# 42 CFR § 2.21: Relationship to federal statutes protecting research subjects against compulsory disclosure of their identity

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/ecfr-42-2.21

## Section

- **Citation:** 42 CFR § 2.21
- **Heading:** Relationship to federal statutes protecting research subjects against compulsory disclosure of their identity
- **Jurisdiction:** Federal
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** September 22, 2026
- **Source:** Publisher's official text
- **Location:** Title 42—Public Health > CHAPTER I—PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER A—GENERAL PROVISIONS > PART 2—CONFIDENTIALITY OF SUBSTANCE USE DISORDER PATIENT RECORDS > Subpart B—General Provisions

## Text

(a) Research privilege description. There may be concurrent coverage of patient identifying information by the regulations in this part and by administrative action taken under section 502(c) of the Controlled Substances Act (21 U.S.C. 872(c) and the implementing regulations at 21 CFR part 1316); or section 301(d) of the Public Health Service Act (42 U.S.C. 241(d) and the implementing regulations at 42 CFR part 2a). These research privilege statutes confer on the Secretary of Health and Human Services and on the Attorney General, respectively, the power to authorize researchers conducting certain types of research to withhold from all persons not connected with the research the names and other identifying information concerning individuals who are the subjects of the research.
(b) Effect of concurrent coverage. The regulations in this part restrict the use and disclosure of information about patients, while administrative action taken under the research privilege statutes and implementing regulations in paragraph (a) of this section protects a person engaged in applicable research from being compelled to disclose any identifying characteristics of the individuals who are the subjects of that research. The issuance under subpart E of this part of a court order authorizing a disclosure of information about a patient does not affect an exercise of authority under these research privilege statutes.
[82 FR 6115, Jan. 18, 2017, as amended at 89 FR 12623, Feb. 16, 2024]

## Nearby sections

- [42 CFR § 2.1 § 2.1 Statutory authority for confidentiality of substance use disorder patient records.](https://www.frixlaw.com/law-library/statutes/ecfr-42-2.1.md)
- [42 CFR § 2.2 § 2.2 Purpose and effect.](https://www.frixlaw.com/law-library/statutes/ecfr-42-2.2.md)
- [42 CFR § 2.3 § 2.3 Civil and criminal penalties for violations.](https://www.frixlaw.com/law-library/statutes/ecfr-42-2.3.md)
- [42 CFR § 2.4 § 2.4 Complaints of noncompliance.](https://www.frixlaw.com/law-library/statutes/ecfr-42-2.4.md)
- [42 CFR § 2.11 § 2.11 Definitions.](https://www.frixlaw.com/law-library/statutes/ecfr-42-2.11.md)
- [42 CFR § 2.12 § 2.12 Applicability.](https://www.frixlaw.com/law-library/statutes/ecfr-42-2.12.md)
- [42 CFR § 2.13 § 2.13 Confidentiality restrictions and safeguards.](https://www.frixlaw.com/law-library/statutes/ecfr-42-2.13.md)
- [42 CFR § 2.14 § 2.14 Minor patients.](https://www.frixlaw.com/law-library/statutes/ecfr-42-2.14.md)
- [42 CFR § 2.15 § 2.15 Patients who lack capacity and deceased patients.](https://www.frixlaw.com/law-library/statutes/ecfr-42-2.15.md)
- [42 CFR § 2.16 § 2.16 Security for records and notification of breaches.](https://www.frixlaw.com/law-library/statutes/ecfr-42-2.16.md)
- [42 CFR § 2.17 § 2.17 Undercover agents and informants.](https://www.frixlaw.com/law-library/statutes/ecfr-42-2.17.md)
- [42 CFR § 2.18 § 2.18 Restrictions on the use of identification cards.](https://www.frixlaw.com/law-library/statutes/ecfr-42-2.18.md)
- [42 CFR § 2.19 § 2.19 Disposition of records by discontinued programs.](https://www.frixlaw.com/law-library/statutes/ecfr-42-2.19.md)
- [42 CFR § 2.20 § 2.20 Relationship to state laws.](https://www.frixlaw.com/law-library/statutes/ecfr-42-2.20.md)

---

Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/ecfr-42-2.21. Check the current official text before relying on it. Not legal advice.
