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		<title>What can go wrong?</title>
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							<p>The protection of human participants in research continues to present challenges for researchers, research institutions and governments, despite efforts to implement and improve regulations. The challenges continue because:</p>
							
							<ul>
								<li>A few researchers ignore the regulations and conduct projects without approvals</li>
								<li>Researchers sometimes fail to get the necessary approvals for protocol changes/amendments</li>
								<li>Governance approval and a REC's favourable opinion are sometimes given to projects that are later deemed to be unethical</li>
								<li>In some areas, there is no agreement as to what is ethical or unethical</li>
								<li>Human errors or mistakes still occur.</li>
							</ul>
							
							<p>We end this module with examples that illustrate how these shortcomings make their way into research, and the impact they can have on public support for research.</p>
							
							<instructional-text><p>Click on each image to learn more about some studies that illustrate what can happen when research involving human participants is not handled responsibly.</p></instructional-text>
							
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							<accessible-text><p>Continue on to learn more about some studies that illustrate what can happen when research involving human participants is not handled responsibly.</p></accessible-text>
							
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								<opinion name="Havasupai diabetes study" img-src="../images/activity_images/course_specific/hsp_1_80_img1.png" img-alt="Alt">
									<p>In the late 1980s, researchers at Arizona State University were granted permission to look for genetic links to diabetes in a remote group of Native Americans (the Havasupai) living in the Grand Canyon. After finding no links to diabetes, the researchers broadened their study to look at schizophrenia, migration patterns and inbreeding.</p>
									<p>These later studies had not been approved and touched on matters that the Havasupai found objectionable. The Havasupai sued the university and reached an out-of-court settlement that provided compensation for damages, funds for health facilities and the return of the DNA samples (Garrison, 2013).</p>
									<p>The case raised awareness about the importance of and the potential weaknesses inherent in informed consent. It also made it clear that information on the population as a whole might have led to interesting and potentially useful discoveries, but was nonetheless seen as objectionable and unwanted by the group being studied. Special populations are now more aware of their rights; however, the impact of the case on researchers and review committees seems to have been more limited (Garrison and Cho, 2013).</p>
								</opinion>
								<opinion name="Baltimore lead abatement study" img-src="../images/activity_images/course_specific/hsp_1_80_img2.png" img-alt="Alt">
									<p>In the 1990s, researchers at the Johns Hopkins Kennedy Krieger Institute conducted a study to assess the effectiveness of different ways to reduce exposure to lead paint in old houses. Lead has neurological effects that are particularly harmful to young children. The research was conducted in inner-city Baltimore, and all the enrolees were African-Americans. Most of the participants were families with young children (Epstein, 2013).</p>
									<p>After the study was completed, two mothers sued the Institute, claiming they were not properly informed about the risks of the study, particularly to their children. In one ruling, a judge agreed and equated the study with the better-known Tuskegee syphilis study (Lewin, 2001). The Institute defended the study, arguing that it was ethical and benefited the community (Pollak, 2002).</p>
									<p>Whether ethical or not, the factor that drew more attention to this case than any other was equity. Many argued that, had the problem with lead paint existed in largely white suburbs, it would not have been handled in the same way (Markowitz and Rosner, 2013).</p>
								</opinion>
								<opinion name="Pre-operative use of beta blockers" img-src="../images/activity_images/course_specific/hsp_1_80_img3.png" img-alt="Alt">
									<p>Erasmus University (Rotterdam, Holland) researcher Don Poldermans was widely respected for his studies of perioperative cardiac care, before being accused of research misconduct and the violation of human participant regulations. One of the key issues seems to have been that there were significant deficiencies with the procedures followed for gaining the informed consent of patients (Husten, 2012). His research on the use of beta blockers before surgery and his role on key committees had influenced European decisions about best practices in surgery.</p>
									<p>After investigating the charges, Erasmus University dismissed Poldermans and some of his publications were retracted. There remains, however, disagreement about the impact of his misconduct. One publication, which was retracted within 48 hours of its publication due to its controversial content, suggested that the misinformation resulting from Poldermans' research could have led to as many as 800,000 excess deaths (Bouri <em>et al.</em>, 2014; Husten, 2014).</p>
									<p>Due to the fact that key records from Poldermans' studies could not be found, Erasmus University was unable to determine the full extent of his misconduct or its impact on patients. Some publications have not been retracted because the extent of the misconduct has not been fully confirmed (Marcus, 2014). Claims made by both the university and Polderman that no patients/participants were harmed have not been confirmed (Husten, 2012; Husten, 2014).</p>
								</opinion>
								<opinion name="Online psychological profiling" img-src="../images/activity_images/course_specific/hsp_1_80_img4.png" img-alt="Alt">
									<p>In a 2013 paper, researchers at Cambridge University's Psychometrics Centre showed that: "Facebook Likes can be used to automatically and accurately predict a range of highly sensitive personal attributes including: sexual orientation, ethnicity, religious and political views, personality traits, intelligence, happiness, use of addictive substances, parental separation, age, and gender" (Kosinski, Stillwell and Graepel, 2013).</p>
									<p>Subsequently, a company called Cambridge Analytica adapted these methods to target online political advertising; however, it did not gain permission to use personal data. Following a media investigation into election campaigns, the company was closed down in 2018 due to numerous legal proceedings. Regulators also fined Facebook five billion dollars for giving Cambridge Analytica access to data from 87 million users without consent (BBC News, 2019).</p>
									<p>While there is no evidence that the original researchers accessed data without permission, and were not directly involved with Cambridge Analytica, this example shows how easily research can be misappropriated if the necessary safeguards are not put in place.</p>
								</opinion>
								<opinion name="Documenting international special education research " img-src="../images/activity_images/course_specific/hsp_1_80_img5.png" img-alt="Alt">
									<p>Can childhood language impairment, learning difficulties, Asperger syndrome, dyscalculia and other education-related problems be treated? If so, how? Methods for treating these conditions were presented in a series of papers published by a research team that started its research in Malaysia and continued it in Singapore, until its validity was questioned by a whistle-blower.</p>
									<p>After a series of investigations by Nanyang Technological University (NTU) in Singapore and the <em>Journal of the American Academy of Special Education Professionals</em> (JAASEP), JAASEP eventually retracted nine articles submitted by the research team, in part based on a finding in a NTU report that there were issues with the signatures on the parental consent forms used for the study.</p>
									<p>This was one of a series of problems that eventually led to the decision to retract the papers. When called upon to document their findings and the consent process, the researchers could not produce the evidence that was needed. For a detailed discussion of this case, see the retraction notice linked to in the "Useful links" pod (JAASEP, 2016).</p>
								</opinion>
							</opinions>
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								<h4>Havasupai diabetes study</h4>
								<p>In the late 1980s, researchers at Arizona State University were granted permission to look for genetic links to diabetes in a remote group of Native Americans (the Havasupai) living in the Grand Canyon. After finding no links to diabetes, the researchers broadened their study to look at schizophrenia, migration patterns and inbreeding.</p>
								<p>These later studies had not been approved and touched on matters that the Havasupai found objectionable. The Havasupai sued the university and reached an out-of-court settlement that provided compensation for damages, funds for health facilities and the return of the DNA samples (Garrison, 2013).</p>
								<p>The case raised awareness about the importance of and the potential weaknesses inherent in informed consent. It also made it clear that information on the population as a whole might have led to interesting and potentially useful discoveries, but was nonetheless seen as objectionable and unwanted by the group being studied. Special populations are now more aware of their rights; however, the impact of the case on researchers and review committees seems to have been more limited (Garrison and Cho, 2013).</p>
								<hr>
								<h4>Baltimore lead abatement study</h4>
								<p>In the 1990s, researchers at the Johns Hopkins Kennedy Krieger Institute conducted a study to assess the effectiveness of different ways to reduce exposure to lead paint in old houses. Lead has neurological effects that are particularly harmful to young children. The research was conducted in inner-city Baltimore, and all the enrolees were African-Americans. Most of the participants were families with young children (Epstein, 2013).</p>
								<p>After the study was completed, two mothers sued the Institute, claiming they were not properly informed about the risks of the study, particularly to their children. In one ruling, a judge agreed and equated the study with the better-known Tuskegee syphilis study (Lewin, 2001). The Institute defended the study, arguing that it was ethical and benefited the community (Pollak, 2002).</p>
								<p>Whether ethical or not, the factor that drew more attention to this case than any other was equity. Many argued that, had the problem with lead paint existed in largely white suburbs, it would not have been handled in the same way (Markowitz and Rosner, 2013).</p>
								<hr>
								<h4>Pre-operative use of beta blockers</h4>
								<p>Erasmus University (Rotterdam, Holland) researcher Don Poldermans was widely respected for his studies of perioperative cardiac care, before being accused of research misconduct and the violation of human participant regulations. One of the key issues seems to have been that there were significant deficiencies with the procedures followed for gaining the informed consent of patients (Husten, 2012). His research on the use of beta blockers before surgery and his role on key committees had influenced European decisions about best practices in surgery.</p>
								<p>After investigating the charges, Erasmus University dismissed Poldermans and some of his publications were retracted. There remains, however, disagreement about the impact of his misconduct. One publication, which was retracted within 48 hours of its publication due to its controversial content, suggested that the misinformation resulting from Poldermans' research could have led to as many as 800,000 excess deaths (Bouri <em>et al.</em>, 2014; Husten, 2014).</p>
								<p>Due to the fact that key records from Poldermans' studies could not be found, Erasmus University was unable to determine the full extent of his misconduct or its impact on patients. Some publications have not been retracted because the extent of the misconduct has not been fully confirmed (Marcus, 2014). Claims made by both the university and Polderman that no patients/participants were harmed have not been confirmed (Husten, 2012; Husten, 2014).</p></p>
								<hr>
								<h4>Online psychological profiling</h4>
								<p>In a 2013 paper, researchers at Cambridge University's Psychometrics Centre showed that: "Facebook Likes can be used to automatically and accurately predict a range of highly sensitive personal attributes including: sexual orientation, ethnicity, religious and political views, personality traits, intelligence, happiness, use of addictive substances, parental separation, age, and gender" (Kosinski, Stillwell and Graepel, 2013).</p>
								<p>Subsequently, a company called Cambridge Analytica adapted these methods to target online political advertising; however, it did not gain permission to use personal data. Following a media investigation into election campaigns, the company was closed down in 2018 due to numerous legal proceedings. Regulators also fined Facebook five billion dollars for giving Cambridge Analytica access to data from 87 million users without consent (BBC News, 2019).</p>
								<p>While there is no evidence that the original researchers accessed data without permission, and were not directly involved with Cambridge Analytica, this example shows how easily research can be misappropriated if the necessary safeguards are not put in place.</p>
								<hr>
								<h4>Documenting international special education research</h4>
								<p>Can childhood language impairment, learning difficulties, Asperger syndrome, dyscalculia and other education-related problems be treated? If so, how? Methods for treating these conditions were presented in a series of papers published by a research team that started its research in Malaysia and continued it in Singapore, until its validity was questioned by a whistle-blower.</p>
								<p>After a series of investigations by Nanyang Technological University (NTU) in Singapore and the <em>Journal of the American Academy of Special Education Professionals</em> (JAASEP), JAASEP eventually retracted nine articles submitted by the research team, in part based on a finding in a NTU report that there were issues with the signatures on the parental consent forms used for the study.</p>
								<p>This was one of a series of problems that eventually led to the decision to retract the papers. When called upon to document their findings and the consent process, the researchers could not produce the evidence that was needed. For a detailed discussion of this case, see the retraction notice linked to in the "Useful links" pod (JAASEP, 2016).</p>								
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										<p><strong>Havasupai diabetes study</strong></p>
										<p>Garrison, 2013 &ndash; <a href="https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5310710/" target="_blank">Genomic Justice for Native Americans: Impact of the Havasupai Case on Genetic Research</a></p>
										<p>Garrison and Cho, 2013 &ndash; <a href="http://www.ncbi.nlm.nih.gov/pubmed/24089655" target="_blank">Awareness and Acceptable Practices: IRB and Researcher Reflections on the Havasupai Lawsuit</a></p>
										<p><strong>Baltimore lead abatement study</strong></p>
										<p>Epstein, 2013 &ndash; <a href="http://www.nybooks.com/articles/2013/03/21/lead-poisoning-ignored-scandal/" target="_blank">Lead Poisoning: The Ignored Scandal</a></p>
										<p>Lewin, 2001 &ndash; <a href="http://www.nytimes.com/2001/08/24/us/us-investigating-johns-hopkins-study-of-lead-paint-hazard.html" target="_blank">U.S. Investigating Johns Hopkins Study of Lead Paint Hazard</a></p>
										<p>Pollak, 2002 &ndash; <a href="http://www.ncbi.nlm.nih.gov/pubmed/15017953" target="_blank">The Lead-Based Paint Abatement Repair and Maintenance Study in Baltimore: Historic Framework and Study Design</a></p>
										<p><strong>Pre-operative use of beta blockers</strong></p>
										<p>Bouri <em>et al.</em>, 2014 &ndash; <a href="http://www.ncbi.nlm.nih.gov/pubmed/23904357" target="_blank">Meta-Analysis of Secure Randomised Controlled Trials of Beta-Blockade to Prevent Perioperative Death in Non-Cardiac Surgery</a></p>
										<p>Husten, 2014 &ndash; <a href="http://www.forbes.com/sites/larryhusten/2014/01/15/medicine-or-mass-murder-guideline-based-on-discredited-research-may-have-caused-800000-deaths-in-europe-over-the-last-5-years/" target="_blank">Medicine Or Mass Murder? Guideline Based on Discredited Research May Have Caused 800,000 Deaths In Europe Over The Last 5 Years</a></p>
										<p>Husten, 2012 &ndash; <a href="http://www.forbes.com/sites/larryhusten/2012/10/09/erasmus-medical-center-releases-final-report-on-cardiovascular-research-scandal/" target="_blank">Erasmus Medical Center Releases Final Report On Cardiovascular Research Scandal</a></p>
										<p>Marcus, 2014 &ndash; <a href="http://retractionwatch.com/2014/09/29/critics-of-poldermans-work-baffled-by-nejm-stance-on-decrease-papers/" target="_blank">Critics of Poldermans' Work Baffled by NEJM Stance on DECREASE Papers</a></p>
										<p><strong>Online psychological profiling</strong></p>
										<p>Kosinski, Stillwell and Graepel, 2013 &ndash; <a href="http://www.ncbi.nlm.nih.gov/pubmed/24889601" target="_blank">Experimental Evidence of Massive-Scale Emotional Contagion Through Social Networks</a></p>
										<p>BBC News, 2019 &ndash; <a href="https://www.bbc.co.uk/news/world-us-canada-48972327" target="_blank">Facebook 'To Be Fined $5bn Over Cambridge Analytica Scandal'</a></p>
										<p><strong>Documenting international special education research</strong></p>
										<p>JAASEP, 2016 &ndash; <a href="https://www.naset.org/index.php?id=4494" target="_blank">Retraction Statement</a></p>
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							<p>As noted, some of the ongoing concerns about the protection of human participants in research are based on troubling examples of misconduct and neglected responsibility. Others show that there can be thoughtful disagreement about what is or is not ethical in research. Whatever the source of the concerns and the resulting problems, responsible protection relies heavily on institutional support and commitment.</p>
							
							<h3>Your experience</h3>
							
							<p>When researchers engage in irresponsible practices, either accidentally or deliberately, institutional support and climate sometimes play a role.</p>
							
							<instructional-text><p>Indicate whether you agree or disagree with the following statements. Once you have submitted your answers, you will then be able to see how others taking this module have responded.</p></instructional-text>
							<instructional-text-accessible><p>Consider each statement and reflect on your level of agreement or disagreement.</p></instructional-text-accessible>
							
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									<poll poll-id="10488802" noscript-text="The review requirements and regulations for my field of research provide adequate protection for research participants."></poll>
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									<!-- POLL START -->
									<poll poll-id="10488803" noscript-text="My university places a strong emphasis on the protection of human participants in research."></poll>
									<!-- POLL END -->
								</process-page>
								<process-page>
									<!-- POLL START -->
									<poll poll-id="10488804" noscript-text="RECs that review research in my field understand our research and are responsive to researchers' needs."></poll>
									<!-- POLL END -->
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								<process-page>
									<!-- POLL START -->
									<poll poll-id="10488805" noscript-text="My department takes the protection of human participants in research seriously."></poll>
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									<!-- POLL START -->
									<poll poll-id="10488806" noscript-text="My colleagues place strong emphasis on the protection of human participants in research."></poll>
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								<h4>Question 1 of 5:</h4>
								<p>The review requirements and regulations for my field of research provide adequate protection for research participants.</p>
								<p><strong>Answer options:</strong></p>
								<ul>
									<li>Strongly agree</li>
									<li>Agree</li>
									<li>Neutral</li>
									<li>Disagree</li>
									<li>Strongly disagree</li>
									<li>Not applicable</li>
								</ul>
								<hr>
								<h4>Question 2 of 5:</h4>
								<p>My university places a strong emphasis on the protection of human participants in research.</p>
								<p><strong>Answer options:</strong></p>
								<ul>
									<li>Strongly agree</li>
									<li>Agree</li>
									<li>Neutral</li>
									<li>Disagree</li>
									<li>Strongly disagree</li>
									<li>Not applicable</li>
								</ul>
								<hr>
								<h4>Question 3 of 5:</h4>
								<p>RECs that review research in my field understand our research and are responsive to researchers' needs.</p>
								<p><strong>Answer options:</strong></p>
								<ul>
									<li>Strongly agree</li>
									<li>Agree</li>
									<li>Neutral</li>
									<li>Disagree</li>
									<li>Strongly disagree</li>
									<li>Not applicable</li>
								</ul>
								<hr>
								<h4>Question 4 of 5:</h4>
								<p>My department takes the protection of human participants in research seriously.</p>
								<p><strong>Answer options:</strong></p>
								<ul>
									<li>Strongly agree</li>
									<li>Agree</li>
									<li>Neutral</li>
									<li>Disagree</li>
									<li>Strongly disagree</li>
									<li>Not applicable</li>
								</ul>
								<hr>
								<h4>Question 5 of 5:</h4>
								<p>My colleagues place strong emphasis on the protection of human participants in research.</p>
								<p><strong>Answer options:</strong></p>
								<ul>
									<li>Strongly agree</li>
									<li>Agree</li>
									<li>Neutral</li>
									<li>Disagree</li>
									<li>Strongly disagree</li>
									<li>Not applicable</li>
								</ul>
								<hr>
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							<p>Generally, research institutions (acting as research sponsors) and researchers take their responsibility to protect human participants in research seriously. But are they taking their responsibility seriously enough? If you looked at these results from the perspective of a research participant, would you want the agreement and commitments to be stronger? Where there is not "strong agreement", what could be done to improve the situation? Would clearer rules or better review procedures help? And, most importantly, how might you take steps to improve the standards for research involving human participants, both for you personally as a researcher and in your wider team/institution?</p>
							
							<h3>Summary</h3>
							
							<p>For research involving human participants to retain its position as a reliable source of information about health and behaviour, researchers who study human participants must:</p>
							
							<ul>
								<li>Ensure that their research follows best practices for their field of research</li>
								<li>Respect the time, dignity and privacy of the individuals participating in their research</li>
								<li>Get the necessary approvals, including review by a REC, and ensure continued oversight of the research.</li>
							</ul>
							
							<p>Researchers who fail to live up to these standards risk damaging their own reputation, potentially harming the participants they study, and undermining the trust the public has in research.</p>
							
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