Ethical Issues in Qualitative Research

An Introduction

Why are ethical principles important? Some Famous Examples

The Tuskegee Syphilis Study

Formal apology to surviving participants in the Tuskegee Study, President Bill Clinton, the Whitehouse, 1997

Willowbrook Hepatitis Study

• The Willowbrook State School was an institution for the retarded, as mentally challenged persons were referred to at that time, on Staten Island, New York. During the 1950s, Dr. Saul Krugman was the director of research at Willowbrook. • He knew that many children there would develop hepatitis because of overcrowding and other unsanitary conditions. In fact, many members of the staff developed hepatitis as well. Dr. Krugman also knew that the virus responsible for hepatitis did not have hosts outside human beings. • He was persuaded that these conditions justified research on the disease in humans. He initiated a project at Willowbrook to study gamma globulin injections to determine whether they would protect the children from infection. The injections did seem to have a strong protective effect.

• Dr. Krugman then admitted new residents of the school to special quarters and fed them virus samples he had collected from the other children. • When protest arose regarding his exposure of these children to hepatitis virus, Dr. Krugman defended his work. If he had not infected the children as part of research, they would have developed hepatitis anyway because of their school's communal housing. This research, he said, was akin to an experiment in nature, and no level of improved hygiene would have protected the children. He noted, too, that he had been given permission from parents to experiment on their children.

• It is true that children were enrolled with parental consent. A letter explaining the research was sent to parents whose children were on a waiting list for admission to Willowbrook. Immediate admission was the reward for parents who signed the letter; parents who did not provide consent were not assured of immediate admission. Also, the letter explained the benefits of a new preventative for the Hepatitis virus. The letter is reproduced below.

Willowbrook Consent Form

• > > > > > > > > Willowbrook State School > Office of the Director > Staten Island, New York > November 15, 1958 > Dear_______________: > We are studying the possibility of preventing epidemics of hepatitis on a new principle. Virus is introduced and gamma globulin given later to some, so that either no attack or only a mild attack of hepatitis is expected to follow. This may give the children immunity against this disease for life. We should like to give your child this new form of prevention with the hope that it will afford protection. > Permission form is enclosed for your consideration. If you wish to have your child given the benefit of this new preventative, will you so signify by signing the form. > Sincerely, > H. H. Berman, MD > Director

The Nuremburg Code

Overarching Ethical Principles

(Gillis &Jackson, 2002) Principles of Ethical Research Respect for person Beneficence Justice Methods for protecting human participants Informed consent Institutional review Boards

Some key considerations in ethical conduct during the research process

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Comparing ethical principles of all research with medial ethical principles

: Respect for person, Beneficence, Justice revisited.

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The relational aspect of qualitative research

: Comparing professional codes of conduct with ethical conduct in qualitative research: a comparison with the College of Registered Nurses Professional Boundaries document (CRNNS, 2002)

Key considerations (cont’d)

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Protection of participants through the informed consent process favors formalized interaction between researcher and participant.

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Strength of qualitative research methods often lies in the informality of the communication as well as the iterative nature of the research process.

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How can we reconcile these two conflicting dynamics? (Fritz, 2008)

CNA Code of Ethics: Comparing with Research Ethics

CNA CODE

1. Safe, competent ethical care 2. Dignity 3. Confidentiality 4. Justice 5. Accountability 6. Quality Practice Environments

Codes of Research Ethics

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College of Registered Nurses Boundaries Document

Comparing relationship boundaries in: 1. Professional Nursing Relationships 2 Personal Relationships 3. The Research Relationship (Please use handout: CRRNS boundaries in Professional Relationships document (2004)

Applying Ethical Principles: working through some case examples

1) You want to study adolescent social interaction during the sharing of a cafeteria meal.

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Who are the research participants?

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What are the risks?

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How will you minimize the risks?

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Who needs to provide informed consent?

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What are your main ethical concerns?

2) You want to study the social interaction among university students when they are preparing for the BURMAC hockey game.

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Who are the research participants?

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What are the risks?

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How will you minimize the risks?

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Who needs to provide informed consent?

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What are your main ethical concerns?

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The obligation to inform people that they are part of a research project is universal, no matter what your methods.

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Always be honest about who you are, what your research is about, why you want to talk, and what you will do with the information.

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Depending on your methods, written informed consent may not always be necessary and may, in fact, negatively impact the quality of your research. Always consult the REB for guidance and work with them to come to mutually agreeable solutions to protect the participants as well as the integrity of your research process. (Fritz, 2008)

The Informed Consent Process revisited

( Described in detail using Informed Consent sample circulated in class: An Institutional Ethnography of Nurses’ Stress in PICU; McGibbon, 2004) • • • • • • • • •

Study Title Researcher Funding Source Introduction Purpose of the Study Study Design Potential Harms Potential Benefits Withdrawal from Participation

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Costs and Reimbursements Confidentiality Research Rights Contact Persons Participant Consent Statement by person providing information on the study Statement by person obtaining consent