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News archiveback to 2015

Legally binding agreement on human cloning?

Since Dolly the Sheep was cloned, the question of whether human reproductive cloning should be banned or pursued has been the subject of international debate. Researchers argue that a robust global governance framework on human cloning should draw on recent successes in climate change and business ethics for inspiration (Springer). Read more »

Call for new cancer drugs suitable for kids

The children's cancer foundation ctiticizes the new generation cancer treatments in their yearly report. These drugs are only tested on adults and thereby often cannot be used to treat children (Läkartidningen). Read more »

The EU Bioethics Council is back

The European Commission has again appointed members to its European Group on Ethics in Science and New Technologies (SMER). Read more »

Protection for research results will be considered

An investigator will make an inquiry into whether the legal protection of research results needs strenghtening in order to fascilitate innovation (Swedish Government). Read more »

PubMed indexing no guarantee against being predatory

A new study of predatory journals in neuroscience show that they are not listed in DOAJ, Scopus, or MEDLINE, but many of them are indexed in PubMed (article in Neuroscience). Read more »

Patient data should not have been released

Stockholm County Council did not follow the patient data act when an external company gained direct access to patient data for inclusion in a research project (Dagens Medicin). Read more »

Sexual harassment defined as scientific misconduct?

A major U.S.-based scientific geophysics society is on the verge of expanding its definition of research misconduct to include sexual harassment (Science). Read more »

Two researchers guilty of misconduct, says investigation

A Swedish university has concluded that two professors studying tissue engineering are guilty of misconduct in two published papers (Retraction Watch). Read more »

New order for investigating misconduct suggested

The public inquiry has now given its proposal (see right column with new documents). Read commentary by the Swedish Research Council »

Top Takeaways from the Common Rule Amendments

A column discusses premier takeaways from the recent amendments to the Federal Policy for the Protection of Human Subjects (Jurist Twenty). Read more »

A solution in search of a problem: Streamlining the FDA

President Trump is calling for a massive overhaul of US Food and Drug Administration regulations ( Read more »

No More 'Beall's List'

Librarian removes controversial list of "predatory journals" and publishers, reportedly in response to "threats and politics" (Inside Higher Ed). Read more »

The U.S. final rule is now updated

The U.S. federal agencies have issued an update of the regulations that safeguard individuals who participate in research. It strengthens protections for people who volunteer to participate in research, while ensuring that the oversight system does not add inappropriate administrative burdens, particularly to low-risk research (U.S. Department of Health and Human Services). Read more »

Updated publication guidelines

The ICMJE has updated the so-called Vancouver rules, to address questions on predatory publishing, when to correct and retract, and more. An annotated version identifying the changes can be found here.

New organisation for RECs proposed

In a governmental pm it is suggested that Sweden should have an organisation for ethical review of research that uses the advantages both of regional presence and the efficacy and uniformity that a central authority brings. Read more »

Statcheck exposes inconsistent p values in articles

A Dutch researcher has created software that automatically extracts statistics from articles to reveal misleading p values. Read more »

Questionable research practices blurring boundaries

Infamous cases of misconduct such as that of Paolo Macchiarini are just the extremes on a long spectrum of dubious research practices, say Nick Butler, Helen Delaney and Sverre Spoelstra, in Times Higher Education. Read more »

European regulator to release all data from clinical trials

EMA is currently implementing a policy of publishing all the clinical data it receives from pharmaceutical companies, in a bid to promote transparency in clinical trials (BioEdge). Read more »

Suggested changes to reports in genetics

Standard ethics reporting such as “consent and approval was obtained” is no longer meaningful, but meaningful ethics reporting is possible without higher word counts and could support public trust as well as networked research, claims Chin et al. (PLoS Biology). Read more »

80 % of China's clinical trial data compromised

Just over 80% of clinical trial data submitted to support new drug registrations in China have been revealed as fraudulent or substandard by the country's drug regulator (BMJ). Read more »

Corporate culture has no place in academia

Academic capitalism contributed to the mishandling of the Macchiarini case by officials at the Karolinska Institute in Sweden, argues Olof Hallonsten (Nature). Read more »

Expert Group: Macchiarini cheated

The surgeon Paolo Macchiarini is guilty of research misconduct, says the expert group on research misconduct in a statement (Dagens Nyheter). Read more »

Macchiarini investigations prompt resignations

After several investigations have heavily criticized the Karolinska hospital and Karolinska Institute, heads are rolling (Dagens Medicin). Read more »

Why there soon will be more scandals

Is it the focus on excellency and Nobel prices that have led us astray, asks Anders Johansson in an opinion piece (Aftonbladet). Read more »

EU overhauls first-in-human trials rules after disaster

On 21 July, the EMA announced in a concept paper that it wants to improve strategies to identify and reduce risks in first-in-human studies on healthy volunteers. Read more »

Objections to changes in US research regulation

The US government's proposed overhaul of regulations that govern research with human subjects is flawed and should be withdrawn, an independent advisory panel said on the 29th of June (Nature). Read more »

New EU law for medical devices

The new EU legislation aims at improving safety and innovation in this area (Swedish Medical Products Agency). Read more »

AMA modernize its Code of Medical Ethics

The AMA has voted to adopt a modernized version of its Code of Medical Ethics, capping an 8-year process to update the guideline for relevance, clarity and consistency, according to a statement (Healio). Read more »

Importing drugs för research

For safety reasons use of medicines are closely monitored. Drugs from another EES country not licensed for use in Sweden can still be used for care situations, but no such opprtunity exist for research purposes. Therefore the Swedish Medical Products Agency has issued a new proposal. Read more »

Drugs withdrawn after suspicions of misconduct

Licenses for four medicines have been temporarily withdrawn after a decision by the Swedish Medical Products Agency. The company who performed clinical trials on the drugs is supsected for misconduct. Read more »

Improve safety of first-in-human trials

EMA has sterted work on new guidelines for First-in-Human-trials. This in co-operation with the EU Commission amd the member states. In these trials a new drug is tested for the first time in humans. (Medical Products Agency). Read more »

EU leaders call for open access

In what Carlos Moedas calls a "life-changing" move, EU member states agreed on an ambitious new OA target. All scientific papers should be freely available by 2020, the Competitiveness Council concluded after a 2-day meeting (Science). Read more »

Published sensitive data on 70 000 dating online

Reprehensive and unethical, critics say. Publicly available information, state the students who made the data public. The university assumes no responsibility ( Read more »

Scientists plan to synthesise human genome

A group of scientists has been criticised for holding a high-level, behind-closed-doors meeting to discuss a project to synthesise a complete human genome within ten years (BioNews). Read more »

DOAJ delists thousands of journals

A leading index of open-access journals, The Directory of Open Access Journals (DOAJ), is set to shrink by more than one-quarter after delisting around 3,300 titles as part of an effort to exclude questionable and inactive publishers (Nature). Read more »

Karolinska questioned again

The big national project for biobanking, BBMRI, led by Karolinska institute, has shipwrecked after accusations of wrongdoing (Dagens Medicin). Read more »

Patient-centered approach to informed consent

Traditional informed consent documents tend to be too lengthy and technical to facilitate proper patient engagement. Patient-centered, short informed consent content could be equally informative, while minimizing patient burden and producing greater patient engagement, a study claims (Med Decis Making). Read more » failing?

With no clear benefits to researchers, a frustrating user experience, and no penalties for non-compliance, is becoming increasingly irrelevant to clinical researchers and the world at large with each passing day. What does this mean for public access to research results, asks Kent Anderson (The Scholarly Kitchen). Read more »

New tool for finding reporting guidelines

A new search tool is now avaliable from Penelope and EQUATOR. Read more »

Four retractions follow findings of negligence

A Swedish ethical review board has censured two biologists and Uppsala University for events related to “extensive image manipulations” in papers published between 2010 and 2014. The case has led to criticism from an outside expert over the current system in Sweden for handling such investigations (Retraction Watch). Read more »

Update: PhD might loose doctorate (UNT)

Time to stop three-phase trials?

This is asked in the BMJ, as "it is unethical to subject people to a treatment that cannot, in itself, benefit them", as is done in non-oncology phase 1 studies. Read more »

Hippocratic Oath revision

It's time to update the Declaration of Geneva, says the World Medical Association. The oath was drafted 67 years ago, as a response to Nazi workd war II atrocities. Since then, only minor revisions have been made (BioEdge). Read more »

EU and US reach data transfer agreement

Since outlawing the Safe Harbour framework last year, the EU has been negotiating with the US regarding an agreeable and legal replacement for the transfer of personal data (Pan European Networks). Read more »

Amgen launches platform to help fix reproducibility crisis

Drug company hopes to provide a new home for studies that try to replicate previous experimental results (Times Higher Education). Read more »

Discussion of the KI case

Recently, a series of television programmes have brought wide attention to the KI surgeon who might have committed misconduct. Läkartidningen has collected all its articles and social comments are a plenty. Read more »

Open data & methods for peer review

Authors of scholarly articles shall provide data and methods openly for peer review. That is the goal for researchers in the Peer Reviewers’ Openness Initiative (PRO), which has been created by researchers in order to make it easier to control results and stop misconduct (SUHF). PRO website »

Proposal on sharing clinical trial data

A proposal from the International Committee of Medical Journal Editors, based on there beinfg an ethical obligation to responsibly share data generated by interventional clinical trials as participants have put themselves at risk (NEJM). Read more »

Catastrophic clinical trial in France

One man has been pronounced brain dead and another six are in a critical condition after a stage-one pain-relief drug trial was carried out in France (BioEdge). Read more »

Biobanking in the Sharing Era

Next-gen biobanking are embracing high-speed data and sample management, but find sharing difficult (GEN). Read more »

Publishers embrace scheme to end name confusion

On January 7, some of the world's largest academic publishers and scientific societies announced that they will encourage or require researchers to sign up with ORCID (Science). Read more »

European research escapes stifling demands

Proposed legislation had threatened the use of genomic and clinical data in medical studies, but the new rules exempt research from some strict provisions (Nature). Read more »

New data protection reform in EU

New rules will address concerns from citizens by strengthening the existing rights and empowering individuals with more control over their personal data (EU Commission). Read more »

Law ignored, patients at risk

Prestigious US medical research institutions have flagrantly violated a federal law requiring public reporting of study results, depriving patients and doctors of complete data to gauge the safety and benefits of treatments, a STAT investigation has found (Vascore). Read more »

Law does not cover need for ethical guidance

Just a small part of ethical dilemmas is covered by the act on ethical review. We lack a forum for a living ethical discussion, says Gunnel Colnerud, professor emerita at Linköpings universitet (Curie). Read more »

Personal data saves lives

Researchers across Europe claim that they use personal data in a safe, secure way to grow our collective understanding of disease. The Data Saves Lives campaign calls on the EU to ensure that the upcoming Data Protection Regulation strikes a crucial balance between safeguarding privacy and vital research. Read more »

Scrap new act on whistleblower protection

A new law on protection of whistleblowers is presently prepared. But it won't make it easier to report or protect the one reporting, and should therefore be scraped, the well-known whistleblower Per Kornhall writes (Svenska Dagbladet). Read more »

It is unethical not to do research

Apart from all the approvals needed to do clinical research, consent is required. Nowadays patients are not encouraged to take part which lowers participation, says Hugo Lagercrantz at KI (Curie). Read more »

The age of contractualism in bioethics?

Recently, contractualism has become a favored perspective in bioethics and research ethics. J.S. Blumenthal-Barby ponders the merits and draw-backs of this ( blog). Read more »

KI reported to JO for misconduct evaluation

A former professor at Karolinska institutet now wants the "Justitieombudsman" to scrutinize the report where a surgeon was cleared of misconduct (Läkartidningen). Read more »

European Privacy Supervisor Proposes Ethics Board

The European Data Protection Supervisor has urged exploration of the "ethical dimension in future technologies to retain the value of human dignity and prevent individuals being reduced to mere data subjects". Read more »

Estimating the reproducibility of psychology

The largest effort yet to replicate psychology studies shows that of the 100 prominent papers analyzed, only 39% could be replicated unambiguously (NRIN). Read more »

HHS to Overhaul Research Subject Protections

The Notice of Proposed Rulemaking will make US protections for human research subjects more uniform by streamlining some informed consent rules and using other means to reduce ambiguity around clinical trials (RAPS). Read more »

PubPeer co-founder revealed

After 3 years in the shadows, the anonymous co-founder of a popular and controversial website that allows users to critique published research has revealed himself (Science). Read more »

Registered trials make positive findings vanish

A study showing a fall in positive trial results after the roll-out of attracted much attention on social media (Nature). Read more »

Cancer patients in research often unrealistic

Cancer patients take part in drug studies in the belief that they might get cured, a dissertation by Tove Godskesen shows (Dagens Medicin). Read more »

PEERE-ing into peer review

A EU project exploring issues around journal and grant peer review, and running from 2014 to 2018, is presented by its chair (Exchanges blog). Read more »

DI demands better consent information

The Swedish Data Protection Agency has reviewed 4 drug companies' research in healthcare - and found problems with patient information and responsibilities for personal data handling. Read more »

Thus should misconduct be combated

Sweden lacks a good system for investigating accusations of fraud. When the Government now will make an inquiry it is important that an independent authority is assigned the task, writes the Swedish Research Council. Read more »

EU rejects bid to ban animal testing

A EU-wide campaign to stop laboratory experiments on animals has failed to persuade the European Commission to impose a ban (BBC News). Read more »

Companies ask for access to researchers' emails

In the USA, principles of public access increasingly mandates researchers giving access to mail. If this is a problem and what it entails for research is a disputed issue (Curie). Read more »

Risky research not subject to oversight

After research projects get an initial ethical approval, there are almost no audits and we cannot be sure that they are performed ethically, write Mats Johansson and Linus Broström on DN Debatt. Read more »

Temporary research data law criticised

The Data Inspection Board thinks the temporary law for register-based research, in force until December 31 this year, should not be prolonged. Read more »

Another example of false peer review

The International Journal of Education and Research is a predatory journal published by the so-called Contemporary Research Center Australia, which is based in Bangladesh. It does a fake peer review, shows Jeffrey Beall. Read more »

Inappropriate manipulation of peer review

Following a thorough investigation, BMC can now provide a further update on their discovery last year of attempts to manipulate the peer review process at several of their journals. Read more »

New act on register research delayed?

Last year, a new act making it possible to build registries for future research use was proposed. Now the law might be delayed (Curie). Read more »

Fortsatt giltighet av lagen (2013:794) om vissa register för forskning om vad arv och miljö betyder för människors hälsa (Ministry of Education)

The Disappearing Links

A recent court ruling in Europe might make it harder to check the validity of scientific literature (Copy, Shake, and Paste). Read more »

Doctor Seeking To Perform Head Transplant

Arthur Caplan finds the idea both "rotten scientifically and lousy ethically" (Forbes). Read more »

NIH and monkey research protests

The US animal rights group PETA claims tests on primates are inhumane, but NIH maintains the research is important to understanding human health (Bethesda Beat). Read more »

Danish court clears misconduct case

Danish judges have overruled scientists, concluding that a panel of experts erred in finding a physiologist guilty of misconduct (Retraction Watch). Read more »

What if grants were refunded after fraud?

If institutions had to refund any grants built upon retracted papers, accountability for publically funded research might be strenghtened, suggests Leonid Schneider (Retraction Watch). Read more »

Sharing clinical trial data now "expected norm"

Investigators, sponsors, and other stakeholders in clinical research should foster a culture in which data sharing is the expected norm, a US Institute of Medicine committee has concluded in a recent report (BMJ News). Read more »

World's strongest open access policy

The Gates Foundation has announced the world’s strongest policy in support of open research and open data. If strictly enforced, it would prevent Gates-funded researchers from publishing in journals such as Nature and Science (Nature News). Read more »

Parthenotes fall outside patent ban

The European Court of Justice has cleared the way for the patenting of human parthenotes for industrial and commercial purposes, clarifying the definition of 'human embryo' excluded from patentability in European Law (BioNews). Read more »

The latest news are published on the start page of CODEX!

Last update: 2017-08-21

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