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An Overview of Research Ethics

For Module 10: Research Ethics

Rachel Klimmek

on 7 May 2011

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Transcript of An Overview of Research Ethics

Research Ethics Rachel Klimmek, BS RN OCN This presentation has been designed to provide you with an overview of :

A. The History of Research Ethics

B. Development of Modern Codes of Ethics

C. Ethical Dilemmas in Research

D. The Belmont Report

E. Procedures for Protecting Study Subjects

F. Strategies to Prevent or Address
Violations of Research Ethics

G. How to Critique Ethics in Research

Let's get started! Codes of Ethics:

Nuremberg Code
Declaration of Helsinki
The Belmont Report
Government-imposed Codes
Professional Codes of Ethics

Three Guiding Principles from the Belmont Report:

Respect for Human Dignity
Ethical Dilemmas in Research:

A situation in which the rights of study participants
are in direct conflict with requirements for a rigorous
study .

The assigned reading in your textbook presents
several examples of ethical dilemmas in research. The Nuremberg Code:

The Nuremberg Code was developed in
the wake of World War II, in response to
a series of horrific medical experiments
carried out by Nazi scientists.

You'll learn more about the Nuremberg
Code when you read about The Doctor's
Trial later in this module. The Declaration of Helsinki was adopted by
the World Medical Association (WMA) in 1964.

It expanded on principles laid out in the Nuremberg
Code and encouraged researchers to put the health &
safety of their research participants ahead of other
considerations. There are also professional codes
of research conduct, including
some specific to nursing.

Your textbook reading discusses
several of these, including:

1897: Code of Ethics for the Nursing Profession
1968: ANA Guidelines on Ethical Values
1970: ANA Commission on Nursing Research
2001: ANA Code of Ethics with Interpretive Statements


Right to protection from harm.

Potential harms in research include:
Physical harms (for example, an adverse effect of an experimental medication)
Psychological harm (You'll see an example of this with the Stanford Prison Experiment!)
Economic harm (one of the reasons researchers will often compensate participants for their time) As part of Beneficence, harm should be minimized:

Participants have the right to freedom from exploitation (for example, being taken advantage of because of their vulnerable status)
Researchers should consider the risk/benefit ratio of research (see Box 5.1, p. 126):
- Minimal Risk means risk that is no
greater than that which is ordinarily
encountered in daily life or during
routine procedures
- The RISK should NEVER exceed the
potential humanitarian benefit of the
For example, researchers might wonder whether a
new medication prolongs the lives of persons with a
certain type of cancer. This might raise an ethical
dilemma for the researchers: The best way to test the
new drug would be through an RCT where some patients
get it and some do not. If the drug is effective, those patients
who've received the drug would have benefited. But what
about those who did not? On the other hand, the untested
drug might also harm those who take it. As the example suggests, research can be fraught with ethical
dilemmas. Although researchers seek the highest-quality evidence
to support practice, they also have a duty to protect the human rights
of their subjects. This can include conflict-of-interest situations where
a researcher has an incentive to violate this sacred trust, such as the
potential of financial rewards for a new drug or other breakthrough. Researchers will often state any "Conflicts of Interest" at the beginning
of a research presentation or at the end of peer-reviewed manuscript.

The existence of these dilemmas is precisely why it is important to have clear codes of ethics to govern the conduct of research. The Belmont Report, issued by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research in 1978, has provided a model for many of the guidelines for protecting study subjects adopted by research agencies across the United States.

"The Belmont Report articulated three primary ethical principles on whic standards of ethical conduct in research are based: beneficence, respect for human dignitiy, and justice" (Polit & Beck, 2010, p. 121). ETHICAL PRINCIPLE #2: RESPECT FOR HUMAN DIGNITY

This includes:
The Right to Self-Determination
The Right to Full Disclosure (including informed consent!) RIGHT TO SELF-DETERMINATION:

"The principle of self-determination means that prospective participants have the right to decide voluntarily whether to participate in a study, without risking penalty or prejudicial treatment. It also means that people have the right to ask questions, to refuse to give information, and to withdraw from the study."
(Polit & Beck, 2010, p. 123)

Researchers must be careful not to engage in COERCION - "explicit or implicit threats of penalty for failing to participate in a study or excessive rewards from agreeing to participate", such as an overly generous financial incentive (Polit & Beck, 2010, p. 123). RIGHT TO FULL DISCLOSURE:

This means that during the process of informed consent (and throughout the study)
the researcher has fully described:
Nature of study
Right to refuse participation
Researchers' responsibilities
Risks & benefits of the research

This can be complicated when researchers are engaging in deception or covert data collection/concealment. Both are discussed in your textbook on page 123. Spy Camera ETHICAL PRINCIPLE #3: JUSTICE

This includes:
The Right to Fair Treatment
The Right to Privacy

Fair & nondiscriminatory selection
Respect for Diversity
Non-prejudicial treatment
Honoring all agreements
Access to personnel
Access to professional assistance
Debriefing of subjects, if needed
Courteous treatment

Data should be kept in the strictest confidence.

1. Anonymity: This means the data cannot be linked to a participant by anyone, including the researchers themselves. (For example, a participant fills out & submits an anonymous online survey where they do not record any information that could be used to identify them).

2. Confidentiality: These procedures should be followed if anonymity is not possible.
ID numbers to identify study participants
Locked files & secure hard drives/computer servers/use of firewalls
Researchers should destroy identifying information once no longer needed
Restrict access to data to authorized personnel/research team members
Obtain a Certificate of Confidentiality for data on legally-sensitive topics (such as intimate partner violence). Once a Certificate of Confidentiality has been obtained, researchers cannot be compelled to share their research data in court or other legal proceedings. This protects the identities and disclosures of their research participants. INFORMED CONSENT Informed consent is an important legal principle for protecting study subjects' Right to Self-Determination (a component of Respect for Human Dignity).

No investigator may involve humans as research subjects without obtaining informed consent from those subjects or legally-authorized representatives. An informed consent document should:

Title of protocol
Invitation to participate
Basis for subject selection
Overall purpose of the study
Explanation of study procedures
Description of risks & benefits
Alternatives to participation
Financial obligations of researchers
Assurance of confidentiality
What will happen in case of injury
HIPAA Disclosure
Procedures for withdrawing from study
Offer to answer questions
Concluding consent statement
Identification of Investigators
Who to contact if the subject experiences a
problem or has a concern/complaint about the
study or the conduct of the researchers (often this
is a contact person at the Institutional Review Board)
It should be easy to COMPREHEND the Informed Consent document. Critical information should be communicated & understood. This means the information is presented:
In a simple format
With adequate Font Size
Clear terminology (no medical jargon)

Some Word Processing programs have a "Readability" function that can inform the researcher as to the complexity of language in their consent forms. (For example, the Flesch-Kincaid score which tells you what grade level the document has been written at.)
Here's an example of an Informed Consent:

The POWER OF FREE CHOICE means that research participants should always be given the option of choosing whether or not to participate in research.

Most often researchers will obtain WRITTEN CONSENT, where the subject signs & dates an informed consent document and gets to keep a copy for themselves.

Sometimes ORAL CONSENT will be obtained by the researchers. This means research subjects receive information about the study and then inform the researchers verbally as to whether or not they are willing to participate. This is sometimes the case in research that involves MINIMAL RISK.

Researchers may also rely on IMPLIED CONSENT (see p. 127). Implied consent may be obtained when research involves self-administered questionnaires. If a study subject returns the questionnaire to the researcher, the researcher may conclude that this person has consented to participate in the research. However, this is not always the case.

Generally, research participants must be at least 18 years old or an emancipated minor in order to give consent. Some groups cannot always give informed consent. There are others who are considered particularly vulnerable to the risks of research. Groups that are considered VULNERABLE SUBJECTS include:

Mentally/emotionally disabled persons
Severely ill or physically handicapped persons
Terminally ill
Institutionalized persons (including those in prisons or medical institutions such as nursing homes)
Pregnant women Occasionally, a researcher may seek a

A waiver of informed consent means that researchers do not have to obtain informed consent (written, oral, or otherwise) from their study subjects. This might be appropriate in certain, very specific situations such as an observational study of emergency room procedures where participants might be unconscious or otherwise unable to provide consent before data is gathered.

Research that involves a Waiver of Informed Consent must meet strict requirements:
No more than MINIMAL RISK
Waiver will not adversely affect the rights & welfare of study subjects
Research could not feasibly be done without the waiver
Whenever appropriate, research subjects will be given additional pertinent information after participation (for example, the researcher might go back to an ER patient later in their hospitalization, once they are stabilized, to explain the study & the data that was gathered) Other Ethical Issues related to research can include:
Proper treatment of Animals in research (covered in your textbook on p. 133)
Research Misconduct such as:
- Plagiarism
- Fabrication of study results
- Falsification of data

These issues are discussed in greater depth on pages 134-135 of your textbook. Later in this module, you will examine several case studies where researchers engaged in research misconduct.

Any nurse who suspects that research misconduct has occurred should report their concerns to a supervisor or other person in a position to investigate the situation and take appropriate steps to address any harm done. However, this should be done in a manner that preserves the privacy & safety of research participants.
Animal Rights in Research:

Regulated by Federal Laws:
- Overseen by the USDA
- 1985: Improved Standards for the
Laboratory Animals' Act

Institutions conducting Animal Research
must have an Animal Care & Use

Several of the nurse researchers here at Johns Hopkins SON conduct important research using animal models. This includes nurse scientists like
Dr. Gayle Page & Dr. Sharon Kozachik. Data
obtained from animal studies is essential for
certain types of important research. Ethical aspects of studies are increasingly likely to be reviewed before permission is granted to begin the study.

Studies may be reviewed by Human Subjects Committees, Research Ethics Boards (REBs - often in Canada), or Institutional Review Boards.

In the U.S., all Federally-funded studies must undergo review by an Institutional Review Board (IRB). IRBs must have a specific structure:

Membership must consist of at least 5 members including:
At least one non-scientific representative
At least one person not affiliated with the institution
Members cannot all be the same gender or practice the same profession

Sometimes a study will qualify for what is called, "Expedited Review". This means that the study involves MINIMAL RISK. and that the IRB will review it but in a less comprehensive fashion that other studies which have more risk or procedures for study subjects.

A study that involves NO APPARENT RISK to study subjects (such as a review of death certificates), or a study that does not actually qualify as research, may qualify for EXEMPTION from review by an IRB. When research misconduct or violations of subjects' rights are suspected, the Office of Research Integrity may be called to investigate. In one of your assigned readings, you were asked to review the case of Ellen Roche. If you haven't already read the article, take the time to do that now. What have we learned from Ellen Roche?

24 year old lab technician at JHU
Health volunteer in study of mechanisms of asthma
Inhaled Hexamethonium, which restricts the airway to mimic asthma symptoms
Died 1 month later
On July 19, 2001, the Federal government suspended all Federally-funded research at Johns Hopkins What researchers should have known:

Hexamethonium had been used in previous asthma studies which were provided to the IRB
Although previously-approved by the FDA as an oral antihypertensive agent, this approval had been discontinued when more effective agents were developed & the drug was suspected in some deaths
Previous deaths were unknown to the IRB & to the investigators, although discovered after the fact when reviewing literature from the 1950's

IN OTHER WORDS, THIS SHOULD NEVER HAVE HAPPENED. This tragedy resulted in several important changes to the structure of IRBs at Johns Hopkins:

Increased # of IRBs from 2 to 4
Increased specialization of IRBs
Increased IRB-Investigator Interaction
Increased staff (including a consent form specialist)
Addition of ethics experts to each committee
Standardization of protocol applications Much like an IRB, you can also critique the ethical aspects of research studies.

In this course, you will complete a research article critique that will involve questions about research ethics.

Although ethics are important, some research articles do not include detailed explanations of procedures to protect study participants due to space considerations. However, you will generally find a brief explanation of these procedures, and whether a study was reviewed by an ethics committee or IRB, in the METHODS section of a research report. It is important to consider the following when reviewing research reports:

Did investigators obtain IRB approval?
Were the methods appropriate & safe for study participants?
Were participants subjected to physical, psychological, or financial harm as a result of their participation in the study?
Was data ever gathered without permission from study participants?
Was the privacy of study participants protected?
Did participants receive adequate (but not coercive) compensation for their time?
Did the study involve any vulnerable subjects?
If so, were appropriate protections put into place?
Did researchers choose their participants fairly? (In other words, were any groups omitted who should have been included? This has long been the case with certain groups such as minorities, older adults, pregnant women & children). This concludes this presentation on Research Ethics.

If you have questions, be sure to post them to the Course Discussion Board, or participate in the LiveChat! with your TA this week.

The next part of this module will involve reading about or watching examples of real-world cases of research gone wrong. As you review these examples, try to put yourselves into the shoes of the investigators. How do you think this could have happened? What might you have done differently?

You will be working with other members of your EBP Group to review these real-world examples and respond on the Group Discussion Board. Enjoy!
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