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Prototype devices

It is recognized that a manufacturer may wish to submit a small number  of "prototype models" of a device to clinical investigation in order to assess safety and/or performance; and those such prototypes may need to undergo a number of changes prior to large-scale production.
United States

Note: This list contains the information of all the important departments and agencies which involve in the human subjects research and clinical research. All the departments subscribe to the Common Rule, which is subpart A (last updated in 2005) of the relevant section of the Code of Federal Regulations. As indicated below, some departments and agencies subscribe to additional subparts:
Subpart B: Additional Protections for Pregnant Women, Human Fetuses, and Neonates (2001)
Subpart C: Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects (1978)
Subpart D: Additional Protections for Children Involved as Subjects in Research (1991)


Legislations

  1. United States Code Title 10, Section 980: Limitation on Use of Humans as Experimental Subjects
  2. Protection of Pupil Rights Amendment (1974)
  3. Family Educational Rights and Privacy Act (1974)
  4. Food, Drug, and Cosmetic Act, 21 USC Sections 355 and 371 (Device coverage – Section 360) (2004)
  5. Public Health Service Act, 42 USC Section 262 (1944)
  6. Privacy Act, 5 U.S.C. § 552a (1974)
  7. Health Insurance Portability and Accountability Act (1996)


Regulations

  1. 22 CFR 225, Subpart A
  2. Executive Order 12333, Subparts A, B, C, D
  3. 16 CFR 1028, Subpart A
  4. 7 CFR 1c, Subpart A
  5. 15 CFR 27, Subpart A
  6. 32CFR 219, Subpart A
  7. DoD Directive 3216.02 (2002)
  8. Army: AR 70-25, AR 40-38
  9. Navy: SECNAVINST 3900.39 series
  10. Air Force: AFI 40-402 (2005)
  11. Office of the Under Secretary of Defense for Personnel and Readiness: USUHS Instruction 3201
  12. Defence Threat Reduction Agency:  DTRA Directive 3216.1, DTRA Instruction 3216.2
  13. 34 CFR 97 Subpart A (1991) and Subpart D (1997), 34 CFR 98 (1984), 34 CFR 99 (2000), 34 CFR 350.4(c )and 356.3(c ) (1991)
  14. 10 CFR 745 (1991), Subpart A
  15. Order 1300.3, Order 481.1
  16. 45 CFR 46 Subparts A, B, C and D
  17. 24 CFR 60, Subpart A
  18. 28 CFR 22 (1976), 28 CFR 46 (1991), Subpart A, 28 CFR 512 (1994)
  19. 49 CFR 11, Subpart A
  20. 38 CFR 16 (1991), Subpart A, 38 CFR 17.85 (1998)
  21. 40 CFR 26: Subpart A: Common Rule, Subpart B: Prohibition of Intentional Exposure Research Conducted or Supported by EPA in Children and Pregnant or Nursing Women (2006), Subpart C: Additional Protections for Observational Research Conducted or Supported by EPA in Pregnant Women and Fetuses (2006), Subpart D: Additional Protections for Observational Research Conducted or Supported by EPA in Children (2006), Subpart K: Regulation of Third-Party Intentional Exposure Research for Pesticides in Non-Pregnant, Non-Nursing Adults (2006), Subpart L: Prohibition of Third-Party Intentional Exposure Research for Pesticides in Children and Pregnant or Nursing Women (2006)
  22. 14 CFR 1230, Subpart A
  23. 45 CFR 690, Subpart A
  24. 21 CFR 50 (1980), 21 CFR 312 (1987), 21 CFR 56 (2001), 21 CFR 812 (2007)
  25. HIPAA Privacy Rule: Standards for Privacy of Individually Identifiable Health Information, Final Rule, 45 CFR parts 160 and 164 (2002), HIPAA Security Rule, 45 CFR parts 160, 162, and 164


Guidelines

  1. Protection of Human Subjects in Research Supported by USAID: A Mandatory Reference for ADS Chapter 200 (2006)
  2. Good Clinical Practice in FDA-Regulated Clinical Trials
    NIH:
  3. Protecting Personal Health Information in Research: Understanding the HIPAA Privacy Rule (2004)
  4. Research Repositories, Databases, and the HIPAA Privacy Rule (2004)
  5. Institutional Review Boards and the HIPAA Privacy Rule (2004)
  		 


Opinion Poll

Which one of the following do you think is the most common reason for participating in clinical trials?
 
This opinion poll provides an informal way for the clinical research community to express its views on current topics. The results are not a scientific poll and do not necessarily reflect the percentages of all clinical researchers who agree with these positions.
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