Review the following and the 3 questions need to answered (1) Review section XXXXXXXXXXof the revised Common Rule on “expedited review.” Why does this category exist? What are the most important...

1. Expedited Review
An Expedited review process is an initial review process which was introduced in the 2004 after revising the regulations (DHHS 45 CFR 46.110 & FDA, 21 CFR 56.110) of Department of Health and human services and Food and Drug administration by committee for the fast track approval of some research especially the biomedical projects which are involved in minimal risk or no risk to the human subjects with minimal changes in the project as it is associated with the ethics [1].
The categories of the list for Expedited review was published in the Federal register by the HSS secretary which will be further reviewed by the IRB (Institutional Review Board). The expedited review will be revised for every 8 years after the discussion of the secretary with other federal agencies for a revision and the list of Expedited review research project will be available at the HSS office. It is long procedure which takes time for the approval as it is involved in the detailed study of the research. This study involves reviewing the study by various reviewers along with the IRB chairperson for the approval and the project will be approved if is accepted if majority members agree [2].
Applicability Factors of the Expedited Review:
The IRB committee is involved in reviewing the following list chosen by the HHS secretary and is involved in reviewing:
1. The IRB screens the list of studies HHSs suggested unless there is no risk associated in the project [3].
2. The IRB is involved in the reviewing the minor changes in the project which can minuses the risk of the proposed project within the stipulated time.
3. The IRB will not consider the age of the subjects.
4. In IRB review no identification of the subjects were used as it is involved in the risk of the criminal, civil or financial liability [4].
5. This study is not used for evaluation of classification of the human subjects research.
6. The informed consent followed in the research study should meet the standard requirements which will be review by the IRB committee.
7. The IRB also review the categories of the research studies.
Expedited review Research categories are:
1. It approves the research when the new drug application does not require the 21 CFR Part 312 [1].
2. It reviews the studies where the medical devices is exempted from the 21 CFR Part 812 and the medical devices being used in the studies should be properly labelled [1].
3. Types of blood sample collection based on their age, weight etc. by various procedures like finger stick, venepuncture etc.
4. Research involved in the Collection of the biological samples by using the non-invasive approach.
5. Research involved in the non-invasive data collection like data of X-ray etc....