Very interesting . . . .
By James Coyne PhD
Posted: October 20, 2013
The World Medical Association has just released the latest revision of Declaration of the Helsinki Ethical Principles for Medical Research Involving Human Subjects. You can find the full document open access here.
Released on the fiftieth anniversary of the original declaration, the seventh revision will serve as the basis for regulating research involving human subjects. It will also provide the principles for evaluating research protocols submitted to what are called Institutional Review Boards (IRBs) in the United States and to similar bodies elsewhere and as the basis for judging the ethics of investigator behavior.
Manuscripts submitted for publication will have to declare that any research being reported has been reviewed by such bodies and is consistent with the revised Declaration of Helsinki.
The second paragraph of the document notes that it is addressed primarily to physicians, but that others who are involved in medical research are encouraged to adopt the same principles. Based on the reception of past versions of the Declaration of Helsinki, it can be expected that the review of psychological research, whether or not is conducted in medical settings or with medical patients, will be held to the same standards.
The revised standards thus have profound implications for the conduct of psychological research.
One provision is that the design of every research study be preregistered in a publicly accessible place before the first research participant is even enrolled. The requirement is that investigators will have to commit themselves publicly to basic features of their designs, including numbers of research participants enrolled and the primary outcomes on which the efficacy of the invention will be evaluated. They are allowed to make subsequent revisions, but any revisions have to be recorded, along with a preservation of what was originally proposed.
Preregistration of randomized clinical trials (RCTs) has already been a requirement for subsequent publication of results in many journals. If there is no preregistration of a clinical trial, there will be no consideration for publication. But requirement has been inconsistently adopted as a condition for publication in psychology journals and inconsistently enforced.
Granting agencies increasingly require that research they fund involving RCTs will be preregistered, but many psychological intervention studies are simply noncompliant. Checking published randomized clinical trials of psychological interventions, one finds that more recent ones are registered, but that often the outcomes reported in the published papers differ from what is reported in the registration. Alternatively, the registration involves designation of a primary outcome that could be assessed by a full range of measures, without stating which measure will be used. Researchers thus assess psychological distress with the BDI, the CES-D, the distress thermometer, adjective checklists, and a battery of self-reported anxiety measures. They then pick the measures that make the intervention looked most effective. This is the source of rampant selective reporting of outcomes and confirmatory bias. The proportion of clinical trials that report negative outcomes continues to decline, and there’s little doubt that this stems from selective reporting, not improvement in the design and evaluation of interventions.
What is radical is that the revised Declaration of Helsinki extends the ethical requirement that trials be registered to cover all research, not just randomized clinical trials.
Does that mean that all social psychology lab studies and even correlational observational studies be registered? The revised declaration seems to be requiring that, but it would be difficult to imagine the requirement taking hold anytime soon.
It remains to be seen just in what form this expansion of registration will be accommodated, but it has profound implications for transparency and replicability of psychological research. Even if the revised declaration is not enforced to the letter in psychological research, it will set new standards for this research’s evaluation.
The demand for replicability of psychological research will now be facilitated by investigators having to preregister the details of their designs ahead of time, at least for expanded range of designs. We can expect investigators still tried to find wiggle room, but it will be harder to simplify designs after research has been initiated or completed by dropping whole cells or experimental conditions when their inclusion embarrasses the interpretation that investigators are trying to promote.
Another expansion of the Declaration of Helsinki that is relevant to psychological research is the elaboration of the ethical requirements for dissemination, i.e., publication, of research.
Paragraph 36 states
Researchers, authors, sponsors, editors and publishers all have ethical obligations with regard to the publication and dissemination of the results of research. Researchers have a duty to make publicly available the results of their research on human subjects and are accountable for the completeness and accuracy of their reports. All parties should adhere to accepted guidelines for ethical reporting. Negative and inconclusive as well as positive results must be published or otherwise made publicly available. Sources of funding, institutional affiliations and conflicts of interest must be declared in the publication. Reports of research not in accordance with the principles of this Declaration should not be accepted for publication.Again, it is unclear how long it will take and what form these requirements will be implemented.
Authors, editors, and publishers of journals have a lot invested in the current practices of suppressing and spinning negative findings. But now those of us who oppose such practices can raise ethical issues when authors spin findings or journals continue to protect their impact factor by publishing only positive studies.
In recent months, draft versions of the revised declaration have already been made available for comment. There has already been some debate, and the recent release of the final document in JAMA was accompanied by some critical commentary. We can be confident that once professional psychological associations become aware of the new requirements for psychological research, there will be intense controversy over whether psychologists should adopt the standards or even whether they have any choice.
Let’s have no illusions. There are a lot vested interests in current editorial practices, but now we are better armed to challenge them, with an ethical code that declares that what we want is not only best practices, it is what is ethical. That in itself is a game changer.
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About James Coyne PhD
James C. Coyne, Ph.D. is Professor of Psychology in the Department of Psychiatry, Director, Behavioral Oncology Research of the Abramson Cancer Center, and a Senior Fellow at the Leonard Davis Institute for Health Economics, all at the Perelman Medical School of University of Pennsylvania. Additionally, he is Professor of Health Psychology, University of Groningen Medical Center (UMCG), the Netherlands. Previously, he served on the faculties of University of California, Berkeley and University of Michigan School of Medicine. Dr. Coyne has been elected a Fellow of the American Psychological Association, Society of Behavioral Medicine, and Academy of Behavioral Medicine. His critical commentaries have challenged whether psychosocial intervention extends the survival of cancer patients, whether recommended and mandated depression programs improve patient outcomes, and whether meta analyses of behavioral medicine commissioned by professional organizations are valid and credible. A 2008 systematic review and meta-analysis in JAMA of screening for depression among cardiovascular patients was designated by BMJ as one of the eight top papers of the year. He is known for presenting and defending controversial positions and for promoting reform of the clinical and health psychology journals. He is the co-author or editor of a number of books including the 2009 Screening for Depression in Clinical Settings: An Evidence-Based Review (Oxford University Press) with Alex Mitchell.