Collaborations and Team Science (Cont.)
Intervention Delivery
Once the participant is enrolled, it is time to initiate the study tasks. How those activities are implemented needs to follow the IRB protocol. Adhering to the study protocol is the only way that you will know whether the intervention produced a change in the variable being studied. The research team members need to be trained to follow the protocol and understand the implication to the research data if the protocol is changed. Changing the study is only acceptable if a problem is observed and the research investigator obtains approval from the IRB to make a change. Changing a protocol in the field, even slightly, can influence the study data.
In addition to following the protocol, all research staff must be trained to protect the privacy of research participants as well as the confidentiality of data they provide as part of the study. When working in community or clinic settings, the data management plan will need to cover data collection, transportation, storage and sharing processes. All who will be working with research participants should be knowledgeable of the data management plan and strategies for protecting the privacy of research participants. In community-based research, this is particularly important as the research assistant (e.g., CHW/Promotores) may know the research participant outside of the research setting.
Data Management
The collection, storage and overall management of data is also part of the research protocol and related training. The research team will need to understand the nature and sensitivity of personal health data planned for collection. How to handle research information include not only collection and documentation but, in many cases, transporting these data from a clinic or community site back to the research setting. Training should address differences between data confidentiality and participant privacy protections as well. As noted, the intervention delivery needs to be consistent for the data collected to be meaningful. Providing examples of what can influence the interpretation of study data needs to be explicit.
- Personal health data is sensitive.
- Learn how to handle collection, documentation, and transportation of data.
- Know the difference between Data Confidentiality vs. Participant Privacy Protections
- Promote consistent intervention delivery for meaningful data.