Ch. 3 Research

• Unit 3: Ethical and Legal Considerations in Research

  This unit focuses on ethical concepts for the design, conduct, and reporting of research. Included are the legal considerations that guide the research process as well as regulations related to privacy.
• Legal and Ethical Considerations

  • Ethical guidelines
  • How we should conduct research
  • Legal guidelines
  • How we are required to conduct research
• Nuremberg Code


  In response to war crimes against humanity
• Declaration of Helsinki


  • Adopted by the World Medical Association
  • Differentiates between therapeutic and non-therapeutic research
  • Focus on informed consent
• Belmont Report


  Ethical Principles and Guidelines for the Protection of Human Subjects of Research
• Respect for Persons


  • Individuals participating in research should be treated as autonomous beings capable of making their own decisions
  • Fundamental: Informed consent
• Respect for Persons


  • Specific protections for members of vulnerable populations
  • Limited autonomy (e.g., children, patients with dementia, prisoners)
  • Vulnerable subjects are any prone to harm or exploitation
• Beneficence: Do No Harm


  Making efforts to secure the well-being of subjects by doing no harm, and maximizing the possible benefits and minimizing the possible harms in study design
• What Kind of Harm?

  • Physical harm
  • Psychological harm
  • Social harm
  • Economic harm
• Justice


  Subjects' rights to fair treatment and fairness in distribution of benefit and burden. Researchers may not take advantage of underprivileged persons in order to benefit those who are privileged.
• Other Ethical Guidelines

  • Explain the research procedure clearly to subjects
  • Obtain proper and informed consent
  • Ensure the confidentiality of participants
  • Maintain appropriate documentation
  • Adhere to research protocols
  • Report results in a fair and factual manner
• Informed Consent


  A process of information exchange that includes recruitment materials, verbal dialogue, presentation of written materials, questions and answers, and an agreement documented by signature.
• Issues in Using Social Media


  • Any principle that would apply to face-to-face research should apply to social media
  • Subject should control the interaction
  • Respect for privacy–set up separate pages
  • Public should be unable to determine the data that are being used for the research
  • Proficiency in using privacy settings
• Legal and Regulatory Guidelines for Conducting Research


  • Common law
  • Administrative law
  • Statutory law
  • Tort law
• Institutional Review Boards

  • Research institution group that reviews and oversees all research involving human subjects
  • Ensures that studies meet all federal regulation criteria
  • Primary responsibility: Protecting subjects from harm
• Types of IRB Studies

  • Exempt: Studies that pose no risk for subjects
  • Expedited: Studies that pose only minimal risk for subjects
  • Full reviews: All research that poses more than minimal risk to subjects
• Research Involving Animals


  • Guidelines hold researchers accountable for the humane treatment and care of animals through the "three R's": Reduce the number of animals used in experiments, Refine experimental procedures to minimize pain and suffering, Replace animal subjects with nonanimal alternatives when feasible
• Research Misconduct


  • Fabrication
  • Falsification
  • Plagiarism
  • Undisclosed conflicts of interest
  • Misleading authorship
  • Duplicate publication
• A priori


  Conceived or formulated before an investigation
• Beneficence


  A basic principle of ethics that states that persons should have their decisions respected, be protected from harm, and have steps taken to ensure their well-being
• Ethics


  A type of philosophy that studies right and wrong
• Exempt Review


  A review of study proposals that pose no risk to subjects; the full institutional review board is not required to participate
• Expedited review


  A review of study proposals that pose minimal risk to subjects; one or two institutional review board members participate
• Full disclosure


  Reporting as much information about the research as is known at the time without threatening the validity of the study. This practice allows the subject to make an informed decision as to whether to participate.
• Full Review


  A review of study proposals that pose more than minimal risk to subjects, that do not qualify for exempt status, and in which the full institutional review board committee participates
• Health Insurance Portability and Accountability Act

  Legislation passed by Congress in 1996, which protects the privacy of personal health information
• Informed Consent


  A process of information exchange in which participants are provided with understandable information needed to make a participation decision, full disclosure of the risks and benefits, and the assurance that withdrawal is possible at any time without consequences. This process begins with recruitment and ends with a signed agreement document.
• Institutional review board

  The board required in research institutions that reviews and oversees all research involving human subjects and ensures studies meet all federal regulation criteria, including ethical standards
• Justice


  A basic principle of ethics that incorporates a participant's right to fair treatment and fairness in distribution of benefit and burden
• Nontherapeutic research


  Studies that are carried out for the purpose of generating knowledge. They are not expected to benefit the research subject but may lead to improved treatment in the future
• Respect for persons


  A basic principle of ethics stating that individuals should be treated as autonomous beings who are capable of making their own decisions. Persons who have limited autonomy or who are not capable of making their own decisions should be protected.
• Right of privacy


  A person's right to have his or her health information kept confidential and released only to authorized individuals and to have his or her body shielded from public view
• Therapeutic research


  Studies in which the subject can be expected to receive a potentially beneficial treatment
• Vulnerable populations


  • Groups of people with diminished autonomy who cannot participate fully in the consent process. Such groups may include children, individuals with cognitive disorders, prisoners, and pregnant women.
• Research involves asking questions, collecting data, analyzing results, drawing conclusions, and communicating findings.