Nursing research is a research that provides evidenced used to support nursing practices.
HISTORICAL BACKGROUND
• 1940 The Nazi Medical Experiment used of prisoners of war and other race to conduct human experiment without their consent that exposed them to severe harm and death
• 1932 The Tuskegee Syphilis Study sponsored by US Public Service where participants without syphilis were also inoculated and medical treatment where deliberately withheld for these participants. The same US doctor who worked in the Tuskegee Study inoculated the prisoners in Guatemala in the 1940’s
• 1960’s The Willowbrook Study infected mentally ill children with hepatitis virus
ETHICAL PRINCIPLES FOR PROTECTING STUDY PARTICIPANTS
Code of Ethics
• 1978 The National …show more content…
It is a guideline affecting research sponsored by US government
• The Department of Health and Human Services (DHHS) established a Code of Federal Regulations, which serves as guidelines in the US foe examining ethical characteristic of the study.
What is the Institutional Review Board (IRB)?
• To ensure proposed study obey federal requirement for ethical research
• IRB can approve, change, disapprove proposed plan
• IRB has five or more members (at least one is not a researcher, one not affiliated with an institution, needs to be different gender from different profession with an institution (e.g. lawyer, clergy is suitable)
• Expedited review by one IRB chairperson for minimal risk research (e.g. employing, quality assurance, human factor, interview, focus group study)
• EXEMPTION TO IRB- no risk to participants
Before starting a research study, the researcher must:
• Submit a research plan to Institutional Review Board (IRB)
• Go through training on ethical conduct and certification process …show more content…
Researcher needs to comply with Privacy Rule since participant’s health care information is protected by HIPAA.
PROCEDURES FOR PROTECTING STUDY PARTICIPANTS
Risk/Benefit Assessment- the researcher can conduct a risk/benefit assesment to evaluate the benefits of participating and share this information with the participants. “ Minimal Risks” are risks that are no greater than experiences in daily life or routine testing. Stipend pay as rewards can be utilized.
Informed Consent and Participants- letting the participants know, understand, and comprehend the information from the research and the ability to consent or decline study voluntarily. Informed consent can be written (7th or 8th grade level) and orally presented witnessed by a third party. “Implied consent” is when a returned questionnaire shows voluntary consent for participation. Participant’s sign consent to access their health information
Confidentiality Procedure- participants data need to be kept confidential through anonymity, the use of identification number, applying for a Certificate of Confidentiality, debriefing session, open communication, and referrals to other
HISTORICAL BACKGROUND
• 1940 The Nazi Medical Experiment used of prisoners of war and other race to conduct human experiment without their consent that exposed them to severe harm and death
• 1932 The Tuskegee Syphilis Study sponsored by US Public Service where participants without syphilis were also inoculated and medical treatment where deliberately withheld for these participants. The same US doctor who worked in the Tuskegee Study inoculated the prisoners in Guatemala in the 1940’s
• 1960’s The Willowbrook Study infected mentally ill children with hepatitis virus
ETHICAL PRINCIPLES FOR PROTECTING STUDY PARTICIPANTS
Code of Ethics
• 1978 The National …show more content…
It is a guideline affecting research sponsored by US government
• The Department of Health and Human Services (DHHS) established a Code of Federal Regulations, which serves as guidelines in the US foe examining ethical characteristic of the study.
What is the Institutional Review Board (IRB)?
• To ensure proposed study obey federal requirement for ethical research
• IRB can approve, change, disapprove proposed plan
• IRB has five or more members (at least one is not a researcher, one not affiliated with an institution, needs to be different gender from different profession with an institution (e.g. lawyer, clergy is suitable)
• Expedited review by one IRB chairperson for minimal risk research (e.g. employing, quality assurance, human factor, interview, focus group study)
• EXEMPTION TO IRB- no risk to participants
Before starting a research study, the researcher must:
• Submit a research plan to Institutional Review Board (IRB)
• Go through training on ethical conduct and certification process …show more content…
Researcher needs to comply with Privacy Rule since participant’s health care information is protected by HIPAA.
PROCEDURES FOR PROTECTING STUDY PARTICIPANTS
Risk/Benefit Assessment- the researcher can conduct a risk/benefit assesment to evaluate the benefits of participating and share this information with the participants. “ Minimal Risks” are risks that are no greater than experiences in daily life or routine testing. Stipend pay as rewards can be utilized.
Informed Consent and Participants- letting the participants know, understand, and comprehend the information from the research and the ability to consent or decline study voluntarily. Informed consent can be written (7th or 8th grade level) and orally presented witnessed by a third party. “Implied consent” is when a returned questionnaire shows voluntary consent for participation. Participant’s sign consent to access their health information
Confidentiality Procedure- participants data need to be kept confidential through anonymity, the use of identification number, applying for a Certificate of Confidentiality, debriefing session, open communication, and referrals to other