Professional Ethics Report (PER), which has been in publication since 1988, reports on news and events, programs and activities, and resources related to professional ethics issues, with a particular focus on those professions whose members are engaged in scientific research and its applications.
Each quarterly issue is comprised of a cover story addressing one particular issue or event, sometimes written by an expert outside the AAAS; a series of timely, in the news stories; brief updates from the societies; and useful resources and announcements.
PER was first published on the web in the Spring of 1995. Archives of Professional Ethics Report are available here.
Volume XXV, Number 3, Summer 2012
Cover Story
In the News
- UK Research Institutions Seek a “National Framework” for Research Integrity
- Politics of Sea Level Rise in North Carolina Part Two
- UN Declares Human Rights the Same Online as Off
- NSF Plans to Review Awardee Compliance with Responsible Conduct of Research Requirements
In the Societies
Resources
Announcements
Contributing Staff
- Michael Bueno, Contributing author
- Rebecca Carlson, Deputy Editor and contributing author
- Mark Frankel, Editor
- Eeshan Khandekar, Contributing author
- Elizabeth Resor, Contributing author
To Subscribe: To receive electronic versions of PER, please subscribe by filling out this form: http://listserv.aaas.org/mailman/listinfo/per.
This newsletter may be reproduced without permission as long as proper acknowledgement is given. ISSN: 1045-8808
Cover Story
A Canadian Approach to Responsible Conduct of Research
Susan V. Zimmerman
Susan V. Zimmerman is the Executive Director of the Secretariat on Responsible Conduct of Research for the Canadian Institutes of Health Research, Natural Sciences and Engineering Research Council, Social Sciences and Humanities Research Council in Ottawa, Canada.
Why a new framework for responsible conduct of research?
Canada’s three research Agencies [1] have adopted a fresh approach to promoting the responsible conduct of research (RCR). Launched in December 2011, the Tri-Agency Framework: Responsible Conduct of Research [2] replaces a 1994 policy on research integrity. The Framework responds to the public’s appetite for greater accountability and transparency in publicly funded research with a broadened scope, increased transparency and harmonized approach to handling allegations of breach of Agency policy.
Highlights of the Framework
The Framework demonstrates that good research practices encompass more than simply avoiding fabrication, falsification and plagiarism. It sets out four objectives:
- ensure that the funding decisions made by the Agencies are based on accurate and reliable information;
- ensure public funds for research are used responsibly and in accordance with funding agreements;
- promote and protect the quality, accuracy, and reliability of research funded by the Agencies; and
- promote fairness in the conduct of research and in the process for addressing allegations of policy breaches [3].
The Framework takes a broad approach to the responsible conduct of research. Failure to comply with any Agency policy constitutes a breach, and may result in recourse by the Agency. The Framework includes the Tri-Agency Research Integrity Policy [4]. Breaches of this policy include not only fabrication, falsification and plagiarism, but also destruction of research records, redundant publications, invalid authorship, inadequate acknowledgement of the contributions of others, and mismanagement of conflict of interest [5]. In addition to the research integrity policy, the Framework also specifies that misrepresentation in applications for Agency funds or related documents, and mismanagement of grants and awards also constitute breach of Agency policy. Finally, researchers must comply with all Agency policies and legislation that are specific to certain types of research [6]. These include, for example, Agency policy on the ethical conduct of research involving humans [7], animal care policies and guidelines, and federal government guidelines on laboratory biosafety and controlled goods. Compliance begins the moment a researcher applies for funding, and continues throughout the life of the research project.
The primary purpose of the approach adopted is not to identify and punish wrongdoing, but to ensure respect for all policy and legal requirements. This approach is more rigorous because the scope of good practice is broader than a focus on misconduct; the requirements for compliance are therefore more expansive than in traditional research integrity policies. The Framework is also tougher on researchers because, for the first time, the Agency presidents have the authority to disclose the name of a researcher who commits a serious breach [8] of Agency policy, as well as the nature of the breach, the institution where he or she was employed at the time of the breach, and the institution where the researcher is currently employed [9].
Previously, publication of the name of researcher found to have committed a breach was recourse only available to the presidents as an exception to the operation of the federal Privacy Act in situations where public safety was at risk. As part of the changes introduced with the new Framework, the Agencies now require researchers to sign a consent form prior to applying for Agency funding, permitting the president of the relevant Agency to impose this recourse – but only in instances of serious breach. This is a significant step towards improving the transparency and accountability that is key to public trust in the research enterprise. By taking this step, Canada has placed itself in the forefront of RCR policy reform, internationally.
In another new feature, the Framework explicitly sets out the authority of the Agencies to take immediate action in exceptional circumstances. What constitutes exceptional circumstances depends on “the severity and urgency of the alleged breach, its possible consequences and the potential financial, health, safety or other risks involved.” [10] For example, where it is alleged that research participants are in physical danger, or that a researcher is diverting a large grant for personal benefit, the Agency may order the research halted, or the funds frozen, or it may require the institution to take these steps.
The Framework also places responsibility on institutions themselves. Again, the emphasis is on promoting responsible conduct, not punishing bad behavior. Under the Framework, “[i]nstitutions shall strive to provide an environment that supports the best research and that fosters researchers’ ability to act honestly, accountably, openly and fairly in the search for, and dissemination of, knowledge.” [11]
The Framework calls for a commitment by institutions and the Agencies to foster and maintain an environment that supports and promotes the responsible conduct of research [12]. While there is no clear recipe for achieving this goal, the Framework does set out the distinct roles and responsibilities of researchers, institutions and the Agencies. A policy alone cannot create a positive research environment, but by setting minimum standards of acceptable behavior, and creating joint responsibility for upholding those standards, the Framework provides a solid foundation for fostering such an environment.
Of course, the Agencies will take action in response to bad behavior. Failure to appropriately fulfil its responsibilities in the prompt and thorough investigation of allegations of breach, or failure to report its findings to the Agencies can result in recourse against an institution [13]. Ultimately, an Agency could suspend or cancel an institution’s eligibility to receive funding. However, the Agency would work with the affected institution to resolve the issues before imposing such a severe measure.
Implementation
Until the introduction of the Framework, each Agency had its own process for addressing allegations of breach of the integrity policy. Ultimately, each Agency president determined the appropriate sanction to impose for each breach of policy. As each Agency acted independently, the possibility existed that similar types of cases might be treated differently by different Agencies.
The new Framework is accompanied by a new structure for implementation. The Agencies have established a single panel to advise the presidents on all allegations involving any of the three Agencies: the Panel on the Responsible Conduct of Research. This independent group of senior academics and administrators reviews the final report on each allegation provided by the institution responsible for the investigation. The Panel reviews an anonymized version of the report and recommends to the relevant Agency president the recourse, if any, that it considers appropriate for the president to impose, in addition to whatever recourse has been adopted by the institution. The Panel’s mandate advising the Agency presidents on matters relating to responsible conduct of includes other responsibilities, such as research, and on the revision of the Framework. The Panel is supported by a single, central office: the Secretariat on Responsible Conduct of Research.
Together, the Panel and the Secretariat ensure a harmonized approach to addressing allegations of breach and Agency policy. The research community and the public can therefore be confident that all allegations are handled in a consistent manner.
How effective is the Framework?
Like all policies promulgated by the Agencies, the Framework is binding on institutions not through force of law, but by the operation of a Memorandum of Understanding [14] that is binding on all eligible institutions. In order to be eligible for Agency funding, an institution must agree to respect and to ensure that its staff and students respect all the policies of the Agencies. This standard agreement, arrived at in consultation with institutions, university administrators, faculty associations and other stakeholders, applies to all eligible institutions [15].
Without general powers of inspection, the Agencies rely on those involved in the research enterprise, including researchers, peer reviewers, research participants and journal editors, to alert them to instances of alleged non-compliance. The Agencies do, however, conduct financial audits to ensure appropriate use of public monies. These may also serve to uncover breaches of policy. While reliance on allegations may appear to be a less forceful enforcement mechanism than regulatory powers of inspection, in fact such powers are not effective unless supported by significant resources. Absent those, reliance on the research community itself is a necessary element of maintaining the integrity of the research enterprise.
Under the Framework, as was the case previously, the responsibility for investigating allegations of breach lies with the institutions. In the experience of the Agencies, academic institutions, on the whole, take their investigative and enforcement powers very seriously, and fulfil their reporting responsibilities to the Agencies with appropriate diligence.
The Framework has, however, strengthened the accountability of this system by setting out clear timelines within which institutions must conduct inquiries [16] and investigations. The deadline for inquiries is two months, and investigations may take a further five months. Timelines may only be extended upon provision of a satisfactory justification to the Secretariat. All inquiries and investigations that involve Agency funds must result in a report to the Agencies.
The Framework has also enhanced the accountability of this process by requiring that any institutional investigation committee must include at least one member external to the institution. This is another significant step toward strengthening the transparency and accountability of the process for addressing allegations of breach. This requirement is not (yet) common in national guidelines on responsible conduct of research.
Finally, it is worth noting that the reach of the Framework extends beyond research that is funded by the Agencies. The Framework requires that eligible institutions adopt internal policies to address all allegations of breach in a way that meets the minimum requirements of the Framework. Similarly, all researchers who apply for or hold Agency funding must adhere to the Framework [17].
Promotion of Responsible Conduct of Research
The Secretariat and Panel on Responsible Conduct of Research are developing a number of educational resources to facilitate the implementation of the Framework. These include an interactive, on-line tutorial similar in design to the tutorial [18] developed for the Agencies’ Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans.
The Secretariat plans to broadcast a webinar introducing the Framework in October 2012. Once aired, that webinar will be posted to the Panel’s website: www.rcr.ethics.gc.ca/eng/index/. The Secretariat and Panel also respond on an ongoing basis to requests for interpretation of the Framework from the research community and the public. These resources and activities are all offered free of charge.
With the globalization of research, the Agencies look forward to sharing their experience with the Framework at the upcoming 3rd World Conference on Research Integrity, to be held in Montreal in May 2013. The Agencies are also pleased to be participating in the efforts of the Global Research Council to explore and develop principles of research integrity at its 2013 Summit Meeting in Berlin.
Conclusion
The development of the new Framework on Responsible Conduct of Research by Canada’s three research Agencies signals their shared commitment to promote a positive research environment. The Framework provides clear guidelines that articulate the responsibilities of researchers, institutions and the Agencies. The new Panel and Secretariat provide a central resource for facilitating the implementation of these guidelines and harmonizing the Agencies’ responses to findings of breach. This initiative demonstrates the commitment of the Agencies, with the support of the Government of Canada, to enhancing the accountability and transparency of the research enterprise.
References
[1] The Canadian Institutes of Health Research, the Natural Sciences and Engineering Research Council and the Social Sciences and Humanities Research Council (the Agencies).
[2] Tri-Agency Framework: Responsible Conduct of Research (the Framework); www.rcr.ethics.gc.ca/eng/policy-politique/framework-cadre/
[3] Framework, Article 1.3.
[4] Framework, Article 2.1.
[5] Framework, Article 3.1.
[6] Framework, Article 2.4 and 3.1.4.
[7] 2nd edition of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2); http://www.pre.ethics.gc.ca/eng/policy-politique/initiatives/tcps2-eptc2/Default/
[8] What constitutes a “serious breach” may vary depending on the context. The definition provided in the glossary of the Framework states: “In determining whether a breach is serious, the Agency will consider the extent to which the breach jeopardizes the safety of the public or brings the conduct of research into disrepute. This determination will be based on an assessment of the nature of the breach, the level of experience of the researcher, whether there is a pattern of breaches by the researcher, and other factors as appropriate.
Examples of serious breaches may include:
- Recruiting human participants into a study with significant risks or harms without Research Ethics Board approval, or not following approved protocols
- Using animals in a study with significant risks or harms without Animal Care Committee approval, or not following approved protocols
- Deliberate misuse of research grant funds for personal benefit not related to research
- Knowingly publishing research results based on fabricated data
- Obtaining grant/award funds from the Agencies by misrepresenting one’s credentials, qualifications and/or research contributions in an application
[9] Framework, Article 6.1.4(c).
[10] Framework, Article 6.1.5.
[11] Framework, Article 4.2.
[12] Framework, Article 1.1.
[13] Framework, Article 5.
[14] Memorandum of Understanding: Roles and Responsibilities in the Management of Federal Grants and Awards (the MOU).
[15] The Draft Agreement on the Administration of Agency Grants and Awards by Research Institutions is reviewed every five years. A new version is in the final stages of consultation and should come into effect by December 2012; www.cihr-irsc.gc.ca/e/45201.html
[16] An inquiry is the preliminary step which establishes the reasonableness of the allegation.
[17] Framework, Article1.2.
[18] The TCPS 2 tutorial, known as the Course on Research Ethics, or CORE, is available at http://www.pre.ethics.gc.ca/eng/education/tutorial-didacticiel/
In the News
UK Research Institutions Seek a “National Framework” for Research Integrity
Universities UK, the body that represents the higher education institutions of Britain, released The Concordat to Support Research Integrity on July 11, 2012. The Concordat offers a “comprehensive national framework” for promoting research integrity and handling allegations of misconduct. The five commitments it presents are equally targeted at the activities of researchers, universities and other research institutions, employers and funders, indicating that all actors have a part to play in maintaining an ethical research environment in the UK [1].
The Concordat is a response to the findings of a conference held in January by the British Medical Journal (BMJ) and the Committee on Public Ethics (COPE) that raised concerns about the state of research ethics in UK institutions, in particular the response to allegations of misconduct [2]. Attendees were leaders in academics research and publishing, as well as representatives of the relevant government and funding organizations [2]. Cause for concern came in part from a study by the BMJ released around the same time as the conference that found 13% of medical researchers and doctors had firsthand knowledge of “inappropriately adjusting, excluding, altering or fabricating data.”
Furthermore, because the responsibility to respond to allegations of misconduct lies with the universities or research institutions where the allegations are made, some members of the conference believed there could be a conflict of interest in reporting such allegations. However, a representative of the universities assured the conference attendees that the universities were “not remotely complacent” when it came to allegations of misconduct [3].
The five commitments of the Concordat emphasize: (1) maintaining high standards of research; (2) following all ethical, legal and professional guidelines; (3) encouraging a “culture of integrity” in research institutions; (4) relying on “transparent, robust and fair processes” to manage allegations of misconduct; and (5) assessing progress made through regular reviews [1]. The signatories to the Concordat are the Department for Employment and Learning, the Higher Education Funding Councils for England and Wales, the National Institute for Health Research, Research Councils UK, the Scottish Funding Council, Universities UK and the Wellcome Trust. The research community has responded enthusiastically. Early supporters include the Academy of Medical Sciences, the Association of Research Managers and Administrators, the Committee on Publication Ethics, the Consortium for Research Excellence, Support and Training, and the Government Office for Science.
A “comprehensive action plan” scheduled for release in September 2012 will outline more specific implementation strategies, although all grant-giving organizations in the UK have already agreed to adopt the main themes of the Concordat as part of their qualification process [4].
For a digital copy of the Concordat, see [1]. For a complete and up to date list of supporters, see the Universities UK website [5].
[1]http://www.universitiesuk.ac.uk/Publications/Documents/TheConcordatToSupportResearchIntegrity.pdf
[2]http://www.bmj.com/content/345/bmj.e5402
[3] http://www.nature.com/news/british-science-needs-integrity-overhaul-1.9803
[4] http://www.nature.com/news/uk-funders-seek-integrity-upgrade-1.10991
[5]http://www.universitiesuk.ac.uk/PolicyAndResearch/PolicyAreas/Research/Pages/Researchintegrity.aspx
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Politics of Sea Level Rise in North Carolina, Part Two
The scientific community is almost unanimous on the existence of climate change. However, the American public is not. In fact, close to 30% of Americans still reject evidence of climate change, according to a Pew Center report [1], thereby making it difficult to take action. This is exactly what occurred earlier this year when an internationally criticized bill was drafted by the North Carolina General Assembly. An article on an initial version of this bill, NC HB 819, was published in an earlier PER issue (Volume XXV, Number 2). NC HB 819 was drafted in response to North Carolina’s Coastal Resource Commission’s (CRC) estimate that the sea-level rise at the coast would be 39 inches by 2100 and its attempt to use this for regulatory purposes. NC-20, a coastal development group and the key backer of this bill, disagreed with the 39-inch prediction, offered its own prediction of 8 inches, and criticized the CRC for not taking into account the “economic consequences of preparing the coast for a one-meter rise in sea level,” [2] most of which would be associated with infrastructure adjustment, insurance premiums, and loss of developable land due to the flood plains that would be created.
On August 3, a newer version of the bill cleared both the state House and Senate and became law without the signature of Governor Bev Perdue [3]. This new law places a moratorium on the Coastal Resource Commission (CRC) and the Division of Coastal Management of the Department of Environmental and Natural Resources from defining sea-level-rise rates for regulatory purposes before July 2016. In the interim, however, the law instructs the CRC to deliver an updated assessment of sea level rise and study the economic and environmental costs and benefits of developing or not developing sea level rise regulations. Nowhere in the law, however, is there a prohibition on local governments defining their own sea-level-rise rates for regulatory purposes [4].
Gov. Perdue cited local-control as her rationale for allowing the bill to become law. However, she also stated that the General Assembly should re-visit the issue to consider how to provide state agencies the same flexibility granted to local governments. Gov. Perdue’s decision drew criticism, especially from environmental groups. Derb Carter, director of the Southern Environmental Law Center said, “We’re disappointed in the governor’s decision not to veto these bills.”[5] ‘These bills’ being HB 819 as well as three other environmental laws offering benefits to special interests. Unlike environmentalists, Tom Thompson, NC-20 chairman, was pleased with the decision stating that, “there is absolutely no harm in waiting 4 years.” [6]
However, waiting to establish regulation may spell danger for the state. North Carolina, “with its…low-lying coastline,” [7] is threatened by sea-level rise. In fact, the U.S Geological Survey (USGS) claims that sea level rise along the East Coast between NC and Massachusetts is accelerating at three to four times the global rate [8]. Thus, the costs NC-20 claims as wasteful may be necessary for the state to meet the challenge of climate change, especially on its coast.
Molly Diggins, state director of the N.C Sierra Club, expressed this concern. In addition to claiming that the new law is “essentially the same bill [9]” (that received international criticism), she also stated that HB 819 would enable developers to build in unsafe areas, creating future costs that taxpayers will have to pay “to restore infrastructure” [9] that should not have been built.
Overall, the law has been criticized for nearsightedness, and legislators have been accused of ignoring science. On the other hand, proponents of the bill stated that “we’re asking for that best science” and that NC needs to put “a moratorium on predictions of sea level rise until scientific techniques improve.” [10] This, however, creates a dangerous precedent. As science is constantly advancing, this excuse can be used at any time to debunk scientific outcomes whenever inconvenient.
[1] http://www.people-press.org/2011/12/01/modest-rise-in-number-saying-there-is-solid-evidence-of-global-warming/
[2] http://abcnews.go.com/US/north-carolina-bans-latest-science-rising-sea-level/story?id=16913782
[3]http://www.ncleg.net/gascripts/billlookup/billlookup.pl?Session=2011&BillID=H819
[4]http://www.ncleg.net/Sessions/2011/Bills/House/PDF/H819v6.pdf
[5]http://www.charlotteobserver.com/2012/08/01/3422844/sea-level-bill-will-become-law.html
[6]http://www.charlotteobserver.com/2012/08/02/3424434/nc-gov-green-lights-watered-down.html
[7]http://www.newsobserver.com/2012/08/01/2234915/nc-cant-outlaw-global-climate.html
[8] http://abcnews.go.com/US/north-carolina-bans-latest-science-rising-sea-level/story?id=16913782
[9]http://www.charlotteobserver.com/2012/08/02/3424434/nc-gov-green-lights-watered-down.html
[10] http://abcnews.go.com/US/north-carolina-bans-latest-science-rising-sea-level/story?id=16913782
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UN Declares Human Rights the Same Online as Off
On July 6, 2012, the UN Human Rights Council passed a resolution affirming that human rights must be protected on the Internet. The resolution states that “the same rights that people have offline must also be protected online, in particular freedom of expression.” [1] Eighty countries approved the resolution, including the United States. Notable objectors to the resolution included China, India and Russia. The resolution was cosponsored by the Tunisian envoy, Moncef Baati, who spoke of the important role that the internet played in mobilizing the people of Tunisia to overthrow President Ben Ali in 2011[2].
Yet, the resolution goes beyond the right to freedom of expression. It describes “the global and open nature of the Internet as a driving force in accelerating progress towards development in its various forms” and also as “an important tool… for exercising human rights.” [1] It encourages the promotion of Internet access and information and communication technology, calling for states “to promote and facilitate access to the Internet.” [1] In her opening remarks, the UN High Commissioner for Human Rights, Navi Pillay, similarly stressed the need to give priority to Internet access. “Freedom of expression on the Internet requires access to the Internet in the first place,” she stated [4].
Internet access and usage has been dramatically expanding globally, with usage increasing more than 500% since 2000 [3]. However, that translates to merely 32% of the world’s population in 2011 using the Internet [3]. Asia has the largest number of Internet users – over 1 billion – but China and India, the two most populous countries in Asia, did not approve the resolution [3].
With such marked growth, the Internet has become the new frontier for states to manage. Pillay acknowledged that the Internet could be the site of illegal activities, but she warned that “methods to identify and track down criminals may be used to crack down on human rights” [4]. She also explained that there was a danger of private companies restricting freedom of expression on the Internet when those providers of service decide to turn over their users’ personal information or censor what they can access, either at the request of a state or for commercial purposes [4].
For the full text of the resolution and to see a list of the countries that approved it, see [1].
[1]http://geneva.usmission.gov/2012/07/05/internet-resolution/
[2]http://www.reuters.com/article/2012/07/05/net-us-rights-internet-idUSBRE8640DE20120705
[3]http://www.internetworldstats.com/stats.htm
[4]http://www.ohchr.org/en/NewsEvents/Pages/DisplayNews.aspx?NewsID=12245&LangID=e/
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NSF Plans to Review Awardee Compliance with Responsible Conduct of Research Requirements
The National Science Foundation’s (NSF) Office of Inspector General (OIG) is inviting public comment on a planned data collection scheme for its review of institutional and awardee compliance with responsible conduct of research (RCR) requirements. Section 7009 of the America COMPETES Act (42 U.S.C. 1862o-1) makes it a requirement to ensure “each institution that applies for financial assistance from the Foundation for science and engineering describe in its grant proposal a plan to provide appropriate training and oversight in the responsible and ethical conduct of research…” [1] Officially implemented by NSF in January 2010, it requires award recipients to create RCR training programs for undergraduate students, graduate students, and postdoctoral researchers taking part in the proposed research [2]. NSF leaves it up to the individual institution and awardee to develop the content and methods of program implementation. However, multiple NSF funded projects, such as the Ethics CORE Digital Library, Ethics in Science and Engineering National Clearinghouse, and theOnline Ethics Center Enhancements and America COMPETES offer materials that are designed to be used for RCR based trainings [3].
Conducted via video-conference, NSF OIG will interview three groups for its data collection:
- Upper-level administrators to assess the overall institutional commitment to the program, through dedicated financial and staff resources, and communication of program expectations to both students and faculty;
- Program administrators themselves, in providing information on course content, participation of students and faculty, compliance checking, oversight, and resource allocation;
- Participants (e.g. students and post-docs) to detail their experiences in the course, providing judgment on format, duration, content, and whether an RCR is of any benefit.
NSF OIG anticipates querying up to 100 institutions (20 per year), and between 100 to 500 respondents per year. The collected data will be used to inform both NSF and Congress on RCR compliance, and perhaps lead to developing further recommendations to strengthen individual programs.
The public comment period opened on September 14, and closes on November 13 of this year. Comments are invited on: the necessity or utility of the data collection scheme; estimates of burden upon the Agency; means of enhancing quality and clarity of respondent information and collection; and whether automated methods would alleviate both Agency and respondent burden in collection [4]. After the comment period closes, NSF will seek approval for the proposed data collection from the Office of Management and Budget.
For further information, or to submit a comment, contact Suzanne Plimpton at splimpto@nsf.gov
[1]http://www.nsf.gov/oig/Poynter_Center_May_2011.pdf
[2]http://www.nsf.gov/pubs/policydocs/pappguide/nsf10_1/aag_4.jsp#IVB
[3]http://www.nsf.gov/bfa/dias/policy/rcr.jsp
[4] https://federalregister.gov/a/2012-22686
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In the Societies
The AAMC Conflicts of Interest Metrics Project
Initially announced on March 31, 2012, the Association of American Medical Colleges (AAMC) has launched registration for its Conflicts of Interest (COI) Metrics Project. Impetus for the project was the U.S. Department of Health and Human Services’ final rule on financial conflicts of interest (FCOIs) related to the conduct of research funded by the Public Health Service (PHS). The aim of the COI Metrics Project is to help the National Institutes of Health (NIH) gauge the outcomes and effectiveness of the regulatory change on member medical schools and teaching hospitals.
The new rule, titled “Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought,” expands on previous regulation established in 1995, by lowering the threshold on financial interests that must be disclosed to institutions. Institutions are required to determine if such interests are related to research funded by the federal government, and to make information on identified FCOIs available to the public. Overall, the goal of the regulation is to “promote objectivity in research [by ensuring] that the design, conduct, and reporting of research…[is] free from bias resulting from Investigator financial conflicts of interest.” [1]
Participants in the Metrics Project will provide AAMC with data on general institutional characteristics, detailed historical data of the number and types of disclosures received from investigators, FCOIs identified by the participating institution, those reported to the NIH, and supplemental data on the institutional costs and investment of rule implementation [2]. However, no individually identifiable data about institutional faculty or staff will be collected. Each institution will report their annual data starting with the year prior to the August 24, 2012 implementation of the rule (historical data) through to December 31, 2015 [3].
The data will be de-identified and aggregated by AAMC, then sent to participating institutions and NIH. Though NIH is not obligated to use it, the aggregate data can be used in an agency-level review of both the individual and institutional burden of the rule, and to assess the overall efficacy of the changes in regulation. The project itself is not funded by NIH and does not change the normal obligation of an institution to report on individual FCOIs, as AAMC will not submit that information on behalf of the institution.
For additional information on the AAMC – COI Metrics Project, you can visit its webpage at www.aamc.org/metricsproject.
[1]http://grants.nih.gov/grants/policy/coi/coi_faqs.htm?print=yes౐
[2]https://www.aamc.org/download/302432/data/metricsfaqs.pdf
[3]https://www.aamc.org/download/302428/data/metricsoverview.pdf
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Resources
New Educational Website: Tuskeegee Bioethics Revisited
The National Center for Bioethics in Research and Health Care at Tuskegee University recently launched the educational ethics resource “Tuskegee Bioethics Revisited.” The goal of the new website is to “enhance the well-being of people throughout the United States by promoting ethical considerations of human health related research, education and service, particularly for African Americans and other health disparity populations in Black Belt counties and beyond, derived from the analysis and synthesis of targeted issues associated with race/ethnicity, gender and class.” [1]
The website features presentations from the Tuskegee University 2012 Public Health Ethics Intensive Course, a gallery of photos and a blog. There is also a link to a “virtual museum” that allows the user to hear the history and view artifacts related to the U.S. Public Health Service syphilis study that was conducted between 1932 -1972 in Alabama.
The website can be found at http://www.tuskegeebioethicsrevisited.org.
[1]http://www.tuskegeebioethicsrevisited.org/index.php/aboutus/
Announcements
Call for Abstracts – The seventh International Congress on Peer Review and Biomedical Publication invites abstract submissions for the meeting on September 8-10, 2013 in Chicago. The Congress is organized by JAMA and the BMJ. Suggested topics include: bias and efforts to eliminate biased reporting, research and publication ethics, mechanisms for improving quality of reporting, models for peer review and scientific publication, dissemination of scientific information. The deadline for abstract submission is March 1, 2013. Contact Annette Flanagin with questions at jama-peer@jama-archives.org.
Call for Abstracts – The 3rd World Conference on Research Integrity invites submission of abstracts on empirical research on research integrity and analyses of related topics. The conference, which will be held May 5-8, 2013 in Montreal, Canada, will focus on responsible conduct of research, research integrity and publication of research. Areas of particular interest for the upcoming conference include: integrity in cross-national, cross-disciplinary and cross-sector partnerships; trust in science including political and media issues, responses to misconduct, and correction of the scientific record; emerging challenges in research integrity associated with new technologies and scientific frontiers; and fostering research integrity through policies, codes, standards and training. The deadline for submission is October 15, 2012. For more information, contact Melissa Anderson mand@umn.edu. To read more about the conference, go to http://www.wcri2013.org/overview_e.shtml.
Call for Applications – The National Academy of Engineering’s Center for Engineering, Ethics and Society calls for students to apply to attend the National Institute on Energy, Ethics and Society. NIEES is a week-long educational seminar designed for graduate students. The seminar will be held at the Arizona State University Tempe campus, April 7-13, 2013. More information can be found at http://onlineethics.org/Projects/EESE/NIEES.aspx. The deadline for application is October 31, 2012.
Call for Papers – The Association for Practical and Professional Ethics (APPE) seeks submissions for the Twenty-Second APPE Annual Meeting. The meeting will take place February 28-March 3, 2013 in San Antonio, Texas. The call invites individual presentations from all disciplines and professions interested in advancing scholarship, teaching and a general understanding of practical and professional ethics. Submissions may include formal papers, panel presentations, roundtable discussions, case studies, and pedagogical demonstrations. APPE also invites authors to submit a recent publication for an Author Meets the Critics session and/or Lunch with an Author. The deadline for submission is November 1, 2012. For additional instructions, see http://appecallforpapers.wordpress.com/.
Call for Papers – The journal Ethics and Information Technology invites article submissions for a special issue on “Ethics of Social Networks for Special Needs Users.” The journal is particularly interested in submissions that identify ethical issues and their resolution by devising policies and proposing design solutions. Some possible themes include minimum age and protection of minors, effect of a daily use of social networks on kids development including school performance, cyber-bullying, harassment and violence arising from social network usage among children, accessibility of elderly or disabled persons to social networks, digital divide and e-inclusion, ethical issues such as identity, agency and autonomy for special needs users, and generational gaps and solidarities arising from social network usage. The deadline for submission is September 30, 2012. Articles should be submitted using the online system at www.editorialmanager.com/etin. For more information, contact Caroline Rizza at Caroline.rizza@jrc.ec.europa.eu.
Call for Papers - ETHICOMP 2013 requests abstract submissions for the upcoming meeting at the University of Southern Denmark in Kolding, Denmark on June 12-14, 2013. The overall theme for the meeting is “the possibilities of ethical information and communication technology.” Possible topics include education and training, design, governance, emerging technologies, and technological integrity. Abstracts should be submitted by October 8, 2012 using the online system https://www.easychair.org/account/signin.cgi?conf=ethicomp2013. For more information, contact Simon Rogerson at srog@dmu.ac.uk.
Conference – The United States Army Command and General Staff College, Combined Arms Center at Fort Leavenworth, Kansas and the CGSC Foundation, Inc. are hosting a symposium entitled, “The Ethics of Vicarious Warfare” December 3-6, 2012. The symposium will be held at the Lewis and Clark Center in Fort Leavenworth, Kansas. The program will cover broad areas of the use of military technology, prevention of mass atrocities, the professional military ethic, and the future of civil/military relationships. Some specific topics may include the future of military ethics education, the use of drones in combat, and the ethical future of military technology. For more information, see http://www.leavenworthethicssymposium.org/.
Conference – The Cleveland Clinic is hosting the third Brain Matters conference on neuroethics October 23-25, 2012 in Cleveland, Ohio. The focus of the conference is on ‘Values at the Crossroads of Neurology, Psychiatry & Psychology.’ A primary theme of the conference will be ethical dilemmas posed by conditions without an identifiable biological correlate in both research and clinical settings. Registration and more information is available here: www.clevelandclinic.org/BrainMatters3.
Course – The Learning Institute is offering a short course for the 140th Annual Meeting of the American Public Health Association. The course is designed to provide public health professionals with tools and practical examples to address the ethical challenges that commonly arise in public health practice. The course will take place October 28, 2012, at the Moscone Center in San Francisco, CA. Registration is available at http://www.apha.org/meetings/registration/. To read other Learning Institute course descriptions, see http://www.apha.org/programs/education/edannualmtg/LISchedule.
Event – On October 10, 2012, Assistant Secretary of State Michael Posner, Bureau of Democracy, Human Rights and Labor will be speaking at the American Association for the Advancement of Science about “Science and Academic Freedom in the Digital Age.” The discussion will look at the implications of the movement to protect Internet freedom – the exercise of human rights online – for the work of scientists and engineers. There will also be a discussion of potential opportunities for collaboration, and the ways in which developments in Internet policy influence broader science and human rights issues. To register, go to https://www.signup4.net/Public/ap.aspx?EID=SCIE21E.
Event – On October 23, 2012 the American Association for the Advancement of Science and the Dana Foundation will host the second public event in their Neuroscience and Society Series on the topic of “The Science and Impact of Traumatic Brain Injury.” Speakers will discuss the current state of neuroscience research on traumatic brain injury (TBI) in the context of sport and combat; the areas of research that seem most promising for preventing and treating TBI; and a personal account of the first-hand the effects of TBI on U.S. soldiers. The event will be held at AAAS headquarters in Washington, DC. For more information and to register, go to http://srhrl.aaas.org/projects/science_society/neurosociety/TBI.shtml
Fellowship – The University Center for Human Values invites applications for the Laurance S. Rockefeller Visiting Faculty Fellowships. Fellows will spend the 2013-2014 academic year at Princeton researching and writing on topics related to human values in public and private life. Scholars from all disciplines may apply. All materials must be submitted by November 5, 2012. To apply, visit https://jobs.princeton.edu/applicants/jsp/shared/Welcome_css.jsp.
Nominations – The Office for Human Research Protections is seeking nominations of qualified candidates for appointment to the Secretary’s Advisory Committee on Human Research Protections. The Committee provides advice and recommendations to the Secretary of the Department of Health and Human Services and the Assistant Secretary for Health on matters pertaining to the continuance and improvement of functions within the authority of HHS directed toward protections for human subjects in research. Nominations must be submitted by October 9, 2012. Instructions for submitting nominations are included in the Federal Register notice, which can be accessed at http://www.gpo.gov/fdsys/pkg/FR-2012-09-07/html/2012-22103.htm.
Video Challenge – The National Academy of Engineering’s Center for Engineering, Ethics and Society and the Online Ethics Center invite student submissions to their video challenge. Students are asked to identify an ethical issue that is important for the nation’s energy future. The short film should examine the ethical aspects of the issue as well as potential approaches to addressing it. The deadline to submit a video is November 30, 2012. For more information, go to http://www.onlineethics.org/Projects/VideoChallenge.aspx