Quiz 2 Flashcards
(32 cards)
Ethical Research
A systematic investigation designed to develop or contribute to generalizable knowledge that conforms to accepted standards of conduct.
The Tuskegee Study of Untreated Syphilis
-Began in 1932
-Documented the natural disease progression of syphilis in black men.
-Macon County, Alabama
-600 men. 399 had syphilis. 201 did not. All living in poverty.
-Were not told that they were in an experiment but rather that they were being treated for “bad blood”.
Participants given “free medical exams and treatment, meals, adn upon death a burial stipend was paid to their survirors.
-1945, Penicillin was approved to treat syphilis but this study still continued without the participants being treated.
-Ended in 1972
Nazi War Crimes
- Took place btwn 1939-1945
- Medical researchers in Nazi Germany conducted a wide range of heinous and often fatal experiments on prisoners of concentration camps, without their consent.
- In 1946, the Nuremburg Doctors’ Trial was held where 16 out of the 23 physicians were found guilty. However, they could not be found guilty of violating the rights of human participants because at the time, there were no accepted standards.
The Nuremberg Code
- Framed by American judges who were judging nazi doctors.
- This code is made up of : Hippocratic ethics and the protection of human participants into a single document
- Known as the most important document in the history of ethics in medical research.
- Comprised of 10 standards that researchers should stick to when conducting experiments on human participants.
- Included in this code: Requirement of voluntary informed consent, the recognition that risks must be weighed against anticipated benefits; and the caveat that experiments should only be conducted by scientifically qualified persons.
Willowbrook Hepatitis Study
- A state school for cognitively disabled children on Staten Island.
- Hepatitis was widespread at this school and researchers wanted to study the natural course of viral hepatitis as well as the efficacy of gamma globulin.
- Parents gave their consent but were not fully informed of the possible hazards involved with their kids being inoculated with a mild form of hepatitis.
- Parents were under the impression that if they did not give consent then their kids will not be taken care of.
- Researchers defended their actions, by saying that because hepatitis was widespread at the institution, then the kids probably wouldve gotten it anyways.
Jewish Chronic Disease Hospital Study
- 1963
- 2 doctors injected live cancer cells into hospitalized patients with chronic diseases.
- Wanted to see if those that were debilitated with a chronic disease rejected cancer cells, albeit at a slower rate, than healthy patients.
- This study was so wrong that it was brought to the attention of the Board of Regents of the State University of New York.
- Upon review, they found that the research protocol had NOT been presented to the hospitals review committee AND the patients’ physicians were unaware of their patients involvement in this study.
- The doctors were found guilty of “fraud, deceit, and unprofessional conduct in the practice of medicine.
The National Research Act
- The development of the regulatory process governing the ethical conduct of researchers began with the signing of this.
- 1974
- Created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.
- This commission was put in charge of identifying the key components of ethical research involving human participants and developing guidelines to ensure that human research is conducted in accordance with those principles.
Belmont Report
- 1979
- Drafted by National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.
- Identified 3 basic principles:
1. Respect for persons
2. Beneficence
3. Justice
Respect for persons
- Incorporates 2 ethical convictions:
1. Individuals should be treated as autonomous agents
2. Persons with diminished autonomy are entitled to protection. - “In research involving human subjects, respect for persons implies that, when given adequate info about the research project, that subjects voluntarily decide to participate”
Autonomous Person
An individual capable of deliberation and personal goals and of acting under the direction of such deliberation.
- Demonstrating respect for an A.P would be respecting their decisions and opinions, unless they are harmful to others.
- Showing a lack of respect could be rejecting, or interfering with a persons ability to carry out or act on their opinions and choices. Another example would be withholding info, for no compelling reason, for the purpose of interfering with an individuals ability to make a decision.
- 2 hallmarks for an AP, they have the ability to both understand and process info and should they choose to participate in a research study, they are free to do so without being coerced.
Diminished Autonomy
An individual who is not able to act as an autonomous agent and therefore, is not capable of deliberation and personal goals and of acting under the direction of such deliberation
Vulnerable population
The disadvantaged sub-segment of the community.
-When a person has limitations on either their capacity or voluntariness.
-Decreased freewill to inability to make informed choices.
Example: Children, prisoners, intellectual disabled persons, the elderly, etc.
Coercion
Occurs when an overt threat of harm is intentionally presented by one person to another in order to obtain compliance.
Ex: an elderly women who is a resident in a nursing home is forced to choose between participating in a research study or leaving the nursing home.
Undue Influence
Occurs through an offer of an excessive, unwarranted, inappropriate or improper reward or other overture in order to obtain compliance.
-Opposite of coercion.
Ex: An investigator promising her students extra credit if they participate in her research project.
Beneficence
-Requires that persons are treated in an ethical manner by
1.Protecting them from harm
2.Maximizing possible benefits and minimizing possible risks of harm
This does not mean that there are not any risks involved to participants
Justice
An injustice occurs when a person who is entitled to a benefit is denied said benefit, without good reason, or when a burden is unduly imposed.
- The selection of research participants must be fair, avoiding participants from a population (educationally or economically disadvantaged) or selecting participants from a certain population.
- example: Tuskegee Study of Untreated Syphilis
Common Rule
-Operationalized the principles in the Belmont report by setting the rules and procedures researchers must follow when conducting human subject research.
-Rules include:
Developing an Institutional Review Board (IRB)
Setting standards on what information must included in the consent forms
The level of review studies must go through
The policies for human subjects protection in health science research can be found under the department of Health and Human Services regulations, 45 CFR Part 46
This regulation has 4 subparts which include:
a. Also known as the Federal Policy or the Common Rule
b. Additional protections for pregnant women, human fetuses, neonates
c. Additional protections for prisoners
d. Additional protections for children
Institutional Review Board
- Common Rule mandates this
- The IRB is a group that has been assembled for the primary purpose of reviewing research proposals to ensure that the rights and welfare of human subjects participating in research studies are protected.
- IRB reviews research proposals to ensure everything/anyone in experiment will be safe and respected
- IRB has the power to stop any experiment
Dr. Beecher
- Was instrumental in raising awareness regarding ethical research practices.
- Wrote the seminal paper on the ethics of research in 1966, exposing research studies that put the generation of new knowledge above ethical treatment of human subjects.
Subpart A of 45 CFR 46
Sets the standards for the IRB, including the board composition, type of required for a proposed research project, and required elements in an informed consent. -There are 3 levels of review: Exempt from review Expedited review Full review
Exempt from Review
The Common Rule allows research activities to be exempt from IRB full review when they are considered low risk and the involvement of human participants is within one of the categories defined by the Department of Health and Human Services.
- Ex: educational settings and research that uses educational tests
- A signed consent form is not required
- ex: surveying educators regarding the use of a new curriculum, evaluating the use of a revised standardized test, etc.
Expedited Review
- The Common Rule allows research activities that:
1. present no more than minimal risk to human subjects
2. Involve only procedures listed in one or more of the following categories, may be reviewed by the IRB through the expedited review procedure. - Research activities in this category include the collection of human data (weight and height), imaging tests, and blood and bodily fluids.
Full Review
Research on participants or any protected pop.(fetuses, pregnant women, prisoners, etc) that involves more than minimal risk needs to be brought before the IRB for a full review.
