Your Ongoing Responsibilities After Your Protocol Has Been Approved
[NOTE: Where this document refers to contacting the IRB, such contacts should usually be done via the CAP system unless an urgent situation requires immediate attention by the IRB Chair or the Assistant Director for Research Compliance.]
Once the IRB has approved your research project, and the protocol has been granted IRB Approval or Exempt Approval, you may begin conducting research.
While the IRB may have granted initial approval for the project, your involvement with the IRB does not end when your project has been approved. You need to communicate with the IRB throughout the entire course of the project. As the Investigator you need to be familiar with your ongoing responsibilities for the conduct of your research and what/when you need to report to the IRB.
- Conduct the research in accordance with ethical guidelines such that the rights and confidentiality of participants are protected and risks to participants are minimized.
- Keep abreast of and conduct the research in accordance to the policies and procedures of the Loyola University Chicago IRB, the published guidelines for the ethical conduct of research relevant to the field of inquiry, as well as state and Federal regulations (For research conducted outside of the USA must be conducted in accordance with any pertinent international regulations).
- Maintain the integrity of the project as it was approved by the IRB by following the procedures and using the materials that were approved by the IRB. This includes using copies of the consent form that have been stamped by the IRB when obtaining signed consent from participants, unless a Waiver has been approved.
- Obtain IRB Approval for any changes to a project or the research materials by submitting an Amendment Application detailing the proposed changes before implementing changes to a project, unless a change is needed in response to an emergency situation.
- Maintain IRB Approval for the entire duration of the project. You must submit Continuing Review Applications to the IRB for all Protocols approved through Expedited or Full Board Review well in advance of each Approval Expiration Date.Exempt Protocols: Protocols that are granted Exempt Approval do not have an IRB Approval expiration date. As such Exempt Protocols do not need to complete Continuing Review each year. The Investigator only needs to notify the IRB each year as to whether the project will continue for an additional year.
- Inform the IRB of any Unanticipated Problems and/or Adverse Events.
- Perform all the procedures to protect the confidentiality and privacy of participants as described in the protocol application and consent forms. This may include following the procedures outlined in the protocol as to how data are collected and stored, de-identifying data that will be maintained after the research has been completed, destroying audio-tapes or paper surveys, destroying the key that links participants’ identities to their research responses, and/or using appropriate precautions to mask participants identities when the research is presented publicly.
- Inform the IRB when the research has been completed or if your affiliation with the University changes, whichever occurs first. To close a project, investigators must submit the Request to Close a Project form in CAP.
- Maintain IRB certification for the entire duration of the project through the IRB’s on-line training course and ensure that all personnel associated with your project also maintain their certification (see CITI instructions).
- Maintain all IRB related documentation for three years after the research has been completed. This includes copies of IRB approval letters, IRB applications, and consent forms that have been signed by participants.
- Inform the IRB if your contact information changes, as the IRB needs to have a means to contact you during the course of your research. As the IRB must use Loyola email addresses to communicate with you, you must regularly check your Loyola email account to ensure that you receive message from the IRB.
Any changes to an approved research protocol or a consent document must be submitted for review and approved by the IRB prior to implementation, except when necessary to eliminate apparent immediate hazards to participants. This includes any changes to:
- the participant population and/or inclusion/exclusion criteria
- recruitment methods or materials
- consent procedures
- intervention and/or assessment procedures
- data recording and/or management procedures
- consent documents and/or consent scripts
- the faculty sponsor
- any cooperating institutions
- purpose of research (e.g. faculty/staff project submitted for funding, dissertation or master's thesis)
Changes in original protocol must not be implemented until the IRB has approved them, except when necessary to eliminate apparent immediate hazards to participants. If a change to the approved protocol is implemented without IRB, you must notify the IRB as soon as possible.
To apply for an Amendment, you need to submit a completed Amendment Application form, including any revised research materials that require changes (e.g., consent forms, recruitment materials, instruments, letters from cooperating institutions, etc.). All revised consent forms must be submitted as Word documents (.doc). If you are revising documents in Microsoft Word, turn on Word's Track Changes feature before you make changes to your documents.
If you are a student, your Faculty Sponsor must submit your Amendment Application to the IRB to verify that s/he has read and approved your Application.
Amendment Applications that qualify for Expedited Review are reviewed on a rolling basis. Generally it takes the IRB 5 business days to review an Amendment Application. Amendment Applications that must be reviewed by the Full Board are reviewed at IRB Full Board Meetings that are held once every month. Amendment Applications for Full Board Review must generally be received by the Office of Research Services two weeks before the Full Board Meeting Date. Please review the IRB's current Full Board Meeting and Submission Schedule for the submission deadlines and meeting dates for the current term.
Amendment Applications that propose minor changes to research will be reviewed via Expedited Review.
If your protocol was originally reviewed by the Full Board and your Amendment Application proposes significant changes to the research or will increase the risks to participants where the risks to participants will be more than minimal, your amendment must be reviewed by the Full Board.
If you are unsure of whether your Amendment will need to be reviewed by the Full Board or if it can be reviewed via Expedited Review, you are welcome to contact the Board Chair or the Assistant Director for Research Compliance for clarification.
When the IRB provides Approval for research it is only for a specified period of time and is always for a period of time that is less than one year. Investigators must have active IRB Approval, however, in order to conduct any research activities. Investigators must apply for Continuing Review if they wish to conduct research activities after the initial Approval Expiration date. The initial Approval Expiration Date is stated on the letter of IRB Approval.
The IRB will also send Investigators a Continuing Review Reminder email 2 months before the Approval Expiration Date. While the IRB will send reminder notices to Investigators 2 months prior to the Approval Expiration Date, it is the Investigator’s responsibility to ensure that active IRB Approval is maintained.
Protocols that are approved as Exempt do not need to be re-approved by the IRB through the Continuing Review process. The IRB will send you an email each year to check-in to see whether the project has been completed. If the IRB does not receive a response or if you indicate that the Exempt research has been completed, the IRB will close out the Exempt file.
You must have Active IRB Approval to conduct any research activity involving human subjects. If you intend to conduct research activities after the IRB Approval Expiration date that was last assigned to your protocol, then your protocol must be re-approved through the IRB's Continuing Review process. All research activities must stop once IRB Approval for a project has expired. The IRB cannot provide extensions for the submission of Applications for Continuing Review.
Active IRB Approval is no longer necessary if the following conditions have been met:
- The only on-going research activities are data analysis and/or writing. All interactions, interventions, and data collection with participants have been completed.
- All identifying information has been removed from the data and destroyed, unless participants gave explicit consent for identifiers to be maintained after the research has been completed (such as participants signing a deed of gift agreement to donate the research records to a public archive). All code keys that link participants’ ID #s with identifying information have been destroyed.
- The final data disposition procedures have been completed as they were detailed in the consent form and protocol application.
Continuing Review applications can be reviewed either via Expedited or Full Board Review. Full Board Review of Continuing Review Applications is required if the research was not originally eligible for Expedited Review, unless all of the following three conditions are satisfied:
- Enrollment of new participants is permanently closed,
- All research-related interventions with human subjects have been completed, and
- The involvement of participants only includes long-term follow-up.
Please note that all Continuing Review applications for research that involves more than minimal risk must be reviewed by the Full Board, unless all of the three conditions above are satisfied.
If you are unsure which review mechanism your Continuing Review application is eligible for, please contact the IRB so you can know how to plan the submission of your Continuing Review application appropriately.
The Investigator is responsible for ensuring that continuing review occurs before approval expires.
Full Board: Continuing Review Applications that must be reviewed by the Full Board must be submitted to the IRB at least 6 weeks in advance of the IRB Approval Expiration Date. Continuing Review Applications must be submitted so far in advance in order to ensure that the IRB can review the application at a Full Board meeting before Approval expires. If a Continuing Review Application that must be reviewed by the Full Board is received less than 6 weeks before the next Approval Expiration Date the IRB cannot guarantee that the Application will be reviewed before the Approval Expiration Date.
Expedited Review: Continuing Review Applications that may be reviewed via Expedited Review must be submitted to the IRB at least 2 weeks in advance of the IRB Approval Expiration Date. If a Continuing Review Application that may be reviewed via Expedited Review is received less than 2 weeks before the next Approval Expiration Date the IRB cannot guarantee that the Application will be reviewed before the Approval Expiration Date.
The following needs to be submitted to the IRB in order to apply for Continuing Review:
- A completed Continuing Review Application
- A PDF of all stamped IRB approved Consent Forms from the last approval period (if you did not obtain written informed consent from participants you may not have any stamped Consent Forms)
If you are still enrolling new participants and need to obtain Informed Consent you must also submit:
- Each Consent Form saved as a Word document (.doc) that needs to be re-approved
If you are a student, your Faculty Sponsor must submit your Application for Continuing Review to the IRB by email to verify that s/he has read and approved your Continuing Review Application.
IRB approval automatically expires on the IRB Approval Expiration date because the IRB grants Approval for projects for a limited amount of time only. If a Continuing Review Application is not received and if the IRB does not grant a new approval period then all research activities must stop before the IRB Approval Expiration date.
If an Investigator does not apply for Continuing Review before the Approval Expiration date and IRB Approval expires, the Investigator must stop all activity with human subjects and sumbit closure application to the IRB.
The IRB considers the level of risk to participants, the nature of methodology, and the experience of the investigator when determining the length of the IRB Approval period.
The IRB may require that continuing review occur more frequently in any of the following circumstances: a) the research involves greater than minimal risk to the participants, b) the methodology is such that refinements or modifications may occur as the project progresses, c) the investigator is relatively inexperienced with the research methodology, d) there are other concerns related to participant selection, recruitment procedures, informed consent process, confidentiality, or data monitoring.
Investigators are required to report any unanticipated problems and adverse events to the IRB.
Unanticipated Problems. An Unanticipated Problem is any incident, experience, or outcome that meets all of the following criteria:
- Unexpected (in terms of nature, severity, or frequency) given (a) the research procedures that are described in the protocol-related documents, such as the IRB-approved research protocol and informed consent document; and (b) the characteristics of the subject population being studied;
- Related or possibly related to participation in the research (possibly related means there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research); and
- Suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.
Example: An Investigator conducting longitudinal research on college students’ experiences throughout two years of college loses a laptop that contains a file with participants’ names, participant ID codes, phone numbers, and email addresses.
Adverse Events. An adverse event is any event that includes any untoward or unfavorable medical occurrence in a human subject, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the subject’s participation in the research, whether or not considered related to the subject’s participation in the research.
Adverse events encompass both physical and psychological harms. They occur most commonly in the context of biomedical research, although on occasion, they can occur in the context of social and behavioral research.
Example: An Investigator is conducting a qualitative analysis of how participants diagnosed with borderline personality disorder evaluate their out-patient therapy groups. The consent form indicates that participating in the interview may lead to a participant experiencing emotional or psychological distress. While discussing another member of the therapy group in an interview, a participant becomes upset and the Investigator ends the interview and calls the group therapist to meet with the participant.
Serious Adverse Events. Some adverse events fall into the category of serious adverse events. Serious adverse events include any of the following:
- results in death;
- is life-threatening (places the subject at immediate risk of death from the event as it occurred);
- requires inpatient hospitalization or prolongation of existing hospitalization;
- results in a persistent or significant disability/incapacity;
- results in a congenital anomaly/birth defect; or
- any other adverse event that, based upon appropriate medical judgment, may jeopardize the participant’s health and may require medical or surgical intervention to prevent one of the other outcomes listed in this definition.
Notifying the IRB of Reportable Events. How and when the IRB should be notified of a reportable event depends on the type of event. If you are unsure of how an event should be categorized, please contact the Assistant Director for Research Compliance for clarification.
Non-Serious Adverse Events should be reported to the IRB the next time the project is up for review (in the next Application for Continuing Review or in the Request to Close, whichever will be submitted first).
Unanticipated Problems and Serious Adverse Events should be reported to the IRB within one week of their occurrence or within one week of the Investigator becoming aware of such an incident. After one of these events occurs you should submit a letter (or email) detailing the event to the Assistant Director for Research Compliance for review. The letter should include the following information:
- Your Name, Protocol Number, and the Project Title
- A detailed description of the event including how and when the event occurred, how many participants were involved in the event, and your involvement in the event
- A statement describing any harms experienced by participant(s) and any additional risks participants may be subject to as a result of the incident
- A detailed description of your plan of how to respond to the incident and any follow-up actions that will be taken
NOTE: If you are a student, the letter must be emailed to the IRB by your Faculty Sponsor.
Investigators are responsible for closing their projects once they have finished conducting research with human subjects.
A project should be closed when all research activities with human subjects have been completed or when the Principal Investigator leaves Loyola University Chicago.
If your project satisfies the following three criteria then research activities with human subjects have been completed and your project is ready to be closed:
- The only on-going research activities are data analysis and/or writing. All interactions, interventions, and data collection with participants have been completed.
- All identifying information has been removed from the data and destroyed, unless participants gave explicit consent for identifiers to be maintained after the research has been completed (such as participants signing a deed of gift agreement to donate the research records to a public archive). All code keys that link participants' ID #s with identifying information have been destroyed.
- The final disposition procedures have been completed as they were detailed in the consent form and protocol application.
Examples of protocols that can be closed:
- An Investigator conducting interviews recorded interviews on audio-tape. The audio-tapes were later transcribed. When the audio-tapes were transcribed no identifying information about participants were recorded, all names were replaced by pseudonyms. The Investigator has finished analyzing the transcripts and is currently only writing up the research for publication. The audio-tapes have been destroyed and the key linking pseudonyms to participants’ real names has been destroyed. The Investigator may now close the Protocol.
- An Investigator collected paper surveys from participants. Participants were asked to record their name on the survey so the Investigator could follow-up with them if necessary. The survey responses were entered into a database and each survey was assigned an ID number. The Investigator has finished conducting all follow-up contact with participants and is only finishing up analyzing the data set. The Investigator has destroyed the hard copies of the surveys, the code key that links participants’ names to participants’ IDs, and the records of participants’ contact information. The Investigator may now close the Protocol.
In order to close out a project, you need to submit the Request to Close a Project form in CAP.
If you are a student, your Faculty Sponsor must submit your Request to Close to the IRB to verify that s/he has read and approved your request.
Requests to close a project are reviewed by IRB staff members. Based on your responses to the questions in the application the staff member will review your application to determine the following:
- All research activities with human subjects have ended and the project is ready to be closed.
- The numbers of participants you report is consistent with the number of participants the IRB has previously approved you to recruit and the numbers you have indicated in any previous Continuing Review Applications.
- Whether any adverse events or unanticipated problems have occurred during the last approval period.
- Whether the findings from the research have resulted in information that should be reported to participants.
If the IRB staff determines that the project is ready to be closed, all of the information is consistent with your approved application and any past continuing review applications, and no further information needs to be provided to participants then your Protocol will be Closed.
If any of the responses to questions in the Request to Close application need clarification or if the IRB requires the Investigator to conduct follow-up with participants, the Investigator will be notified by email of the clarification or follow-up that is needed.
Investigators will be notified by email when the IRB has closed their project.
Loyola University Chicago cannot maintain responsibility for the protection of human subjects in research when investigators are no longer affiliated with the institution. Persons no longer affiliated with the institution include students who have graduated and faculty and staff who are no longer employed by the University. Thus, it is policy that students, faculty and staff must close their projects upon leaving Loyola, UNLESS another individual at Loyola is willing to assume full responsibility for the project as the "primary investigator". There are two circumstances where this may be appropriate:
- In cases where a departing student wishes to continue working on his/her dissertation for publication purposes, the faculty sponsor may assume the role of "primary investigator" in order to allow the student to continue working on the project.
- In cases where another faculty member wishes to continue an existing project on behalf of a departing member of the University, he or she may assume the role of "primary investigator." The departing member may also maintain his/her involvement in the project by becoming the co-investigator.
In both cases, the departing Principal Investigator must fill out the Amendment Application and submit it to the IRB. The individual assuming the role of ‘primary investigator’ must also provide documentation that he/she agrees to take full responsibility for ethical and legal conduct of the project. An email from the individual assuming the role of "primary investigator" should be sent to the IRB indicating his/her willingness to take on full responsibility for the project.
Even in cases when Investigators are departing the University prior to completion of the research, they must close their projects.