1. Biomedical Research Using review boards to ensure ethical and appropriate scientific research.

2. Proposed study: One of the most irritating parts of eating fast food is the pain caused by salt from the French fries entering small paper cuts on the hands. This study will be studying the amount of pain involved with pouring different types of natural salts into paper cuts on the hands of human babies. If successful, we hope to identify less painful alternatives to regular salt. Procedure : 1.1,000 newborn human babies will be randomly selected from hospitals around the state of Oregon and sent to a secret lab on Mount Hood. 2.Once in the lab, each baby will be given a paper cut on the palm of his or her hand. 3.Four groups of 250 babies each will then be given French fries with different types of salt used to flavor the fries. a)Group 1: Standard table salt (Sodium Chloride ~ NaCl) b)Group 2: Iodized table salt (Sodium Chloride with Iodine ~ NaCl + I) c)Group 3: Sea Salt (various natural salts with assorted minerals) d)Group 4: Salt substitute (Potassium Cholride ~ KCl) 4.If the babies cry when they get the salt on the paper cut, that will be a positive test for pain. If the babies don’t cry, that will be negative. 5.After the study is completed, babies will be sent back to the hospital.

3. Using Humans as Research Subjects The Review Process

4. Human Subjects in Research An official review board must approve the proposed study procedures before any research begins.

5. Human Subjects in Research The review board evaluates and determines: Risk level Potential for benefit of the study Requirement for informed consent of research subjects Requirement for a qualified scientist to be involved in the research Whether humans are appropriate research subjects in proposed study

6. Human Subjects in Research Informed Consent required when human research subjects: Are naturally at risk due to disease Are members of a federally protected risk group, such as pregnant women, prisoners, children/minors Are at more than a minimal risk or will be exposed to emotional stress

7. Human Subjects in Research Does the example given at the beginning of class satisfy the IRB requirements?  The potential benefit of research outweighs the risk to research subjects in the study  Humans are suitable research subjects  No non-human animal alternative exists or  Prior testing with animals has led to this study  The science methods of the proposed research are sound and will yield appropriate data  Research subjects have given informed consent  There is minimal risk to research subjects

8. What about using animals for scientific research studies? The Review Process for Using Animals as Research Subjects

9. Animal Subjects in Research Researchers wishing to use animals as research subjects must also wait to start their research until their proposal is approved by a special review board.

10. Animal Subjects in Research Animal study review boards use national guidelines to help make a determination if the animal subjects and the study methods proposed are appropriate.

11. Animal Subjects in Research To gain review board approval: The study must show a benefit to human or animal health, advancement of knowledge, or the good of society. Will the results of this study have a positive impact on society or add to our understanding of medicine and health?

12. Animal Subjects in Research To gain review board approval: The animal species used in the study must be appropriate. Would a more primitive animal be just as good?

13. Animal Subjects in Research To gain review board approval: The number of animals used in the study must be appropriate. Would fewer animals be just as good for this study?

14. Animal Subjects in Research To gain review board approval: There must be an attempt to limit the amount of discomfort, distress, pain, or death for the animals. Is harm, pain, or death of the animal necessary for the completion of this study?

15. Animal Subjects in Research To gain review board approval: The scientific methods used in this study will lead to valid data and will help to answer the research question. Are the procedures and data collection methods well designed to produce good data?

16. Animal Subjects in Research To gain review board approval: Animal care and breeding must be performed and supervised by qualified people. Are the animals made as comfortable as possible during the study?

17. Animal Subjects in Research To gain review board approval: The actual experimentation on living animals must be done by qualified, experienced people. Are real scientists doing the research?

18. Animal Subjects in Research To gain review board approval: The fate of the animals after the conclusion of the study must be justified. Will the animals be euthanized during/after the study? Will the animals be successfully returned to a reasonable quality of life?

19. Animal Subjects in Research You will use these same guidelines to evaluate a hypothetical research proposal. While the scenarios in this activity may contains real scientific concepts, none of the scenarios in this activity are actual proposed studies. They have been created specifically for this exercise.

20. Possible Review Panel Outcomes Approved ~ ready to proceed with study!

21. Possible Review Panel Outcomes Approved ~ ready to proceed with study! Deferred ~ researcher needs to make some changes and re-submit the proposed study for final approval before research can begin.

22. Possible Review Panel Outcomes Approved ~ ready to proceed with study! Deferred ~ researcher needs to make some changes and re-submit the proposed study for final approval before research can begin. Declined ~ this study has major scientific problems! No amount of re-writing will help this study. Researcher needs to go back to the drawing board.