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EBP Law & Ethics
Legal and Ethical Issues with Research
| Question | Answer |
|---|---|
| Enacted in 1996 to protect the privacy of an individual's information | HIPAA (Health Insurance Portability and Accountability Act |
| Four elements of ethical research are | Protecting subjects, Benefits vs. Risks, Informed consent, Institutional approval |
| Disciplined study of morality | Ethics |
| What should one's behavior and character be is an example of | Morality |
| Unlawfully studied progression of untreated syphilis in black men. | Tuskegee Project (1932-1972) |
| People in this study thought they were just receiving free health care | Tuskegee Project (1932-1972) |
| This drug was found to be an effective cure against syphilis in 1940 | Penicillin |
| A social movement claiming to improve genetic features of human though Selective breeding and sterilization | Eugenics |
| International principles of human experimentation brought on as a result of Nazi war crimes | Nuremburg Code |
| Set of ethical principles regarding human experimentation as set by the World Medical Association | Declaration of Helsinki (1964) |
| Widely regarded as the Cornerstone document of human research ethics | Declaration of Helsinki (1964) |
| This organization set guidelines to protect human research subjects (1973) | DHEW (Department of Health, Education, and Welfare) |
| Passed in 1974 by US | National Research Act |
| This was created by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in 1979 | Belmont Report |
| This report attempted to summarize the basic ethical principles for research | Belmont Report (1979) |
| This report provided moral framework on use of humans in experimental research | Belmont Report (1979) |
| The Belmont Report lead to the establishment of _______ in the department of _______ | OHRP(Office for Human Research Protections) HHS(Health and Human Services) |
| This agency set regulations requiring institutional review boards for the protection of human subjects | OHRP in the department of HHS |
| This type of research provides an opportunity to receive experimental tx that may provide benefits. Therapeutic or Nontherapeutic? | Therapeutic Research |
| This type of research generates knowledge for discipline. Therapeutic or Nontherapeutic? | Nontherapeutic Research |
| This type of research benefits future generations. Therapeutic or Nontherapeutic? | Nontherapeutic |
| This type of research WILL NOT benefit current subjects. Therapeutic or Nontherapeutic? | Nontherapeutic |
| The freedom to participate or not is known as autonomy, beneficence, or justice? | Autonomy |
| The promise to above all, do no harm is known as autonomy, beneficence, or justice? | Beneficence |
| Fair treatment in regards to benefits and risk of research is known as autonomy, beneficence, or justice? | Justice |
| Not using coercion is adhering to which ethical principle? | Autonomy |
| Full disclosure and no deception adhere to which ethical principle? | Autonomy |
| Voluntary Consent adheres to which ethical principle? | Autonomy |
| Self-determination is adheres to which ethical principle? | Autonomy |
| Freedom from harm relates to which ethical principle? | Beneficence |
| Freedom from exploitation relates to which ethical principle? | Beneficence |
| Risk/benefit ratios such as high anticipated benefit may balance high risk relates to which ethical principle? | Beneficence |
| Fair tx (even if pt chooses not to participate) relates to which ethical principle? | Justice |
| Right to privacy, animinety, and confidentiality relate to which ethical principle? | Justice |
| Fair selection of subjects and treatment during study relates to which ethical principle? | Justice |
| Paying subjects large sums of money would violate which ethical principle? | Justice |
| This federal program does clinical investigations regarding human subjects involving products and drugs. | US Food and Drug Admin (FDA) |
| Animal studies are also included in this federal programs product and drug investigations | US Food and Drug Admin (FDA) |
| This act was implemented in 1003 to protect individual's private health information | HIPAA |
| This act protects individually identifiable health information | HIPAA |
| Under HIPPA regulation the following must be removed in order to de-identify health information | Name, location, dates, phone, SS, MRN, photos, etc... |
| Unauthorized access to raw medical data is a breach of what? | Confidentiality |
| These people are given extra protection of right to self-determination | Vulnerable groups |
| These people are defined as have decreased ability or an inability to give informed consent | Vulnerable groups |
| Vulnerable subjects include | Legally and mentally incompetent, neonates/infants/children, terminally ill, and institutionalized persons. |
| Four Elements of informed consent include | Purpose of research, duration, description of procedures, and identification of procedures. |
| Four reasons for intervention pertaining to informed consent include | Unforseeable risks, subject termination, additional costs, early subject withdrawl |
| This institution reviews research projects and ensures that ethical standards are met in relation to the protection of the rights of subjects | Institutional Review Boards (IRBs) |
| This 1974 act requires research study reviews (Part of IRB) | National Research Act |
| Protection of rights and welfare, voluntary consent, and benefit/risk balances are functions of the | Institutional Review Board (IRB) |
| Which level of review invovles no risk | Exempt from Review Procedures |
| Level in which there is research on regular educational strategies such as use of educational tests | Exempt |
| Level in which data are recorded so subjects cannot be identified. Public data also used. | Exempt |
| Level of review which involves minimal risk | Expedited |
| Level of review involving collection of hair and nails | Expedited |
| Level of review involving collection of excreta and external secretions (Venipuncture) | Expedited |
| Level of review involving recordings using noninvasive procedures and study of existing data (Weight, medical records) | Expedited |
| Level of review involving vulnerable population or potential harm/risk | Complete |
| Level of review involving greater than minimal risk | Complete |
| Level of review involving giving chemicals and invasive procedures | Complete |
| Fraud research protocol violations are examples of | Research Misconduct |
| Fabrication, falsification, forging of data are examples of | Research Misconduct |
| Plagiarism is an example of | Research Misconduct |
| Putting subjects at risk without consent is an example of | Research Misconduct |
| Name the five Human rights as outlined by the ANA | Self-determination, privacy, anonymity and confidentiality, fair treatment, and protection from harm. |
Created by:
Blitzkid22
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