Human Subjects Research in the News

October, 2015

September, 2015

  • Chronic Fatigue Syndrome: A Call for Real Answers to a Real Disease
    MedPage Today

    Many individuals with chronic fatigue syndrome (CFS), or the preferred term myalgic encephalomyelitis (ME/CFS),   struggle with immune and neurologic symptoms that are misunderstood by many healthcare providers. Funding for research is short in supply, and competition is strong. 

  • It’s My Nervous System That’s Lazy
    New York Times

    A new study shows that the human nervous system strives to conserve energy, even when energy savings are minor. 

  • HHS Announces Proposal to Improve Rules Protecting Human Research Subjects
    U.S. Department of Health and Human Services

    The U.S. Department of Health and Human Services and fifteen other Federal Departments and Agencies have announced proposed revisions to modernize, strengthen, and make more effective the Federal Policy for the Protection of Human Subjects that was promulgated as a Common Rule in 1991.  A Notice of Proposed Rulemaking (NPRM) was put on public display on September 2, 2015 by the Office of the Federal Register.  The NPRM seeks comment on proposals to better protect human subjects involved in research, while facilitating valuable research and reducing burden, delay, and ambiguity for investigators. It is expected that the NPRM will be published in the Federal Register on September 8, 2015.  There are plans to release several webinars that will explain the changes proposed in the NPRM, and a town hall meeting planned to be held in Washington, D.C. in October.


    Some of the major changes being proposed that will better protect research subjects and help build public trust are the rules relating to informed consent. With regard to informed consent in general (such as consent to participating in clinical trials), the rules would be significantly tightened to make sure that the process becomes more meaningful. Consent forms would no longer be able to be unduly long documents, with the most important information often buried and hard to find. They would need to give appropriate details about the research that is most relevant to a person’s decision to participate in the study, such as information a reasonable person would want to know, and present that information in a way that highlights the key information. In addition, to assure that these rules do indeed change current practices, there will be a one-time posting requirement for the consent forms for clinical trials, so that anyone drafting a consent form will do so knowing that it will eventually be subject to public scrutiny.


    In addition, informed consent would generally be required for secondary research with a biospecimen (for example, part of a blood sample that is left over after being drawn for clinical purposes), even if the investigator is not being given information that would enable him or her to identify whose biospecimen it is. Such consent would not need to be obtained for each specific research use of the biospecimen, but rather could be obtained using a “broad” consent form in which a person would give consent to future unspecified research uses.


    The NPRM also attempts to strengthen the effectiveness and efficiency of the oversight system by making the level of review more proportional to the seriousness of the harm or danger to be avoided. Research that poses greater risk to subjects should receive more oversight and deliberation than less risky research. The NPRM seeks to avoid requirements that do not enhance protection and impose burden, which can decrease efficiency, waste resources, erode trust, and obscure the true ethical challenges that require careful deliberation and stakeholder input. Cumbersome and outdated regulatory standards overwhelm and distract institutions, IRBs, and investigators in ways that stymie efforts to appropriately address the real risks and benefits of research. 


    The result of these types of changes, as the NPRM proposes to implement them, is that some studies that currently require IRB review would now become exempt. Some that are currently exempt would specifically be declared as outside the scope of the regulations (“excluded”), and thus would not require any administrative or IRB review. Further, in terms of determining when a study is exempt, a web-based “decision tool” will be created. That decision tool will provide a determination of whether or not a study is exempt. That result, so long as the tool was provided with accurate information, will be presumed by the Common Rule agencies to be an appropriate determination of exempt status. It is expected that in many instances the tool would be used by the investigators themselves, thus obviating both the need for further review and the concern that the institution might be subjecting itself to future liability by allowing investigators to use the tool.  For all of the excluded and exempt research activities, this NPRM also affirms the importance of applying the ethical principle of respect for persons, in addition to the importance of abiding by this principle in fully regulated non-exempt research involving human subjects. 


    The following list encompasses the most significant changes to the Common Rule proposed in the NPRM:

    1) Improve informed consent by increasing transparency and by imposing stricter new requirements regarding the information that must be given to prospective subjects, and the manner in which it is given to them, to better assure that subjects are appropriately informed before they decide to enroll in a research study.

    2) Generally require informed consent for the use of stored biospecimens in secondary research (for example, part of a blood sample that is left over after being drawn for clinical purposes), even if the investigator is not being given information that would enable him or her to identify whose biospecimen it is. That consent would generally be obtained by means of broad consent (i.e., consent for future, unspecified research studies) to the storage and eventual research use of biospecimens.

    3) Exclude from coverage under the Common Rule certain categories of activities that should be deemed not to be research, are inherently low risk, or where protections similar to those usually provided by IRB review are separately mandated.

    4) Add additional categories of exempt research to accommodate changes in the scientific landscape and to better calibrate the level of review to the level of risk involved in the research. A new process would allow studies to be determined to be exempt without requiring any administrative or IRB review. Certain exempt and all non-exempt research would be required to provide privacy safeguards for biospecimens and identifiable private information. New categories include:

    a. certain research involving benign interventions with adult subjects; b. research involving educational tests, surveys, interviews or observations of public behavior when sensitive information may be collected, provided that data security and information privacy protections policies are followed; c. secondary research use of identifiable private information originally collected as part of a non-research activity, where notice of such possible use was given; d. storing or maintaining biospecimens and identifiable private information for future, unspecified secondary research studies, or conducting such studies, when a broad consent template to be promulgated by the Secretary of HHS is used, information and biospecimen privacy safeguards are followed, and limited IRB approval of the consent process used is obtained.

    5) Change the conditions and requirements for waiver or alteration of consent such that waiver of consent for research involving biospecimens (regardless of identifiability) will occur only in very rare circumstances. 

    6) Mandate that U.S. institutions engaged in cooperative research rely on a single IRB for that portion of the research that takes place within the United States, with certain exceptions.  To encourage the use of IRBs that are otherwise not affiliated with or operated by an assurance-holding institution (“unaffiliated IRBs”), this NPRM also includes a proposal that would hold such IRBs directly responsible for compliance with the Common Rule.

    7) Eliminate the continuing review requirement for studies that undergo expedited review and for studies that have completed study interventions and are merely analyzing data or involve only observational follow-up in conjunction with standard clinical care.

    8) Extend the scope of the policy to cover all clinical trials, regardless of funding source, conducted at a U.S. institution that receives federal funding for non-exempt human subjects research.


    In sum, the proposed modifications described above are designed to continue to uphold the ethical principles upon which the Common Rule is based, as applied to the current social, cultural, and technological environment.

August, 2015

  • Many Psychology Findings Not as Strong as Claimed, Study Says
    New York Times

    From the article "the new analysis, called the Reproducibility Project, found no evidence of fraud or that any original study was definitively false. Rather, it concluded that the evidence for most published findings was not nearly as strong as originally claimed." 

July, 2015

  • Conflicts of Interest on Institutional Review Boards Remain Problematic
    The Wall Street Journal

    Before a medical school or teaching hospital can proceed with a clinical trial, the study has to be approved by an institutional review board. Also known as an ethics committee, these panels are designed to protect participants and ensure scientific validity. But to what extent are IRB members aware of conflicts of interest stemming from their industry relationships that may compromise their role?

June, 2015

  • University of Minnesota to overhaul research protections

    More than a decade after a young man committed suicide during a psychiatric clinical trial at the University of Minnesota—and a bioethicist there spent years lobbying for changes to the school’s clinical trials system—the university is announcing major changes to how it oversees trials and protects its most vulnerable research subjects. Last week, the school released a 75-page document describing an effort to restructure its system and calm its critics. Changes include tighter conflict-of-interest rules; a larger institutional review board (IRB) whose members will be compensated; improved training for researchers working with vulnerable populations, such as the severely mentally ill; and a board of external advisers to monitor the university’s efforts.

May, 2015

  • NIH to Develop Strategic Plan

    Dr. Collins told the subcommittee, “As a federal research agency, we are acutely aware that to achieve our mission we must serve as effective and efficient stewards of the resources provided by the American public. One way we are doing this is by focusing on prioritization of NIH resources. This involves developing advanced methods of portfolio analysis, identifying compelling scientific opportunities, fostering creative trans-NIH collaborations, and enhancing use of the Common Fund.”

  • Bipartisan Leaders Release #Cures2015 Discussion Draft as Legislative Process Continues

    After nearly a year of listening to patients, innovators, researchers, providers, consumers, and regulators, bipartisan Energy and Commerce Committee leaders have released a discussion draft marking continued progress in the 21st Century Cures initiative. On Thursday, exactly one year to the day since full Committee Chairman Fred Upton (R-MI) and Rep. Diana DeGette (D-CO) launched the initiative, the Subcommittee on Health will hold a legislative hearing to review the draft. The committee has held eight hearings, issued a number of white papers, and committee members have hosted more than two-dozen roundtables across the country to generate ideas for this initiative. The discussion draft is the product of months of bipartisan negotiations and bipartisan staff continues working toward finalized legislation. 

  • In the wake of new cures bill, NIH celebrates while FDA mulls responsibilities

    A day after the much-heralded rollout of a new draft bill to accelerate biomedical innovation, lawmakers got some feedback from officials at the National Institutes of Health (NIH) and the Food and Drug Administration (FDA). In a hearing held by the Health Subcommittee of the U.S. House of Representatives’ Energy and Commerce Committee, much of the buzz centered around a proposal to bump up NIH funding—a dramatic change from a previous version of the bill, known as the 21st Century Cures Act. The new draft recommends $10 billion in extra funding for NIH over 5 years.

  • Company Creates Bioethics Panel on Trial Drugs

    The move, to be announced by the company on Thursday, is believed to be the first of its kind in the industry and, given the size and influence of the drug maker, could inspire other companies to follow suit. It comes as a small but growing number of patients with terminal illnesses have sought the right to obtain drugs still in the testing phase that show promise for treating their diseases.

March, 2015

  • University of Minnesota suspends psychiatric drug studies enrollment
    Science Insider

    The University of Minnesota has halted patient enrollment in all psychiatric drug studies after a state report criticized the school’s handling of a suicide during a clinical trial in 2004. The report, released last Thursday by Minnesota’s Office of the Legislative Auditor, says the university’s reaction to both the death of 27-year-old Dan Markingson and subsequent calls for investigation have “seriously harmed” its credibility and reputation. The report also argues that the Markingson case “raises serious ethical issues and numerous conflicts of interest, which University leaders have been consistently unwilling to acknowledge.” Markingson had been enrolled in a trial for antipsychotic drugs while committed involuntarily to a university hospital. One of the trial leaders was his treating psychiatrist.

  • Have Research Ethics Committees Got It Wrong? A New Study Looks at What Participants in Medical Research Actually Want
    Huffington post

    Traditionally, the "gold standard" of informed consent for participation in medical research entails that participants need to consent to every new research study, which means that they need to be contacted and re-consented each time. Biomedical research today increasingly involves large international consortia of researchers using large data sets that may be physically located in dispersed locations across the globe. Seeking specific informed consent in these circumstances, particularly for each potential new use of samples or information, is challenging, expensive and often practically impossible. Some institutions thus use so-called "broad consent", by which research participants agree to a range of future uses of their samples and data. This can be particularly helpful in situations where at the time of the initial consent, it is impossible to predict how data and samples will be used in the future. Broad consent has thus been seen as a feasible compromise between individual autonomy and practical feasibility.

January, 2015

  • The Anatomy of Medical Research: U.S. and International Comparisons

    Medical research is a prerequisite of clinical advances, while health service research supports improved delivery, access, and cost. Few previous analyses have compared the United States with other developed countries.

  • How the U.S. underfunds research for migraines, asthma and depression
    Washington post

    Overall medical investment in the United States grew at just .8 percent per year between 2004-2012, a major slowdown from the 6 percent annual growth between 1994 and 2004, according to the study in the policy journal JAMA. The United States remains the dominant global funder of new medical research discoveries, but its lead — and the economic advantages that come with it — has been slipping. In the past 30 years, the country's global share of research patents considered the most valuable dropped from 73 percent to 59 percent.

  • IOM urges vast changes in clinical trial data sharing

    “The issue is no longer whether to share clinical trial data, but what specific data to share, at what time, and under what conditions,” wrote Dr. Bernard Lo, chair of the IOM committee on strategies for responsible sharing of clinical trial data, in his preface. The guidelines represent an attempt to balance the interests of stakeholders with the public demand for information on the effectiveness and safety of therapies, he said.

  • Top 10 Medical Research Issues and Trends to Watch in 2015

December, 2014

  • Scientists Often Skip A Simple Test That Could Verify Their Work

    That omission is a problem. One study found that between 18 percent and 36 percent of all cell lines have been misidentified. And this kind of mistaken identity is one reason that many results from experiments run in scientific labs can't be reproduced elsewhere.

    "These are really not very easy discussions to have," says Leonard Freedman, founding president of the Global Biological Standards Institute. "Irreproducibility is kind of an uncomfortable subject to talk about, particularly among researchers."

  • Mistaken Identities Plague Lab Work With Human Cells
  • NIH takes step to speed the initiation of clinical research by ensuring use of single IRB
    National Institutes of Health

    The National Institutes of Health issued a draft policy today to promote the use of single institutional review boards or IRBs, in multi-site clinical research studies. IRBs play a critical role in assuring the ethical conduct of clinical research, and studies must be reviewed and approved by an IRB before they can begin. When the regulations for protection of human subjects were first published, most clinical research was conducted at a single institution. Since then, the research landscape has evolved, and many studies are carried out at multiple sites and within large networks. Studies that go beyond a single site are often able to recruit more individuals from diverse populations. These multi-site studies can often generate important results in less time. However, working through IRB review at each site can add delay without increasing the protections for the research participants in the study.

November, 2014

  • NIMH creates new unit to support its research domain criteria initiative
    National Institutes of Health

    The aim of the RDoC initiative is to accelerate the pace of research that translates basic science into clinical settings by understanding the multi-layered systems that contribute to mental function. The RDoC approach emphasizes neurodevelopment and environmental effects, in keeping with modern views about the genesis of mental disorders. 

  • No safety concerns yet in trials of GSK's Ebola vaccine

    The experimental shot uses a single Ebola virus gene from a chimpanzee virus to generate an immune response. Because it doesn't contain any infectious virus material, it can't infect those being vaccinated.

  • HHS and NIH take steps to enhance transparency of clinical trial results
    National Institutes of Health

    The U.S. Department of Health and Human Services today issued a Notice of Proposed Rulemaking (NPRM), which proposes regulations to implement reporting requirements for clinical trials that are subject to Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA). The proposed rule clarifies requirements to clinical researchers for registering clinical trials and submitting summary trial results information to, a publicly accessible database operated by the National Library of Medicine, part of the National Institutes of Health. A major proposed change from current requirements is the expansion of the scope of clinical trials required to submit summary results to include trials of unapproved, unlicensed, and uncleared products.

  • NIH and FDA Toughen Rules on Reporting Medical Trials
    National Institutes of Health

October, 2014

  • The FDA takes steps to strengthen cybersecurity of medical devices
    U.S. Food and Drug Administration

    The FDA’s concerns about cybersecurity vulnerabilities include malware infections on network-connected medical devices or computers, smartphones, and tablets used to access patient data; unsecured or uncontrolled distribution of passwords; failure to provide timely security software updates and patches to medical devices and networks; and security vulnerabilities in off-the-shelf software designed to prevent unauthorized access to the device or network. The FDA has neither an indication that specific devices or systems have been purposely targeted, nor reports that any patients have been harmed as a result of cybersecurity breaches, but remains concerned about device-related cybersecurity vulnerabilities and their potential to adversely impact public health.

  • NIH Announces First Wave of Funding for BRAIN Initiative Research

    Calling it "the beginning of an ambitious journey", the National Institutes of Health announced its first wave of grants in support of the BRAIN Initiative. This initial round of awards totals $46 million to support the goal of developing deeper understanding of the brain that will ultimately catalyze new treatments and cures for devastating brain disorders and diseases.

  • Can Big Data Tell Us What Clinical Trials Don’t?
    The New York Times
  • After Election 2014: Biomedical Funding
    Science Insider

    Regardless of which party ends up controlling the Senate, the research community is unlikely to abandon its embrace of the innovation deficit as a persuasive tool in funding battles. (A coalition of scientific societies, including AAAS, publisher of ScienceInsider, has even created a website for the concept.) More money for research is only part of the pitch, however; groups are also using the phrase to highlight the importance of steady, predictable growth in the research enterprise.

    In applauding Harkin’s bill, for example, the Association of American Medical Colleges touches on both ideas. Its leaders cite the need “not only to restore the purchasing power the NIH has lost to inflation over the past decade, but also to provide the sustained, long-term predictable funding growth essential to catalyze scientific momentum and address current and emerging health challenges.”

September, 2014

  • First Vaccine for Dengue Fever Shows Promise in 2nd Big Trial
    The New York Times

    The number of dengue cases has been increasing rapidly worldwide in part because of urbanization, since the mosquito that carries the disease is well adapted to urban areas. Dengue is even moving out of tropical areas in developing countries to industrialized countries in more temperate zones.

    Sanofi said that in the second trial, as in the first, the vaccine was more effective in people previously exposed to dengue. That might make the vaccine especially useful in endemic areas, where people often are exposed more than once, but it would probably make it less useful for tourists traveling to an infected area.

  • Can Big Data and patient-informed consent coexist?

    A physician studying a relatively rare disease, meanwhile, could easily recruit thousands of, say, cystic fibrosis patients from a database that included millions of people. “I will no longer have to spend years recruiting 3,000 patients for a study, because I will already have 10,000 banging on the door,” says Michael Lauer, director of the Division of Cardiovascular Sciences at the National Heart, Lung, and Blood Institute.

  • Fantasy Video Game Teaches Kids About Clinical Trials

    “The Paper Kingdom is a novel approach, adapting an established media platform to the need for conveying important educational content to kids,” Marceau says. “This is the kind of innovative synthesis of technology and public health research at which NERI excels.” 

  • AAMC Responds to FDA’s Draft Guidance on Informed Consent
    Association of American Medical Colleges

    The AAMC urged the FDA to “consider this guidance document an opportunity to reinforce that a document capturing required elements of informed consent is only a component of the ethical obligation to ensure that research subjects have meaningful awareness of what their participation in a clinical trial means to them,” and expressed concern that the draft guidance could result in longer documents for potential research subjects.

  • Ebola: Volunteer Opportunities to help
    American Society of Tropical Medicine and Hygiene

    IMMEDIATE NEEDS: Both Wellbody and Last Mile are looking for a few long term volunteers to help with the current activities of community outreach and primary health care stewardship in this environment including:

    1. Physicians who can do health facility preparedness, training at hospital level on Ebola case isolation and setting up isolation/referral pathways
    2. RNs who can do community-based training, support management for CHWs & Primary Health Care Centers
    3. Experienced health systems professional to support staffing to MoHs national incident management committee (ideally health systems background)
  • Health Researchers Will Get $10.1 Million to Counter Gender Bias in Studies
    The New York Times

    Women are not adequately represented in many clinical trials of new drugs and medical devices. The gender bias starts at an early stage of the scientific process: Traditionally many investigators have worked only with male lab animals, concerned that the hormonal cycles of female animals would add variability and skew study results.

  • Washington Highlights NCATS Announces Changes to CTSA Program
    Association of American Medical Colleges

August, 2014

  • Learning to Do Research the Hard Way
    Inside Higher Ed

    An interesting conversation about evolving understandings of research ethics in library sciences. From the article:

    Librarians who are largely DIY researchers have two models in front of them: the scholar’s way and the corporate way. We’re used to learning how to improve web designs from tech blogs. We’ve designed surveys based on the advice of marketing gurus. We know that Google and Amazon and Facebook violate privacy in troubling ways, but since they set the standard for UX we sometimes think it is time we stopped being so fussy about privacy.

  • As Ebola’s Toll Rises, Drug Makers Race to Test Medicines
    New York Times

    From the article: 

    But with the largest ever Ebola outbreak now having killed more than 1,000 people in West Africa, drug companies and doctors are scrambling to see whether any existing medicines or drugs under development can help stem the epidemic.

  • Co-Workers Take Dim View of Women Who Seek Flex Time: Study
    Medline Plus NIH

    From the article:

    When employees asked to work from home for childcare-related reasons, nearly 70 percent of participants said they would be "very likely" or "likely" to approve the request if it was made by a man. But only about 57 percent said they would grant the request when made by a woman.

    In these cases, 24 percent of participants said men who made such a request were "extremely likeable," while only 3 percent of participants said women who made such a request were "extremely likeable."

  • Ebola, Ethics, and Public Health: What Next?
    Annals of Internal Medicine
    From the article:

    Drug testing requirements are designed to ensure that drugs are sufficiently safe and effective to be recommended to the public.  No such evidence exists for these drugs.  Moreover, U.S. researchers have been accused many times of exploitation (including of poor people in Africa) when testing new treatments during devastating public health outbreaks (6-8).


July, 2014

  • Discovery at U of I Will Help Doctors Predict Preeclampsia

    This discovery utilized specimen banking, as described in the article:

    The biomarker discovery comes after 2 years of research. But researchers say it would have taken much longer if they hadn’t been able to get samples from the Maternal Fetal Tissue Bank at the U of I. The bank keeps samples of things like blood, tissue, and urine that pregnant women, who agree to take part in the study, give during their routine visits.

June, 2014

  • Symbolic Slap at Social Sciences
    Inside Higher Ed

    From the post: The U.S. House of Representatives early Friday morning approved an increase in overall funding for research at the National Science Foundation but also endorsed an effort to pare social science studies that the agency funds. 

  • 7 Tesla MRI scanner installed
    The Loop UI Health Care

    From the article: The scanner will produce high-resolution images of microscopic structures within the human body and brain, allowing researchers to measure subtle changes in the size, function, and metabolism of specific brain structures associated with disease. For example, the scanner will let researchers measure tiny fluctuations in blood flow and metabolic processes that signal differences in brain activity. UI researchers will use the 7T scanner to investigate how the brain processes sound information; look at subtle abnormalities in white matter caused by brain disease and trauma; and detect age-related brain changes that affect decision-making.

  • Gender-specific research improves accuracy of heart disease diagnosis in women
    American Heart Association
  • Killing a Patient to Save His Life
    New York Times

    From the article:

    "scientists have never tried anything like this in humans, and the unconscious patients will not be able to consent to the procedure. Indeed, the medical center has been providing free bracelets to be worn by skittish citizens here who do not want to participate should they somehow wind up in the E.R...

    In order to obtain an exemption to federal informed consent rules, the hospital held two town hall meetings on the university campus, placed advertisements on buses, and made sure the news got in newspapers catering to minority readers."

May, 2014

  • BC’s Irish project leads to arrest of Gerry Adams
    Boston Globe

    An oral history research project on the conflict in Northern Ireland at Boston College leads to an arrest of Sinn Fein leader, Gerry Adams. Two participants in the project implicated Adams in their taped interviews; they had agreed to interviews with the understanding that information would be kept confidential until their deaths. 

    Research Ed Moloney, a journalsit who worked on the Belfast Project, expressed concerns about the subopena for the research records. From the article:

    “The damage is done,” he said. “The whole process of conducting academic research in the United States of America on sensitive subjects with confidential sources has been dealt a death blow..."

April, 2014

  • Most Medical Devices Approved for Kids Only Tested on Adults: Study
    FDA evaluates all devices for safety and effectiveness based on the indications and data provided by the sponsor, Laine said.
    "Because of the small populations involved in pediatrics, many devices may be approved by the Humanitarian Device Exemption pathway, which provides an alternate marketing path if certain criteria are met for rare conditions," she said. "The FDA considers flexible and adaptive clinical trial designs when reviewing devices in any small population. Additionally, the FDA takes into consideration the availability of alternative treatment options."
    For the study, the researchers looked at the pre- and post-market testing of devices the FDA considers Class III, or high risk.
  • Grants: Funder storm

    From the article:

    The outlook has brightened somewhat, however: in January, Congress released a 2014 spending deal that suspended sequestration for two years and slightly boosted the budgets for the US National Science Foundation (NSF) in Arlington, Virginia, and the US Department of Energy (DOE) Office of Science over 2012 levels. The NIH, however, took a US$800-million cut, continuing a ten-year downward trend (see Nature 505, 461–462; 2014).

    But some observers worry that last year's trauma will continue to influence the attitudes and decisions of scientists in training for some time. “A graduate student who looks at their principal investigator and sees how much trouble they're having is discouraged from going out into academia and setting up their own lab,” says Laurie Glimcher, dean of Weill Cornell Medical College in New York City. “I'm sure we're going to lose some of the next generation of scientists.”


March, 2014

  • Women Still Left Out of Medical Research: Report
    Medline Plus

    From the article: "while women are now more routinely included in clinical trials and an entire field of women's health has emerged beyond reproductive health, "there are still enormous gaps in the scientific process as it relates to women," said Johnson, who is executive director of The Connors Center for Women's Health at Brigham and Women's Hospital in Boston."

  • Living With Cancer: The Cost of Trials
    New York Times

    Phase 1 Clinical Trial participant describes an experience with a trial-required CT scan. Be sure to read the interesting comments.  

February, 2014

  • UI receives $17 million for automotive safety research
    Iowa Now

    Several projects will receive funding from this grant, including one of the first comprehensive consumer driving surveys.


  • The Long Tail for Biomedical Research
    Columbia Business School

    The United States devotes a lot of money to developing biomedical innovations: combined, the public and private sectors spend about 140 billion dollars on medical research every year. The Federal Government, primarily through the National Institutes of Health (NIH), does very basic upstream research, while private industry does more applied research to translate it into treatments and commercialize it, such as developing new drugs.

January, 2014

  • Drivers engaged in other tasks about 10 percent of the time

    From the article: Risks of distracted driving were greatest for newly licensed teen drivers, who were substantially more likely than adults to be involved in a crash or near miss while texting or engaging in tasks secondary to driving, according to the researchers from the National Institutes of Health and Virginia Tech.

  • Study: Two-sizes-too-small 'Grinch' effect hampers heart transplant success
    Iowa Now

    Current protocols for matching donor hearts to recipients foster sex mismatching and heart size disparities, according to a first-of-its kind analysis by physicians at the University of Maryland School of Medicine and the University of Iowa. Matching instead by donor heart size may provide better outcomes for recipients, who already face a scarcity of resources as they await a transplant.

  • Ease Up on Social Science
    Inside Higher Ed

    The article discusses DHHS proposed revisions to the Common Rule, and the implications--positive and negative--for Behavioral and Social Sciences researchers.  

December, 2013

  • UI selected for nationwide stroke research network
    Iowa Now

    From the article:

    "The new system is intended to streamline stroke research by centralizing approval and review, lessening time and costs of clinical trials, and assembling a comprehensive data sharing system," said Dr. Petra Kaufmann, associate director for clinical research at the National Institute of Neurological Disorders and Stroke (NINDS) in a prepared statement. NINDS will fund and manage the NIH Stroke Trials Network, or NIH StrokeNet.

  • Avid Cellphone Use by College Kids Tied to Anxiety, Lower Grades
    Medline Plus

    From the article:

    A new study suggests that college students who can't keep their hands off their mobile devices -- "high-frequency cellphone users" -- report higher levels of anxiety, less satisfaction with life and lower grades than peers who use their cellphones less frequently.
    If you're not college age, you're not off the hook. The researchers said the results may apply to people of all ages who have grown accustomed to using cellphones regularly, day and night.


  • Clots Tied to Heart Pump Open Debate on Risks Patients Face in Trials
    New York Times
  • 2013 Research Highlights

    A list of clinical breakthroughs, promising medical advances, and insights from basic research in 2013. 

  • Medical trials for kids don't always match global need

    From the article: 

    "We have this laissez-faire attitude of how health research will precede - that companies, government and foundations will identify the most important areas to do trial and analyses," Dr. Clay Johnston said. "This type of research shows that doesn't happen as well as we'd like."

November, 2013

  • Youth football and concussions: Worth the risk? UI Sports Medicine study will compare injury rates for youth flag and tackle football
    Iowa Now

    “Given the increased media attention to youth tackle football, we have had many patients inquire about the injury risk of tackle football and/or whether flag football was safer or recommended,” Smoot says. “Seeing no data to adequately address these questions, we decided to look at our own region (in eastern Iowa, tackle football is available in some areas for second graders through junior high age; most junior highs have tackle programs).”

  • National Advanced Driving Simulator receives grant
    Iowa Now

    NADS is a center for driving simulation excellence located at the UI’s Research Park in Coralville, Iowa. The facility is home to a range of simulators that offer varying levels of driving realism.

    NADS employees are a collection of experts unmatched in their experience in working with all aspects of driving simulation. Development and research conducted at the NADS—sponsored by government, military, and industry partners—save lives, improve quality of life for motorists, advance the state of the art in driving simulation, and improve the efficiency and productivity of the vehicle manufacturing sector.

  • Psychology graduate students win dissertation grants for human subjects research
    Iowa Now

    One of the projects described in the article:

    Zhen Wu has been awarded a grant from the National Science Foundation to support her dissertation research. The title of her project is "Doctoral Dissertation Research: How Does Pointing Facilitate Word Learning?" Her research will address how and why pointing influences young children’s word learning in real-time contexts. Wu is working under the supervision of Julie Gros-Louis, UI assistant professor of psychology.

  • Doctors Say Heart Drug Raised Risk of an Attack
    New York Times

    Article highlights concerns with data sharing in an industry sponsored clinical trial. From the article:

    Studies and lawsuits have shown that many clinical trial results, particularly negative ones, are not published. Critics say that hampers medical practice and violates an obligation to patients, who try experimental treatments in part to advance knowledge.

October, 2013

  • Clinical Trials Continue, but Only at a Crawl
    New York Times

    From the article:

    While enrollment has slowed significantly, it has not stopped. On Wednesday, more than a week into the shutdown, N.I.H. officials said that the agency had continued to admit critically ill patients to existing clinical trials, of which more than 1,400 run at any given time. About 12 patients were enrolled between Oct. 1, when the government shutdown began, and Oct. 8. Most were cancer patients, said Renate Myles, an N.I.H. spokeswoman.

  • Iowa cancer researcher denied federal funds, but gets grant instead
  • Improving colon cancer screening rates in Iowa Main Page Content Mailing educational material and a testing kit to patients more than tripled screening rates
    Iowa Now

    "Mailing educational materials and FIT kits directly to patients in primary care practices across Iowa led to much higher colon cancer screening rates compared with usual care," Levy says. "The results suggest that mailed education along with fecal immunochemical tests may save lives by increasing the early detection of colon cancer. Practices and health care systems wishing to increase colon cancer screening rates should consider systematically mailing information and the take-home test to patients due for colon cancer screening. We would encourage people to talk with their health care provider about getting screened for this potentially preventable disease."

September, 2013

  • UI vaccine unit wins multimillion dollar federal contract
    Iowa Now

    From the article:

    "The capability to respond to emerging diseases is extremely important and this national network of VTEUs allows us to rapidly test vaccines in response to potential pandemic threats," Winokur says. "By conducting trials throughout the VTEU network we also can identify the roadblocks that might impair rapid response in a pandemic setting."

  • UI gets set to welcome powerful new scanner
    Iowa Now

    "The UI will be one of only about 20 research institutes with the instrument."

  • Patient Outcomes Improved by Pay-For-Performance
    NIH Research Matters

    An interesting project attempting to assess how physician incentives affect long-term outcomes. From the article: 

    There were 4 key quality goals. All are known to reduce long-term cardiovascular risk: aspirin or antithrombotic medication prescription, blood pressure control, cholesterol control, and smoking cessation interventions. For the P4P clinics, a financial incentive was paid to physicians when a patient met a quality goal. Incentives were tiered; higher payments were given when patients who were sicker, or who had Medicaid or were uninsured, met goals. Maximum payments were $200 per patient and $100,000 per clinic. The effects were assessed from April 2009 through March 2010.

August, 2013

July, 2013

  • Is It Safe to Take Medication While Pregnant? It isn’t unethical to test drugs on pregnant women. It’s unethical not to

    From the article:

    Pharmaceutical companies are not willing to navigate the legal and ethical minefield of testing drugs on pregnant women, especially because pregnancy lasts only nine months, a short window in which the tests could pay off in additional sales. As a result, drugs are often prescribed to this population off-label, meaning that they haven’t been specifically approved for pregnant women. The editors of the Drug and Therapeutics Bulletin argue that not only is enrolling pregnant women into drug trials important, it’s unethical not to do so. The authors of a New England Journal of Medicine review of how pregnant women were treated during the H1N1 flu pandemic say such research “is not only permissible but also imperative.”

June, 2013

May, 2013

  • PCBs are everywhere
    Iowa Now

    “This is not good news, and it certainly applies to all of us,” says Keri Hornbuckle, professor of civil and environmental engineering in the UI College of Engineering and senior author on the paper. “I thought it would be worse in a very industrial city than in a rural community. Our results really shook us up. We all have PCBs in our blood, and they are coming from somewhere. We don’t make them in our bodies.”

  • Psychology Is WEIRD: Western college students are not the best representatives of human emotion, behavior, and sexuality

    The author questions the tendency of social/behavioral scientists to rely upon homogenous research subject pools. 

    From the article:

    "WEIRD is the phenomenon that plagues a lot of psychology and other social science studies: Their participants are overwhelming Western, educated, and from industrialized, rich, and democratic countries. They’re WEIRD. And not only are they WEIRD, they are overwhelmingly college students in the United States participating in studies for class credit. Thinking about the source of the data for a lot of hyped, overinterpreted psychology research puts the results into a whole new light."

  • Children of Long-Lived Parents Less Likely to Get Cancer
    Science Daily

    Longevity isn't the only genetic benefit of long-live parents; resistance to cancer, diabetes and stroke are also indicated. Additionally, "these protective effects are passed on from parents who live beyond 65 -- far younger than shown in previous studies, which have looked at those over the age of 80."

March, 2013

  • Federal Overhaul of Rules for Human Research Hits Impasse
    The Chronicle of Higher Education

    From the article:

    The government has received more than 1,100 public comments on the rule-change ideas, suggesting heavy interest in change, Mr. Schrag said. The fact that the revision process involves multiple agencies helps explain why success may be even tougher in this case than in rules changes involving a single agency, he said.

  • US bioethicists recommend more tests before child anthrax vaccine trials
    Nature News Blog

    Addressing risk, from the article:

    ...clinical trials are not normally conducted in children unless there is a chance that children can benefit from the trials. And the risk of a bioterror attack is uncertain, making such trials ethically complicated.

January, 2013

  • ‘Rehab’ helps errant researchers return to the lab

    How to handle scientific research misconduct? From the article:

    “Sometimes these are very talented researchers,” says James DuBois, an ethicist at Saint Louis University, who leads the rehab programme, called RePAIR (Restoring Professionalism and Integrity in Research). “We believe that if we can equip them with certain skills, they can return to the field as very productive individuals.”

  • Twice the Price

    An editorial in the journal Nature describes why "scientists everywhere should be disturbed that two separate pieces in Nature this week report on the lack of oversight of potential waste and overlap between research grants." 

  • Published clinical trials shown to be misleading
    Science News

    From the article:

    In comparing public and private descriptions of drug trials conducted by pharmaceutical giant Pfizer, researchers discovered discrepancies including changes in the number of study participants and inconsistent definitions of protocols and analyses.

  • Fighting Cancer: Better Models Make Better Drugs
    Huffington Post
  • Extroverts not always team players
    Iowa Now
  • 40 Years After Tuskegee: Reuniting Medical Research and Practice

    An interesting examination of current ethics regulations, from the article:

    For almost forty years, maintaining a sharp distinction between medical research and medical practice has been the cornerstone of biomedical ethics and the federal regulations that oversee how research with human subjects is conducted. The need to build a firewall between research and practice emerged during a period of intense societal focus on egregious violations of human rights that occurred in research, including most notably the Tuskegee Syphilis Study. The dominant concern then was to protect patients and other subjects from risky and exploitative research.


    Today, however, the segregation model we put in place to protect patients is actually harming them.

November, 2012

  • HPV vaccine may benefit HIV-infected women
    NIH News

    Women with HIV may benefit from a vaccine for human papillomavirus (HPV), despite having already been exposed to HPV, a study finds. Although many may have been exposed to less serious forms of HPV, more than 45 percent of sexually active young women who have acquired HIV appear never to have been exposed to the most common high-risk forms of HPV, according to the study from a National Institutes of Health research network

  • MRI and EEG could identify children at risk for epilepsy after febrile seizures
    NIH News

    Seizures during childhood fever are usually benign, but when prolonged, they can foreshadow an increased risk of epilepsy later in life. Now a study funded by the National Institutes of Health suggests that brain imaging and recordings of brain activity could help identify the children at highest risk. The study reveals that within days of a prolonged fever-related seizure, some children have signs of acute brain injury, abnormal brain anatomy, altered brain activity, or a combination.

  • Two NIH landmark studies show power of epidemiology research; underscore need to address health disparities
    NIH News

    From the article:

    Researchers from the NIH-supported Reasons for Geographic and Racial Differences in Stroke (REGARDS) study found that black men and women were about twice as likely to die from coronary heart disease (CHD) compared with their age-matched white counterparts. Black women had a higher incidence of fatal and nonfatal coronary disease than white women. The findings are based on an analysis of 24,443 men and women.

  • Rethinking Reading: UI study breaks new ground in reading development research
    Iowa Now

    From the article: We were interested in not just whether they could do exactly what we were teaching, but whether they could learn something more robust that would enable them to apply what they had learned to new tasks and new words.

  • Does Gender Warp Our View of Depression?
    Health Magazine

    A University of Iowa study says men are less likely to be seen as depressed—even when they are. James B. Potash, MD, study editor and UI professor of psychiatry, says there has been relatively little focus on education and depression in men.

  • Sanctions imposed in 2004 U drug trial death
    Minneapolis StarTribune

    Article discusses tragic outcome for subject of drug trial, raises concerns about issues of informed consent.

  • Scientists Hope Obama Continues Support for Basic Research
    New York Times

    Federal agencies like the National Institutes of Health, NASA and the National Science Foundation would all see their budgets drop by about 8 percent, if the "fiscal cliff" leads to tax cut expirations.

  • Empowering Patients through Informed Consent

    From the article: In assessing the advancing field of whole genome sequencing, the Commission recommends protecting and empowering patients through the “evaluation and adoption of a robust and workable informed consent process.”  Informed consent is more than a form to be signed; it is a process that involves an active discussion between patient and clinician or researcher.  Informed consent is a demonstration of respect for persons, the ethical principle that serves as the cornerstone of the Commission’s report.

  • Malaria Vaccine Candidate Gives Disappointing Results
    New York Times

    From the article:

    Like an H.I.V. vaccine, one against malaria has proved an elusive goal...Three shots of the vaccine, known as RTS, S or Mosquirix and produced by GlaxoSmithKline, gave babies fewer than 12 weeks old 31 percent protection against detectable malaria and 37 percent protection against severe malaria, according to an announcement by the company at a vaccines conference in Cape Town.

  • Italian police detain 9 cardiology doctors, accused of experimenting on patients
    The Windsor Star

    The investigation began over a year ago after consumer groups raised alarm about some suspicious deaths at the Polyclinic hospital in the northern city of Modena.

  • How to strengthen health research capacity in Africa, by researchers
    The Guardian Nigeria

    DETERMINED to identify solutions to key national health problems, Nigerian researchers have given a blueprint on how to strengthen health research capacity in Africa.

  • The Impact of Sequestration on NIH

    Conclusion: America should be investing more in medical research, not less. Report details the reasoning.


June, 2012

June, 2011

July, 2010

June, 2010