Assignment Instructions
In order to understand how an Institutional Review Board functions and the type of knowledge one needs to participate in a research study involving human participants, you will link to the Office of Research Integrity, RCR Resource Development Program’s “Teaching the Responsible Conduct of Research in Humans” website at https://ori.hhs.gov/education/products/ucla/default.htm. The tutorial will help you identify research activities that involve human participants and help you understand how to protect the rights and welfare of all human participants involved in research.
Please download and review the attached document, and follow the instructions.
Supporting Materials
IRB ASSIGNMENT – PROTECTING HUMAN RESEARCH PARTICIPANTS
INSTRUCTIONS
In order to understand how an Institutional Review Board functions and the type of knowledge one needs to participate in a research study involving human participants, you will link to the NIH Office of Extramural Research on-line tutorial Protecting Human Research Participants (PHRP). The tutorial will help you identify research activities that involve human participants and help you understand how to protect the rights and welfare of all human participants involved in research.
Assignment Instructions:
Please go to the following website: Teaching the Responsible Conduct of Research in Humans by Dr. Stanley G. Korenman
https://ori.hhs.gov/education/products/ucla/chapter2/default.htm
Read and review all the components of Chapter 2.
Afterward, use the material from the website to answer the questions pertaining to the IRB. Please complete the questions within this document, and not a separate document.
You can use additional web resources to answer, in addition to the information provided in the link above.
Please list all references, including the website, in APA format at the bottom of the completed page
Upload the completed document when you are finished, by the end of Week 7, in the IRB assignment area.
Answer the following questions and submit in a word document.
What are the 3 principles identified in the Belmont Report and what do they mean?
Who are the types of persons with diminished autonomy and entitled to additional protections?
You do not need to study information on protections for international research.
What are the 3 fundamental aspects of informed consent and what do they mean?
You do not need to study waivers of informed consent.
What considerations are there for informed consent for persons with diminished autonomy?
When a child is involved in research what is the child’s “assent”.
When is community consultation and consent needed in addition to an individual person’s informed consent?
Identify and describe the five different types of research risks?
What is a certificate of confidentiality as it applies to research?
Know that anticipated benefits of research must be greater than potential harms: risk-benefit analysis. How does the concept of “generalizable knowledge” apply to this?
What type of compensation is allowed for research participation?
What is meant by therapeutic misconception?
What is equipoise?
What are ideal methods to protect the confidentiality of research data?
Institutional Review Board (IRBs): are they required by the federal government? How many members are there and are they boards of an institution or of the federal government? What is their role? What is the relationship between the IRB and the researcher?
What are the two principles of social justice as they relate to research?
What is the difference between equity vs equality?
What is the government’s position on minorities, women and children in research?
What is a placebo and when are they justified for use?
What are examples of cultural norms and informed consent for research?
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