- In the article The 50th Universally of The Declaration of Helsinki “Progress but many remaining the challenges,” Milium, Wendel And Emanuel argue that though there have been improvement in ethical principles guiding medical research, more so , those that include human participants ,much more needs to be done. Foremost, they state that the World Medical Association declaration of Helsinki remains the basis upon which different parties in medical research rely in determining the ethical appropriateness of their studies (Millum 2143).
The authors assert that the latest revisions which coincided with the 50th anniversary of the declaration were timely, extensive and justified, since they included the views of the stakeholders. Further, they single out the inclusion of compensation for participants or victims of research gone awry for the first time in the declaration as being essential. They also state that better dissemination of study results regardless of negative or positive as being key to improving the value of medical research (Millum 2143).
Nevertheless, they contend that the declaration still has some major flaws as follows. Firstly, they argue that the near continuous revision of the declaration highly undermines the authority of the statement. Further, they argue that the declaration asserts that its main audience is physicians while in essence it is should address all stakeholders in medical research. These include, healthcare professionals, research sponsors, ethics committee, governments among others. They also argue that the clause on informed consent is largely inadequate as if fails to provide among other things waiver of consent for adults in some studies. It also fails to state when broad consent should be requested particularly on biological samples use in futures studies (Millum 2143).
The declaration also bars persons who cannot consent from participating in researches other than those that caused their incapacity. This limits the number of possible research participants even when the potential medical benefits would have been immense. Consequently, the intended protection of the incapacitated transforms into a barrier from medical progress. The declaration also bars researchers from posing any net risks to participants regardless of the value gotten. The researchers argue that this is conflicting since researches are highly susceptible to risks (Millum 2144).
In protecting the poor and vulnerable communities, they argue that the declaration is vague since it does not explain why the poor are more susceptible to exploitation. It also states that the vulnerable must benefit from the research they participate while some researches intervention may be ineffective. Lastly they note that the declaration does not address testing of interventions which would be of significance to some groups while being ineffective in other areas.The article is of great significance since it objectives cites the pros and cons of the revised declaration of Helsinki. Further, it raises thoughts on areas that out to be addressed for the improvement of ethical standards in the area of medical research (Millum 2144).
Millum, Joseph. The 50th Anniversary of the Declaration of Helsinki: Progress but Many Remaining Challenges. Journal of American Medical Association, vol. 310, no. 20, 2013, pp. 2143-2144.