Legal issues in research

Pmc5037952legal and ethical issues in researchcamille yip,1 nian-lin reena han,2 and ban leong sng1,31department of women's anaesthesia, kk women's and children's hospital, bukit timah, singapore2division of clinical support services, kk women's and children's hospital, bukit timah, singapore3anesthesiology and perioperative sciences academic clinical program, duke-nus medical school, singaporeaddress for correspondence: dr. License, which allows others to remix, tweak, and build upon the work non-commercially, as long as the author is credited and the new creations are licensed under the identical ctlegal and ethical issues form an important component of modern research, related to the subject and researcher. This article seeks to briefly review the various international guidelines and regulations that exist on issues related to informed consent, confidentiality, providing incentives and various forms of research misconduct. Relevant original publications (the declaration of helsinki, belmont report, council for international organisations of medical sciences/world health organisation international guidelines for biomedical research involving human subjects, world association of medical editors recommendations on publication ethics policies, international committee of medical journal editors, cose white paper, international conference on harmonisation of technical requirements for registration of pharmaceuticals for human use-good clinical practice) form the literature that are relevant to the ethical and legal aspects of conducting research that researchers should abide by when conducting translational and clinical research. Hence, specific ethical advice should be sought at local ethics review words: confidentiality, ethics, informed consent, legal issues, plagiarism, professional misconductintroductionthe ethical and legal issues relating to the conduct of clinical research involving human participants had raised the concerns of policy makers, lawyers, scientists and clinicians for many years. The purpose of a clinical research is to systematically collect and analyse data from which conclusions are drawn, that may be generalisable, so as to improve the clinical practice and benefit patients in future. Therefore, it is important to be familiar with good clinical practice (gcp), an international quality standard that is provided by the international conference on harmonisation of technical requirements for registration of pharmaceuticals for human use (ich),[1] or the local version, gcp of the central drugs standard control organization (india's equivalent of us food and drug administration)[2] and local regulatory policy to ensure that the research is conducted both ethically and legally. In this article, we will briefly review the legal and ethical issues pertaining to recruitment of human subjects, basic principles of informed consent and precautions to be taken during data and clinical research publications. Some of the core principles of gcp in research include defining responsibilities of sponsors, investigators, consent process monitoring and auditing procedures and protection of human subjects.

3]issues related to the research participantsthe main role of human participants in research is to serve as sources of data. Researchers have a duty to ‘protect the life, health, dignity, integrity, right to self-determination, privacy and confidentiality of personal information of research subjects’. 4] the belmont report also provides an analytical framework for evaluating research using three ethical principles:[5]. For persons – the requirement to acknowledge autonomy and protect those with diminished autonomybeneficence – first do no harm, maximise possible benefits and minimise possible harmsjustice – on individual and societal atment of research subjects is considered research misconduct (no ethical review approval, failure to follow approved protocol, absent or inadequate informed consent, exposure of subjects to physical or psychological harm, exposure of subjects to harm due to unacceptable research practices or failure to maintain confidentiality). However, due to the research-centred, rather than patient-centred primary purpose, additional relevant information must be provided in clinical trials or research studies in informed consent form. There are also general principles regarding risk assessment, scientific requirements, research protocols and registration, function of ethics committees, use of placebo, post-trial provisions and research publication. 4]table 1essential components of an informed consentspecial populationsinformed consent may be sought from a legally authorised representative if a potential research subject is incapable of giving informed consent[4] (children, intellectual impairment). The involvement of such populations must fulfil the requirement that they stand to benefit from the research outcome. 4] the ‘legally authorised representative’ may be a spouse, close relative, parent, power of attorney or legally appointed guardian.

The hierarchy of priority of the representative may be different between different countries and different regions within the same country; hence, local guidelines should be l case: emergency researchemergency research studies occur where potential subjects are incapacitated and unable to give informed consent (acute head trauma, cardiac arrest). 7] researchers must obtain deferred informed consent as soon as possible from the subject (when regains capacity), or their legally authorised representative, for continued participation. 7]issues related to the researcherlegal issues pertaining to regulatory bodiesvarious regulatory bodies have been constituted to uphold the safety of subjects involved in research. It is imperative to obtain approval from the appropriate regulatory authorities before proceeding to any research. The researchers are expected to be aware of these authorities and the list of various bodies pertinent to india are listed in the article “research methodology ii” of this ng bias, inappropriate research methodology, incorrect reporting and inappropriate use of informationgood, well-designed studies advance medical science development. Poorly conducted studies violate the principle of justice, as there are time and resources wastage for research sponsors, researchers and subjects, and undermine the societal trust on scientific enquiry. 1]fraud in research and publicationde novo data invention (fabrication) and manipulation of data (falsification)[6] constitute serious scientific misconduct. 13] tools such as similarity check[14] are available to aid researchers detect similarities between manuscripts, and such checks should be done before submission. 16] this practice could artificially enlarge one's scientific work, distorting apparent productivity and may give an undue advantage when competing for research funding or career advancement.

11]salami publication slicing of data from a single research process into different pieces creating individual manuscripts from each piece to artificially increase the publication volume. 6]authorship and its various associationsthe icmje recommendation lists four criteria of authorship:Substantial contributions to the conception of design of the work, or the acquisition, analysis or interpretation of data for the workdrafting the work or revising it critically for important intellectual contentfinal approval of the version to be publishedagreement to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and s:article | pubreader | epub (beta) | printer friendly | navigation gic planhistorycore valuescenters and programsdepartment administrationdirectoryabout chaffiliated hospitalsclinical programscareer opportunitiesprofessional logyclinical pharmacologyendocrinologygastroenterologygeneral internal medicinehematology/oncologyimmunologyinfectious research connectiu research administrationresearch resourcespositions & opportunitiesfor l studentsmedical school curriculumresidency training programfellowship training ion & ipating zational l administration production l neuroscience l as public issues in judge & policy makers should al outreach issues in chers seeking to administer alcohol in their studies have to take into account a complicated balancing of the medical science, the legal requirements and the cultural context that may make turn research that is legal into unethical research. The debate about at what age drinkers can be included in a study is clouded when it comes to the administration of alcohol by the researcher. Chezem from the indiana alcohol research center participated in the 2005 work of updating and revising the original use in use of animals in research is predicated upon many practical considerations. The cost of research using human subjects is much greater than that of using animal models. But the economic aspect is not the best reason for the use of animals; rather, the ethical requirements from the nuremberg code forward have guided the research use of animals before testing upon humans. Two excellent web resources for considering the ethical use of animals in research are listed below:Foundation for biomedical al association for biomedical research (nabr). The history of patient protection is a short one in the united states and we now have several mechanisms aimed at protecting the preservation of trust in the researchers and the research enterprise is essential to the continuation of research. The use of information gathering technology and electronic communications pose unrecognized danger to research participation.

But the researchers should be cautioned that the protection from the certificate is dependent upon the researcher and staff maintaining the security of the names and information in an absolute fashion. And l statute creating for the certificate of confidentiality (current language):The secretary may authorize persons engaged in biomedical, behavioral, clinical, or other research (including research on mental health, including research on the use and effect of alcohol and other psychoactive drugs) to protect the privacy of individuals who are the subject of such research by withholding from all persons not connected with the conduct of such research the names or other identifying characteristics of such individuals. Drug login | mdep a alcohol research center545 barnhill driveeh 317 indianapolis, in 46202 ph: (317) 274-8438 fax:(317) ncbi web site requires javascript to tionresourceshow toabout ncbi accesskeysmy ncbisign in to ncbisign l listj clin patholv. 4); 2006 s:article | pubreader | epub (beta) | pdf (128k) | ok of research aslegal issues in r summarythis chapter addressed the administrative consequences that could result from a breach of an ethical responsibility to the participants in research or to the institution. It should be noted again that ethical obligations are not invariably coextensive with legal obligations and vice versa. As we saw in chapter 4, the overriding theme is the protection of the research participants and the consequences of a failure to do so. However, it is also clear from the discussion in chapter 5 that there are legally-imposed limits on the extent to which participants may be protected from the disclosure of information about them and/or their wunable to display preview. Fraud in medical research: hearings before the house subcommittee on the investigation and oversight of the committee on science and technology. The ethics of scientific research: an analysis of focus groups of scientists and institutional representatives.

Springer, boston, er book ts and alised in to check le on all sales tax included if about institutional use cookies to improve your experience with our re workshop - legal issues in open research are herehome » events » openaire workshop - legal issues in open research re workshop - legal issues in open research to main : 08:30-13:00 / 14:00-16: of event: associated audience: research managers, librarians, researchers, project coordinators, data archive managers, repository managers, it specialist, policy development managers and policy : university of barcelona (aula magna, gran via de les corts catalanes, 585 barcelona) - https:///maps/r measurements from sensors, results from simulations or interview recordings, modern scholarship generates incredible amounts of digital information which, properly kept and shared, holds the potential to drive new research and innovation. Recognising this, funders are implementing policies for rdm and data sharing, such as the horizon 2020 open research data pilot, which aims to improve and maximise access to the research data generated by eu-funded projects. This growing interest in open access, preservation and dissemination of research data, however, brings with it a number of legal challenges in areas including intellectual property considerations, data protection and 8th openaire workshop will explore legal hindrances and possible solutions to open up research data. It will examine the issues and acquaint the audience with a critical understanding of the key legal issues surrounding open research data, including data protection, ipr and psi and foster data sharing and re-use by giving pragmatic direction and concrete recommendations to stakeholders on what are their legal obligations and how best to negotiate them. The workshop will be also the opportunity to discuss the new openaire legal study (summary here) and to present the data anonymization service developed by the openaire it experts. 30-10:30 - the studies: legal studies in making data open and open research data pilot: personal data and psi rules, andreas wiebe and nils dietrich, university of göttingen (openaire) [presentation]. Interoperability of research data: principles and implementation guidelines, christoph bruch, helmholtz open science coordination office (rda/codata legal interoperability interest group) [presentation]. 30-11:00 - the funders:  lessons n 2020 open research data pilot, jean-claude burgelman, directorate general for research and innovation of the european commission [presentation]. Wiebe and nils dietrich, university of göttingen (openaire); christoph bruch, helmholtz open science coordination office (rda/codata legal interoperability interest group); jean-claude burgelman, directorate general for research and innovation of the european commission.

Openaire, funded by the european commission under h2020, is the open access infrastructure for research in europe, based on the network of open access repositories and open access journals. Openaire aims to promote open scholarship and substantially improve the discoverability and reusability of research publications and re is organizing a set of workshops which are raising awareness of openaire and its associated activities. These outreach workshops are concentrating on the uptake of the open access and open data ec mandate, other national funders open science requirements and also each focusing on a topical subject in infrastructure development that reflects the outcomes of the research studies in openaire and be open to a wide, diverse audience (+ info: https:///workshops/). This article: for nominations for codata officers (president and vice-president(s)) and executive committee members: deadline 9 april codata deliver on its strategy to mobilise the data revolution for research!