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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.

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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 104 general checks that belong to any agreement: structure, parties and signatures, defined terms, cross-references, dates, amounts, and one-sided terms.

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