Toolkit for Researchers
Best Practices for Conducting Research
Conducting current and best practices research is critical to developing a full understanding of a problem and all of its components from multiple and varied perspectives. Over time, each researcher develops their own method for conducting research. There is no one best way to conduct the research; it is more a question of finding the method that works best for you and your research area. This toolkit offers guidance, resources, tips, and tools to enabling you to conduct research in an ethical manner, adhering to regulatory requirements while ensuring scientific integrity.
Quality Assurance and Quality Improvement Program
The Quality Assurance (QA) component of the Florida Atlantic University Human Research Protection Program (HRPP) evaluates the current practices of the IRB and FAU 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 FAU 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)
- 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.
|Consenting||Standard of Practice vs. Research|
|Review Categories and Determinations||QA/ QI Projects vs. Research QA/ QI Checklist|
|Deception in Research||Risks and Benefits|
Other Educational Opportunities
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 FAU 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.
Class or Faculty Meeting Outreach
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.
|Event Reporting Log||To keep track of events that have occurred, even if they did not require reporting to the FAU IRB.||August 1, 2023|
|Informed Consent Process Checklist||To document that the consent process includes all of the required components and that it is following the approved process in the protocol.||August 1, 2023|
|Letter of Cooperation||Guidance and template for researchers for external and internal collaborations||August 1, 2023|
|Note to File||To document the ongoing conduct of a research project. Examples of appropriate use of a note to file includes failure of research team to sign and/or date a signed consent form, documenting a missed time point to complete a survey, etc.||August 1, 2023|
|Recruitment Flyers||FAU branded flyers to assist in study recruitment.||August 1, 2023|
|Research Staff Training Log||To document that individual project staff have completed all required training. This log is used to document individual team member training at the initiation of the study or as new team members are added.||August 1, 2023|
Federal Regulations for the Protection of Human Subjects