ETHICAL PRINCIPLES FOR PROTECTING STUDY PARTICIPANTS Belmont Report- articulates three primary ethical principles on which standards

of ethical conduct in research are based: 1. Beneficence 2. Respect for human dignity 3. Justice

Beneficence - to minimize harm and to maximize benefits 1. The right to freedom from harm and discomfort Nonmaleficence- to avoid, prevent, or minimize harm Participants must not be subjected to unnecessary risks for harm of discomfort, and their participation in research must be essential to achieving scientifically and societally important aims. Harm and discomfort can take many forms: physical, emotional, social, or financial. Strategies to minimize harm: 1. Research should be conducted only by qualified people. 2. Ethical researchers must be prepared to terminate research anytime. 3. It is almost always advisable to experiment with animals or tissue cultures before proceeding to tests with humans. The psychological consequences of participating in a study are usually subtle and thus require close attention and sensitivity. The need for sensitivity may be greater to qualitative studies, which often involve in-depth exploration into highly personal areas. 2. The right to protection form exploitation Involvement in a research study should not place participants at a disadvantage or expose them to situations for which they have not been prepared. Exploitation may be overt or malicious, but it might also be more subtle. Nurse researcher may have nurse-patient relationship so special care may need to be exercised to avoid exploiting the bond. Munhall (2001) has argued that qualitative nurse researchers have the responsibility of ensuring that the therapeutic imperative of nursing (advocacy) takes precedent over the research imperative (advancing knowledge) if conflict develops. Respect for human dignity 1. The right to self-determination Self-determination-the prospective participants have the right to decide voluntarily whether to participate in a study, without risking any penalty or prejudicial treatment. Coercion-explicit or implicit threats of penalty from failing to participate in a study or excessive rewards from agreeing to participate. 2. The right to full disclosure Full disclosure-the researcher has fully described the nature of the study, the persons right to refuse participation, the researchers responsibilities, and likely risks and benefits.

two types of bias: 1. biases resulting from inaccurate data 2. resulting from sample recruitment problems Techniques: Covert data collection or concealment-the collection of information without participants knowledge and thus without their consent. Deception-deliberately withholding information about the study, or providing participants with false information. Deception and Concealment are problematic ethically. The collection of data from people over the internet. Schrum (1995) has offered some guidelines for use by researchers. Justice 1. The right to fair treatment The equitable distribution of benefits and burdens of research. The selection of study participants should be based on research requirements and not on vulnerability or compromised position of certain people. Imposes particular obligations toward individuals who are unable to protect their own interest. Distributive justice also imposes duties to neither neglect nor discriminate against individuals and groups who may benefit from advances in research. 1. The researchers must treat people who decline to participate in a study in a nonprejudicial manner. 2. They should honor all agreements with the participants. 3. They demonstrate sensitivity and respect. 4. They give participants access to research personnel 5. They afford participants courteous and tactful treatment at all times. 2. The right to privacy Researchers should ensure that their research is not more intrusive than it needs to be and that participants privacy is maintained throughout the study. Confidentiality Health Insurance Portability and Accountability Act of 11996- articulates federal standards to protect patients medical records and other health information. Standards for Privacy of Individually Identifiable Health Information Privacy rule- April 14, 2003