OPHS-IRB QUESTION AND ANSWER
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 involving human subjects. This list will include the Principal Investigator as well as Co-Investigators, collaborating investigators, study coordinators, etc.
Can a student be the Principal Investigator?
No...At UNTHSC, student investigators are required to have a faculty member as the principal investigator of record.
The length of protocol review depends on adequacy of the information given to the OPHS and IRB. Incomplete or unclear information or research documents may delay the review process. The IRB as well as OPHS must have sufficient time to carry out an effective and accurate review to ensure subject safety and compliance with federal regulations.
For Exempt category research, review can range from 1-5 business days depending on the information given. In most cases, Expedited review can be completed within 5 - 7 working days, unless needed information is missing or incomplete.
Full Board protocols are subject to a longer time period as they are reviewed by a convened Board. 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. This type of review may take from 1-7 business days depending on the completeness and accuracy of given information.
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 OPHS for guidance on the information and documents needed to conduct an effective review. In addition, OPHS offers investigators a unique service to facilitate the IRB review process. Investigators may request a "pre-review" from OPHS staff before formally submitting to the IRB. Pre-review can identify potential questions and issues that may arise during the review process. Any issues can then be addressed by the investigator prior to IRB submission and may quicken the formal review and approval process. If you are interested in having a pre-review done, please contact us through our main office number or the appropriate OPHS Human Research Protection Coordinator (if known). Pre-review is a courtesy service and is dependent on coordinator availability. Turn-around time for pre-review may take up to 5-7 business days.
Note: Pre-review does not guarantee final formal IRB approval or that no issues or concerns may arise during IRB review. Pre-review is a "guidance" service offered by OPHS. It is the IRB that makes final determination.
Will notification of approval come back to me?
OPHS sends IRB Board Actions and documents to the principal investigator or research coordinator (when applicable).For student-oriented research, Board Actions are normally sent to the faculty advisor (principal investigator) . However, if the student investigator would like to receive Board Actions or IRB approved documents, please indicate to OPHS staff the appropriate mailing address or availability for pick up.
Will OPHS send notification of upcoming Continuing Review to the Principal Investigator?
On behalf of the IRB, OPHS does send out a courtesy letter reminding principal investigators about upcoming continuing review. Notification is sent out 1-2 months before set study expiration date. However, it is the principal investigator's responsibility (not the IRB) to keep up with every aspect of their study including when to a submit progress report for continuing review.
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 who are employed by UNTHSC or UNT Health. Study investigators and key personnel employed by an external organization do not need to submit a COI to the IRB.
Can off-site investigators or key personnel submit their Conflict of Interest forms to OPHS via fax or email?
Faxed COI documents are acceptable, but "per" or "on behalf" signatures are not. All documents (originals, copies, or faxes) requiring key personnel signatures must have that person's signature.
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 ensure subject's autonomy and minimize risk, conflict of interest must 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.
What if I am involved in a research study subject to multi-site IRB review (i.e. JPS as well as UNTHSC)?
If you are newly submitting a protocol for review and also require review from another IRB, OPHS recommends you submit first your protocol to UNTHSC IRB. OPHS Policy, guided by federal regulations, states those involved in human subject research and working for UNTHSC (or will be presenting the research under the UNTHSC name) are subject to UNTHSC IRB review. Once the protocol has been reviewed and approved here, it can be submitted for IRB review elsewhere.
OPHS will work with the investigator and other participating IRBs (when needed) during the process of a multi-site review. In particularly, address any modifications to the protocol. If an investigator needs to amend their protocol upon request of another IRB, submit a request for modifications with the appropriate documents. If the information conflicts with UNTHSC IRB standard language or policy, please contact OPHS staff for assistance.
In some cases you may need to get the approval of the outside IRB first before submitting to us. We recommend this if the majority of the research is being conducted at that institution and UNTHSC employees are involved in a smaller role (for example, data analysis). OPHS staff can help you decide which approach will be best. In all cases, UNTHSC faculty and staff should not participate in any research activities related to the project until it is approved by the UNTHSC IRB.
Do I need UNTHSC IRB approval if my project has received approval at another IRB where I am conducting some of my research?
Under federal regulations and guidance, UNTHSC IRB policy states investigators working for UNTHSC or publishing using the UNTHSC name are required to submit research involving human subjects for UNTHSC IRB review. Submission is particularly important if the majority or some of the research elements will be conducted at UNTHSC or UNT Health.
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 IRB category determination and approval from that institution. For Expedited or Full Board category research, submit a protocol synopsis along with the appropriate research-related documents (e.g. questionnaire) for proper UNTHSC IRB review and determination. For Exempt category research, fill out and submit the Exempt application form available at our website.
On a case-by-case basis, UNTHSC IRB may acknowledge and accept other IRB determination of research originally approved elsewhere.
For ongoing studies subject to multi-site review and approval, please submit a copy of each IRB stamped consent document (if differ from UNTHSC) to have on file.
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 IRB. ALL of the following requirements must be met to waive informed consent:
- The research presents no more than minimal risk to subjects
- The waiver will not adversely affect the rights and welfare of the subjects
- The research could not practicably carried out without the waiver; and
- Whenever appropriate, the subjects will be provided with additional pertinent information after they have participated in the study.
The IRB may still require a summary or oral description of essential research information be disclosed to the subject.
How do I know when to submit a HIPAA waiver with my Exempt or Expedited IRB application?
A HIPAA waiver is necessary if your study will involve using, collecting or analyzing protected health information AND HIPAA authorization cannot be practicably obtained from the subject. Some examples include, but not limited to, a retrospective chart review or a survey asking health information where a waiver of informed consent has been granted. For more information about HIPAA authorization waiver, visit "Informed Consent Guidelines" link or call OPHS staff.
Do I always have to use an IRB-stamped Informed Consent?
According to federal guidance and UNTHSC IRB policy, 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 is being used. In addition, it may minimize the risk of study personnel using the wrong consent form if various versions exist.
Please contact OPHS if you need further clarification or guidance regarding this issue.
How do I request a change/addition to key personnel?
To change/add key personnel to the protocol, submit a signed Application for Change of Key Personnel. In addition, submit certification of CITI and conflict of interest forms (for Expedited and Full Board studies) for EACH added key personnel. Protocol revision is not necessary except in the case of a change in the Principal Investigator.
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 in 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 chair to be no more than minimal risk or does NOT increase the current risk level of the study. Non-substantial modifications (e.g. revise PI 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 chair 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 and OPHS staff make this initial risk assessment and determination to bring the protocol amendment to full board review. Previously IRB-approved Expedited category study (minimal risk) can also be subject to Full Board review if a 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.
How do I submit protocol modifications after IRB approval?
Send in a signed memorandum by the Principal Investigator briefly explaining and listing the modifications/amendment you want to incorporate to the protocol. The memo must include protocol name and IRB number. With the memorandum, attach "track changes" 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.
"Track changes" can be accessed in MS word 2003 by going under "Tools" and select "Track Changes". You may also want to display the track changes toolbar by going to "View" and "Toolbars". Once you have printed out the track changes version, you may "Accept All Changes" to print out a clean version. For those with MS word 2007, you may go under the "Review" ribbon and click "Track changes".
For more information on protocol modifications, please visit "Protocol Amendments" link found in this website.
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 OPHS or IRB review. Protocol modification(s) must be reported to the OPHS as certain changes can increase risk to subject or change the type of review (Expedited or Full Board). To report a change in Exempt category research, the principal investigator needs to submit a signed memo describing the intended modification. Often times, minor changes only require a note to file and OPHS acknowledgement with no IRB board action. However, if the OPHS Director and staff assess modifications to increase risk to subject or compromise eligibility criteria for Exempt category, the study is given to the IRB chair for review. The principal investigator may be asked to provide additional information for proper IRB review.
How do I report a protocol deviation or violation to the IRB?
The principal investigator should promptly report to the IRB a protocol deviation or violation within 10 business days of when the event was discovered by sending in a signed memo (PI) describing the event AND a completed Protocol Violation Reporting Form (see "Forms"). The memo should also include a corrective plan or solution for preventing such event from occurring again. The protocol deviation or violation will be reported to the convened board for consideration and review regardless of the type of category originally approved under. Any board findings or notifications will be sent to the principal investigator.
For more guidance on this topic, please visit the "Guidance" portion of our website or click here.
In accordance with federal regulations, it is necessary for all individuals identified as "key personnel" 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 include written verification that each of the key personnel has successfully completed the appropriate educational tutorial/program designated by the UNTHSC Office for the Protection of Human Subjects (OPHS) through the CITI (Collaborative IRB Training Initiative) Course in the Protection of Human Subjects, with links located on the UNTHSC IRB web site. For CITI training log-in instructions, please click here.
Current UNTHSC IRB Policy upholds CITI certification for three years. Key personnel should renew their certification in order to maintain research studies active. This can be done through a refresher course on the CITI website every two 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 CITI help desk for assistance found on their "contact us" page. UNTHSC does not maintain the CITI website.
How do I register on the CITI website to complete CITI training (for first time users)?
If you are a first-time CITI trainee, you must complete the BASIC CITI course, which is a series of short modules regarding human subject protection. This certification is valid for 3 years.
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 Basic CITI training course, please click here.
How do I log into CITI and take the REFRESHER course (for NON-first time CITI trainees)?
Recall that CITI (Basic) training is valid for only three years. After three years, a brief "refresher" course can be taken through the CITI website to renew CITI certification. This "refresher" course will need to occur every two years.
To log on, go to the CITI main page...log in using your CITI User ID and Password you set up for your initial CITI training, then click on
Add a course or update your learner groups for University of North Texas Health Science Center
Once in there, scroll down to "Question 2" which references the Refresher course options...Select an Option (Biomedical, Social Behavioral, etc.) and follow the instructions from there.
For additional instructions on how to log into CITI and take the REFRESHER CITI training course, please click here.
What documentation of human subject education training do I need to submit for collaborating non-UNTHSC or UNT Health investigators?
Acceptable training for outside investigators and study personnel includes CITI, NIH, and institutionally based "research with human subjects" programs. Please submit hard copy documentation with your IRB application or Application for Change in Study Personnel. OPHS will not be able to verify completion of CITI training online for investigators that are not affiliated with UNTHSC. If you are having trouble acquiring a hard copy of the training certificate from the investigator, please contact us to discuss.
How do I submit a protocol to the IRB?
Please submit all protocols to the Office for the Protection of Human Subjects located in CBH Suite 160 during business hours.
Exempt Review:
(1) Exempt application (with original PI signature)
(2) CITI training Certificates for EACH listed Key Personnel
If applicable...
(3) Informed Consent or Cover Letter
(4) Data collection tools or instruments (survey, questionnaires, etc.)
(5) Recruitment Materials (flyers, emails, advertisements, etc.)
(6) Telephone scripts/oral scripts
(7) Waiver of Written or Documentation of Informed Consent...This may require a Cover or Recruitment Letter. Please contact OPHS staff or view on-line guidance for further assistance.
(8) Waiver of HIPAA Authorization for the use of health information...Please contact OPHS staff for further guidance before submitting the application.
(9) Research Agreements
(10) Letters of permission or cooperation, and/or approvals from other IRBs
Please submit all protocols to the Office for the Protection of Human Subjects located in CBH Suite 160 during business hours.
Expedited Review:
(1) Expedited Review IRB Application (with original PI signature)
(3) Conflict of Interest Form for EACH listed Key Personnel
(4) CITI training Certificates for EACH listed Key Personnel
(5) Informed Consent Form or Cover Letter (in lieu of Informed Consent)
If applicable...
(6) Grant Application
(7) Recruitment Materials (flyers, emails, advertisements, etc.)
(8) Surveys/Questionnaires
(9) Telephone scripts/oral scripts
(10) Assent Forms/Parental Permission Forms
(11) Research Agreements with other institutions for the use of data or specimens
(12) Letters of permission or cooperation, and/or approvals from other IRBs
Please submit all protocols to the Office for the Protection of Human Subjects located in CBH Suite 160 during business hours.
Note that investigators must submit the appropriate amount of hard-copies for proper IRB review. No E-versions of research-related documents will be accepted.
New IRB Full Board Protocol:
(1) Signed Original of the IRB New Protocol Application
(2) Twenty (20) Copies of the following documents:
- IRB New Protocol Application
- Protocol Synopsis
- Informed Consent Documents
- Recruitment ads, flyers, questionnaires, etc.
(3) Four (4) Copies of the following documents:
- Federal grant application (if applicable)
- Clinical Protocol (for Clinical Trials)
- Investigator's Brochure (if applicable and for Clinical Trials
- All Correspondence related to this protocol for the Sponsor
(4) One (1) Copy of the following documents:
- Curriculum Vitae of Principal Investigator
- Conflict of Interest (COI) for EACH listed key personnel on project
- Certificate of Training for Human Subject Research (CITI) for EACH listed key personnel on project
Please submit all protocols to the Office for the Protection of Human Subjects located in CBH Suite 160 during business hours.
Note that investigators must submit the appropriate amount of hard-copies for proper IRB review. No E-versions of research-related documents will be accepted.
Continuing Review for Expedited Review:
(1) Two (2) hard-copies of the following documents:
- Progress Report Form (with original SIGNED copy)
- Protocol Synopsis (current IRB-stamped version)
- CONSENT FORM (current IRB-stamped version)
- Clean ("unstamped") copy of the Consent Form
- Other IRB approved research-related documents (i.e. flyers, questionnaires, etc.)
(2) One (1) hard-copy of the following documents:
- Conflict of Interest forms for EACH listed key personnel
- CITI certificates for EACH listed key personnel
Please submit all protocols to the Office for the Protection of Human Subjects located in CBH Suite 160 during business hours.
Note that investigators must submit the appropriate amount of hard-copies for proper IRB review. No E-versions of research-related documents will be accepted.
Continuing Review for Full Board:
(1) Original SIGNED Progress Report with a CLEAN (hard) copy of EACH Consent Form
(2) Twenty (20) hard-copies of the following documents:
- Progress Report
- EACH Informed Consent (current IRB stamped version)
- Recruitment ads, flyers, questionnaires, etc.
(3) One (1) hard-copy of the following documents:
- CITI for EACH listed key personnel on project
- Conflict of Interest forms for EACH key personnel
Please submit all protocols to the Office for the Protection of Human Subjects located in CBH Suite 160 during business hours.
Note that investigators must submit the appropriate amount of hard-copies for proper IRB review. No E-versions of research-related documents will be accepted.
Full Board Amendment:
(1) SIGNED original memo from the PI requesting protocol amendment. The memo should include the elements or modifications found within the proposed amendment and provide brief justification.
(2) Twenty (20) Copies of the following:
- Signed Memo
- Track changes version of the modified research documents (i.e. informed consent, protocol synopsis, etc.) reflecting proposed amendment
(3) A CLEAN Copy of the modified research document(s) reflecting proposed amendment (to be stamped)
Please submit all protocols to the Office for the Protection of Human Subjects located in CBH Suite 160 during business hours.
Final Report:
(1) One (1) copy of the following documents:
- SIGNED original Progress Report (check final report)
- Current IRB-stamped Informed Consent
When are new full board protocols due?
|
Meeting Date |
Protocol Due |
|
(1st Tuesday) |
(3rd Monday) |
| September 9* | August 18 |
| October 7 | September 15 |
| November 4 | October 13 |
| December 2 | November 10 |
| January 6 | December 8 |
| February 3 | January 20 |
| March 3 | February 16 |
| April 7 | March 17* |
| May 5 | April 20 |
| June 2 | May 18 |
| July 7 | June 15 |
| August 4 | July 20 |
* Denotes holiday conflict with usual schedule
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 it was received.