Human Research Protection Forms and Guidance
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.
| Reference ID | Policy Name |
|---|---|
| 13040 | Virginia Tech Human Subjects Research Policy |
| Reference ID | Document Name |
|---|---|
| HRP-001.1 | Definitions |
| HRP-002.1 | Researcher and Investigator Responsibilities |
| HRP-005.1 | Global Human Subjects Research |
| HRP-010 | Human Research Protections Training Requirements |
| HRP-013.1 | LARs Minors and Guardians |
| HRP-015.1 | ClinicalTrials.gov Registration |
| HRP-040.1 | IRB Meeting Preparation |
| HRP-041.1 | IRB Meeting Conduct and HRPP After Action |
| HRP-090.1 | Informed Consent Process for Research |
| HRP-091.1 |
Written Documentation of Consent |
| HRP-092.1 | Payments to Research Participants |
Protocol Templates
| Reference ID | Template Name |
|---|---|
| HRP-503 | Virginia Tech Human Research Protocol |
| HRP-503 | Tips for the Virginia Tech Human Research Protocol |
| HRP-503a |
This protocol template is designed for human subjects research that involves surveys, questionnaires, focus groups, or educational tests. This new template is similar to the original version and includes all the required elements, but has been modified to be more applicable to these types of research activities, resulting in a shorter protocol template. If you are unsure of what template is the most appropriate, please email irb@vt.edu. |
| HRP-503a |
Tips for the Survey Research Template |
| N/A | Existing Data Protocol |
| N/A | Human Research Determination |
Consent Templates
| Reference ID | Form Name |
|---|---|
| HRP-502 | Biomedical Consent |
| HRP-502 |
Social Behavior Informed Consent |
| HRP-502p | Parent Permission * |
| N/A | Key Information for Consent Form |
* For studies that involve minors, permission from the parents for the minor(s) to participate in the research will need to be obtained.
Information Sheet
An information sheet can be used for human subjects research that qualifies for an exemption and when the IRB has approved a waiver of documentation of informed consent.
| Reference ID | Name |
|---|---|
| N/A | Information Sheet for Studies Without Consent |
Assent Template
This template should be used for studies in which the researcher plans to obtain assent. “Assent” means a child’s affirmative agreement to participate in research. For research studies that involve minors assent can be obtained from children who are capable of providing assent.
| Reference ID | Template Name |
|---|---|
| HRP-502.A | Assent Template |
| HRP-502.B | Assent Template (for children ~ 8 – 12 years old) |
Other Templates
| Reference ID | Template Name |
|---|---|
| N/A | Virginia Tech Flyer Template |
| Reference ID | Document Name |
|---|---|
| N/A | Considerations When Conducting Alcohol Administration Studies |
| N/A | Exempt Guidance for Amendments in PMS |
| N/A | Guidance for Researchers: Family Educational Rights and Privacy Act and Research with Student Records |
| N/A | Guidance on Class Projects vs. Research |
| N/A |
Guidance on Research with Deception |
| N/A | Guidance for Researchers using Student Data or Students as Research Participants |
| N/A |
Key Information for Consent Form |
| N/A |
Regulatory Binder Checklist |
| N/A | Track Changes Instructions |
| N/A | Virginia Tech Athletics Department Protocol on Student-Athlete Participation in Research Virginia Tech Athletics Department receives numerous requests for student-athletes and teams to participate in research. As part of the university community, the Virginia Tech Athletics Department would like to foster research opportunities within the community in a safe, productive, and ethical manner. In order to protect student-athlete’s welfare and privacy, they require that all proposed research projects be sent to the Virginia Tech Athletics Department research subcommittee for review and approval before having any contact with coaching staff or student-athletes. The subcommittee will not review any applications without an IRB approval. |
| Reference ID | Checklist Name |
|---|---|
| HRP-401 | Pre-Review Checklist |
| HRP-402 | HRPP and Single Member Review Checklist |
| HRP-410 |
Waiver or Alteration of Consent Process |
| HRP-411 | Waiver of Written Documentation of Consent Checklist |
| HRP-412 | Pregnant Women Checklist |
| HRP-415 | Prisoners Checklist |
| HRP-416 | Minors Checklist |
| HRP-417 | Cognitively Impaired Adults Checklist |
| HRP-418 | Non-Significant Risk Device Checklist |
| HRP-419 | Waiver of Consent for Emergency Research Checklist |
| HRP-441 | HIPAA Waiver of Authorization Checklist |
| Reference ID | Worksheet Name |
|---|---|
| HRP-301 | Review Materials |
| HRP-302 | Approval Intervals |
| HRP-303 | Communication of Review Results |
| HRP-304 | IRB Composition |
| HRP-305 | Quorum and Expertise |
| HRP-306 |
Drugs and Biologics |
| HRP-307 | Devices |
| HRP-308 | Pre-Review |
| HRP-313 | Single Member (Expedited) Review |
| HRP-314 | Criteria for Approval |
| HRP-315 | Advertisements |
| HRP-316 | Payments |
| HRP-317 | Short Form of Consent Documentation |
| HRP-318 | Additional Federal Agency Criteria |
| HRP-319 | Limited IRB Review |
| HRP-320 | Scientific or Scholarly Review |
| HRP-321 | Review of Information Items |
| HRP-322 | Emergency Use |
| HRP-323 | Criteria for Approval HUD |
| HRP-324 | Contracts |
| HRP-325 | Device Compassionate Use |
| HRP-330 | HIPAA Authorization |
| HRP-331 | FERPA Compliance |
| HRP-332 | NIH GDS Institutional Certification |
| HRP-333 | Certificate of Confidentiality |
| Reference ID | Form Name |
|---|---|
| HRP-1812 | Local Context - Virginia Tech IRB of Record |
| HRP-1814 | Request to Rely on an External IRB |
| HRP-1855 | Request for Individual Investigator Agreement |
Information regarding required trainings can be found on the Office of Research and Innovation Required Trainings page.
For questions or concerns: 540-231-3732 or irb@vt.edu. For more information regarding human research protection, see the Human Research Protection program website.