Regulatory Issues in Laboratory Management – PLS4/595D

Mid-Term ExamDue: 5pmMarch 20th 2007

INSTRUCTIONS

All students MUST answer question #20.

Undergraduate Students: Answer 15 of the 20 questions. (You must include question #20 in your 15). You will get extra credit if you do more.

Graduate Students: Answer all 20 questions.

Use this document to answer the questions. Return it to me via email () by 5pm on Tuesday, March 20th. When you save your answers in this document, do a “save as…” and rename it with your last name as the first part of the file name. eg Brigham-PLS4-595d-Mid-Term-3-20-07.doc

You may use any resources you wish to answer the questions. Most answers are in your lectures notes, but there is one in particular that you will have to use the internet.

If you have questions, I will not be in my office during Spring Break, but can be reached by email.

EXAM

  1. Give 3 historical milestones for FDA GLP regulations. Include a brief description and significance of each.
  1. During the course of your research you think you have found a compound that may have value as a drug. What must you do to show the FDA that this drug is a good candidate for clinical studies. (What regulations must you now follow in your laboratory? List 3 or 4 issues you think are most critical.)
  1. The Tuskegee Study, started in 1930, was finally brought to the public’s attention in 1972 and halted. What were the some of the ethical issues involved in this study?(There is a description of the study on the website ‘Assignments’ page. The file is called BadBlood.pdf)
  1. List the different Phases of Clinical Trials and the purpose of each.
  1. What is the role of the Institutional Review Board (IRB)
  2. The IRB functions is an editorial service that includes editing the Subject Informed Consent document
  3. The IRB makes institutional policy regarding clinical decisions for practicing physicians.
  4. The IRB is a “confidentiality committee” that determines how medical record information is shared outside of research.
  5. The (IRB) determines whether the rights and welfare of the subjects are adequately protected.

ANSWER: ______

  1. Indicate which Belmontprinciple is most important:
  2. Respect - treat others as autonomous agents, allow people choice.
  3. Beneficence - acts of kindness that go beyond charity and duty…various obligations (i.e., do no harm, promote good).
  4. Justice - treat people fairly.
  5. None of the above. One Belmont principle is not more important than another.

ANSWER: ______

  1. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research:
  2. Was commissioned to develop guidelines to assure that human research was conducted ethically.
  3. Was commissioned to develop guidelines solely for the protection of participants in biomedical research.
  4. Is a recently formed Commission to determine litigation between participants and Principal Investigators.
  5. Was commissioned many years ago and prepared documents related to informed consent.

ANSWER: ______

  1. What products are subject to regulations under Good Manufacturing Practices?
  1. A critical part of monitoring the safety of devices is the reporting of problems. Using the FDA website, answer the following:
  1. What center within FDA regulates devices and the reporting of adverse events.
  1. Find and list the purpose of MDR on the FDA website. (What does MDR stand for?)
  1. Find an instance of a reported problem. List the device, the manufacturer and the event that was reported.
  1. What are the three types of misconduct monitored by the UA Office of Research Integrity?
  1. ______
  1. ______
  1. ______
  1. What would you do if you thought you noticed one or more of these problems in your lab?
  1. What is the role of the Office of Technology Transfer at the University of Arizona?
  1. How do most researchers at the University of Arizona secure funding for their research?
  1. The initial implementation of the HIPAA regulations was to assist people in:
  1. Not having to file health care claims
  2. Rights for accessing their medical records
  3. Changing jobs and not losing health care benefits
  4. Receiving a Notice of Privacy practices
  5. Accurate and timely claims payment

ANSWER: ______

  1. HIPAA regulations include:
  1. Standardized transaction formats for electronic transmission
  2. Standards for Use and Disclosure of Protected Health Information
  3. Requirement for training of staff on HIPAA regulations
  4. Covered Entities to implement policies and procedures specific to HIPAA
  5. All of the above

ANSWER: ______

  1. Staff should report privacy concerns or violations to their supervisor or to the Privacy Officer.

__ True

__ False

  1. Describe the two animal cruelty events that precipitated public outcry which finally led to the passage of the Laboratory Animal Welfare Act of 1966:
  1. Which of the following animals WOULD NOT be covered under the animal welfare act. List all that WOULD NOT be covered below:
  1. Dogs used in research
  2. Cows at a private dairy
  3. Prairie dogs used in wildlife research by a university
  4. A kitten being shipped by a private individual via an airline carrier
  5. Bobcats at the DesertMuseum
  6. Arabian horses on a private breeding farm
  7. Mus musculus mice used in biomedical research

ANSWER (list all that apply): ______

  1. In reviewing animal studies to determine whether to approve or disapprove the research, IACUC members consider the balance of ethical cost. This includes balancing SCIENTIFIC VALUE versus ETHICAL COST. Please list the factors that are considered for:

Scientific Value:AndEthical Cost

  1. Ethical balance problem: Give your determination on ethical balance; show the scientific value and ethical cost issues you found to make your determination

An aquaculturalist is studying Gila Chubs in the Gila river and submits his protocol to the IACUC of the UAZ. This species is endangered and the information from the study will help to determine if there are pollutants in the water that are affecting the survival of the fish. The results will also show if there are pollutants that could affect humans that use the river for recreation. The researcher nets fish and collects fecal samples from them to run assays on mineral content of feces. Animals are hand held for about a minute to collect the sample and then returned to the water. Utilize the ethical balance scale to determine whether you would approve this protocol. Draw out the balance scale and also describe your thoughts as you evaluate the study. Would you or would you not approve the protocol.