AM-ME: Prepare Data Collection Structures

Institutional Review Board 

When planning to conduct human subjects research, such as AM-ME, an Institutional Review Board (IRB) approval is needed to ensure safety of research subjects. Protocols were developed for each iteration of data collection for focus groups, interviews, and surveys. Team AM-ME submitted an initial application, six modifications to update survey items and add protocols, and three administrative changes!  For each submission, a cover letter, application, and relevant materials were submitted for review. The timeline for our IRB reviews ranges from around three days for an administrative change to one month for the initial review. Your IRB may be different. 

One important distinction for this CEnR project was to ensure that the IRB understood that the AM-ME Research Group members were not research subjects for the purpose of the IRB review, but rather research team members. While the AM-ME Research Group provide their input on topics related to the study for data interpretation purposes, this viewpoint is part of the expertise they bring to the project.    

For AM-ME, a second review of materials was required by Bloomington Public Schools (BPS) IRB and community stakeholders. Surveys given to all middle and high school students were shared publicly for comment by the community.  

Data sharing expectations/security 

During the partner phase when contracting, data sharing agreements were established with subrecipients and the school district. All organizations involved with this project are held to Child Trends Security Policy through these agreements. See Securing Project Funding for more information about these agreements. To ensure data security, we used a Secure Data SharePoint (SDS) and secure analytics server, Azure Secure Data (ASD), to store and analyze data collected and shared from our district partner. We set these SDS and ASD drives up prior to data transfers and collection to avoid delays in data cleaning and analysis.    

Consent forms 

Various consent forms were needed for participants of the school survey, focus groups, and interviews. Prior to administering the survey for students, parents were given the opportunity to review the survey and sign an opt-out form if they did not want to allow their child to participate. Both the survey and opt-out forms were translated to Spanish and Somali to ensure parents were able to understand the types of questions we would be asking their child.   

Data collection for focus groups and interviews required additional consent forms, differentiated for adults and students. The focus group parental consent form required signature from the parent. The staff consent form could be completed online through RedCAP.   

Sample consent and opt-out forms can be found below. 

Determine recruitment process 

The recruitment process was largely handled in the research group meetings. They determined the timelines, roles, and creating materials (e.g., flyers, talking points).  

To learn more about the recruitment process, review the AM-MR Research Group Meetings linked below.

Fidelity measures for data collection 

Fidelity Measures are checks for the implementation of the data collection process. We created charts with assigned tasks for team members to ensure protocols were followed for data collection and secure data storage. For more information on the focus group and interview protocols, check out Collect Qualitative Data.