Are There Research Studies That Do Not Require IRB Approval?

Are There Research Studies That Do Not Require IRB Approval? Publicly available data do not require IRB review. Examples: census data, labor statistics. What types of research require IRB approval? FDA regulations generally require IRB review and approval of research involving FDA-regulated products (e.g., investigational drugs, biological products, medical devices and dietary supplements) (21 CFR

Did Congress Authorize The Iraq War?

Did Congress Authorize The Iraq War? With the support of large bipartisan majorities, the U.S. Congress passed the Authorization for Use of Military Force Against Iraq Resolution of 2002. The resolution asserts the authorization by the Constitution of the United States and the United States Congress for the President to fight anti-United States terrorism. Did

Who Has The Power To Ratify Treaties And Confirm Appointments?

Who Has The Power To Ratify Treaties And Confirm Appointments? The Constitution gives to the Senate the sole power to approve, by a two-thirds vote, treaties negotiated by the executive branch. The Senate does not ratify treaties. Who does the Constitution give the power to ratify treaties to? The Constitution gives to the Senate the

Who Must Approve Presidential Appointments Quizlet?

Who Must Approve Presidential Appointments Quizlet? Presidential appointments to high-level positions must be consented to by the Senate by majority vote. The presidential power to make treaties is subject to the “advice and consent” of two-thirds of the Senate. Who has the power to approve all presidential appointments? The Constitution also provides that the Senate

Who Does The IRB Protect?

Who Does The IRB Protect? The IRB is concerned with protecting the welfare, rights, and privacy of human subjects. The IRB has the authority to approve, disapprove, monitor, and require modifications in all research activities that fall within its jurisdiction as specified by both the federal regulations and institutional policy. Who should be on an

What Products Do Not Need FDA Approval?

What Products Do Not Need FDA Approval? Examples of cosmetics are perfumes, makeup, moisturizers, shampoos, hair dyes, face and body cleansers, and shaving preparations. Cosmetic products and ingredients, and their labeling, do not require FDA approval before they go on the market. There’s one exception: color additives (other than coal-tar hair dyes). What products must

How Often Does IRB Approved Research Have To Be Reviewed?

How Often Does IRB Approved Research Have To Be Reviewed? An IRB must conduct continuing review of research at intervals appropriate to the degree of risk, but not less than once per year (45 CFR 46.109(e)). How long is IRB approval valid for? A copy of all documentation reviewed is to be maintained for at