Intro to Research

Question 1

Nuremburg Trials

Answer 1

Conducted to prosecute Nazi leaders for crimes against humanity. A substantial proportion of the trials involved Nazi physicians who had forced prisoners to undergo appalling, inhumane procedures in the name of clinical research such as injection of typhus into the blood, and direct ophthalmic injection of toxic substances

Question 2

Nuremburg Codes

Answer 2

articulated the basic requirements for conducting research in a manner that respects the fundamental rights of human subjects

Question 3

Favorable Risk to Benefit Analysis

Answer 3

An aspect of Nuremberg code in which the result of being in the research process that positive or good outcomes must outweigh the negative

Question 4

Institutional Review Board (IRB)

Answer 4

• The National Institutes of Health created a Clinical Research Center which later became policy after funding form the Public Health Service that required evaluation of the ethical aspects of human-subjects research.
• The decision of whether a study is ethical should be determined at its inception, not after the results are known.
• Policies and procedures defined that IRBs must follow when considering research, and established the criteria for IRB approval of research proposals – now overseen by Office for Human Research Protections, whose job is to develop and oversee compliance with regulations for the protection of human subjects – Common Rule regulations that guide IRB decision making/approvals

Question 5

Declaration of Helsinki

Answer 5

1. The interests of the subject should always be placed above the interests of society.
2. Every subject should get the best-known treatment.

Question 6

Willowbrook State School

Answer 6

Hepatitis transmission was performed on mentally challenged children in an extended-care facility

Question 7

Jewish Chronic Disease Hospital

Answer 7

Live cancer cells were injected into the bloodstream of chronically ill, mostly demented, elderly patients; subjects had illnesses that compromised the immune system, and this study was designed to determine the influence of weakened immune system on spread of cancer

Question 8

Tuskegee Syphilis Study

Answer 8

Funded by the United States Public Health Service to investigate the natural history of untreated syphilis in humans; longest running study in which participants with known syphilis was not offered treatment; subjects were from one of the most vulnerable populations: uneducated, poor, African-American sharecroppers from Macon County, Alabama

Question 9

Contraception Clinic Study

Answer 9

Indigent persons in San Antonio, TX enrolled in a randomized, blinded, placebo-controlled study on the various effects of contraception pills; indigence rendered them unable to seek contraceptive advice or medication elsewhere; none were informed that they were participating in this type of research or that they might be receiving placebo, and many had unplanned pregnancies

Question 10

National Research Act 1974

Answer 10

1. It established the modern IRB system for oversight of human-subjects research
2. It created the National Commission for Protection of Human Subjects of Biomedical and Behavioral Research (National Commission) - established the ethical framework for considering and approving research with vulnerable populations: e.g., children, pregnant women, prisoners, and persons with impaired decision-making ability

Question 11

Belmont Report

Answer 11

Describes the 3 fundamental principles that are now accepted as the minimum requirements for ethical human subjects’ research: respect for persons, beneficence, and justice

Question 12

Respect for Persons

Answer 12

1. each person has the right to self-determination
2. persons with diminished autonomy (“vulnerable” people who lack the capability of self-determination) are entitled to additional protection to prevent exploitation

Question 13

Four research requirements for respect for persons

Answer 13

1. Participants must voluntarily consent to participate in research.
2. The consent must be informed consent.
3. Participants’ privacy and confidentiality must be protected.
4. Participants have the right to withdraw from research participation without penalty or repercussions

Question 14

Beneficence

Answer 14

Research be designed to maximize benefit and minimize harm

Question 15

Justice

Answer 15

Relates to the distribution of risk across society; the research should not systematically select specific classes of individuals simply because they are readily available where research is conducted or because they are “easy to manipulate as a result of their illness or socioeconomic condition; enrollment must be directly related to the study; The implication is that research should not systematically exclude a specific type of person (e.g., children or pregnant women) who might benefit from participation or to whom the research results are likely to apply

Question 16

Evidence based practice (EBP)

Answer 16

Method of clinical decision making and practice that integrates scientific evidence and clinical expertise along with patient’s values and circumstances

Question 17

Evidence (3 sources)

Answer 17

1. Clinical Expertise
2. Scientific Research
3. Patient values and circumstances

Question 18

Scientific Research

Answer 18

Emperical evidence acquired through systematic testing of a hypothesis

Question 19

Clinical research

Answer 19

Involves human subjects and answers questions about diagnosis, intervention, prevention and prognosis in relation to disease or injury

Question 20

5 Steps of EBP Process

Answer 20

1. Identify the need for Information and develop a focused and searchable clinicial question
2. Conduct a search to find the best possible research evidence to answer your question
3. Critically Appraise research evidence for applicability and quality
4. Integrate the critically appraised research evidene with clinical expertise and Patient’s values and circumstances
5. Evaluate the effectiveness and efficacy of efforts of steps 1-4 and identify ways to improve them in the future