IMI – industry guidelines and ethical considerations for myopia control report

Lyle Gray, Lyndon Jones, Bjorn Drove, Jose Manuel Gonzalez-meijome, Timo Kratzer, Steve Newman, Jason J Nichols, Arne Ohlendorf, Stephanie Ramdass, Jacinto Santadomigo-Rubido, Katrina L Schmid, Donald Tan, Kai-Ooh Tan, Fuensanta A Vera-Diaz, Yee-Ling Wong, Kate L Gifford, Serge Resnikoff

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Abstract

PURPOSE. To discuss guidelines and ethical considerations associated with the development and prescription of treatments intended for myopia control (MC).
METHODS. Critical review of published papers and guidance documents was undertaken, with a view to carefully considering the ethical standards associated with the investigation, development, registration, marketing, prescription, and use of MC treatments.
RESULTS. The roles and responsibilities of regulatory bodies, manufacturers, academics, eye care practitioners, and patients in the use of MC treatments are explored. Particular attention is given to the ethical considerations for deciding whether to implement a MC strategy and how to implement this within a clinical trial or practice setting. Finally, the responsibilities in marketing, support, and education required to transfer required knowledge and skills to eye care practitioners and academics are discussed.
CONCLUSIONS. Undertaking MC treatment in minors creates an ethical challenge for a wide variety of stakeholders. Regulatory bodies, manufacturers, academics, and clinicians all share an ethical responsibility to ensure that the products used for MC are safe and efficacious and that patients understand the benefits and potential risks of such products. This International Myopia Institute report highlights these ethical challenges and provides stakeholders with recommendations and guidelines in the development, financial support, prescribing, and advertising of such treatments.
Original languageEnglish
Pages (from-to)M161
JournalInvestigative Ophthalmology & Visual Science
Volume60
Issue number3
DOIs
Publication statusPublished - Feb 2019

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Myopia
Industry
Guidelines
Marketing
Prescriptions
Minors
Therapeutics
Financial Support
Patient Care
Clinical Trials
Education

Keywords

  • conflict of interest
  • ethical prescribing
  • informed consent
  • medical device
  • myopia control

Cite this

Gray, L., Jones, L., Drove, B., Gonzalez-meijome, J. M., Kratzer, T., Newman, S., ... Resnikoff, S. (2019). IMI – industry guidelines and ethical considerations for myopia control report. Investigative Ophthalmology & Visual Science, 60(3), M161. https://doi.org/10.1167/ iovs.18-25963
Gray, Lyle ; Jones, Lyndon ; Drove, Bjorn ; Gonzalez-meijome, Jose Manuel ; Kratzer, Timo ; Newman, Steve ; Nichols, Jason J ; Ohlendorf, Arne ; Ramdass, Stephanie ; Santadomigo-Rubido, Jacinto ; Schmid, Katrina L ; Tan, Donald ; Tan, Kai-Ooh ; Vera-Diaz, Fuensanta A ; Wong, Yee-Ling ; Gifford, Kate L ; Resnikoff, Serge. / IMI – industry guidelines and ethical considerations for myopia control report. In: Investigative Ophthalmology & Visual Science. 2019 ; Vol. 60, No. 3. pp. M161.
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title = "IMI – industry guidelines and ethical considerations for myopia control report",
abstract = "PURPOSE. To discuss guidelines and ethical considerations associated with the development and prescription of treatments intended for myopia control (MC).METHODS. Critical review of published papers and guidance documents was undertaken, with a view to carefully considering the ethical standards associated with the investigation, development, registration, marketing, prescription, and use of MC treatments.RESULTS. The roles and responsibilities of regulatory bodies, manufacturers, academics, eye care practitioners, and patients in the use of MC treatments are explored. Particular attention is given to the ethical considerations for deciding whether to implement a MC strategy and how to implement this within a clinical trial or practice setting. Finally, the responsibilities in marketing, support, and education required to transfer required knowledge and skills to eye care practitioners and academics are discussed.CONCLUSIONS. Undertaking MC treatment in minors creates an ethical challenge for a wide variety of stakeholders. Regulatory bodies, manufacturers, academics, and clinicians all share an ethical responsibility to ensure that the products used for MC are safe and efficacious and that patients understand the benefits and potential risks of such products. This International Myopia Institute report highlights these ethical challenges and provides stakeholders with recommendations and guidelines in the development, financial support, prescribing, and advertising of such treatments.",
keywords = "conflict of interest, ethical prescribing, informed consent, medical device, myopia control",
author = "Lyle Gray and Lyndon Jones and Bjorn Drove and Gonzalez-meijome, {Jose Manuel} and Timo Kratzer and Steve Newman and Nichols, {Jason J} and Arne Ohlendorf and Stephanie Ramdass and Jacinto Santadomigo-Rubido and Schmid, {Katrina L} and Donald Tan and Kai-Ooh Tan and Vera-Diaz, {Fuensanta A} and Yee-Ling Wong and Gifford, {Kate L} and Serge Resnikoff",
note = "Author 3.3, 3.4 and Section 5. Overall review and editorial commentary. Acceptance from VoR Pub date - available from webpage re issue OA article, CC-BY-NC-ND DOI (from VoR) not working Not found in other repository. ET 14/11/19",
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Gray, L, Jones, L, Drove, B, Gonzalez-meijome, JM, Kratzer, T, Newman, S, Nichols, JJ, Ohlendorf, A, Ramdass, S, Santadomigo-Rubido, J, Schmid, KL, Tan, D, Tan, K-O, Vera-Diaz, FA, Wong, Y-L, Gifford, KL & Resnikoff, S 2019, 'IMI – industry guidelines and ethical considerations for myopia control report', Investigative Ophthalmology & Visual Science, vol. 60, no. 3, pp. M161. https://doi.org/10.1167/ iovs.18-25963

IMI – industry guidelines and ethical considerations for myopia control report. / Gray, Lyle; Jones, Lyndon; Drove, Bjorn; Gonzalez-meijome, Jose Manuel; Kratzer, Timo ; Newman, Steve; Nichols, Jason J; Ohlendorf, Arne; Ramdass, Stephanie; Santadomigo-Rubido, Jacinto; Schmid, Katrina L; Tan, Donald; Tan, Kai-Ooh; Vera-Diaz, Fuensanta A ; Wong, Yee-Ling; Gifford, Kate L ; Resnikoff, Serge.

In: Investigative Ophthalmology & Visual Science, Vol. 60, No. 3, 02.2019, p. M161.

Research output: Contribution to journalArticle

TY - JOUR

T1 - IMI – industry guidelines and ethical considerations for myopia control report

AU - Gray, Lyle

AU - Jones, Lyndon

AU - Drove, Bjorn

AU - Gonzalez-meijome, Jose Manuel

AU - Kratzer, Timo

AU - Newman, Steve

AU - Nichols, Jason J

AU - Ohlendorf, Arne

AU - Ramdass, Stephanie

AU - Santadomigo-Rubido, Jacinto

AU - Schmid, Katrina L

AU - Tan, Donald

AU - Tan, Kai-Ooh

AU - Vera-Diaz, Fuensanta A

AU - Wong, Yee-Ling

AU - Gifford, Kate L

AU - Resnikoff, Serge

N1 - Author 3.3, 3.4 and Section 5. Overall review and editorial commentary. Acceptance from VoR Pub date - available from webpage re issue OA article, CC-BY-NC-ND DOI (from VoR) not working Not found in other repository. ET 14/11/19

PY - 2019/2

Y1 - 2019/2

N2 - PURPOSE. To discuss guidelines and ethical considerations associated with the development and prescription of treatments intended for myopia control (MC).METHODS. Critical review of published papers and guidance documents was undertaken, with a view to carefully considering the ethical standards associated with the investigation, development, registration, marketing, prescription, and use of MC treatments.RESULTS. The roles and responsibilities of regulatory bodies, manufacturers, academics, eye care practitioners, and patients in the use of MC treatments are explored. Particular attention is given to the ethical considerations for deciding whether to implement a MC strategy and how to implement this within a clinical trial or practice setting. Finally, the responsibilities in marketing, support, and education required to transfer required knowledge and skills to eye care practitioners and academics are discussed.CONCLUSIONS. Undertaking MC treatment in minors creates an ethical challenge for a wide variety of stakeholders. Regulatory bodies, manufacturers, academics, and clinicians all share an ethical responsibility to ensure that the products used for MC are safe and efficacious and that patients understand the benefits and potential risks of such products. This International Myopia Institute report highlights these ethical challenges and provides stakeholders with recommendations and guidelines in the development, financial support, prescribing, and advertising of such treatments.

AB - PURPOSE. To discuss guidelines and ethical considerations associated with the development and prescription of treatments intended for myopia control (MC).METHODS. Critical review of published papers and guidance documents was undertaken, with a view to carefully considering the ethical standards associated with the investigation, development, registration, marketing, prescription, and use of MC treatments.RESULTS. The roles and responsibilities of regulatory bodies, manufacturers, academics, eye care practitioners, and patients in the use of MC treatments are explored. Particular attention is given to the ethical considerations for deciding whether to implement a MC strategy and how to implement this within a clinical trial or practice setting. Finally, the responsibilities in marketing, support, and education required to transfer required knowledge and skills to eye care practitioners and academics are discussed.CONCLUSIONS. Undertaking MC treatment in minors creates an ethical challenge for a wide variety of stakeholders. Regulatory bodies, manufacturers, academics, and clinicians all share an ethical responsibility to ensure that the products used for MC are safe and efficacious and that patients understand the benefits and potential risks of such products. This International Myopia Institute report highlights these ethical challenges and provides stakeholders with recommendations and guidelines in the development, financial support, prescribing, and advertising of such treatments.

KW - conflict of interest

KW - ethical prescribing

KW - informed consent

KW - medical device

KW - myopia control

U2 - 10.1167/ iovs.18-25963

DO - 10.1167/ iovs.18-25963

M3 - Article

VL - 60

SP - M161

JO - Investigative Ophthalmology & Visual Science

JF - Investigative Ophthalmology & Visual Science

SN - 0146-0404

IS - 3

ER -