Syphilis Study at Tuskegee
Jewish Chronic Disease Hospital Study
It was written by the National Commission for the Protection of Human Subjects.Option 1
It articulated ethical principles that formed the basis for the HHS Human Subjects Regulations.Option 2
Belmont is another word for individual autonomy and respect.Option 3
It was a seminal document about the concept of informed consent.Option 4
All of the above
Has reached the legal age to provide informed consent in the State.
Is willing to accept certain risks if the research will benefit others in the future
Understands the risks and benefits of his or her participation and is able to make a voluntary decision if adequate information is provided.
Meets all eligibility criteria for a study and asks the investigator if she or he may participate.
They are a neonate.
They are incarcerated or involuntarily confined.
They are unconscious.
All of the above.
Provide written informed consent
Provide written permission
Provide assent, unless the IRB determines that they are too young
That women have completed the first trimester.
That the study be conducted first in men
Permission of the father.
Consideration of risks and potential benefits for the fetus and the pregnant woman.
Keeping data in a password-protected database
Storing images in a secured cabinet
Coding data or specimens and keeping the key to the code in a separate, locked drawer
All of the above are ways to maintain confidentiality
Scientific uncertainty that one study intervention is superior to another
A reasonable balance of risks and benefits to research subjects
When the probability and magnitude of harm or discomfort is not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological exams
A double blind controlled trial
A family member's consent for another individual may be sufficient, as long as community consent is given
Federal regulations preclude the conduct of PHS-funded research
Community consent to participate in the research study is sufficient and no IRB approval is required
In addition to the cultural norm, individual informed consent is required
Inclusion of children in research
Inclusion of women and minorities in research
Treatment for research subjects in HIV/AIDS antiretroviral studies following completing of trials in developing countries
All of the above
Obtain knowledge of the local context by talking to those who have traveled to the region
Defer to an IRB that is in the situated within the local research context
Ask specialists with direct knowledge of the local research context to participate in IRB discussions
B or C
A or C
Voluntariness, Equipoise, Respect
Voluntariness, Comprehension, Disclosure
Benefits, Comprehension, Privacy
Disclosure, Equipoise, Privacy