Module 6

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Module 6: Ethics of Research with Human Subjects

American Psychological Association – April 2nd, 1998

Institutional Training for Research Involving Human Subjects

The American Psychological Association (APA) originally published “Ethical Principles in the Conduct of Research with Human Participants” in 1973, revised in 1983. Dramatic shifts have occurred in the context in which research occurs. This has resulted in new ethical challenges:

1. Behavioral research is expanding into biomedical contexts and settings where research priorities are being integrated with non-research institutions, communities, and diverse populations

2. Research involves a broad range of populations that may have special concerns, i.e., children, substance abusers, teen mothers, chronically ill, mentally ill or challenged, minorities, etc.

3. Sensitive issues have been added to research agenda, i.e., domestic violence, incest, sexual practices. These create tension between right to privacy and the need for careful research.

4. Advances in electronic technologies for gathering, analyzing, storing, and sharing data have raised new ethical issues not covered by earlier guidelines

Therefore, new codes published by Office for the Protection from Research Risks (OPRR) and the APA need to be addressed.

Ethics of Research with Human Subjects

Responsibilities of researchers can be sorted into four sets: Responsibilities to

science

society

students, apprentices, or trainees in research, and

participants of the research

The primary focus of this information will be on responsibilities to participants in research

Five basic principles are covered in the APA guidelines

Respect for Persons and their Autonomy

Beneficence and Nonmalfeasance

Justice

Trust

Fidelity and Scientific Integrity

Principle I - Respect for Persons and their Autonomy

Researchers should respect the human participants in their investigations as persons of worth whose participation is a matter of their autonomous choice. If persons have diminished autonomy, whether because of immaturity, incapacitation, or circumstances that severely restrict their liberty, they require special concern.

Principle II - Beneficence and Nonmalfesance

In the planning and conduct of research with human participants, the researcher should maximize the possible benefits and minimize possible harms from the research

Principle III - Justice

Risks and benefits of research should be equally shared by all. Unfortunately, this ideal is rarely fully achieved. Historically, risky new procedures were traditionally tried on ward patients with the benefits enjoyed largely by patients in private care. Threats to justice in psychological research arise from the almost inherent power differential between the experimenter and the research participant. Real or perceived power differentials necessitate safeguards against exploitation. Additionally, to prevent gender inequities, Justice may require sampling designs that pertain to women as well as to men.

Principle IV - Trust

Researchers must establish and maintain a relationship of trust with participants in their research. Participation is based upon explicit agreement about the

Participant’s experience

Consequences of the participation

Researcher’s obligations, privacy, confidentiality, etc.

Principle V - Fidelity and Scientific Integrity

The researcher is committed to the discovery and promulgation of truth. The researcher must do good science, and must not falsify, misrepresent data, or falsely claim the work of others.

Scientific integrity -- truthfulness, is not open to compromise.

Informed Consent

Psychologists should have concern for the rights, dignity, and welfare of their research participants. They must carefully inform potential participants about the studies for which they are volunteering. This should include a clear statement of the purpose and procedures, the risks and benefits, and the obligations and commitments of both participants and researchers.

The resulting explicit agreement is generally documented through the use of a written consent form, which should be clear, fair, and not exploitive. Consent by the potential participant should be voluntary, informed, and given by a competent individual. It is the responsibility of the researcher to guarantee that such consent has been obtained prior to allowing a volunteer to participate in a research protocol.

The consent process is more than simply obtaining a signature from the potential participant, it is communicating necessary information to the participant. In order to do this, the researcher must first assess the participant’s mental and legal ability to provide informed consent, as well as the participant’s ability to comprehend the information being communicated. Individuals with limited autonomy (e.g., children, prisoners, psychiatric patients, etc.) are special populations in which specific safeguards are required.

The following areas are among those to be addressed in ensuring informed consent

1. Invitation to Participate - makes clear that participant is volunteering for research

2. Purpose of the Research - includes over all purpose of the research including research goals at the individual and group level, when appropriate

3. Basis for Participant Selection - is a clear statement as to why the participant is appropriate for the study. Allows prospective participants to exclude themselves if they do not believe they meet criteria for inclusion

The following areas are among those to be addressed in ensuring informed consent

1. Study Procedures - should be clearly described

where will it take place

who will be involved,

what kind of work output will be involved

any therapeutic interventions

2. Description of Risks and Discomforts - volunteers are unable to make informed decisions about whether to participate if they are not adequately informed.

3. Description of Benefits - In general, benefits can be summarized under the general category of anticipated additions to a systematic body of knowledge

4. Available Alternatives - primarily for therapeutic studies in which nonvalidated interventions are being studied

5. Noncoercive Disclaimer - participation should always be voluntary, and the decision to participate or discontinue participation should result in no penalty or loss of benefits to the participant. It is appropriate for researchers to

use reasonable noncoercive inducements to complete a study

state the consequences of early withdrawal (e.g., loss of monetary bonus for completing study).

6. Data Withdrawal - participants should also be informed they may withdraw their data from the study, stating time constraints for that data withdrawal

7. Incomplete Disclosure - information for participants to make an informed decision is necessary. At times, however, information may be withheld. Although not usually the first choice, it is sometimes necessary to omit information in order to protect the validity of the data collected

8. Offer to Answer Questions - it is important that participants know whom to contact if they have any problems or are injured during the study

Barriers to Informed Consent

Comprehension - the participant must understand the information imparted

Limited Competence - should consider those who lack legal capacity to provide consent, e.g., children, prisoners, mentally disabled, etc. (Federal regulations require that parents “permit” or “deny” permission for a child to participate in a research protocol)

Insufficient Time - participants need time to consider all relevant information

Study Design - There are some studies in which full information disclosure would confound study design, e.g. drug vs. placebo studies

Longitudinal Studies - in the course of long-term studies, conditions can change. It is important to remember that consent is an ongoing process

The consent process is a negotiation between the researcher and each potential participant, and requires clear and appropriate communication by researchers - coupled with respect for the autonomy of the individual considering research participation.

Privacy and Confidentiality

Respect for privacy is at the heart of the conduct of ethical research with human subjects. Privacy and confidentially derive from our respect for the autonomy of persons, our desire to do good (beneficence), and the principle of trust. Privacy refers to a person’s interest in controlling other people's access to information about themselves. Confidentiality refers to the right to maintain private information divulged in the course of a professional relationship with a researcher.

Research participants can file a suit for “invasion of privacy under tort law. However, if the researcher has taken reasonable precautions and if the activity is approved by the IRB, they are usually dismissed.

Privacy has two major aspects. The first is the freedom to pick and choose the time and circumstances under which facts about a person, e.g., attitudes, beliefs, opinions, etc., are shared or withheld from others. The second is a person’s right not to be given information that he or she does not want, ie., HIV testing results, standardized testing scores , etc.

Concerns about privacy can result from many sources; sociocultural values, characteristics of the physical environment, and characteristics of the cultural environment.

Anonymity provides excellent protection of privacy. Anonymity means that the identity of participants is not attached to the data, and can never be inferred from the data through any means, ie., social security numbers, addresses, etc.

Confidentiality refers to agreements with persons as to what may be done with their data. Researchers should refrain from sharing private information with others, unless authorized by the participant, or some other justification. Authorization is obtained through the informed consent process.

Confidentiality is becoming increasingly hard to maintain. It can be threatened in many ways

legal actions

government statutes

access by third party groups

data sharing

technical lapses in security

breaches during presentation of data

The best safeguard is to be well-informed about the law, understand the limits to confidentiality, have a well formed consent agreement, and understand techniques that protect data and preserve the participant’s anonymity and privacy.

Maintaining Trust

The trusting relationship between the researcher and participants, established during the informed consent process, should be maintained as the research unfolds. The research team should continue to foster trust by treating research participants and research assistants as respected partners in the research.

Safety of Participants

Federal regulations require that “When appropriate, the research plan makes adequate provision for monitoring data collected to ensure safety of subjects.” Unintended harms can occur during research. Ongoing monitoring may be necessary to evaluate this. Aside from obvious illness or injury, adverse reactions can take the form of shame, anxiety, embarrassment, or an actual pain or distress reaction to a physical stressor

One mitigation response may be to debrief participants at the end of a study, providing them with appropriate reassurances and information about normal reactions

Debriefing

One of the benefits to participants in research is an educational one. Researchers generally inform participants at the end of a study why it was conducted and how the results fit into what is already known. A debriefing session continues the information and education process for both the researcher and the participant. Establishing and maintaining trust and monitoring the safety of research participants is an ongoing process during research.

Researchers should take steps to ensure that:

privacy of participants is continuously protected

actual and potential harms are continuously monitored and acted upon as needed

unique vulnerabilities of participants be given special attention

there be appropriate and effective debriefing procedures

when deception is used, steps to remove any residual negative effect be taken