Navigating the Regulatory Framework for HIV Prevention Research in Adolescents

Centers for Disease Control and Prevention, HIV and Youth, available at <https://www.cdc.gov/hiv/group/age/youth/index.html> (last visited February 24, 2020).

See Centers for Disease Control and Prevention, supra note 1.

45 CFR § 46 (2018).

45 CFR § 46 (2018).

21 U.S.C. § 301–399h (2019).

21 CFR § 50.55 (2019).

21 CFR § 50.3 (o) (2019).

L.J. Bauman , C.A. Mellins , and R. Klitzman , “Whether to Waive Parental Permission in HIV Prevention Research Among Adolescents: Ethical and Legal Considerations,” Journal of Law, Medicine & Ethics 48, no. 1 (2020): 188-201.

Q.L. Moore , M.E. Paul , A.L. Mcguire , and M.A. Majumder , “Legal Barriers to Adolescent Participation in Research About HIV and Other Sexually Transmitted Infections,” American Journal of Public Health 106, no. 1 (2016): 40–44.

Food and Drug Administration, HIV-1 PrEP drug can be part of a strategy to prevent infection in at-risk adolescents, available at <https://www.fda.gov/files/science%20&%20research/published/HIV-PrEP-drug-can-be-part-of-strategy-to-prevent-infection-in-at-risk-adolescents.pdf> (last visited February 24, 2020)

Centers for Disease Control and Prevention, Minors' Consent Laws for HIV and STD Services, available at <https://www.cdc.gov/hiv/policies/law/states/minors.html> (last visited February 24, 2020).

Guttmacher Institute, Minors' Access to STI Services, available at <https://www.guttmacher.org/state-policy/explore/minors-access-sti-services> (last visited February 24, 2020).

See Centers for Disease Control and Prevention, supra note 11.

See Moore, supra note 9.

A.L. Gilbert , A.S. Knopf , J. D. Fortenberry , S.G. Hosek , B.G. Kapogiannis , and G. D. Zimet , “Adolescent Self-Consent for Biomedical Human Immunodeficiency Virus Prevention Research,” Journal of Adolescent Health 57, no. 1 (2015): 113–119.

Food and Drug Administration, supra note 10.

Food and Drug Administration, supra note 10.

Centers for Disease Control and Prevention, HIV in the Southern United States, available at <https://www.cdc.gov/hiv/pdf/policies/cdc-hiv-in-the-south-issue-brief.pdf> (last visited February 24, 2020).

Id.

Id.