How to explain your study procedures

What the Investigator Submits:

Study Procedures:

One time survey on Qualtrics and one time interview with the study team. The interview will be audio recorded.

What is missing?

  • Even studies with minimal procedures still require the who, what, when, where, and how of the entire study.
  • Who will be in charge of recruitment? How many times will participants be contacted? When will this contact occur and how?
  • Where will the study take place?
  • What are the requirements of the participants in the study?
  • How and when will the participant be consented?
  • Are identifiers collected? If so, are they kept with the study data or separately?
  • Where will be the study data be stored? Who will have access to it?

What the IRB wants to see:

Study Procedures:

The Designated Research Team member(s) will be responsible for obtaining the contact list of all employees from the study site. They will then send the initial recruitment email, and two reminder emails at 8 week intervals reminding those who haven’t already taken the survey to do so if they wish to be a part of the study.

The survey will be conducted on Qualtrics and should take about 20-30 minutes to complete. Prior to completing the survey, the participants will be able to read the consent form, and check a box to indicate their consent to participating in the study. The survey will not collect any identifying information, including IP address. At the end of the survey, participants will be asked if they wish to participate in a follow up interview about the research topic. If they select Yes, they will be routed to a separate page which will allow them to provide their email address. The email addresses collected will always be kept separate from the survey data.

At the end of the 8 weeks, the survey will end, and the Designated Research Team member(s) will send out an email to all participants that indicated they wished to participate in the interview. The Designated Research Team member(s) will be responsible for scheduling interviews and sending the interview consent form to the participants via email to review in advance. Interviews will take place in a private place, either at the research site in a private office, or over the phone in a place the participant has designated as secure. The Designated Research Team member(s) will be responsible for obtaining consent prior to the interview and conducting all of the interviews. The interviewer will review the consent form to ensure that the participant does not have questions prior to starting the interview. The interviews should last about 45 minutes to an hour and will be audio recorded. After the interview is complete, the audio recording will be transcribed without any identifiers and the original recording will be destroyed. The transcriptions and survey data will be uploaded onto a secure Harvard server for analysis and storage.