Informed Consent Disclosure To Vaccine Trial Subjects
By Timothy Cardozo and Ronald Veazey | PubMed | December 4, 2020
Patient comprehension is a critical part of meeting medical ethics standards of informed consent in study designs.
The aim of the study was to determine if sufficient literature exists to require clinicians to disclose the specific risk that COVID-19 vaccines could worsen disease upon exposure to challenge or circulating virus.
Methods Used To Conduct The Study:
Published literature was reviewed to identify preclinical and clinical evidence that COVID-19 vaccines could worsen disease upon exposure to challenge or circulating virus. Clinical trial protocols for COVID-19 vaccines were reviewed to determine if risks were properly disclosed.
Results Of The Study:
COVID-19 vaccines designed to elicit neutralising antibodies may sensitise vaccine recipients to more severe disease than if they were not vaccinated.
Vaccines for SARS, MERS and RSV have never been approved, and the data generated in the development and testing of these vaccines suggest a serious mechanistic concern: that vaccines designed empirically using the traditional approach (consisting of the unmodified or minimally modified coronavirus viral spike to elicit neutralising antibodies), be they composed of protein, viral vector, DNA or RNA and irrespective of delivery method, may worsen COVID-19 disease via antibody-dependent enhancement (ADE).
This risk is sufficiently obscured in clinical trial protocols and consent forms for ongoing COVID-19 vaccine trials that adequate patient comprehension of this risk is unlikely to occur, obviating truly informed consent by subjects in these trials.
Conclusions Drawn From The Study And Clinical Implications:
The specific and significant COVID-19 risk of ADE should have been and should be prominently and independently disclosed to research subjects currently in vaccine trials, as well as those being recruited for the trials and future patients after vaccine approval, in order to meet the medical ethics standard of patient comprehension for informed consent.
References
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- Huisman W, Martina BE, Rimmelzwaan GF, Gruters RA, Osterhaus AD. Vaccine‐induced enhancement of viral infections. Vaccine. 2009;27:505‐512. – PMC – PubMed
- Boyoglu‐Barnum S, Chirkova T, Anderson LJ. Biology of infection and disease pathogenesis to guide RSV vaccine development. Front Immunol. 2019;10:1675. – PMC – PubMed
- Chen WH, Hotez PJ, Bottazzi ME. Potential for developing a SARS‐CoV receptor‐binding domain (RBD) recombinant protein as a heterologous human vaccine against coronavirus infectious disease (COVID)‐19. Human Vacc Immunother. 2020;16:1239‐1242. – PMC – PubMed
- Jiang S, He Y, Liu S. SARS vaccine development. Emerg Infect Dis. 2005;11:1016‐1020. – PMC – PubMed
- Tseng CT, Sbrana E, Iwata‐Yoshikawa N, et al. Immunization with SARS coronavirus vaccines leads to pulmonary immunopathology on challenge with the SARS virus. PLoS One. 2012;7:e35421. – PMC – PubMed
Conflict of interest statement
The authors have declared no conflicts of interest for this article.
© 2020 John Wiley & Sons Ltd
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Ronald Reagan’s Torture
By Robert Parry | Consortium News | September 8, 2009
The 2004 CIA Inspector General’s report, released in August 2009, referenced as “background” to the Bush-era abuses the spy agency’s “intermittent involvement in the interrogation of individuals whose interests are opposed to those of the United States.” The report noted “a resurgence in interest” in teaching those techniques in the early 1980s “to foster foreign liaison relationships.”
The report said, “because of political sensitivities,” the CIA’s top brass in the 1980s “forbade Agency officers from using the word ‘interrogation” and substituted the phrase “human resources exploitation” [HRE] in training programs for allied intelligence agencies.
The euphemism aside, the reality of these interrogation techniques remained brutal, with the CIA Inspector General conducting a 1984 investigation of alleged “misconduct on the part of two Agency officers who were involved in interrogations and the death of one individual,” the report said (although the details were redacted in the version released to the public).
In 1984, the CIA also was hit with a scandal over what became known as an “assassination manual” prepared by agency personnel for the Nicaraguan Contras, a rebel group sponsored by the Reagan administration with the goal of ousting Nicaragua’s leftist Sandinista government.
Despite those two problems, the questionable training programs apparently continued for another two years. The 2004 IG report states that “in 1986, the Agency ended the HRE training program because of allegations of human rights abuses in Latin America.”
While the report’s references to this earlier era of torture are brief – and the abuses are little-remembered features of Ronald Reagan’s glorified presidency – there have been other glimpses into how Reagan unleashed this earlier “dark side” on the peasants, workers and students of Central America. … continue
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