Topic: Human Subjects Research

Documentation of Study Visit Interventions/Observations

Purpose The purpose of source documentation is to reconstruct the research study as it happened. It should allow for data to be confirmed, validated, and support the fundamental principle of protecting the participant’s rights, safety and well-being. These templates are intended to assist in documenting study procedures, interventions, observations, etc. Below are several examples that […]

Documentation of Informed Consent

Purpose These templates are intended to assist in documenting the consent discussion and process with potential participants. There are many ways to document the informed consent process. Below are several examples that can be customized to meet your specific study needs/requirements (study populations, optional items etc.). Best Practice Considerations Documentation of the consent/assent process should […]

E-Consent Resources

There are e-consent tools available at WUSTL. Before implementing an e-consent process, it must be approved by the IRB for use in your study. REDCap: DocuSign: See the HRPO Research Guide for more guidance on the use of e-consent.

HRPO Policies, Procedures, & Guidance

The Human Research Protection Office (HRPO) offers Guidance for human studies research, including policies and guidance materials. These resource include HRPO’s Research Guide and WashU IRB Policies, and additional resources. The HRPO Digital Commons hosts educational resources such as publications, presentations, and podcasts related to human subjects research and human research protections. The HRPO Help […]

Office of Information Security

The Office of Information Security works with researchers, offering tools, services, and guidance to protect research, meet regulatory requirements, and ensure the confidentiality, integrity, and availability of data.

HIPAA Privacy Office

The WashU HIPAA Privacy Office works with all members of our workforce including faculty, staff, and students to help them understand their responsibilities to protect the confidentiality of our patients’ health information.