Ethics Test Ardrey Kell Study Guide

investigator

anyone who is involved in conducting the research

Nuremburg Code (1947)

first international code of research ethics. established basic principles that must be observed in order to satisfy moral, ethical, & legal concepts in the conduct of human subject research. verdict in Nazi doctor case.

Nuremburg Code Directive 1

Voluntary consent of the human subject is absolutely essential

Nuremburg Code Directive 2

The experiment must yield generalizable knowledge that could not be obtained in any other way and is not random and unnecessary in nature

Nuremburg Code Directive 3

Animal experimentation should precede human experimentation

Nuremburg Code Directive 4

All unnecessary physical and mental suffering and injury should be avoided

Nuremburg Code Directive 5

No experiment should be conducted if there is reason to believe that death or disabling injury will occur

Nuremburg Code Directive 6

The degree of risk to subjects should never exceed the humanitarian importance of the problem

Nuremburg Code Directive 7

Risks to the subjects should be minimized through proper preparations

Nuremburg Code Directive 8

Experiments should only be conducted by scientifically qualified investigators

Nuremburg Code Directive 9

Subjects should always be at liberty to withdraw from experiments

Nuremburg Code Directive 10

Investigators must be ready to end the experiment at any stage if there is cause to believe that continuing the experiment is likely to result in injury, disability or death to the subject

the Belmont Report

ethical principles & guidelines created in response to Tuskegee Syphillis Study. Principles:

1. Respect for persons

2. Beneficence

3. Justice

Belmont principle of respect for persons

1. Individuals should be treated as autonomous agents

2. Persons with diminished autonomy are entitled to additional protections

Belmont principle of beneficence

Do no harm

Maximize possible benefits and minimize possible harms

Belmont principle of justice

Requires that individuals and groups be treated fairly and equitably in terms of bearing the burdens and receiving the benefits of research

45 CFR 46

Code of Federal Regulations. Codifies the ethical principles for research involving human subjects described in the Belmont Report

a human subject

a living individual about whom an investigator conducting research obtains:

1. Data through intervention or interaction with the individual, or

2. Identifiable private information

research

a systematic investigation designed to develop or contribute to generalizable knowledge

diminished autonomy

An individual with restricted capability of deliberation about personal goals and of limited ability to act under the direction of their deliberations. examples:

• pregnant women

• fetuses

• prisoners

• children

• mentally disabled people

IRB (Institutional Review Board)

specialized committees required by HHS regulations that safeguard the rights and welfare of human subjects. major roles are:

• Initial review and approval or disapproval of the proposed research activity

• Ensuring that the proposed informed consent process meets all of the requirements of 45 CFR 46.116

• Providing continuing oversight for progress reports and protocols for ongoing research studies

informed consent

A legally-effective, voluntary agreement that is given by a prospective research participant following comprehension and consideration of all relevant information pertinent to the decision to participate in a study. an on-going process.

3 fundamental aspects of informed consent

Voluntariness: Individuals' decisions about participation in research should not be influenced by anyone involved in conducting the research

Comprehension: Individuals must have the mental or decisional capacity to understand the information presented to them in order to make an informed decision

Disclosure: must be made in such a way that it provides a reasonable person the information she or he would need in order to make an informed decision

HHS regulations of disclosure

1. The purpose of the study

2. Any reasonably foreseeable risks to the individual

3. Potential benefits to the individual or others

4. Alternatives to the research protocol

5. The extent of confidentiality protections for the individual

6. Compensation in case of injury due to the protocol

7. Contact information for questions regarding the study, participants' rights, and in case of injury

8. The conditions of participation, including right to refuse or withdraw without penalty

waivers of informed consent

IRBs can waive or alter some / all of the required elements of informed consent if all of the following conditions are met:

1. The research involves no more than minimal risk to the subjects

2. The waiver or alteration will not adversely affect the rights and welfare of the subjects

3. The research could not practicably be carried out without the waiver or alteration

4. Whenever appropriate, the subjects will be provided with additional pertinent information after participation

legally authorized representative

An individual authorized under applicable law to consent on behalf of a prospective subject to the subject's participation in the procedure(s) involved in the research.

HHS regulations for pregnant women require

1. Preclinical studies be completed prior to the involvement of pregnant women

2. A consideration of risks and potential benefits for the fetus and pregnant woman

HHS regulations for pregnant women prohibit

1. Inducements of any kind to terminate a pregnancy

2. Investigators from taking part in decisions about terminating a pregnancy

3. Investigators from determining the viability of a neonate

obtaining consent from children

children provide assent to participate in research, to the extent that they are able, and parents / guardians give permission for a child to participate in research. Parental permission must be obtained for research involving children "in accordance with and to the extent that consent is required by 45 CFR 46.116."

Obtaining Informed Consent from Prisoners

requires approval by an IRB whose membership is specifically constituted to address the concerns of this vulnerable population per 45 CFR 46.304. If the research is conducted or supported by HHS, it must also be approved by the Secretary of HHS. requirements:

1. prisoner is gaining no advantages to living situation from research

2. will not effect prisoner's parole, and prisoner is aware of this

community consultation

must do this if individual's interests is intimately entwined with community's interests, or when research involves risk to identifiable populations

clinical trial

A research study in which human subject(s) are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.

risk

probability a certain harm will occur during research.

1. Physical

2. Psychological

3. Social

4. Legal

5. Economic

minimal risk

when the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests

Regulatory Requirement for Explaining Benefits and Risks

HHS regulation requires that investigators consider:

1. protections against risk

2. potential benefits to individual participants

3. importance of the knowledge to be gained

therapeutic misconception

the tendency for research participants to downplay or ignore the risks posed to their own well-being by participation ... [due to] the participants' deeply held and nearly unshakeable conviction that every aspect of their participation in research has been designed for their own individual benefit". 6

equipoise

Substantial scientific uncertainty about which treatments will benefit subjects most, or a lack of consensus in the field that one intervention is superior to another.

coded data

Identifiers are removed from the data in exchange for codes that correspond to the identifiers, and the identifiers are maintained separately from the rest of the dataset.

Research with coded private information or specimens involves human subjects if

1. The private information or specimens were collected specifically for the currently proposed research project through an interaction or intervention with living individuals; or

2. The investigator(s) can readily ascertain the identity of the individual(s) to whom the coded private information or specimens pertain

clinical trial.

A data and safety monitoring plan is required when a proposed study is a _________

justice

• Fair procedures and outcomes are used to select research participants

• There is a fair distribution of benefits and burdens to populations who participate in research

individual justice

investigators should not offer potentially beneficial research only to some patients who are in their favor or select only 'undesirable' persons for risky research.

social justice

• requires that distinction be drawn between classes of subjects that ought, and ought not, to participate in any particular kind of research, based on the ability of members of that class to bear burdens and on the appropriateness of placing further burdens on already burdened persons.

• research should involve persons from groups who are likely to benefit from subsequent applications of the research

• groups should not be selected for inclusion because of easy availability, compromised position, or manipulability

undue burden

Research populations must not be subject to undue burden, wherein they are systematically selected simply because of their easy availability, their compromised position, or their manipulability, rather than for reasons directly related to the problem being studied.

HHS definition of "child"

the need for protections for "children" is defined by the location in which the study will take place and the research procedures. Research that involves children must follow the requirements for parental permission and child assent

NIH definition of "child"

individuals under the age of 18

placebo

An inactive intervention designed to resemble, as much as possible, its active counterpart in clinical research. potential research participants must:

• Understand what placebos are

• Understand the likelihood that they will receive a - placebo

• Be able to provide their fully informed consent that they are willing to receive a placebo

incomplete disclosure

Withholding some information in order to conduct an unbiased study, with the understanding that the information could be material to a decision by prospective participants about whether or not to participate in the study.

waiver of informed consent

• Participation in the research involves no more than minimal risk

• waiver must not adversely affect the rights and welfare of research participants