Advertisement

Adolescent Female Assent in Clinical Trials: A Model Assent Process

  • 1 Citations

Abstract

Multiple issues concerning the assent process for adolescent female participation in clinical trials are present in a process that has historically been based on an adult developmental and cognitive perspective. Adolescents are experiencing physiological and psycho-social, sexual growth and, therefore, should not be approached as though they are adults. This paper addresses important assent elements from the unique developmental perspective of female adolescents including sexual activity, birth control, privacy rights, confidentiality, and pregnancy. A proposed assent process and model assent form addressing these important issues are presented.

This is a preview of subscription content, log in to check access.

Access options

Buy single article

Instant unlimited access to the full article PDF.

US$ 39.95

Price includes VAT for USA

Subscribe to journal

Immediate online access to all issues from 2019. Subscription will auto renew annually.

US$ 189

This is the net price. Taxes to be calculated in checkout.

References

  1. 1.

    National Institutes of Health. Policy and Guidelines on the Inclusion of children as Participants in Research Involving Human Subjects. Bethesda, MD: National Institutes of Health; 1998.

  2. 2.

    Food and Drug Administration. Regulations Requiring Manufacturers to Assess the Safety and Effectiveness of New Drugs and Biological Products in Pediatric Patients. Rockville, MD: Food and Drug Administration; 1997.

  3. 3.

    Food and Drug Administration. Regulations Requiring Manufacturers to Assess the Safety and Effectiveness of New Drugs and Biological Products in Pediatric Patients: Final Rule. Federal Register. 1998;63(December 2):66631–66672.

  4. 4.

    VandenBosch TV, Ward BG, Mattison D. A reappraisal of female adolescent participation in drug clinical trials. IRB. 1999;21(1):1–5.

  5. 5.

    Koren G, Carmeli DB, Carmeli YS, Haslam R. Maturity of children to consent to medical research: The babysitter test. J Med Ethics. 1993;19(3):142–147.

  6. 6.

    Nicholson RH. Medical Research with Children: Ethics, Law and Practice. Oxford: Oxford University Press, 1986.

  7. 7.

    Leikin SL. Minor’s assent or dissent to medical treatment. J Pediatrics. 1983;102(2):169–176.

  8. 8.

    Bookeloo BO, Schamus LA, Cheng TL, Simmens SJ. Young adolescents’ comfort with discussion about sexual problems with their physician. Arch Pediatric Adolescent Med. 1996;150:1146–1152.

  9. 9.

    Cheng TL, Savageau JA, Sattler AL, Dewitt, TG. Confidentiality in health care: A survey of knowledge, perceptions and attitudes among high school students. JAMA. 1993;269(11):1404–1407.

  10. 10.

    Alan Guttmacher Institute. Sex and America’s Teenagers. New York: Alan Guttmacher Institute; 1994.

  11. 11.

    Thompson S. Putting a big thing into a little hole: Teenage girls’ accounts of sexual initiation. J Sex Research. 1990;27(3):341–361.

  12. 12.

    Trussell J, Card JJ, Hogue CJ. Adolescent Sexual Behavior, Pregnancy and Childbearing. In Hatcher RA, Trussell J, Stewart F, Cates W, Setward GK, Guest F, Kowal D. Contraceptive Technology. 17th ed. New York: Ardent Media, Inc.; 1998.

  13. 13.

    Hawke JM, Jainchill N, DeLeon G. The prevalence of sexual abuse and its impact on the onset of drug use among adolescents in therapeutic community drug treatment. J Child Adolescent Substance Abuse. 2000;9(3):35–49.

  14. 14.

    Gilligan C. In a Different Voice: Psychological Theory and Women’s Development. Cambridge, MA: Harvard University Press; 1993.

  15. 15.

    Warren CW, Santelli JS, Everette SA, Kann L, Collins JL, Cassell C, Morris L, Kolbe LJ. Sexual behavior among U.S. high school students, 1990–1995. Family Planning Perspectives. 1998;30(4):170–172; 200.

  16. 16.

    Food and Drug Administration. FDA Information Sheets. Evaluation of Gender Differences in Clinical Investigations. Rockville, MD: Food and Drug Administration; 1995;71.

  17. 17.

    Connor J. Sexually transmitted diseases among teenagers in England and Wales. Communicable Disease Report. CDR Review. 1997;7(12):R173–178.

  18. 18.

    Krowchuk DP. Sexually transmitted diseases in adolescents: An update. Comprehensive Therapy. 1999;25(5):265–271.

  19. 19.

    Rogers AS, D’Angelo L, Futterman D. Guidelines for adolescent participation in research: Current realities and possible resolutions. IRB. 1994;16(4):1–5.

  20. 20.

    Santelli JS, Rosenfeld WD, DuRant RH, Dubler N, Morreale M, English A, Rogers AS. Guidelines for adolescent health research: A position paper of the Society for Adolescent Medicine. J Adolescent Health. 1995;17(5):270–276.

  21. 21.

    Humphey GB, Boon CM, van Linden van den Heuvell GF, van de wiel HB. The occurrence of high levels of acute behavioral distress in children and adolescents undergoing routine venipunctures. Pediatrics. 1992;90(1):87–91.

  22. 22.

    Fassler D. The aetiology and treatment of needle phobia in the young patient—A review. Am J Ortho-psychiatry. 1985;55(3):371–377.

Download references

Author information

Correspondence to Debra Mattison MSW.

Rights and permissions

Reprints and Permissions

About this article

Cite this article

Mattison, D., VandenBosch, T.M., Soskolne, E. et al. Adolescent Female Assent in Clinical Trials: A Model Assent Process. Ther Innov Regul Sci 36, 21–30 (2002). https://doi.org/10.1177/009286150203600106

Download citation

Key Words

  • Female adolescents
  • Clinical trials
  • Assent