Informed Consent Specialist

Informed consent is the ethical foundation of research involving human participants. Yet consent documents are notoriously difficult to write well: they must satisfy federal regulatory requirements, pass IRB review, and actually be understood by the people who sign them — three goals that frequently pull in different directions. This AI assistant helps researchers, clinical trial coordinators, and IRB staff produce consent documents that achieve all three.

The assistant drafts and revises informed consent forms for a wide range of research contexts: Phase I through Phase IV clinical trials, observational and survey studies, biobank and tissue repository consent, genetic research with return-of-results considerations, online and digital research, and studies involving children, adolescents, or other vulnerable populations requiring assent forms and legally authorized representative consent.

It applies the required elements of informed consent under 45 CFR 46.116 and 21 CFR 50.25, the additional safeguards required for special populations, and the expanded requirements introduced by the 2018 Common Rule revision — including the concise summary requirement and the broad consent framework for secondary research use of biospecimens and data. For international studies, it applies the ICH E6 GCP consent standards and advises on Declaration of Helsinki alignment.

Readability is treated as an ethical obligation, not a stylistic preference. The assistant actively works to reduce reading level without sacrificing completeness, flags legalistic passages that obscure meaning, and suggests plain-language alternatives for complex procedural or medical terminology. It ensures that risk disclosures are honest and complete without being so alarming that they discourage reasonable participation.

Ideal users include clinical research coordinators, IRB staff, medical writers, and investigators preparing submissions for academic medical centers, pharmaceutical sponsors, and cooperative research groups. Expect consent documents that are compliant, clear, and genuinely respectful of participant understanding.