Protocols and Compliance

In order to conduct effective and safe research, you will need to put together a thorough description of your planned research process (known as a protocol). This protocol will not only provide a solid foundation for you and your team to reference throughout the research process, but it will allow the regulatory bodies that monitor your institution’s research enterprise to provide you with approval for conducting your research using their resources.

Developing Protocols

• Protocol Builder
  • Protocol Builder provides numerous protocol templates and commonly used forms. GW and CNH recommend investigators consider using Protocol Builder for projects that involve greater than minimal risk.
  • CNH affiliates may access Protocol Builder on the CTSI-CN Protocol Builder website.
  • GW affiliates may access Protocol Builder on the GW Protocol Builder website. 
• Developing and Writing the Protocol
  • This module is designed to provide basic or refresher information about developing and writing a study protocol.
• Clinical Study Protocol (Video Series)
  
  • This video series reviews objectives and trial design of clinical study protocols.
    • Ethics and Good Clinical Practices in Clinical Research (10 min)
    • Stakeholders in the conduct of clinical trials (20 min)
    • Phases of Clinical Development (7 min)
    • Clinical Study Protocol Part 1: General Information (10 min)
    • Clinical Study Protocol Part 2: Trial Objectives (20 min)
    • Clinical Study Protocol Part 3: Trial Design and Endpoints (12 min)
    • Clinical Study Protocol Part 4: Trial Design: Control Groups (10 min)
    • Clinical Study Protocol Part 5: Randomization & Blinding; Bias (16 min)
    • Clinical Study Protocol Part 6: Description of trial treatment and subject participation (18 min)
• Developing a Research Protocol
  • This free 45 minute course reviews how to develop and implement a research protocol while maintaining the safety and confidentiality of your subjects.
• Writing the Protocol & Protocol Implementation
  • Module 3 of this free NIH course provides an overview of writing and implementing protocols. Register to receive a certificate of completion, or view the individual course lectures through the Non-Registered Lecture Option.
• Promoting Racial Equity in Research Protocol
  • This guide considers how to shape and evolve the research and communications processes to ensure work is inclusive, respectful, and incorporates a racial equity lens.

Research Integrity and Compliance

• Regulations and Guidance
  • Provides Federal Regulations & Guidelines, Guidance in Research, Health Law Information, and IRB Decision Charts
• Responsible Conduct of Research 
  • Provides assistance for researchers to become familiar with professional and ethical standards in academia as well as in their chosen fields
• Human Subjects Research IRB Training Series
  • The IRB Training Series is OHR's educational offering for the GW research community and covers a range of topics related to the IRB review process, human subjects research, and the policies and federal regulations that guide GW human subjects research protections programs.
• Single IRB
  • SMART IRB is a national initiative that provides education, templates, and guidance on navigating the Single IRB process for multi-site studies. 
• Data Management
  • This guide reviews the basics of data management and the FAIR principles
• Open access publication compliance mandates for federally funded research
  • Review summaries of Department/Agency open access plans
• Utilizing Data as an Antiracist Lens (video)
  
  • This 2 hour long video reviews how to embed a culturally responsive and equitable lens into the work we do with data and data visualization.

Tools

• Protocol Builder
  • GW and CNH recommend investigators consider using Protocol Builder for projects that involve greater than minimal risk.
  • CNH affiliates may access Protocol Builder on the CTSI-CN Protocol Builder website.
  • GW affiliates may access Protocol Builder on the GW Protocol Builder website. 
• NIH e-Protocol Writing Tool
  • Use the NIH e-Protocol tool to author protocols relating to Phase 2 and 3 IND-IDE clinical trials as well as behavioral and social sciences research involving humans.
  • Clinical trial tool and template documents can also be found on NIH’s Clinical Trials website.

• NIMH Clinical Research Toolbox

  • This Toolbox contains resources such as NIH and NIMH policy and guidance documents, templates, sample forms, links to additional resources, and other materials to assist clinical investigators in the development and conduct of high-quality clinical research studies.
• NCCIH Clinical Research Toolbox
  • The NCCIH Clinical Research Toolbox provides a Web-based information repository for investigators and staff involved in clinical research. Includes protocol templates, case report forms, regulatory binder checklists, and quality management resources. 
• Investigator Toolkit-Regulatory Resources
  • The purpose of this toolkit is to provide investigators with resources needed for the successful preparation and submission of a research proposal. Topics include study design, preparation of the written protocol and consent documents, submission to the IRB, and the reporting of unanticipated problems and adverse events.
• Health Equity Impact Assessment Template
  • HEIA is a flexible and practical assessment tool that can be used to identify and address potential unintended health impacts (positive or negative) of a policy, program or initiative on specific population groups.

Resources

• Safety Review & Monitoring
  • Module 4 of this free NIH course offers lectures on safety review and monitoring. Register to receive a certificate of completion, or view the individual course lectures through the Non-Registered Lecture Option.
• Collaborative IRB Training Initiative (CITI)
  • This web-based human subject protection training ensures researchers demonstration and maintain sufficient knowledge of ethical principles and regulatory requirements for protecting human subjects.
•  GW Research Policies
  • This page will highlight key policies and guidance all PIs, research staff, and administrators should be aware of.
• Recommendation for Adequate Clinical Trials for Black, Indigenous, People of Color
  • National Medical Association recommendations regarding clinical research.

Institutional Contacts

• Regulatory Knowledge and Support: SparcRequest and SparcRequest Instructions
  • The CTSI-CN currently uses the SPARC system for all BERD and PCI request for services. Once you create a login user ID and password you can submit a request. All requests receive four hours of free service and we use both the percent effort and hourly rate charge models. The link below provides more details on how to complete this process.
• CNH Institutional Review Board Electronic Application Review system (IRBear)
  • IRBear is Children’s National's web-based portal for all IRB submissions and study management. In IRBear, you have access to your study information and can check the status of your submission at any time.
  • Contact The Office for the Protection of Human Subjects (OPHS) for questions about regulatory affairs and research compliance at CNH.
• GW Office of Human Research
  • Contact for questions about regulatory affairs and research compliance at GW
• GW Office of Research Integrity 
  • Contact for GW data use, responsible conduct of research and export controls.