ons NAME: HSM 139: ASSESSMENT # 4 (75pts) Instructions-For this assessment, there will be multiple types of questions (multiple choice, short response, true/false, and/or fill-in-the blank). For the multiple choice and true/false questions, please highlight your choice; there will only be one correct response for these items. (5 pts) Dr. Peyton is an experienced OB/GYN physician who has a large 20-29 y/o female patient population; he practices within a local large healthcare system. Dr. Peyton has seen a recent surge in hypertension (while pregnant) within this group. Dr. Peyton starts a protocol (for this demographic) that includes participants signing a consent, completing a questionnaire, blood testing (Lipid Panel, Comprehensive Metabolic Panel, etc), prescribing anti-hypertensives and a one-year follow up. Dr. Peyton intends on publishing the results in the Journal of OB/GYN Medicine. Is Dr. Peyton's protocol considered human subjects research or quality assurance? (Explain) Human Oubject research. He intends to publish the Clubults 2. (3pts) IRB Committee #5 consists of 13 members. How many are needed for a quorum? (Hint: Quorum (Majority)= +1, whole numbers only) 7 memberd 3. (2pts) How many days in advance do IRB committee members receive their materials for the upcoming meeting? (To help you, as this would not be an obvious answer-10-14 days-you don't need to respond to this question) 4. (7pts) Dr. Belushi has been conducting human-based research with some of her 18-22 y/o first- time pregnant patients since 6/15/2018. She received approval for her study on 4/17/2018; study continuance was affirmed (by the IRB) on 8/23/2019. What time period(s) is Dr. Belushi's data viable? What time period(s) cannot be used within Dr. Belushi's study? 5. (7 pts) Monica Winston is a non-scientist affiliated participant on the Regional Medical Center's IRB Committee #2. Her son is a nurse clinician for Dr. Alexander (Electrophysiologist); Dr. Alexander is planning on conducting human research for his patients with severe Atrial Fibrillation; Monica's son will be part of the research team. IRB Committee #2 has been assigned to review Dr. Alexander's new study (application) (Hint: This is an example of Conflict-of- Interest). a. Can Monica review and participate when the IRB committee reviews Dr. Alexander's application? (Yes/No; Explain) NO. It is a conflict of intrest b. What procedure would take place for a situation like this? (Name at least 3 steps).

highlighi vour choice; there wili only be one cortect response for these item. demographic) that inclodes participats signine a consent, cempletine a cuestiontirs, bbod Medicine. 4. Or. Peytor's protocol censidered human subjects tesearch or qualtiv asiurance? (Explent) Wulbuity 2. (3pts) trB Commitree is consists of 13 memberts, How many are needed foe a quorum) 3. (2pts) How many dors in advance do IAB committee members recine their materiab for the upcoming meeting? (Fo help you, as thls would not be an obvibus anwer-10-14 dayeyoo. don't need to respond to this question) 4. (7pts) Dr. Belushi has been conductive human based tesearch with rome er her 1822W/b fintdata viable? What cime periodis) cannot be caed miatin De. Eelughi's study? 5. (7 pts) Monica Winston is a non acientrat uffilated participant on the Mesional Medicat Cinterh interest, responsible for the inkecurate data? klow? 8. [2ets] What does CFR stand for? Regulation: Rules: Guidance: Folicir: IRB? Which one io waulhy used? the OHRPK: a. Name at least 2 functions of the Crob. b. Ueder what requlatory umbrrla does the orap falt under? notes under the Cuincal Truaks rabl. 18. (7 pts) What is the difference betweso Examat, Exonditrd, and hul isa troves (inder either the IRB or TYPES OF REVIEW tub)