Research Chapter 5

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Deception

Deliberately withholding information about the study or providing participants with false information

Harm and discomfort can be:

Physical (injury), emotional (stress), social (loss of social support), or financial (loss of wages)

HIPPA

Articulates federal standards to protect patients' medical records and health information

Why are qualitative researchers often in a better position to do good?

Because of the close relationship they develop with participants

Why do qualitative researchers face the challenge of adequately disguising participants in their reports?

Because the number of respondents is small and because rich descriptive information is presented

What three primary ethical principles on which standards of ethical research conduct are based did the Belmont Report articulate?

Beneficence, respect for human dignity, and justice

Right to freedom from harm and discomfort

Beneficence—minimize harm; maximize benefits

What are examples of vulnerable groups?

Children, mentally or emotionally disabled people, severely ill or physically disabled people, terminally ill, institutionalized people, pregnant women

Self-determination includes freedom from what?

Coercion (explicit or implicit threats of penalty from failing to participate in a study or excessive rewards from agreeing to participate)

Covert data collection

Collecting data without participant's knowledge and thus without their consent

Debriefing

Communication with study participants after participation is complete regarding aspects of the study (explaining the study purpose more fully). Also allows participants to ask questions or share concerns. Researchers can also demonstrate their interest in participants by offering to share study findings with them after the data have been analyzed. Researchers may need to assist participants by making referrals to appropriate health, social, or psychological services.

Right to fair treatment (Justice)

Concerns the equitable distribution of benefits and burdens of research

Implied consent

Consent to participate in a study that a researcher assumes has been given based on participants' actions, such as returning a completed questionnaire

What is an example of an ethical dilemma?

Does a new medication prolong life in patients with AIDS? Are nurses equally empathic in their treatment of male and female patients in the ICU?

What studies are exempt from IRB review?

Educational studies about common educational practices Studies that use existing educational tests or observation of public behavior, if results remain anonymous Studies that use existing educational tests or observation of public behavior, if subjects are public officials or candidates for office Research using existing, de-identified data Studies supervised by Federal departments or agencies, that evaluate programs paid for with public money Studies evaluating taste and food items- consumer acceptance

Right to privacy (Justice) (confidentiality, anonymity)

Ensures that the research is not more intrusive than it needs to be and that privacy is maintained

External Review and Protection of Human Rights

Ethical aspects of a study are increasingly likely to be reviewed before permission is granted to conduct a study. -Human subjects committees -Institutional Review Boards (IRBs) -Research Ethics Boards (REBs—in Canada)

Conflict of interest situations

Expected behavior of nurses conflicts with standard research behavior

When does expedited review get used?

If minimal risk, minimal invasive procedures

When does full review get used?

If there is risk, or if vulnerable populations are involved

Consent form

Includes information about the study purpose, specific expectations regarding participation (how much time will be required), the voluntary nature of participation, and potential costs and benefits

Justice

Includes participant's right to fair treatment and their right to privacy, Equitable selection to participate and equitable distribution of benefits

Respect for human dignity

Includes the right to self-determination and the right to full disclosure

Protection from exploitation (beneficence)

Information provided by participants will not be used against them, Participants should not be placed at a disadvantage. This special relationship should not be exploited.

Public Health Service

Issued a policy statement on the humane care and use of animals, informed consent is not relevant for animals

Why is full disclosure not always straightforward?

It can create biases and sample recruitment problems

What are some steps to ensure breach of confidentiality does not occur?

Maintaining identifying information in locked files, substituting identification numbers for participants' names on records, and reporting only aggregate data for groups of participants

Confidentiality in the absence of anonymity

Other confidentiality procedures need to be implemented. Taking steps to ensure breach of confidentiality does not occur

Informed consent

Participants have adequate information about the study, comprehend the information, and have the power of free choice, enabling them to consent or decline participation voluntarily. Usually sign a consent form

Self-determination (human dignity)

Participants have the right to decide voluntarily whether to participate in a study, without risking prejudicial treatment. People have the right to ask questions, refuse answering questions, and drop out of the study

Why must the need for sensitivity be greater in qualitative studies?

People may reveal deep personal information

Anonymity

Protection of participants' confidentiality such that even the researcher cannot link individuals with the data they provided. Most secure means of protecting confidentiality. The researchers cannot even identify the participant

Confidentiality

Protection of study participants so that the data provided are never publicly divulged. It is a pledge that any information participants provide will not be publicly reported in a manner that identifies them and will not be accessible to others

Belmont Report

Provided a model for many guidelines adopted by disciplinary organizations in the United States. Served as the basis for regulations affecting research sponsored by the US government, including studies supported by the National Institute of Research (NINR)

Confidentiality is most salient in what kind of studies?

Qualitative studies because of their in-depth nature

Right to full disclosure (human dignity)

Receiving a description of the study, the person's right to refuse participation, and potential risks and benefits

What are the two elements on which informed consent is based?

Right to self-determination and the right to full disclosure

Minimal risk

Risk expected to be no greater than those ordinarily encountered in daily life or during routine procedures

Procedures for Protecting Study Participants

Risk-benefit assessments Informed consent Confidentiality procedures Debriefings and referrals Treatment of vulnerable groups External reviews and the protection of human rights (IRB) Ethical issues in using animals in research

Vulnerable group

Special groups of people whose rights in studies need special protection because of their inability to provide meaningful informed consent or because their circumstances place them at higher-than-average of adverse effects -Some (e.g., children) cannot make a truly informed decision about voluntary participation. -Some may be incapable of giving fully informed consent (e.g., cognitively impaired people) -Others (e.g., pregnant women) are at higher-than-average risk.

Research may:

Subject persons to painful or harmful care practices Expose persons to live or potentially harmful substances Deprive persons of adequate care Obtain information or materials from persons which persons or family are not reimbursed for

Assent

The affirmative agreement of a vulnerable subject (a child) to participate in a study, typically to supplement formal consent by a parent or guardian

Code of ethics

The fundamental ethical principles established by a discipline or institution to guide researchers' conduct in research with human (or animal) participants

Certificate of Confidentiality

A certificate issued by the National Institutes of Health in the United States to protect researchers forced disclosure of confidential research information. Allows researchers to refuse to disclose information on study participants in any legal proceeding.

Full disclosure

The researcher has fully described the study, the person's right to refuse participation, and potential risks and benefits

Why are ethical dimensions of a study usually subjected to external review?

The risk of a biased evaluation is increased. This can arise from their commitment to an area of knowledge and their desire to conduct a rigorous study

Stipend

A monetary or other payment to individuals participating in a study, as an incentive for participation and/or to compensate for time and expenses. Can be seen as a mild form of coercion

Why are deception and concealment problematic ethically?

They interfere with people's right to make truly informed decisions about personal costs and benefits of participation

Ethical dilemma

A situation in which there is a conflict between ethical considerations and the research methods needed to maximize the quality of study evidence. Participants rights and study quality are put in direct conflict.

Institutional Review Board (IRB)

A term used primarily in the United States to refer to the institutional group that convenes to review proposed and ongoing studies with respect to ethical considerations. It can approve the proposed plans, require modifications, or disapprove them. Fairness, varying viewpoints and lack of bias are critical.

Risk/Benefit assessment

An assessment of the relative costs and benefits, to an individual study participant and to society at large, of participation in a study; also, the relative costs and benefits of implementing an innovation

Beneficence

An ethical principle that imposes a duty on researchers to minimize harm and maximize benefits for study participants. Human research should be intended to produce benefits Non-maleficence. No exploitation, physical/physiological harm

Process consent

Usually used in qualitative studies because the research design emerges during the study and researchers may not know what the risks and benefits will be. It is continuously renegotiated


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