Download PDFPDF
Implementing post-trial access plans for HIV prevention research
Compose Response

Plain text

  • No HTML tags allowed.
  • Web page addresses and e-mail addresses turn into links automatically.
  • Lines and paragraphs break automatically.
Author Information
First or given name, e.g. 'Peter'.
Your last, or family, name, e.g. 'MacMoody'.
Your email address, e.g.
Your role and/or occupation, e.g. 'Orthopedic Surgeon'.
Your organization or institution (if applicable), e.g. 'Royal Free Hospital'.
Statement of Competing Interests


  • Responses are moderated before posting and publication is at the absolute discretion of BMJ, however they are not peer-reviewed
  • Once published, you will not have the right to remove or edit your response. Removal or editing of responses is at BMJ's absolute discretion
  • If patients could recognise themselves, or anyone else could recognise a patient from your description, please obtain the patient's written consent to publication and send them to the editorial office before submitting your response [Patient consent forms]
  • By submitting this response you are agreeing to our full [Response terms and requirements]

Vertical Tabs

Other responses

  • Published on:
    A conceptual mistake in the definition of access in post-trial access implementation discussion?
    • Ignacio Mastroleo, Researcher, PhD in Philosophy CONICET, Program of Bioethics FLACSO Argentina

    Paul et al. (2018) “Implementing post-trial access plans for HIV prevention research” present a much-needed discussion on the implementation of post-trial access plans. Here, I just want to signal a mistake on the conceptual definition of access, to an otherwise flawless paper.

    If I am correct, the mistake would be related to the formulation of the following question:

    "it the responsibility of researchers and sponsors only to ensure that all participants have access to effective preventive therapies, or does that responsibility extend further, to ensuring that participants actually receive them?" (Paul et al 2018:4)

    I believe that "to ensure that participants have access to an intervention" is logically equivalent to "ensuring that participants actually receive an intervention". The MRCT Center's framework on post-trial responsibility defines access as “[…] the ability, right or permission of an individual to use an object or asset, and implies the removal of barriers to allow such use” (MRCT Center 2017:76). If a person does not actually receive an effective preventive therapy, she does not have the ability to use it. Therefor she has no access. Hence, distinguishing between the above expressions is conceptual mistake.

    Instead, what I believe that the authors wanted to discuss is how much sponsors and researchers need to do to ensure access to an investigational intervention. In fact, irrespective of the abo...

    Show More
    Conflict of Interest:
    None declared.