Updated Helsinki Guidelines for Clinical Research Get Mixed Reviews.

The World Medical Association‘s newly updated “Ethical Principles for Medical Research Involving Human Subjects” are drawing considerable praise, as well as some criticisms.

The guidelines were first penned nearly a half century ago, in 1964, at a meeting of the World Medical Association in Helsinki, Finland, and have since been updated 7 times. Before this most recent update, the last time the document saw revisions was 2008.

The newest update, published online October 19 in JAMA, covers a wide range of topics organized under several headings, including:

  • Risks, Burdens and Benefits

  • Vulnerable Groups and Individuals

  • Scientific Requirements and Research Protocols

  • Research Ethics Committees

  • Privacy and Confidentiality

  • Informed Consent

  • Use of Placebos

  • Post-trial Provisions

  • Research Registration and Publication and Dissemination Results

  • Unproven Interventions in Clinical Practice

Two Viewpoints, both published in the same issue of the journal, help put the revisions in context. In some cases, the editorialists point out perceived shortcomings.

he revised document includes several subsections that give added emphasis to specific issues as well as improve readability, notes Paul Ndebele, PhD, from the Medical Research Council of Zimbabwe, Causeway, Harare, in one perspective . “By so doing, the Declaration of Helsinki is a better and more important authority at what it is aimed at achieving — providing guidance on conducting medical research involving humans.”

Since the first declaration in 1964, research oversight has improved. However, Dr. Ndebele says, improved oversight has sometimes led to an underrepresentation of certain groups in research protocols. The new version of the declaration recommends that heretofore underrepresented groups need to be more involved in clinical trials so they have a chance, along with other groups, of benefiting from successful research. “Instead of excluding groups that have been ordinarily excluded from research, such as minority groups, women, and children, researchers need to clearly justify why these groups have been excluded from research,” he writes.

In addition, he notes that the newer version is more relevant for countries with limited resources as it includes clear language that specifically addresses issues of importance in poor countries. Dr. Ndebele points to one example: “The 2013 version of the Declaration of Helsinki recommends use of unproven interventions in cases for which proven interventions do not exist, after the physician has sought expert advice as well as the patient’s informed consent.”

The 2013 version also discusses issues related to dissemination of health research information. That includes making sure that trials are registered in publicly accessible databases and that those databases include not only trials with positive results but also those with findings that are negative or inconclusive.

Dr. Ndebele emphasizes that informed consent must be a cornerstone of ethical research. The new declaration acknowledges that in some closely knit societies, gaining consent needs to involve other people than the patient, such as community leaders and significant others. “By addressing this reality, the new version is emphasizing respect for culture and community norms as part of the research process,” he writes.

The new guidelines also encourage researchers to make use of videos, vignettes, and other innovative means to explain the rationale for their studies.

Once trials are complete, it is important to give participants feedback on the results, he adds. He believes that doing so demonstrates respect for research participants and also helps demystify research.

Dr. Ndebele concedes that in recent years there has been considerable debate regarding the ethics of conducting medical research in developing countries. However, he says the 2013 update of the guidelines makes progress in addressing the issues surrounding that debate.

In the second Viewpoint, Joseph Millum, PhD, from the Department of Bioethics, Clinical Center, and the Fogarty International Center, National Institutes of Health, Bethesda, Maryland, acknowledge that the 2013 update represents progress. However, they also see a number of challenges that still need to be addressed.

For one, they say, “While the document purports to be a statement of enduring ethical principles, the nearly continuous process of revision undermines its authority.”

In addition, the 2013 document, similar to previous versions, is aimed primarily toward physicians. That is a mistake, they say, as the document offers recommendations for other health professionals, research ethics committees, sponsors, and governments, as well as editors and publishers. “It is time for the [World Medical Association] to recognize that the Declaration of Helsinki should address physicians as well as other health professionals and personnel involved in research,” they write.

Dr. Millum and colleagues add that the 2013 version’s treatment of informed consent remains inadequate. “It fails to recognize the possibility of waiving consent for some research involving competent adults, even though such research is common and widely endorsed.”

Neither does the declaration provide guidance on when it is appropriate to ask participants in studies to give broad consent for donating biological samples that could be used for wide-ranging studies in the future.

Dr. Millum and colleagues also take issue with the way the declaration treats “nonbeneficial studies,” or studies that pose risks to patients without offering compensating benefits.

Research combined with medical care is an increasingly popular way of conducting studies, note Dr. Millum and colleagues, but the declaration only allows such studies if, in the words of the declaration, “this is justified by its potential prevention, diagnostic or therapeutic value.”

In the view of Dr. Millum and colleagues, “The declaration’s lack of clear and consistent guidance regarding when net risks are acceptable creates unnecessary confusion and fuels the unfounded concern that all medical research is inherently exploitative.”

The authors further take issue with the new declaration’s protection of research participants who are vulnerable to harm in 1 or more ways, saying that the document “is confused about what constitutes appropriate protections and the appropriate means to achieve those protections.”

They concede that creating an international document to guide global research is an enormously difficult and complicated task. Hence, they say, it is not surprising that the newest version contains flaws. In spite of those flaws, however, they see the update as a step forward.

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