Regulatory

IHS IRB

While the WATCH program does not conduct research in tribal communities, it does collect various information from key community partners. An application to the Oklahoma City Area Indian Health Service (IHS) Institutional Review Board (IRB) was submitted and approved as exempt from research. The WATCH program is conducted in educational settings involving normal educational practices.

The University of Oklahoma Health Sciences Center IRB also reviews all data collection materials. Intervention materials are not reviewed. The health promotion program evaluation operates under IRB #9773.

Waiver of Informed Consent

This section of the MOP describes some instructions regarding the process of waiving informed consent. Within this document the process for trainings, site requirements, WATCH staff obligations, and expectations are all delineated. Participating ECEs and healthcare clinics prior to implementation will be provided with a Memorandum of Understanding (MOU) or Letter of Support (LOS) that informs them that participation is voluntary and can be concluded at any time. These documents also stipulate that any data collected does not include any identifying information.

A waiver of informed consent is approved by the OUHSC IRB to reduce burden for participants and since the purpose of these data collection are not for dissemination or generalization but to improve the program quality for the respective community.

Of these processes any document serving as a tool for data collection regardless of participant states that participation is voluntary, and the use of data is intended only for data analysis. If any results, information, or data are to be shared, the participants will be informed, and they will receive a copy.

Non-Identifying Information

Data collected for the purposes of WATCH Program implementation do not contain any health protected information and no data from children will be collected. Children’s weight or Body Mass Index (BMI) are not to be collected. If for any reason any identifying information is collected, it will be de-identified and destroyed. There are no names used when sharing documents or analysis with any of our community partners.