Orientation to Research with Human Subjects
Informed Consent
Summary
- The Informed Consent Document must always be signed by either the subjects or their legal representatives.
True/False
- An analysis (weighing) of the risks and the benefits must be presented in an Informed Consent document.
True/False
- The nature of sponsorship of research is a factor in the the risk-benefit analysis performed by potential and participating
subjects.
True/False
- Informed consent is the subject of 45CFR46.116
True/False
- Faculty members may provide model Informed Consent documents for students in their discipline doing similar research.
True/False
- Although anonymity cannot be guaranteed, particularly where participants see one another participating, maintenance of
confidentiality of research records is the default standard.
True/False
- A researcher may determine if a potential or participating subject understands the purposes, risks, and circumstances of a
research project by asking True/False questions.
True/False
- Having once informed a subject of the purposes of a research project, the researcher is under no obligation to provide further
information based on discoveries in the research, changes to the funding of the research, or the experience of adverse effects of
the research by other subjects.
True/False
- The IRB can be considered a removed by-stander after a protocol and its associated documents are approved.
True/False
- Informed consent is a form of contract in which the participant may waive rights to certain civil or criminal law processes and
procedures.
True/False
- A research project does not have to provide immediate benefits to its participating human subjects.
True/False
- Human subjects of research have the right to withdraw from participation in the research at any time, but they must be informed
of the possible physical, psychological, or medical consequences of their withdrawal.
True/False
- All persons with diminished capacity to understand an informed consent document must have a legal representative sign for them,
if they wish to participate.
True/False
- Once collected, the information collected from human subjects may be used for any research purpose.
True/False
- Informed consent documents must be made available in the language the potential or participating subject normally reads.
True/False
If you answered "True" to questions 3, 4, 5, 6, 11, 12, 13, and 15, and "False" to questions 1, 2, 7, 8, 9, 10, and 14, you are correct.
