Requirements ยท Healthcare
Common Rule (45 CFR Part 46)
Federal Policy for the Protection of Human Subjects. 2 Moraph products list it under “Requirements it supports”. The products support this requirement; meeting it remains your organization’s responsibility.
About the rule
What it is
The Federal Policy for the Protection of Human Subjects, known as the Common Rule, sets requirements for research involving human subjects that is conducted or supported by the federal departments and agencies that have adopted it. HHS codifies it at 45 CFR Part 46, Subpart A. It requires review by an institutional review board and the informed consent of participants, and its revised version took effect in 2019.
Source: 45 CFR Part 46 (eCFR). This summary is for orientation only; read the rule itself or ask your counsel for what it requires of you.
Citations
How the products cite it
The exact wording on the product pages, with how many products use each.
- Federal Policy for the Protection of Human Subjects (Common Rule, 45 CFR Part 46) 1 product
- Federal Policy for the Protection of Human Subjects, the Common Rule (45 CFR Part 46) 1 product
For what it requires of your organization, read the rule itself or ask your counsel.
Products
The 2 products that support it
Clinical Trial Patient Recruitment App
Patient-facing mobile app for eConsent, retention, and adverse event reporting in trials.
Lists:
- Federal Policy for the Protection of Human Subjects, the Common Rule (45 CFR Part 46)
Cloud Content
Box storage for unstructured data (research papers, policy docs) under a business associate agreement, configured to support HIPAA safeguards. Sharing and retention decisions remain yours.
Lists:
- Federal Policy for the Protection of Human Subjects (Common Rule, 45 CFR Part 46)
Not sure which requirements apply to you? Request a gap analysis. All requirements: Requirements our products support.