4.2 Protection of Human Subjects

Question 1

The Common Rule

Answer 1

• Federal policy for the protection of human subjects
• Applies to research conducted or supported by the Department of Health and Human Services

Question 2

Institutional Review Boards (IRB)

Answer 2

• Main purpose is to protect human subjects
• IRB Should be consulted before planning a study to gain guidance on working with the research population
• Reviews all research proposals and ensures the researcher submits all necessary documents for review (proposal, consent forms, budget, tools for collecting data)
• Makes sure research studies follow ethical standards and regulations for research with people.
• They check that research is not unnecessarily risky
• They verify that participants have the information they need to make a decision about volunteering for the study
• IRB may not require informed consent for very low risk research however IRB still reviews research
• NOT ALL RESEARCH REQUIRES IRB REVIEW (such as research on leftover blood samples)
• FDA regulates drug research (does not require IRB)
• Research privately funded by a non-profit or corporation that is not regulated by FDA

STAFF
- Must have at least 5 members with various backgrounds who can provide different perspectives on the research
- 1 of these members must not be connected to the institution conducting the research
- 1 of these members must not be a scientist
- 1 of these members be able to review the specific types of research
- 1 of these members must know the community where the research takes place
- IRB members cannot review their own research projects

Question 3

Privacy and Confidentiality

Answer 3

Confidentiality - The security of records and information about individuals

Privacy - Individuals right to know what other people know about them and their interactions with others

Sensitive Information - Anything a subject may not want anyone to know (sexuality, genetic profile, mental health, criminal behavior) that may lead to stigmatization

Identifying Characteristics - Data (name, SSN, physical descriptions, genetic profile) about a research subject that enables someone outside the study group to identify the subject

Question 4

HIPPA Protection

Answer 4

• Protects information from medical records

Question 5

Vulnerable Groups

Answer 5

• Children
• Pregnant Women
• Fetuses/Neonates
• Prisoners
• Elderly

DOES NOT INCLUDE
- Adults with cancer/depression

Question 6

Assent

Answer 6

• Children between the ages of 7-18 should assent to participate in a research study
• Assent does not provide full consent of the study before 18th birthday without parent permission

Question 7

Protection of Basic Human Rights

Answer 7

• Primary based on the ethical concern of diminished autonomy