A study of tissue samples linked to someone's medical records
A study using observations of public behavior at the mall
An anonymous survey given to students enrolled in BIO101
A study using sensitive information collected through a survey voluntarily completed by study participants, in which the survey was coded so respondents could be matched to the mailing list for follow-up.
The Nuremburg Trial
The Tuskeegee Study
The "Common Rule"
The Belmont Report
the Principal Investigator has certified it as expeditable.
it presents no more than minimal risk and involves only those procedures outlined in the federal regulations.
IRB approval is needed as quickly as possible.
the research is being conducted as a class requirement
The design of the study is consistent with sound scientific principles, ethical guidelines, and legal requirements.
Risks to subjects are minimized using procedures consistent with sound research design and that do not unnecessarily expose subjects to risk.
Informed Consent is obtained when required, and additional appropriate safeguards have been provided if potentially vulnerable subjects are to be studied (e.g., children, prisoners,).
The political and community reaction to the research topic being studied.
As soon as the researcher is ready.
As soon as a proposal is submitted.
Two weeks after the committee meets
Only after you have received written (email) approval from the chair of the IRB
Modifications to the research design
Extensions of time required to collect data
All of the above require notification of the IRB
Just faculty and staff
Only researchers who have changed their study since the proposal was submitted
Always less than 7 days
Less than 7 days if exempt or expedited review, after the monthly meeting if full review is required
After the monthly meeting
Immediately if you have special circumstances and need to collect data right away
It should have at least five members
At least three members should have an advanced degree in the scientific field related to the study
No members should have a vested interest in the research study under review
Members should be from diverse backgrounds regarding race, gender, and cultural heritage, and at least one member should not be associated with the institution
Declaration of Helsinki
Respect for Persons
Research Risks And Benefits
A description of foreseeable risks to the participants
A statement describing all the organizations or agencies funding the research study
A statement of describing to what extent records will be kept confidential
A statement that participation is voluntary and participants may refuse to participate or withdraw at any time
For any study that is not classfied as exempt
For non minimal risk studies, or studies where the IRB has requested informed consent
For all projects involving human subjects, except under the specific circumstances outlined in the Common Rule (46.116.f.3 and 46.117.c)
The data and safety monitoring board
The investigator and research team
The U.S. Public Health Service
The United Nations
The World Medical Association
The U.S. Food and Drug Administration
Approve, request modifications or disapprove any research involving human subjects.
Insure that proper procedures and documentation of informed consent have been established by a researcher.
Judge the foreseeable risks and benefits to human subjects within a research project.
Judge the scientific validity of the research methodology employed in a project.