Experimental therapies - definitions and regulations

Main Article Content

Włodzimierz Galewicz


The subject of this article are the definitional and regulatory aspects of experimental (or innovative) therapies, understood either as new and unproven treatment methods that can be tested – and for this purpose used – also in clinical trials, or as applications of these new and unproven procedures in medical practice. After a short introduction, recalling one of the important sources of the concept of experimental or innovative therapy, which was the Belmont Report, I first discuss the problems related to the definition of experimental therapy (as a new and nonvalidated medical procedure used to improve the patient's health), and then the controversial issues related to its regulation (including in particular the required control to which each such therapeutic intervention should be subject). Finally, I point out the importance of the discussions on experimental therapy reported in this article, conducted in other countries or in international contacts, for the necessary revision or reinterpretation of Polish regulations regarding therapeutic experiments.


Download data is not yet available.

Article Details

How to Cite
Galewicz, Włodzimierz. 2023. “Experimental Therapies - Definitions and Regulations”. Diametros 20 (78):16-36. https://doi.org/10.33392/diam.1957.
“Normative problems of innovative therapies, Part 1” – articles
Share |


Agich G.J. (2001), Ethics and innovation in medicine, „Journal of Medical Ethics” 72 (5): 295–296.

ARM (The Alliance for Regenerative Medicine) (2020), Recommendations for the use of Hospital Exemption, URL = https://alliancerm.org/wp-content/uploads/2020/10/ARM-position-on-HE-final-Oct-2020.pdf [dostęp 22.10.2023].

ASRM (Practice Committee of the American Society for Reproductive Medicine) (2013), Definition of experimental procedures: a committee opinion, „Fertility and Sterility” 99 (5): 1197–1198.

Biffl W.L., Spain D.A., Reitsma A.M., Minter R.M., Upperman J., Wilson M., Adams R., Goldman E.B., Angelos P., Krummel T., Greenfield L.J., Society of University Surgeons Surgical Innovations Project Team (2008), Responsible development and application of surgical innovations: a position statement of the Society of University Surgeons, „Journal of the American College of Surgeons” 206 (6): 1204–1209.

Borysowski J., Ehni H.J., Górski A. (2017), Ethics review in compassionate use, „BMC Medicine” 15: 136.

Chan T.E. (2013), Legal and Regulatory Responses to Innovative Treatment, „Medical Law Review” 21 (1): 92–130.

Cowan D.H. (1986), Innovative Therapy versus Experimentation, „Tort & Insurance Law Journal” 21 (4): 619–633.

Earl J. (2019), Innovative Practice, Clinical Research, and the Ethical Advancement of Medicine, „The American Journal of Bioethics” 19 (6): 7–18.

Eyadhy A.A., Razack S. (2008), The ethics of using innovative therapies in the care of children, „Paediatrics & Child Health” 13 (3): 181–184.

FDA (2016), Expanded Access to Investigational Drugs for Treatment Use — Questions and Answers Guidance for Industry, URL = https://www.fda.gov/media/85675/download [dostęp 06.12.2023].

Freedman B., The McGill/Boston Research Group (1989), Nonvalidated Therapies and HIV Disease, „The Hastings Center Report” 19 (3): 14–20.

Ghaemi S.N., Goodwin F.K. (2007), The ethics of clinical innovation in psychopharmacology: Challenging traditional bioethics, „The Journal of Philosophy, Ethics, and Humanities in Medicine” 2: 26.

ISSCR (International Society for Stem Cell Research) (2021), Guidelines for Stem Cell Research and Clinical Translation, URL = https://www.isscr.org/guidelines [dostęp 22.10.2023], pol. Wytyczne dotyczące badania i klinicznego wykorzystania komórek macierzystych, tłum. P. Chołda, [w:] Antologia bioetyki, t. 7: Innowacyjne terapie – nadzieje i zagrożenia, W. Galewicz (red.), TAiWPN Universitas, Kraków 2024 (w przygotowaniu).

Kimmelman J. (2003), Protection at the cutting edge: the case for central review of human gene transfer research, „Canadian Medical Association Journal” 169 (8): 781–782.

Levine R.J. (1978), The Boundaries between Biomedical or Behavioral Research and the Accepted and Routine Practice of Medicine, „Belmont Report”, Appendix I, Paper No. 1, DHEW Pub. No. (OS) 78-0013.

Levine R.J. (1979), Clarifying the Concepts of Research Ethics, „The Hastings Center Report” 9 (3): 21–26.

Lewens T. (2006), Distinguishing treatment from research: a functional approach, „Journal of Medical Ethics” 32 (7): 424–429.

Lindvall O., Hyun I. (2009), Innowacje medyczne a turystyka komórkowa, tłum. P. Chołda, [w:] Antologia bioetyki, t. 7, Innowacyjne terapie – nadzieje i zagrożenia, W. Galewicz (red.), TAiWPN Universitas, Kraków 2024 (w przygotowaniu); tyt. oryg. Medical innovation versus stem cell tourism, „Science” 324 (5935): 1664–1665.

London A.J. (2006), Cutting Surgical Practice at the Joints: Individuating and Assessing Surgical Procedures, [w:] Ethical Guidelines for Innovative Surgery, A.M. Rietsma, J.D. Moreno (red.), University Publishing Group, Hagerstown.

Mastroleo I., Holzer F. (2020), New non-validated practice: an enhanced definition of innovative practice for medicine, „Law, Innovation and Technology” 12 (2): 318–346.

McKneally M.F. (1999), Ethical problems in surgery: innovation leading to unforeseen complications, „World Journal of Surgery” 8: 786–788.

Narodowa Komisja Ochrony Osób Uczestniczących w Badaniach Biomedycznych i Behawioralnych (2011), Raport belmoncki: Etyczne zasady i wytyczne dotyczące badań z udziałem ludzi, tłum. W. Galewicz, [w:] Antologia bioetyki, t.3: Badania z udziałem ludzi, W. Galewicz (red.), TAiWPN Universitas, Kraków 2011: 69–82.

NCPHSBBR (The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research) (1979), The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research, Department of Health, Education, and Welfare, Washington D.C. (tłum. W. Galewicz, Raport belmoncki: Etyczne zasady i wytyczne dotyczące badań z udziałem ludzi, [w:] Antologia bioetyki, t. 3: Badania z udziałem ludzi, W. Galewicz (red.), TAiWPN Universitas, Kraków 2011: 69–82); tekst dostępny także na stronie: URL = https://nil.org.pl/dzialalnosc/osrodki/osrodek-bioetyki/etyka-w-badaniach-naukowych/1725-raport-belmoncki [dostęp 22.10.2023].

Stanford University Medical Center (2011), Innovative Care Guidelines, URL = https://stanfordhealthcare.org/content/dam/SHC/health-care-professionals/medical-staff/policies/innovative-care-guidelines-final-3-18-11-copy.pdf [dostęp 22.10.2023].

Ustawa z dnia 5 grudnia 1996 r. o zawodach lekarza i lekarza dentysty (Dz. U. z 2023 r. poz. 1516).

Wendler D., Anjum S., Williamson P. (2021), Innovative treatment as a precursor to clinical research, „Journal of Clinical Investigation” 131 (15): e152573.

WMA (World Medical Association) (2013), World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects, „Journal of the American Medical Association” 310 (20): 2191–2194; tłum. M. Czarkowski, R. Krajewski, K. Radziwiłł, Ośrodek Bioetyki Naczelnej Rady Lekarskiej, Warszawa, URL = https://nil.org.pl/uploaded_files/art_1585807090_deklaracja-helsinska-przyjeta-na-64-zo-wma-pazdziernik-2013-pelny-tekst.pdf, [dostęp 22.10.2023].