Post Approval Responsibilities
Responsibilities of the PI or the faculty advisor if the PI is a student
Personally conduct or supervise the project by enforcing the protocol as approved by the IRB; The PI/faculty advisor should ensure that no deviations take place from the approved protocol and will immediately report such deviations to the Office of COmpliance within 48 hours
Protecting the rights and welfare of the human subjects
Lead by example - comply with all applicable MTSU policies & procedures, and federal regulations. The PI/faculty advisor MUST maintain detailed record on training and other activities of all of the co-investigators of the approved study
Ensure all of the investigators are qualified (e.g., training are up-to-date, education, expertise) to perform the approved procedures and duties assigned to them during the study;
Updating the Office of Compliance with any changes to the protocol including the list of study personnel;
Prepare and submit reports of adverse events in a timely manner and modifications to the protocol prior to implementing these changes;
Recruit study participants by following the approved guidelines
- all recruitment materials must be approved by IRB prior to posting.
- it is the PI's responsibility to ensure there is no undue coercion or influence when obtaining consent from participants.
Maintain records, including signed consent documents, co-investigator information, recruitment, participant size and other types of documents, for at least three years AFTER the completion of the research;
Submit Progress Reports and Final Reports to the Office of Compliance.
POST APPROVAL PROCEDURES & OBLIGATIONS
The recipient (PI or the faculty advisor (if the applicant is a student) must assume full responsibility that the study will be conducted in the guidelines listed by the research team's approved protocol. Any alteration to the protocol can be done only after obtaining written approval from the IRB or the Office of Compliance. Starting from August, 2015, major changes to the procedures and the instruments may be restricted and the researchers may be be directed to complete a new application. The following are a few procedures and obligations for the researchers in order to keep the protocol active. Depending on the type of protocol, additional restrictions and obligations may be imposed.
The PI or the faculty advisor (if the PI is a student) has to take responsibility of the data collected during the study. All confidential materials need to be secured as proposed in their application. The researchers have to notify the Office of Compliance if there are any breaches or any change of storage location is anticipated. A suitable course of action would be determined upon the researchers' notification. It is mandatory that the researchers store the data in a secure place for up to three (3) years after the study has ended. After this storage time, the investigators MAY destroy the data such that the confidentiality will not be lost.
In addition to the research data, the investigator who is charged with the institutional responsibility is also required to maintain records on the co-investigator(s) of the study, such as role of the investigators, training information & expiration, list of co-investigators and other activities. It is also important to record the dates of addition/removal of the co-investigators to ensure the protocol is always conducted by researchers whose training is up-to-date..
Amendments to Previously Approved Protocols
Currently the "Addenda policy" is being revised and the proposal under review. Please contact the office of compliance (firstname.lastname@example.org) for additional information on creating addendum requests. Also, depending on the category under which the protocol was reviewed and approved, the allowed amendments are also likely to be different.
1. Minor Amendments
Policy in preparation - Addition/removal of investigators, small extensions of participant number and correcting typographical errors to the previously approved documents.
2. Major Amendments
Policy in preparation - addition of a new location for conducting the research activity, minor changes to the instruments, amendments to the informed consent, procedural changes and etc.
Closing a Protocol
An existing protocol can be closed at any time. A mere email notification will suffice for the exempt studies while the investigator must file a final report for expedited and full review protocols. The investigators however should remember that the data collected when the protocol was active needs to be stored in a secure location for up to three (3) years. The data and the location may be subject to OHRP audit any time during this period. Changes in location of the data storage also needs to be notified to the IRB. This is true even after the protocol has been closed or has expired. Click here to know more.
Reporting Adverse Events
All adverse events, such as study-related injuries to the participants and other types of harms that may have happened to the human subjects need to be reported to the Office of Compliance within 48 hours by emailing email@example.com. Other adverse events could include compliance breaches or inadvertent/intentional deviations in the protocol should also be reported. Any event that could potentially place the participant at risk will be deemed as "adverse" and MUST be reported. Subsequent to notifying firstname.lastname@example.org by email,, the researcher MUST submit an Adverse Event Form by providing specifics on the event and what course of action was taken to mitigate the risk(s). The "Adverse Event Form" needs to be completed and submitted within seven (7) days of the event to email@example.com.
Investigator Change Notification
All addition AND removal of investigators should be reported to the Office of Compliance prior to commencing research. The PI or the faculty advisor (if the PI is a student) should submit an Addendum Request to initiate the addition/removal of investigators. Additionally, the new investigator who will be added to the protocol should have completed proper CITI training at the time of the request. Data collected by an individual who is not included in the protocol would not be permissible and may lead to the cancellation of the protocol.
Progress Report and Continuing Review - Expedited and Full Review Protocols
Typically, most IRB approvals for expedited and full member review mechanisms are given for up to one year. At the end of the first year, the investigators can either opt to close the study or to continue the protocol for an additional year. If they choose to close the study, then they will follow the process described above on how to submit a final report. If they wish to continue the study, then they have to submit a request for Continuing Review. The application for a continuing review should be received by the Office of Compliance at least three (3) weeks before the date of initial expiration in order to process the extension in a timely fashion. A continuing review request may be submitted twice for the life of a protocol. After three years, the protocol will automatically expire and a new application needs to be filed. Click here to know more.
Continuing Review of Exempt Protocols
Most exempt protocols approved by the MTSU IRB do not expire as long as the researchers do not deviate from the approved protocol and the study is in good standing. However, the IRB can issue a continuation review on any active exempt protocol to determine if the measures approved in the original protocol are still being followed. If the IRB determines that the methods have deviated from the approved guidelines, then the protocol will be suspended.
CITI Training Status
Required CITI training must be up to date for the entire period of the study while the protocol is active. Although the PI is responsible to ensure if training status is maintained, the co-investigators are also held responsible if training is lapsed during the protocol period.
NOTE: A PROTOCOL CANNOT EXTENDED OR RENEWED ONCE IT EXPIRES.