as quickly as possible. Please note that once you submit your project, you will hear from the IRB staff within 1-2 days to confirm receipt and let you know if any key or critical documents, or items needed for review are missing from the submission.

Full Board protocols are subject to a longer time period as they are reviewed by a convened Board, which meets once per month This amount of time is in addition to any protocol modifications, clarifications or revisions that may be requested by the Board before granting approval.

Minor modifications (minimal risk) may be handled in an expedited manner. Typically, this type of review may take potentially 1-3 weeks, depending on the completeness and accuracy of given information. As always, timelines are provided as an estimate only and may change depending upon the volume of IRB submissions/tasks received as well as the completeness of the information provided by the PI/study team. back to top

What can I do to help the IRB process move quickly?
Submitting a clean, accurate, clear and complete protocol “speeds” the IRB review process. Investigators may call the North Texas Regional IRB for guidance on the information and documents needed to conduct an effective review.

For newer investigators, or investigators who have specific questions or need guidance about submitting a study to the IRB, we do offer an “IRB Consultation”. IRB Consultations may be requested at any time, and cover a variety of different topic areas investigators may be curious about. To schedule an IRB Consultation, please complete/submit the NTR IRB’s “Request a Consultation” form.

Occasionally, investigators may request a “pre-review” from the NTR IRB, prior to a formal IRB review of project. Please note that “pre-reviews” are only offered for Full Board (i.e., Greater Than Minimal risk) submissions, and only in cases of projects which present complex or potentially novel processes or procedures. If you are interested in seeing if your project qualifies for a pre-review, please contact us (well before the IRB submission deadline) through our main office number or contact NorthTexRegIRB@unthsc.edu. A reminder that pre-reviews are a courtesy service and are dependent on staff availability.

Note: Pre-review does not guarantee final, formal IRB approval or that no issues or concerns may arise during IRB review/IRB Meeting. Pre-review is a “guidance” service offered by IRB supporting staff. It is the IRB that makes final determination. back to top

Will notification of approval come back to me?
The North Texas Regional IRB sends the IRB determination letter and approved/stamped research documents to the principal investigator or research coordinator/study staff (when applicable) via the electronic submission system (all study staff who have access to the electronic submission should be able to access the Board Action / IRB determination letter and approved/stamped documents). back to top

Will Principal Investigators receive notification of upcoming Continuing Reviews?
Principal Investigators / study staff will receive notifications about upcoming study expirations / continuing review via the electronic submission system. Notification is sent out as a courtesy beginning 2 months before set study expiration date for Expedited studies, and beginning 3 months prior to set study expiration date for Full Board studies. However, it is the principal investigator’s responsibility (not the IRB’s) to keep up with every aspect of their study, including when to submit a progress report for continuing review. back to top

When do I need to submit Conflict of Interest (COI) statements?
Expedited and Full Board protocols require the submission of a signed COI for all investigators and study personnel. IRB COI forms will need to be submitted for all key study personnel at the time of new study submissions, at the time of continuing review, and whenever new key personnel are added onto the project. In addition, researchers must notify the NTR IRB in the event there is a change in their disclosure within 10 business days.

NOTE: This conflict of interest disclosure for the IRB is separate from the Research Conflict of Interest disclosure required by the Institution. back to top

I have a Conflict of Interest. Does this mean I will have trouble getting my study IRB approved?
Having a conflict of interest does not necessarily mean a study automatically will be disapproved. However, the IRB will assess conflict of interest in relation to subject risk. To that aim, accurate and sufficient information regarding the conflict of interest must be provided to the IRB. Note: To ensure subject’s autonomy and minimize risk, the IRB may require that any conflict of interest be clearly and accurately disclosed in the consent form. If the COI alone increases risk (to the point that study risks outweigh the benefits), the Board may find additional provisions or safeguards are needed in order to approve the study. back to top

External IRB Review Process

What if I am involved in a research study subject to multi-site IRB review (e.g., Cook Children’s as well as NTR IRB)?
If you are submitting a new protocol for review and also require review from another IRB, we recommend you first submit your protocol to the North Texas Regional IRB. The North Texas Regional IRB Policy, guided by federal regulations, states those involved in human subject research and working for one of our partnering institutions (such as UNTHSC, JPS, or UNT Dallas), or will be presenting the research under the names of one of our partnering institutions, are subject to North Texas Regional IRB review. Once the protocol has been reviewed and approved by the NTR IRB, it can be submitted for IRB review elsewhere.

The North Texas Regional IRB will work with the investigator and other participating IRBs (when needed) during the process of a multi-site review. If an investigator needs to amend their protocol upon request of another IRB, please submit a request for modifications with the appropriate documents. If the information conflicts with North Texas Regional IRB standard language or policy, please contact us for assistance.

In some cases, you may need to get the approval of the outside IRB first before submitting to the NTR IRB. We recommend this if the majority of the research is being conducted at that institution and personnel at an NTR IRB partnering institution are involved in a smaller role (for example, data analysis). The North Texas Regional IRB staff can help you decide which approach will be best. In all cases, personnel at NTR IRB partnering institutions (employees, faculty, staff, students, residents, etc.) should not participate in any research activities related to the project until it is approved by the North Texas Regional IRB. back to top

Do I need North Texas Regional IRB approval if my project has received approval at another IRB where I am conducting some of my research?
Per federal regulations and guidance, North Texas Regional IRB procedures state investigators working for one of our partnering institutions, or publishing using one of our affiliate’s names (e.g., student research, etc.), are required to submit research involving human subjects for review and approval by the North Texas Regional IRB. Submission is particularly important if the majority or some of the research elements will be conducted at UNTHSC, JPS, UNT Dallas, etc. back to top

What type of documentation do you need from me related to an external IRB’s review and approval?
If approval has been granted at another IRB, please submit evidence of IRB approval and IRB category determination from that institution. Please submit the IRB-approved version of the protocol synopsis along with the other, appropriate research-related documents (e.g., questionnaires, consent forms) for proper North Texas Regional IRB review and determination.

On a case-by-case basis, North Texas Regional IRB may acknowledge and accept other IRB determinations of research originally approved elsewhere. Please contact the NTR IRB office to discuss any specific scenarios or questions.

For ongoing studies subject to multi-site review and approval, please submit a copy of each IRB stamped consent document (if different from the North Texas Regional IRB) to have on file. back to top

Consent Process

Is it always necessary to give an informed consent document to study participants?
Federal regulations require investigators to obtain subject consent to research unless informed consent has been specifically waived by the North Texas Regional IRB. ALL of the following requirements must be met to waive informed consent [45 CFR 46.116 (f)(3)]:

(1) The research presents no more than minimal risk to subjects;

(2) The research could not practicably be carried out without the requested waiver or alteration;

(3) If the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format;

(4) The waiver will not adversely affect the rights and welfare of the subjects; and

(5) Whenever appropriate, the subjects will be provided with additional pertinent information after they have participated in the study

It is important to note that numbers (1), (2), (3), (4) and (5) must all apply and must be cited as justification for waiver of informed consent.

An example where a waiver of informed consent can be granted is for a retrospective chart review, or a secondary review of data that were collected for another purpose.

In addition to the above, the regulations allow, under specific conditions, to waive the requirement to obtain written informed consent (also known as a “waiver of documentation of informed consent”). To grant this, the study must meet one of the following criteria [45 CFR 46.117(c)(1)]:

That the only record linking the subject and the research would be the informed consent form and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject (or legally authorized representative) will be asked whether the subject wants documentation linking the subject with the research, and the subject’s wishes will govern;
That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context; or
If the subjects or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm, that the research presents no more than minimal risk of harm to subjects and provided there is an appropriate alternative mechanism for documenting that informed consent was obtained.

Note: The North Texas Regional IRB may still require a summary or oral description of essential research information be disclosed to the subject under this type of waiver. Examples of studies which may qualify for a waiver of documentation of informed consent is a minimal risk/de-identified online survey or studies involving deception or incomplete disclosure of study purposes and aims. back to top

How do I know when to submit a HIPAA waiver with my IRB application?
A HIPAA waiver is necessary if your study will involve using, collecting or analyzing protected health information (or individually identifiable health information) AND HIPAA authorization cannot be practicably obtained from the subject. Some examples include, but are not limited to: a retrospective chart review, or a survey asking for health information where a waiver of informed consent has been granted. For more information about HIPAA authorization waivers, visit “Research HIPAA Guidelines” link or contact the North Texas Regional IRB. back to top

Do I always have to use an IRB-stamped Informed Consent?
According to federal guidance and North Texas Regional IRB procedures, investigators need to use the most current IRB-stamped informed consent during the consent process. This not only indicates that the board has officially reviewed and approved the consent form, but provides documentation that an approved consent form is being used. In addition, it may minimize the risk of study personnel using the wrong version of a consent form, if various versions exist. There may be instances where the IRB allows researchers to use the most recent IRB-approved (unstamped) version of other research documents (that are not related to the consent process) given the nature of document distribution (e.g., social media post) or formatting (e.g., standardized/copyright survey instrument). Please contact the NTR IRB for additional guidance regarding when it is permissible and appropriate to do this.

You may also reach out to the North Texas Regional IRB if you need further clarification or guidance regarding this issue. back to top

Protocol Modifications

How do I request a change/addition to research/key personnel?
To change/add research personnel to the protocol (i.e. individuals deemed to be engaged in human subject research), submit a signed Application for Change of Key Personnel. In addition, submit certification of current, completed CITI training and NTR IRB conflict of interest form (for Expedited and Full Board studies) for EACH added research personnel. When adding undergraduates as key, please contact the NTR IRB Office for additional guidance and instruction on what other documents are needed.

Updating the protocol synopsis to reflect current key personnel is not necessary for studies which will be undergoing a continuing review, except in the case of a change in the Principal Investigator. Please note that for studies that do NOT undergo a continuing review (such as Exempt category studies and certain Expedited studies), the protocol synopsis should be updated appropriately at the time of the key personnel change amendment to reflect all current key study personnel. back to top

What is the review process for protocol modifications of already IRB-approved study?
Review of protocol modifications can be conducted in two different ways: Expedited or Full Board.

Federal regulations allow for “expedited” review of minor changes to previously IRB approved research. Under expedited procedures, the IRB Chair, or one or more experienced IRB members designated by the Chair, carry out the review. To qualify for this type of review process, protocol modification(s) must be deemed by the IRB to be no more than minimal risk or does NOT increase the current risk level of the study (i.e., does not increase risk to study participants). Non-substantial modifications (e.g., a request to revise the PI’s contact number) usually fall under this type of review. However, if the list of modifications becomes extensive or complex, regardless of initial minimal risk determination, the IRB may consider it necessary for a Full Board review.

Protocol modification(s) or amendment(s) that are greater than minimal risk or add/remove a component which can increase subject risk are brought to a convened board for review. The IRB Chair makes this initial risk assessment and determination to bring the protocol amendment to full board review. A previously IRB-approved Expedited category study (minimal risk) can also be subject to Full Board review if a proposed protocol modification or amendment increases risk. Some examples of Full Board amendments may include, but are not limited to: an addition of a study arm, randomizing subjects, surveying children about sensitive questions, withdrawing medication, or increasing drug dosage.

Principal Investigators must keep in mind that ALL protocol modifications must be reviewed and approved by the IRB before implementation.

For more information on protocol modifications, please visit “Protocol Amendments” link found in this website. back to top

How do I submit protocol modifications after IRB approval?
Submit (via the electronic submission system), a signed memorandum by the Principal Investigator, a brief explanation, and a list of all the modifications/amendment you want to incorporate to the protocol. The memo must include protocol name and IRB number. With the memorandum, attach a “track changes” (red line) copy of the appropriate documents (protocol synopsis, informed consent, recruitment email, etc.) reflecting those modifications/amendment being requested. In addition, include a clean version of the modified documents. (Once approved, these clean documents will be stamped reflecting IRB approval).

“Track changes” can be accessed in MS word by going under “Review” / “Tools” ribbon and select “Track Changes”. Once you have printed out the track changes version, you may “Accept All Changes” to print out a clean version.

For more information on protocol modifications, please visit “Protocol Amendments” link found in this website. back to top

Do modifications to an already approved Exempt category protocol need to be reported to the IRB?
Yes…Exempt category research means that it is “exempt” from Full Board review but not necessarily from North Texas Regional IRB review. Protocol modification(s) must be reported to the IRB as certain changes can increase risk to subjects or change the type of review (Expedited or Full Board). To report a change(s) in Exempt category research, the principal investigator needs to submit a signed memo describing the intended modification(s). .If the North Texas Regional IRB assesses the modifications to increase risk to subjects or to compromise the study’s eligibility criteria for Exempt category, the study is given to the IRB Chair/Designated Reviewer for further review and reclassification (Expedited vs. Full Board). The principal investigator may be asked to provide additional information for proper IRB review. back to top

Reportable Events

How do I report a protocol deviation or violation to the IRB?
The Principal Investigator should promptly report to the North Texas Regional IRB a protocol deviation or violation within 10 business days of when the event was discovered. The report should describe the event and the PI’s risk assessment of the event (including the rationale for their assessment). Additionally, a corrective plan or solution for preventing such an event from occurring again should be included in the report. Researchers can provide the IRB with all the necessary information by either completing and submitting the Protocol Deviation / Violation Form located on the NTR IRB Forms webpage, or submitting a signed memo by the Principal Investigator, containing the aforementioned information.

For additional guidance, please refer here. back to top

How do I report a Serious Adverse Event (SAE) to the IRB?

The Principal Investigator should promptly report to the North Texas Regional IRB an SAE that occurred for a study participant, within 10 business days of notification of the event. Please note that both on-site (internal events/SAEs occurring for study participants enrolled under a NTR IRB affiliate) and off-site (external events/SAEs occurring for the same study, but for study participants enrolled by a different study site, or non-NTR IRB affiliate) will need to be reported to the NTR IRB. Forms for both On-Site and Off-Site SAEs are available on the NTR IRB website, and below:

NOTE: If the event resulted in death (regardless of whether the event is initially assessed as related to the study), ol, a message must be sent via the electronic submission system (using Project Mail) within 24 hours of notification of the event. This e-mail must contain the following information:

IRB Project #
Principal Investigator
Project Title
Subject’s Initials, Gender and Age
Date and Time of Event
Brief Description of Event
Investigator’s Initial Assessment of Relationship of SAE (death) to the Study

Human Subject Educational Training Requirement

What is CITI training?
In accordance with federal regulations, it is necessary for all individuals identified as “research / key personnel” (i.e. interacting with human subjects directly or indirectly through their data) on a research project involving human subjects to complete educational training on the protection of human research subjects.

When submitting a protocol for IRB review (both new and continuing review), the Principal Investigator must verify that each of the research personnel has successfully completed the appropriate educational tutorial/program designated by the North Texas Regional IRB through the CITI (Collaborative Institutional Training Initiative) Course in the Protection of Human Subjects, with links located on the IRB web site. For general information on Human Subjects Research training, please click here. For CITI training log-in instructions, please click here. back to top

Does CITI training expire?
Current North Texas Regional IRB Policy upholds CITI certification for three years from the date of completion. Everyone will complete the CITI Human Subjects Research (Basic Course) Training every three years. If you are also subject to other IRB reviews (at different institutions), please check with them regarding their policy on educational training for human subject research as it may differ from ours.

If you encounter any problems with CITI, contact the CITI help desk for assistance found on their “contact us” page. The North Texas Regional IRB does not maintain the CITI website. back to top

How do I register on the CITI website to complete CITI training (for first time users)?
Everyone will complete the CITI Human Subjects Research (Basic Course) Training

To do this, visit the CITI main page at https://www.citiprogram.org/default.asp and create a new CITI Username and Password. For additional instructions on how to log into CITI and take the CITI Human Subjects Research – Basic Course, please click here. back to top

What documentation of human subject education training do I need to submit for collaborating non-North Texas Regional IRB investigators?
Acceptable training for outside investigators and study personnel includes CITI, some institutionally based “research with human subjects” programs, in addition to other appropriate Human Subject Research trainings (please check with the NTR IRB if you are unsure of whether or not your training will be accepted). Please submit the training transcript /evidence of training with your IRB application or Application for Change in Study Personnel. North Texas Regional IRB will not be able to verify completion of CITI training online for investigators that are not affiliated with UNTHSC, JPS, or UNT Dallas. It is highly recommended to submit a transcript of the completed Human Subjects Research training modules for all external collaborators. If you are having trouble acquiring a copy of the training certificate from the investigator, please contact us to discuss. back to top

IRB Submission

How do I submit a protocol to the North Texas Regional IRB?
Please submit all protocols to the North Texas Regional IRB via IRBNet. For additional assistance/guidance on this process, please review the NTR IRB IRBNet User Manual.

Continuing Review for Expedited Review or Full Board projects:

For information regarding submitting a Continuing Review of a Research Protocol, please click here.

Minor Modifications to Protocol (not Full Board Amendment):

For information regarding submitting a modification to a Protocol that is not more than “minimal risk“, please click here.

Full Board Amendment:

For information regarding submitting a Full Board Amendment to a Protocol, please click here.

Final Report:

For information regarding submitting a Final Report, please click here.

IRB Submission Deadline

When are new Full Board Protocols due?
The protocol submission deadline (for complete application packet/kit) is the third Monday of the month (usually 2 weeks) prior to the meeting – see schedule. back to top

Are there submission deadlines for new Expedited and Exempt category protocols?
The review process for Exempt and Expedited category research allows for ongoing protocol submission and approval. There is not a set deadline, and protocol review is conducted in the order the submission was received. back to top

Who Can I Contact for General IRB Questions?

Why, the NTR IRB staff of course! We are always happy to answer your questions and discuss any specific IRB-related issues with you.

You can email us at NorthTexRegIRB@unthsc.edu or call us at 817-735-0409.

Please also visit our “IRB Contacts” webpage to contact a specific person/IRB Compliance Manager. back to top

This page was last modified on December 12, 2023