Toolkit for Researchers

The Quality Assurance (QA) component of the Florida Atlantic University Human Research Protection Program (HRPP) evaluates the current practices of the IRB and Florida Atlantic research community against defined standards and best practices of the Office of Human Research Protections (OHRP), FDA, State of Florida, and institutional policy and process. The purpose of this program is to assess research activities conducted under and in accordance with the University’s Federal Wide Assurance Agreement with OHRP.

Visits will occur bi-annually and are intended to be collegial. These visits are an opportunity for researchers to request any help they may need, and to provide feedback on the protocol process. Protocols may selected randomly or for-cause if warranted.

Identifying Projects for Random Review

• Include IRB approved protocols in which subjects have been enrolled or identifiable data have been obtained.
• May include Exempt, Expedited, or Greater than Minimal Risk protocols.
• May include funded projects or unfunded projects.

Identifying Projects for For-Cause Review

• The reviews can be requested by the Florida Atlantic IRB, the Vice President for Research or the University Compliance Officer.
• The reviews are typically implemented due to unusual circumstances, significant risks to subjects, routine failure of an investigator to comply with federal and/or institutional requirements, allegations or concerns about the conduct of the study brought to the IRB’s attention, or any case requiring further scrutiny as deemed appropriate.

Reviewers may ask to see a number of items during the visit. Areas include the following:

• Recruitment & Compensation
• Subject Inclusion and Enrollment
• Informed Consent (Content and Process)
• Data Collection, Storage, Transmittal, Destruction, and Security
• Adverse Events
• Project Personnel (Qualifications and IRB Training)
• Amendments
• Protocol Adherence (Violations/Deviations)
• Other areas as determined by the review

Checklists used by reviewers may be found here . These may be used by researchers at any time during the conduct of their research to assist with protocol compliance and research best practice.

• Know and observe applicable federal regulations, state law and institutional SOPs and/or policies.
• Know and follow the IRB-approved protocol.
• Know the study-related roles and responsibilities of the principal investigator and other research team members. Review the protocol with the research team members, identify and discuss any concerns or questions regarding conduct of the study. Ensure that each research team member has access to the most current documents, including, but not limited to, the informed consent document, protocol, and case report forms.
• Differentiate between the study-related and healthcare provider roles and responsibilities.
• Create and use tools to assist in the compliant conduct of the study (worksheets, data collection forms, logs, checklists, etc.).
• Develop and maintain an effective system for data collection and storage.
• Implement quality assurance measures to ensure your study is conducted in accordance with the IRB approved protocol, institutional policy, and required regulations.

• Principal Investigator Obligations (HRP-400)
• Definitions (HRP-401)
• Documenting Informed Consent (HRP-403)
• Research with Pregnant Women, Fetuses and Neonates (HRP-405)
• Research with Children (HRP-406)
• Research with Prisoners (HRP-407)
• Classroom Research (HRP-408)
• Research with Vulnerable Populations (HRP-409)
• Additional DOD Obligations (HRP-410)
• Additional DOE Obligations (HRP-411)
• Additional DOJ Obligations (HRP-412)
• Additional ED Obligations (HRP-413)
• Additional FDA Obligations (HRP-415)
• Additional ICH-GCP Obligations (HRP-416)

Tools to help researchers navigate the complexities of conducting research. These materials are intended to address any gaps while implementing research.

You can schedule a consultation with an HRPP team member for assistance with your project. We can help you determine if an IRB application needs to be submitted, understand how regulations apply to your project or activity, and answer specific questions about your IRB application. We recommend you have your documents available (protocol, application, consent form, etc.) for sharing. Schedule a consult.

The Florida Atlantic HRPP provides training workshops throughout the year to provide researchers with an overview of the IRB submission process. The workshops are designed to help faculty and students understand the IRB review process and submit concise IRB applications. See our Training Calendar for a schedule of upcoming workshops.

Invite HRPP staff to your meeting, class, or other gathering and we will prepare a presentation specific to your needs. Typically outreach presentations last 60 minutes, including time for question and answer. To schedule an outreach event, email us.

Tools to help researchers manage their protocols as they progress through the research lifecycle. These tools can assist in maintaining compliance and monitoring the conduct of research activities. Use of these tools is encouraged, but not required.

ResearchMatch is a nonprofit program funded by the National Institutes of Health (NIH). It helps to connect people interested in research studies with researchers from top medical centers across the U.S. This national volunteer research registry that brings together researchers and willing volunteers who want to get involved in research studies. It provides a secure, web-based approach to address a key barrier to advancing research: finding research participants. There is no cost to use ResearchMatch. You do, however, need materials approved by the IRB (details below).

ResearchMatch allows researchers to search for de-identified volunteers who have registered themselves as being interested in participating in research. The researcher creates a cohort of people that meet selected key inclusion and exclusion criteria for the study by using the filters on ResearchMatch and then sends their IRB approved message to potential volunteers via ResearchMatch.

Interested participants create a “profile” with their basic health information. This allows researchers to search for potential participants that meet certain criteria. The potential participant can be sent the IRB message about the study and can then choose whether to provide their contact information to the researcher. This is an excellent resource for researchers looking to identify potential participants outside of usual-care settings.

The researcher finds the contact information of those interested individuals on their ResearchMatch dashboard and can then contact them directly.

• Register for ResearchMatch here
• Need help? Free training for researchers occurs every 2nd Thursday of the month. You may also use this guide.
• Using ResearchMatch requires IRB approval. Please use the appropriate language in your application when requesting to use ResearchMatch.
• Here are some contact message examples.
• We recommend you use a REDCap survey/screening survey to recruit participants.

• Federal Regulations for the Protection of Human Subjects
  • 45CFR46 (Office for Human Research Protections)
  • 21CFR50 (Food and Drug Administration)
• The Belmont Report
• Using an E-Consent
• Phase 0 and Phase I Investigator Initiated Projects
• Conducting Research Online
• Florida Atlantic Campus Surveys
• Florida Atlantic RedCap
• Florida Atlantic BHRIC
• Research at Palm Beach County Schools
• Research at Broward County Schools
• External Researchers Recruiting at Florida Atlantic

• National Science Foundation Data Management
• National Institutes of Health Data Management and Sharing Policy
• Office for Human Research Protections (Various Topics)

All of Us Research Program

The National Institutes of Health’s (NIH) All of Us Research Program provides health data from diverse U.S. research participants. FAU researchers can access every tier of the All of Us Research Program including the “Controlled Tier,” which includes genomic data.

For a description of the tiers, to access the data, register with the All of Us Researcher Workbench with a Florida Atlantic email address, visit All of Us.