Resources for Conducting Human Research
The Human Research Protection program and the university research community follow Standard Operating Procedures and use checklists, worksheets, and templates to guide the life cycle of human subjects research at Virginia Tech.
To shorten the timeframe for approval of personnel changes to research protocols, the Human Research Protection program has created a separate process for review and approval of personnel changes.
The change is on the administrative side of Personnel Management and researchers will not need to do anything differently nor will they notice a change in the system.
Researchers that are making personnel changes and other protocol changes should be aware that when a personnel amendment has been approved there might be other changes that are pending approval. When researchers receive approval notification, review it carefully to determine what has been approved.
The Human Research Protection program has a progress reporting form within Protocol Management. Researchers will receive a notification from email@example.com via Protocol Management when the progress report is due. Read the email carefully and follow the instructions.
Progress Reports are required as follows:
- Protocols approved as Expedited after January 2019 – annually
- Protocols approved as Exempt either before or after January 2019 – every 3-years
- For questions, contact the protocol coordinator that has been assigned to the protocol. If a coordinator has not been assigned, contact firstname.lastname@example.org for assistance.
In general, amendments are only required for exempt studies if the changes made to the research could affect the determination of exemption.
Since studies that are determined to be exempt pose the least risk to participants, the Virginia Tech Human Research Protection program office will require amendments if it is an exempt study with limited review or if the change meets one of the criteria outlined in this document. Researchers can find out if the study is Exempt or Exempt with Limited Review by checking the Summary of the specific protocol in the IRB Protocol Management online system.
Unsure whether an amendment is needed? Contact the protocol coordinator that has been assigned to the protocol or send an inquiry to email@example.com for assistance.
When human subjects research is conducted outside of the U.S., additional rules, regulations, and requirements may apply. A set of universal regulations and standards for conducting research outside of the U.S. does not exist, so researchers should be aware of and familiar with any local requirements as well as local cultures, customs, and the scientific and ethical review infrastructures.
Researchers should be prepared to provide documentation of local documentation and approvals, translated documents, and certification of translations. More details on these requirements can be found in the HRP-005.1, SOP: Global Human Subjects Research. Human Research Protection program staff work closely with researchers who need guidance on complying with these requirements.
Researchers that are conducting clinical research should be aware of the requirements to register studies on www.clinicaltrials.gov.
In accordance with Section 801 of the Food and Drug Administration (FDA) Amendments Act (FDAAA 801), the federal government expanded the regulatory requirements and procedures for submitting registration and results information for certain clinical trials. The requirement applies to clinical trials that involve drug, biological, and device products. The rule went into effect January 18, 2017 with the FDA enforcing the requirements.
Similarly, the National Institutes of Health (NIH) has a policy on the Dissemination of NIH-funded Clinical Trials. This policy applies to any clinical trials (includes drug, biological, and device products, surgical procedures, and behavioral interventions).