Ethics in Research and Publication PDF

Ethical Principles in Clinical Research Goal of clinical research: generate useful knowledge about human health and illness ○ Promote benefits to society and future patients ○ Protect and respect rights + welfare of participants...

Ethical Principles in Clinical Research Goal of clinical research: generate useful knowledge about human health and illness ○ Promote benefits to society and future patients ○ Protect and respect rights + welfare of participants People used to develop useful knowledge are at risk of exploitation ○ Goal is NOT to benefit individuals who participate Ethics: study of general nature of morals + specific moral choices to be made by a person ○ Key principles Respect for autonomy: recognizing person’s ability to make their own decisions Intersects with privacy, confidentiality, truth-telling, informed consent Must identify surrogate decision-maker in people who are unable to make informed decisions Beneficence: promoting benefits and welfare of research participant/society Non-maleficence: minimizing harm to patients “Non nocere:” first do no harm Calculate risk vs benefit tradeoff ○ Extensive counseling when risks exceed benefits Justice: equal distribution of risk + benefit (no preferential care) Special protections necessary for vulnerable groups ○ Children ○ Pregnant women ○ Students ○ Employees ○ Prisoners ○ Socioeconomically disadvantaged (underserved/poor) ○ Ethnic minorities ○ Patients with limited education ○ Patients with mental disabilities ○ Animals History of Bioethics Hippocratic oath: contains some of the first ethical principles (including non-maleficence) Tuskegee study: unethical study of the progression of untreated syphilis in black men ○ No informed consent ○ Participants were told they were being treated for bad blood (misleading) ○ Patients only received placebo, even after penicillin approved to treat syphilis Influential code of ethics ○ Nuremberg code Voluntary consent Subjects free to withdraw at any time Avoid unnecessary physical/mental suffering Death + injury should NOT be expected outcome Experiment should be terminated if continuing study will result in injury, disability, death Risks weighed against importance of problem Scientific rigor, good design, proper preparation + facilities to protect subjects, researchers are qualified ○ Declaration of Helsinki Physician can use new therapeutic measure if it offers hope of treating patient Physician can combine medical research with professional care if justified value for patient Potential benefits + risks of new method should be weighed against current method Every patient should be assured of the best proven method Refusal of patient to participate in study must not interfere with physician-patient relationship Physician must state reason for not obtaining informed consent (in people who are unable to give it) ○ Belmont report Basis for the Common Rule which governs all federally funded human subjects research Solidified need for informed consent Requires evaluation of risks + benefits of research Establish need for fair selection of study subjects Requires protocols involving human subjects to be reviewed by institutional review board (IRB) 3 basic ethical principles: respect for persons, beneficence, justice The Common Rule ○ Outlines how a local IRB should be formed + operated ○ Provides criteria for IRB approval of proposals ○ Includes requirements for informed consent ○ Subparts refer to vulnerable subjects (pregnant women, children, fetuses, in vitro fertilization, prisoners) Institutional review board (IRB): assures requirements are satisfied ○ Risk to subjects minimized + reasonable relative to anticipated benefits ○ Selection of subjects is equitable ○ Informed consent from each subject/representative + appropriately documented ○ Research plan makes provisions for monitoring data collection ○ Privacy + confidentiality of subjects are protected ○ Additional safeguards for vulnerable populations International conference on harmonization- good clinical practices ICH/GCP: based on code of nuremberg, declaration of helsinki, belmont report Requirements of Ethical Research 7 requirements of ethical framework Requirements Explanation Justifying Ethical Value Social/scientific value Evaluation of a treatment/theory that will improve health/knowledge Scarce resources + non-exploitation Scientific validity Use of accepted scientific principles + methods to produce reliable + valid data Scarce resources + non-exploitation Fair subject selection Selection of subjects so that vulnerable individuals are not targeted for risky Justice research Favorable risk-benefit Minimizing risks, increasing benefits, ensuring risks are proportionate to benefits Nonmaleficence, beneficence, ratio for patient non-exploitation Independent review IRB (unaffiliated with research) approval of trial design, subject population, Public accountability, minimizing risk-benefit ratio influence of conflicts of interest Informed consent Provision of information to subjects about purpose of research, risks, benefits Respect for autonomy Respect for potential and Permitting withdrawal from research, protecting privacy through confidentiality, Respect for autonomy + welfare enrolled subject informing of new risks/benefits, maintaining welfare Examples of unethical research ○ Obtaining informed consent from groups with diminished autonomy ○ Randomizing patients to placebo when known standard of therapy is available/risks outweigh benefits ○ Vulnerable populations Conducting research on newborns/pediatric patients with unproven safety in adults Conducting research on pregnant women when significant harm to offspring is known Resources for Publication Ethics Office of research integrity (ORI): investigates research misconduct ○ Research misconduct: fabrication, falsification, plagiarism in proposing, performing, reviewing, reporting research results Fabrication: making up results Falsification: manipulating/omitting results so that research isn’t accurately represented in research record Plagiarism: taking another person’s ideas/results without giving credit Does NOT include honest error/differences of opinion Committee on publication ethics (COPE): provides basic principles for reviewers in peer review ○ Only agree to review manuscripts for which they have subject expertise ○ Respect confidentiality ○ Can’t use information obtained from peer review process for personal advantage/disadvantage ○ Declare all conflicts of interests (can seek advice from journal) ○ Be objective and constructive in their reviews Don’t allow reviews to be influenced by origins of manuscript, nationality, religious/political beliefs, gender ○ Provide journals with accurate personal + professional information ○ Recognize that impersonation of another person is considered misconduct Components of Publication Ethics 1. Ethics review/breach of confidentiality ○ Human/animal ethics committee (IRB) approval  ○ Informed consent with human participants ○ Trial must be registered in clinical trials registry ○ Data confidentiality (unless institutional permission) 2. Fabrication + falsification ○ Fabrication: making up results ○ Falsification: manipulating/omitting results so that research isn’t accurately represented in research record 3. Plagiarism: use of previously published ideas without consent/credit ○ Considered plagiarism even is unintentional ○ Editors should expect allegations of plagiarism to be substantiated and treat it seriously ○ Forms of plagiarism Verbatim quotation without acknowledgement Cutting + pasting without acknowledgement Paraphrasing Inaccurate citation Failure to acknowledge assistance Use of material written by professional agencies/other persons Auto-plagiarism Identical pieces of work submitted concurrently ○ How to avoid plagiarism Don’t copy-paste, write concept in own words Acknowledge original sources Cite references accurately Avoid writing several articles of the same kind Use anti-plagiarism tools 4. Authorship: confers credit and responsibility of published work ○ Journals should remind contributors about authorship guidelines (ICMJE) Substantial contributions to development of idea + data Drafts manuscript/performs revisions Gives final approval for publication Agrees to be accountable for work done ○ Each author should be clear about their responsibility (mandatory) ○ Decide on authorship while writing protocol 5. Submission ethics ○ Simultaneous submission: submitting same manuscript simultaneously to different journals ○ Self-citation: citing own publication out of context ○ Predatory journals: characterized by false/misleading information, deviation from best editorial + publication practices, lack of transparency, aggressive/indiscriminate solicitation Publish for a fee without providing peer review/editing Don’t follow academic standards for publishing List available at UGC-CARE 6. Conflicts of interest: anything that interferes with objective presentation, commissioning, peer review, editorial decision-making, publication of research submitted to journal ○ Disclose interests: financials (patent, stock, consultancies), personal, political, intellectual, religious ○ Editors should seek disclosure statements from all authors + peer reviewers (clearly explained) Peer Review Ethics Peer review: process of subjecting scholarly work to scrutiny of others who are experts in the same field ○ Filter to ensure only high quality research is published by determining validity, significance, originality ○ Intended to improve quality of manuscripts that are suitable for publication ISI only considers peer-reviewed journals to receive impact factors Reviewer selection is at discretion of journal editors ○ Peer reviewer: expert in the field that checks for accuracy, quality, validity of methods, revisions ○ Volunteer basis Peer review process ○ Journals provide guidance to peer reviewers ○ Literature search to confirm if similar articles have been previously published + ensure that all relevant articles are cited ○ Comments to author should be direct, specific, actionable, aimed at increasing quality ○ Comments to editors should be on overall importance + quality of manuscript, provide recommendation regarding manuscript’s acceptance Reviews due within 10-30 days ○ Editor communicates final decision to authors Blinding in peer review Type of Blinding Definition Advantages Disadvantages Single-blind Reviewers know authors More honest feedback May delay completing review to but authors don’t know Independent decisions without publish own data first reviewers influence of author Discrimination against authors Double-blind Reviewers and authors Protects authors from reviewer Can be easy for reviewer to don’t know each other bias + maintain review quality determine identity of author Open Reviewers and authors Encourages reviewers to be open May prevent reviewers from being know each other without being disrespectful honest for fear of developing bad Help prevent plagiarism rapport with authors