Subject Complaints, Setbacks and Other Problems & Issues

Congratulations! The protocol you submitted to the Campus IRB has been approved and your research is underway. But what can you do if subjects complain, you experience setbacks, or other sorts of problems and issues present themselves?

The FAQs below provide some possible next steps you can take in the following situations. In almost all cases, we will encourage you to contact the IRB.

You should also contact the IRB office for any questions or clarification, especially if the scenario you encounter is not covered in the FAQs.

Subject Complaints

In all cases in which a participant writes to the researcher with a complaint, it is imperative the researcher reply to the participant as soon as possible. The initial response can be short and simply confirm the complaint was received. A response acknowledging that the complaint was received is required.

It is important that all informed consent processes, including online consent processes, include the Campus IRB protocol number that corresponds to the study. The Campus IRB protocol number is an 8-digit number that begins with a four-digit year followed by a four-digit number (for example: 2020-0100). Including the Campus IRB protocol number increases the likelihood a subject will refer to the protocol ID in their complaint, which can lead to a faster resolution.

If a participant reports they received an incorrect payment amount or that they never received payment, the IRB’s preferred course of action is for you to simply provide the correct compensation amount. The IRB will not discourage researchers from looking into these types of subject requests to track down exactly what happened; however, in our experience, simply paying the participant could turn out to be the most efficient use of your time.

As long as the researchers are able to resolve participants’ compensation requests, they do not have to be reported to the IRB. That said, we are happy to answer any questions you may have.

Contact the IRB as soon as possible, and provide the approved protocol ID# and what you know about the participant’s experience.

Reply to the participant and let them know that they should contact the IRB. Your response should not be dismissive. Provide them with the IRB’s contact information, and also provide them with the protocol ID# for the research study in which they participated.

You should also contact the IRB to report that a participant has complained. If available, provide the IRB office with the contact information for the participant.

Contact the IRB as soon as possible, and provide the approved protocol ID# and what you know about the participant’s experience.

Setbacks and Other Problems & Issues

Don’t panic! This can happen from time to time – especially if your protocol underwent several rounds of revisions.

The first step would be locate the approved consent process. Then, contact the IRB as soon as possible to explain the situation. If possible, include both copies of the consent (the approved version and the un-approved version) to the IRB. Make sure the approved consent will be used for participants going forward.

Separate the data for participants who completed the study on the un-approved consent and hold off on analyzing it until you have spoken with IRB staff.

Because the IRB is charged with protecting participants in research, we do not provide guidance on research design, unless there are potential risks of harm to participants. That said, in our experience, investigators who encounter low participation rates have expanded their subject population, tried different recruitment methods, added incentives, or increased compensation.

Student researchers should consult with their advisors on other possible alternatives.

Changes will probably require an amendment, so please check in with IRB staff before implementing any changes to your approved protocol.

It depends on just how different the actual vs. anticipated participation time is, and whether this impacts expected compensation.

  • If participation is taking MORE time than what is described in the recruitment or consent process, then the IRB would typically advise that the protocol be amended to reflect these changes.
  • If participation is taking LESS time then what is specified in recruitment or consent, that is typically okay. However, an amendment will be necessary if you want to update the protocol so that the duration described in the protocol reflects what is actually happening.

If the protocol needs to be amended to reflect the new study duration, make sure any necessary changes to compensation are updated as well.

Ideally, you have not downloaded the data. In that case, leave the attachment unopened and contact the IRB. If the data have been downloaded, sequester the data and contact the IRB. We will work with you to make sure that the email is properly deleted and that the data provider will resend you the data using the approved methods.

If the data were downloaded, we can coordinate with Duke’s IT department or IT Security Office to handle the downloaded data appropriately.

Sequester the data to restrict access, and contact the IRB. We will work with you to make sure that the data provider will resend you the data without identifiers. There may also be the possibility that the IRB can help you make arrangements for a third-party at Duke to de-identify the data for you.

If the participant is a Duke student.

  • If you are a Duke student researcher, please contact your advisor immediately and copy the IRB at campusirb@duke.edu.
  • If you are faculty or staff researcher, make a report to DukeREACH as soon as possible. Notify the IRB after you have made the report to DukeREACH.

If the participant is not a Duke student.

  • Please contact the IRB office as soon as possible.