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Genetics lab research paper guidelines

Biological sample collections from minors for genetic research: a

the research results must have important health implications and be associated with established and substantial risk. instead, include those data as supplementary material or deposit the data in a publicly available database. however, not all informed consent documents will mention the return of individual genetic results (particularly for studies in which sample collections were done long ago); in these situations, researchers should consult with their irb regarding the appropriateness of communicating individual ror when reliable contact information is available and the result is of high clinical importance. 1existing genetics resources with potential to help support a central advisory committee to make recommendations on what genetic research results should be returned to research participantsrecommendation 4: investigators may choose to return individual genetic results to study participants if the criteria for an obligation to return results are not satisfied (see recommendation 1) but all of the following apply:The investigator has concluded that the potential benefits of disclosure outweigh the risks from the participant’s perspective. figure 1 first establishes that informed consent has been obtained and that the study participant’s identity and contact information are available. in addition, the advisory body may advise on what results the researcher may choose to return, as addressed in our recommendation 4 below.” we do not attempt here to resolve the legal question of whether research labs that are not clia-certified may return individual research results. abstract of the paper should be succinct; it must not exceed 300 words. pending further legal clarification, researchers planning new studies should consider either using a clia-certified lab initially, or planning to confirm results in a clia-certified lab, if there is any expectation of identifying variants that will be of clinical importance to the study participants. actionable means that disclosure has the potential to lead to an improved health outcome; there must be established therapeutic or preventive interventions available or other available actions that may change the course of disease. should consider prospectively whether their study has potential to yield individual research results of clinical importance and describe plans for ror in consent forms and processes. the group recommends the creation of a central body, or bodies, to provide guidance on when genetic research results are associated with sufficient risk and have established clinical utility to justify their return to study participants.

ACMG Practice Guideline: lack of evidence for MTHFR

a minimum, include the following in your figure captions:A figure label with arabic numerals, and “figure” abbreviated to “fig” (e. can be derived from a figure or supporting information file from the paper, and it may be a cropped portion of an image or the entire image. 2: a researcher’s obligation to return individual research results to a study participant should not ordinarily extend beyond study funding. researchers are finding that many study participants wish to receive individual research results 23–25 and direct-to-consumer (dtc) companies are making genotyping available to consumers at steadily decreasing prices 26, 27, with widely variable interpretations of the implications of those individual data. some members of the working group felt that a regulatory requirement for use of clia-certified labs is counter to the ethical obligation of investigators to disclose to study participants information the researchers possess that would be beneficial to those participants, even though the information is not from a clia-certified lab. genetic finding is actionable, that is, there are established therapeutic or preventive interventions or other available actions that have the potential to change the clinical course of the disease. because of the controversy surrounding this issue, the working group encourages those making, interpreting, and implementing clia policies to revisit and clarify them for research studies in a process that ensures broad input from the research community. links to download supporting information files are also available after the reference list. write out in full the genus and species, both in the title of the manuscript and at the first mention of an organism in a paper. because of the strong arguments in favor of respecting research participant choices and the lack of consensus in our group on overriding the participant’s decision in some circumstances, we recommend that when the participant has opted-in or opted-out of receiving results, the investigators honor that decision; when the informed consent is silent, consultation with the irb on possible options is recommended. we encourage authors to use rrids within the text of their papers to identify their model organisms, antibodies, or tools. genetic research on biological material from minors can yield valuable information on the development and genesis of early-onset genetic disorders and the early interaction of environmental and genetic factors.

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Instructions for authors

actionable means that disclosure has the potential to lead to an improved health outcome; there must be established therapeutic or preventive interventions available or other available actions that may change the course of disease. the strengths of the process were the involvement of leading thinkers and researchers on return of results and incidental findings, disciplinary diversity, geographic diversity, and extended time and communication to finalize recommendations. of algorithms and protocol documents for clinical trials, observational studies, and other non-laboratory investigations may be uploaded as supporting information.. gov'tmesh termsadolescentbiological specimen banks/ethicsbiological specimen banks/legislation & jurisprudence*childethics committees, research/legislation & jurisprudencegenetic research/ethicsgenetic research/legislation & jurisprudence*guidelines as topic*humansminors*/legislation & jurisprudenceparental consentpublications/legislation & jurisprudencepublications/statistics & numerical data*specimen handling/ethicsspecimen handling/methods*linkout - more resourcesfull text sourcesnature publishing groupeurope pubmed centralpubmed centralpubmed central canadaother literature sourcescos scholar universepubmed commons home. even in the case where investigators have access to alternate funds, investigators may, but should not be expected to, return results beyond the termination of research fundingin practical terms, investigators cannot maintain an open-ended commitment to return results and thus should plan to have the results provided before the end of the operating grant period. for studies in which an investigator also serves as the clinical care provider to a research participant, the investigator-clinician may be obligated to provide clinically relevant information in his/her possession to the patient even if funding has expired. numbers (and version numbers, if appropriate) should be provided in the data availability statement. investigators should consult with available participants in their studies and work with their irbs to establish what findings are of sufficient health importance that they should be returned..9 [indexed for medline] free pmc articlesharepublication types, mesh termspublication typesmeta-analysisresearch support, non-u. b(2) as follows: “it [clia] applies to research laboratories as well if they report patient-specific results for the diagnosis, prevention or treatment of any disease or impairment of, or the assessment of the health of, individual patients. you are submitting content other than a research article, read the guidelines for other article types. this is a high impact issue because sample handling in research studies may not conform to clia standards, many research laboratories are not clia-certified, newer tests may not be available from clia-certified labs, and many existing biobanks and current studies do not use clia-certified labs.

Biology Research Paper Format

Ethical and Practical Guidelines for Reporting Genetic Research

1existing genetics resources with potential to help support a central advisory committee to make recommendations on what genetic research results should be returned to research participantsrecommendation 4: investigators may choose to return individual genetic results to study participants if the criteria for an obligation to return results are not satisfied (see recommendation 1) but all of the following apply:The investigator has concluded that the potential benefits of disclosure outweigh the risks from the participant’s perspective. results section should provide details of all of the experiments that are required to support the conclusions of the paper. will your study inspire the other members of your field, and how will it drive research forward? when funding for a project ends, investigators may no longer have the resources to maintain or reinitiate contact with participants even though the researchers may continue to publish or complete work from the data set./illustrations:Short reports are brief articles presenting laboratory or clinical work, collected case reports, or single case reports of clinical or scientific significance. this approach would have the added benefit of drawing a line between information generated in research and information generated in the clinical context to guide clinical decisions. even in the case where investigators have access to alternate funds, investigators may, but should not be expected to, return results beyond the termination of research fundingin practical terms, investigators cannot maintain an open-ended commitment to return results and thus should plan to have the results provided before the end of the operating grant period. 3: for consistency and rigor, an independent, national central advisory committee should be established to review evidence for genetic risk factors to offer guidance to investigators, research institutions, and irbs regarding when a genetic result is well enough understood and has sufficiently serious clinical implications to justify an obligation to return genetic research results to study participantshaving a central body generate guidance on what is reportable in genetic studies would provide an opportunity for broad stakeholder input, allow a more consistent approach across research studies, and provide credible guidance for researchers and irbs. the strengths of the process were the involvement of leading thinkers and researchers on return of results and incidental findings, disciplinary diversity, geographic diversity, and extended time and communication to finalize recommendations. some members of the working group felt that a regulatory requirement for use of clia-certified labs is counter to the ethical obligation of investigators to disclose to study participants information the researchers possess that would be beneficial to those participants, even though the information is not from a clia-certified lab. burke, md, msc281division of cardiovascular sciences, nhlbi, bethesda, md2ctr for medical ethics & health policy, baylor college of med, houston, tx3dept of bioethics, cleveland clinic, cleveland, oh4duke inst for genome sciences & policy, duke univ, durham, nc5genetic diseases research branch, nat human genome research inst, bethesda, md6office of population genomics, nat human genome research inst, bethesda, md7dept of bioethics & humanities, univ of washington, seattle, wa8pulmonary & critical care division, univ of california san francisco, san francisco, ca9dept of genetics, harvard med school, boston, ma10ctr for biomedical ethics & society, vanderbilt univ school of law, nashville, tn11dept of laboratory med & pathology, univ of minnesota, minneapolis, mn12iwk health ctr, dept of pediatrics, dalhousie univ, halifax, nova scotia, canada13patient advocate, oakton, va14genetic analysis platform, broad inst, boston, ma15southwest tribal epidemiology ctr, albuquerque, nm16division of med/cardio, johns hopkins univ, baltimore, md17division of med genetics, univ of washington school of med, seattle, wa18college of med, univ of illinois chicago, chicago, il19health futures, llc, washington dc20framingham heart study, nhlbi, framingham, ma21health research affairs, partners health care system, inc.” 28 working group members disagreed on the interpretation of what constitutes compliance with the clia regulations for the return of research results in genetics studies.

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Guidelines for Writing a Scientific Paper

research represents a substantial body of laboratory or clinical work. in addition, the advisory body may advise on what results the researcher may choose to return, as addressed in our recommendation 4 below. the working group concluded that if an investigator is able to return genetic research results after the research funding is exhausted, this is acceptable but not obligatory. in the united states, clia certification is required for all laboratories testing human samples for patient care.” we do not attempt here to resolve the legal question of whether research labs that are not clia-certified may return individual research results. 2: a researcher’s obligation to return individual research results to a study participant should not ordinarily extend beyond study funding. january 2009 the national heart, lung, and blood institute (nhlbi) convened a 28-member multidisciplinary working group to update the recommendations of a 2004 nhlbi working group focused on guidelines to the return of genetic research results..beabstractstored tissue samples are an important resource for epidemiological genetic research. however, guidance from the central body should be advisory, not mandatory, to allow local consideration by irbs, institutions conducting research, community members, and researchers themselves. this is a high impact issue because sample handling in research studies may not conform to clia standards, many research laboratories are not clia-certified, newer tests may not be available from clia-certified labs, and many existing biobanks and current studies do not use clia-certified labs. the group recommends the creation of a central body, or bodies, to provide guidance on when genetic research results are associated with sufficient risk and have established clinical utility to justify their return to study participants. more information on how best to provide data, read our policy on data availability.

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BIO306 Genetics Projects

researchers are finding that many study participants wish to receive individual research results 23–25 and direct-to-consumer (dtc) companies are making genotyping available to consumers at steadily decreasing prices 26, 27, with widely variable interpretations of the implications of those individual data. according to cms, research labs are exempt except as defined in 42 cfr § 493. this group provided expertise in population genetics, laboratory genetics, genomics, statistical genetics, epidemiology, medical genetics, bioethics, genetic counseling, law, public policy, and patient advocacy. in addition, it suggests that a time limit be established to limit the duration of obligation of investigators to return genetic research results. in addition, it suggests that a time limit be established to limit the duration of obligation of investigators to return genetic research results. cover letter will be available to the editors and to external peer reviewers as necessary, so be careful not to reveal anything of a confidential nature., boston, ma22office of policy, communications & education, nat human genome research inst, bethesda, md23epidemiology & genetic research program, nat cancer inst, bethesda, md24division of endocrinology, diabetes & nutrition, univ of maryland school of med, baltimore, md25charles b. not cite the following sources in the reference list:Unavailable and unpublished work, including manuscripts that have been submitted but not yet accepted (e. burke, md, msc281division of cardiovascular sciences, nhlbi, bethesda, md2ctr for medical ethics & health policy, baylor college of med, houston, tx3dept of bioethics, cleveland clinic, cleveland, oh4duke inst for genome sciences & policy, duke univ, durham, nc5genetic diseases research branch, nat human genome research inst, bethesda, md6office of population genomics, nat human genome research inst, bethesda, md7dept of bioethics & humanities, univ of washington, seattle, wa8pulmonary & critical care division, univ of california san francisco, san francisco, ca9dept of genetics, harvard med school, boston, ma10ctr for biomedical ethics & society, vanderbilt univ school of law, nashville, tn11dept of laboratory med & pathology, univ of minnesota, minneapolis, mn12iwk health ctr, dept of pediatrics, dalhousie univ, halifax, nova scotia, canada13patient advocate, oakton, va14genetic analysis platform, broad inst, boston, ma15southwest tribal epidemiology ctr, albuquerque, nm16division of med/cardio, johns hopkins univ, baltimore, md17division of med genetics, univ of washington school of med, seattle, wa18college of med, univ of illinois chicago, chicago, il19health futures, llc, washington dc20framingham heart study, nhlbi, framingham, ma21health research affairs, partners health care system, inc., boston, ma22office of policy, communications & education, nat human genome research inst, bethesda, md23epidemiology & genetic research program, nat cancer inst, bethesda, md24division of endocrinology, diabetes & nutrition, univ of maryland school of med, baltimore, md25charles b. investigators should consult with available participants in their studies and work with their irbs to establish what findings are of sufficient health importance that they should be returned. information guidelines for more details about submitting supporting information and multimedia files.

PLOS Genetics: A Peer-Reviewed Open-Access Journal

creation of an entity charged to provide guidance to irbs, investigators, research institutions and research sponsors would provide rigorous review of available data, promote standardization of study policies regarding return of genetic research results, and enable investigators and study participants to clarify and share expectations for the handling of this increasingly valuable information with appropriate respect for the rights and needs of participants. it is not appropriate to suggest recent collaborators or other researchers at your institution. high-throughput technologies have been developed, whole genome sequencing is a reality, additional “omics” measures are now available, and wide data sharing among investigators is expected. genetic finding is actionable, that is, there are established therapeutic or preventive interventions or other available actions that have the potential to change the clinical course of the disease. ask that all authors of research articles include a 150–200 word non-technical summary of the work as part of the manuscript to immediately follow the abstract. and all available works can be cited in the reference list..958827pmcid: pmc3090664nihmsid: nihms272954ethical and practical guidelines for reporting genetic research results to study participants: updated guidelines from an nhlbi working grouprichard r. in the united states, clia certification is required for all laboratories testing human samples for patient care. the research resource citation guidelines provide instructions on how to cite the resource in the manuscript.: consent genetics, ethics, research genetics, risk rediction, single nucleotide polymorphism geneticsintroductionin 2004, the national heart, lung, and blood institute (nhlbi) convened a working group that led to the publication of a conference report and recommendations on returning genetic research results to research participants 1. because of the strong arguments in favor of respecting research participant choices and the lack of consensus in our group on overriding the participant’s decision in some circumstances, we recommend that when the participant has opted-in or opted-out of receiving results, the investigators honor that decision; when the informed consent is silent, consultation with the irb on possible options is recommended..iblhn@rztisbafauthor information ► copyright and license information ►copyright notice and disclaimerpublisher's disclaimerthe publisher's final edited version of this article is available free at circ cardiovasc genetsee other articles in pmc that cite the published article.

Preparing Manuscripts for Submission | Genetics

: consent genetics, ethics, research genetics, risk rediction, single nucleotide polymorphism geneticsintroductionin 2004, the national heart, lung, and blood institute (nhlbi) convened a working group that led to the publication of a conference report and recommendations on returning genetic research results to research participants 1. this recommendation suggests that investigators (and funders) make available sufficient resources to implement ror during the award period. this approach would have the added benefit of drawing a line between information generated in research and information generated in the clinical context to guide clinical decisions. high-throughput technologies have been developed, whole genome sequencing is a reality, additional “omics” measures are now available, and wide data sharing among investigators is expected. sample collections from minors for genetic research: a systematic review of guidelines and position papers. january 2009 the national heart, lung, and blood institute (nhlbi) convened a 28-member multidisciplinary working group to update the recommendations of a 2004 nhlbi working group focused on guidelines to the return of genetic research results. creation of an entity charged to provide guidance to irbs, investigators, research institutions and research sponsors would provide rigorous review of available data, promote standardization of study policies regarding return of genetic research results, and enable investigators and study participants to clarify and share expectations for the handling of this increasingly valuable information with appropriate respect for the rights and needs of participants..iblhn@rztisbafauthor information ► copyright and license information ►copyright notice and disclaimerpublisher's disclaimerthe publisher's final edited version of this article is available free at circ cardiovasc genetsee other articles in pmc that cite the published article. 1decision flow diagram on the return of individual genetic research results to study participantswhen contact information is available, the decision to return individual results depends on the nature of the research findings. for studies in which an investigator also serves as the clinical care provider to a research participant, the investigator-clinician may be obligated to provide clinically relevant information in his/her possession to the patient even if funding has expired. the content of the remaining 18 documents was categorized according to four themes: consent, principles of non-therapeutic research on vulnerable populations, ethics committee approval and difference between anonymous and identifiable samples./illustrations:Communication articles include a brief descriptions of significant clinical or laboratory findings.

Biological sample collections from minors for genetic research: a

PLOS ONE: accelerating the publication of peer-reviewed science

b(2) as follows: “it [clia] applies to research laboratories as well if they report patient-specific results for the diagnosis, prevention or treatment of any disease or impairment of, or the assessment of the health of, individual patients. however, guidance from the central body should be advisory, not mandatory, to allow local consideration by irbs, institutions conducting research, community members, and researchers themselves. match the label of your figure with the name of the file uploaded at submission (e. researchers should make clear to study participants during the informed consent process that individual research results will ordinarily not be returned after the award period ends. journals require authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception. when submitting a manuscript online, authors must provide a data availability statement describing compliance with plos's policy. the final recommendation urges investigators to engage the broader community when dealing with identifiable communities to advise them on the return of aggregate and individual research results. the research results must have important health implications and be associated with established and substantial risk. the final recommendation urges investigators to engage the broader community when dealing with identifiable communities to advise them on the return of aggregate and individual research results. they also argued that results from labs that are not clia-certified can still have analytic validity and may be returned by investigators if clearly labeled as research results and accompanied with a warning that the results should not be used for clinical decisions until they are confirmed in a clia-certified lab. figure 1 first establishes that informed consent has been obtained and that the study participant’s identity and contact information are available. authors are encouraged to select repositories that meet accepted criteria as trustworthy digital repositories, such as criteria of the centre for research libraries or data seal of approval.

because of the controversy surrounding this issue, the working group encourages those making, interpreting, and implementing clia policies to revisit and clarify them for research studies in a process that ensures broad input from the research community. resource identifiers are unique resource identifiers (rrids) for citing resources used in the research. researchers should make clear to study participants during the informed consent process that individual research results will ordinarily not be returned after the award period ends.” 28 working group members disagreed on the interpretation of what constitutes compliance with the clia regulations for the return of research results in genetics studies. this group provided expertise in population genetics, laboratory genetics, genomics, statistical genetics, epidemiology, medical genetics, bioethics, genetic counseling, law, public policy, and patient advocacy. recommend and encourage you to deposit laboratory protocols in protocols. the current address should be listed in the byline and clearly labeled “current address. this recommendation suggests that investigators (and funders) make available sufficient resources to implement ror during the award period. 3: for consistency and rigor, an independent, national central advisory committee should be established to review evidence for genetic risk factors to offer guidance to investigators, research institutions, and irbs regarding when a genetic result is well enough understood and has sufficiently serious clinical implications to justify an obligation to return genetic research results to study participantshaving a central body generate guidance on what is reportable in genetic studies would provide an opportunity for broad stakeholder input, allow a more consistent approach across research studies, and provide credible guidance for researchers and irbs. on preprint servers, if the manuscript is submitted to a journal and also publicly available as a preprint. however, a systematic reflection on the ethical and policy issues arising from the participation of minors in biobank research is missing. genetics publishes original research that clearly demonstrates novelty, importance to a particular field, biological significance, and conclusions that are justified by the study.

of medical genetics is a leading international peer-reviewed journal covering original research in human genetics, including reviews of and opinion on the latest developments. however, not all informed consent documents will mention the return of individual genetic results (particularly for studies in which sample collections were done long ago); in these situations, researchers should consult with their irb regarding the appropriateness of communicating individual ror when reliable contact information is available and the result is of high clinical importance..958827pmcid: pmc3090664nihmsid: nihms272954ethical and practical guidelines for reporting genetic research results to study participants: updated guidelines from an nhlbi working grouprichard r. should consider prospectively whether their study has potential to yield individual research results of clinical importance and describe plans for ror in consent forms and processes. other members of the group felt that it was important for all individual results that were returned to participants to come from a clia-certified lab because the clia-specified processes offered significant potential benefits to participants (primarily in the realm of analytic validity and reduced risk of returning results to the wrong person), and that use of a clia-certified lab was practicable in nearly all circumstances. the working group concluded that if an investigator is able to return genetic research results after the research funding is exhausted, this is acceptable but not obligatory. authors are encouraged to decide how best to present their ideas, results, and conclusions, but all research should be presented in a form that is readable to those in the field, easily understood by scientists outside of the immediate discipline, and comprehensible to readers whose first language is not english. the given data doi into the full data availability statement, which is requested in the additional information section of the plos submission form. 1decision flow diagram on the return of individual genetic research results to study participantswhen contact information is available, the decision to return individual results depends on the nature of the research findings. they also argued that results from labs that are not clia-certified can still have analytic validity and may be returned by investigators if clearly labeled as research results and accompanied with a warning that the results should not be used for clinical decisions until they are confirmed in a clia-certified lab. when funding for a project ends, investigators may no longer have the resources to maintain or reinitiate contact with participants even though the researchers may continue to publish or complete work from the data set. guidelines on submission and editorial policies for journal of medical genetics please refer to the bmj author hub.


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