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Loyola University Chicago

Institutional Review Board

Section Four

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.

  1. Conduct the research in accordance with ethical guidelines such that the rights and confidentiality of participants are protected and risks to participants are minimized.
  2. 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).
  3. 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.
  4. 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.
  5. 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.
  6. Inform the IRB of any Unanticipated Problems and/or Adverse Events.
  7. 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.
  8. 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.
  9. 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).
  10. 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.
  11. 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.

Amendments

Continuing Review

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. Under what circumstances do you need to apply for Continuing Review?

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.

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.

Additional Reporting Responsibilities

Investigators are required to report any unanticipated problems and adverse events to the IRB.

Closing Projects

Investigators are responsible for closing their projects once they have finished conducting research with human subjects.

Loyola

Institutional Review Board
Loyola University Chicago · 6439 N. Sheridan Road, Suite 400 · Chicago, IL 60626-5309
Phone: 773.508.2471 · Fax: 773.508.8942 · E-mail: irb@luc.edu

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