Research Practitioner

Meet the newest ethical and legal challenge of obtaining and using data via the internet: The dark web

Wednesday, March 1, 2017

Are you afraid of the dark? What thoughts come to mind when you hear the word “dark”? Scary? Hidden? Sinister? Mysterious? Shadowy? The opposite of dark, of course, is “light” — and this signifies transparency, full disclosure, openness, and clarity. It is in this context that research professionals increasingly are using what is called the “dark web” to collect and use data for studies that are looking at activities that are often, but not always, illegal. What makes the dark web both intriguing and worrisome for researchers is not the kind of information it includes but rather the methods used to obtain the data (neither the usual search engines nor by hacking passwords).

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Lies and the career research subject

Wednesday, February 1, 2017

Patients can also lie about their health to be accepted into a trial. Some even make their “living” going from one trial to another. The problem will continue, some observers say, until a national registry is put into place to catch these kinds of problems.

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HHS/NIH finalize requirements for clinical trial reporting

Sunday, January 1, 2017

Faced with noncompliance of required reporting of clinical trial information, the U.S. Department of Health and Human Services (HSS) issued a final rule last September that gave more specifics about registering certain clinical trials and submitting summary results information to ClinicalTrials.gov. The rule also expanded the legal requirements for submitting registration and results information for clinical trials involving FDA-regulated drug, biological, and device products. National Institutes of Health (NIH)-funded trials fell under reporting requirements, as well, as the NIH issued a complementary policy at the same time. NIH-funded trials must register and submit summary results information to ClinicalTrials.gov even if the trials are not subject to the final rule. Although the enhancements add measures to improve the amount of clinical trial information on ClinicalTrials.gov, some researchers in favor of total transparency say that enforcement action and penalties still fall short.

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Study shows that almost half of pediatric trials are not finished or published

Tuesday, November 1, 2016

As Research Practitioner highlighted earlier this year, clinical research results have been disclosed late or not at all at least 95% of the time since reporting of results from human studies to the federal government’s ClinicalTrials.gov database became mandatory in 2008.1  Most of these trials, however, use adult subjects. Researchers at Boston’s Children Hospital in Massachusetts decided to examine the reporting of pediatric study results and found that almost half of the studies had been discontinued or not published.

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New NIH policy ties funding approval to single IRB review

Saturday, October 1, 2016

The wait is over. For the past few years researchers and their respective research institutions have faced the distinct probability that the regulations to protect individuals who agree to volunteer in a research study will be significantly changed. After much discussion on proposed changes to the Common Rule in the Notice of Proposed Rulemaking (NPRM), the Department of Health and Human Services (HHS) is poised to publish a Final Rule. “We expect to publish the Final Rule before the end of the year,” according to an HHS spokesperson.

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Advancing patient protection through proposed Common Rule changes for informed consent

Thursday, September 1, 2016

Research practitioners eagerly anticipate finalization and publication of the revised U.S. Federal Policy for the Protection of Human Subjects, known as the Common Rule, which is scheduled to be released in September 2016. Many experts speculate that the revised policy may not be published as expected, yet there appears to be consensus that change in the rules governing human subjects is inevitable; the question remains as to what will be the final rulemaking and the impact on research practice. More than five years have passed since the impending change was announced in an Advance Notice of Proposed Rulemaking (ANPRM) on July 26, 2011 [FR 2011; 76(143): 44512-44531]. After consideration of substantive public debate, the U.S. Department of Health and Human Services and 15 other Federal Departments and Agencies published a Notice of Proposed Rulemaking (NPRM) with prospective revisions to the Common Rule on September 8, 2015 [FR 2015; 80(173): 53933-54060]. Stakeholders have carefully reviewed the proposed revision, provided essential feedback during an extended open comment period, and continued to consider the implications of potential new requirements as they await publication of a final rulemaking.1,2

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VP Biden Comments on Trial Reporting Deficiencies

Monday, August 1, 2016

Two stories in the March/April 2016 issue of Research Practitioner recently have been updated. The first, “Bial Trial Highlights Reporting Deficiencies,” highlighted a study by the publication STAT that looked at the mandatory reporting of results of human studies of new treatments to the federal government’s ClinicalTrials.gov database.1

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Update of E6: The ICH GCP Guideline

Monday, August 1, 2016

The International Conference on Harmonisation’s (ICH) Guideline for Good Clinical Practice (GCP; document E6) is currently being revised. The FDA published the new version, which will be called E6 (R2), as a draft document in the Federal Register in June 2015. The draft contains numerous revisions that address changes in the scale, complexity, and cost of clinical trials since the previous version was adopted. Since clinical researchers have access to new technology and risk management processes that may increase efficiency and focus on relevant clinical trial activities, E6 is being amended to encourage the implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording, and reporting, while ensuring that human subject protection and data integrity are maintained. In addition, the update includes changes to clarify standards on electronic records and essential documents. Ultimately, the new document is designed to help clinical researchers protect human subjects, maintain data quality and integrity, and properly document trial results. This article will highlight the key changes that affect research practitioners. These revisions are expected to be reviewed and accepted within ICH and then incorporated into the E6 document by the end of 2016.

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Spotlight Continues to Shine on Pragmatic Clinical Trials

Friday, July 1, 2016

Federal human subject protection regulations have gone a long way to protect the safety of clinical trial participants. However, research professionals say that these regulations view clinical research as a highly controlled system somewhat separate from medical practice.1 This results in medical decision-makers not having high-quality evidence to make the choices in treating patients, they say. “As the field of clinical research has evolved to address this gap, it has become challenging to apply the current regulatory and ethical paradigms.” They say this is particularly evident among an increasing number of “pragmatic” clinical trials. Pragmatic trials are designed to reflect real-world medical care by recruiting broad populations of patients, embedding the trial into the usual healthcare setting, and leveraging data from health systems to produce results that can be readily used to improve patient care, according to the Patient-Centered Outcomes Research Institute (PCORI) in Washington, DC.

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Author John Grisham promotes technology funding through book

Wednesday, June 15, 2016

Funding clinical trials to test new technology is always a struggle. The Focused Ultrasound Foundation in Charlottesville, Virginia, however, has a new strategy. It turned to best-selling author of legal thrillers and board member John Grisham to promote focused ultrasound. The result is a short book, The Tumor, that Grisham wrote and made available free to the public. The book has brought new light to the therapy but also criticism that it is more of an advertisement than a story.

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