Informed Consent (Research / Clinical) review
Informed consent under 45 C.F.R. § 46.116 (Common Rule) + 21 C.F.R. § 50 (FDA). Prose elements only.
Review your document — free → See a sample report- 9 document-specific checks
- + 114 general checks
- Nothing uploaded
- Free forever (MIT)
What it checks
Statement that the study involves research + purpose / duration
Informed consent must state that the study involves research, the purpose, and the expected duration of participation.
Critical · HC-001
Risks / discomforts disclosure
Informed consent must describe reasonably foreseeable risks / discomforts.
Critical · HC-002
Benefits — direct and indirect
Informed consent must describe benefits (or absence of direct benefit) to the subject and to others.
Critical · HC-003
Alternative procedures / treatments
Informed consent must disclose appropriate alternatives.
Critical · HC-004
Confidentiality of records
Informed consent must describe how confidentiality of records is maintained.
Critical · HC-005
Voluntary participation + withdrawal right (no penalty / loss of benefits)
Informed consent must state that participation is voluntary and the subject may withdraw without penalty / loss of benefits.
Critical · HC-006
Contact persons — research questions + research-related injury + subject rights
Informed consent must identify contacts for research questions, research-related injuries, and subject rights.
Critical · HC-007
FDA-regulated study — § 50.25 additional elements (when applicable)
If the study is FDA-regulated, the consent must include § 50.25 elements (the ClinicalTrials.gov statement for applicable clinical trials, FDA inspection of records).
Warning · HC-008
Compensation for injury (when applicable)
For research involving more than minimal risk, the consent should describe compensation / medical treatment for research-related injury.
Warning · HC-009
Every run also applies 114 general checks that belong to any agreement: structure, parties and signatures, defined terms, cross-references, dates, amounts, and one-sided terms.
How it works
- Open vaulytica.com — no account, nothing to install.
- Drop your PDF or DOCX, or paste the text. The document type is detected and only the checks that belong to it run, inside your browser tab.
- Get a Word report in which every finding quotes the clause and cites the rule and source behind it — one of 1,946 checks across 286 document types.
More healthcare documents
- Business Associate Agreement (HIPAA)
- BAA — Business Associate to Subcontractor (HIPAA)
- Clinical Trial Agreement
- Data Use Agreement for a Limited Data Set (HIPAA)
- HIPAA Notice of Privacy Practices
- Management Services Agreement (Medical or Dental Practice)
- Medical Director Agreement
- Notice of Privacy Practices Acknowledgment
- Payer / Provider Participation Agreement
- Patient Authorization for Release of PHI
- Physician Employment Agreement
- Telehealth Informed Consent