biomedical research using review boards to ensure ethical and appropriate scientific research

Biomedical Biomedical ResearchResearch

Using review boards to ensure ethical Using review boards to ensure ethical and appropriate scientific research. and appropriate scientific research.

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.

Using Humans as Research Subjects

Using Humans as Research Subjects

The Review Process

Human Subjects in ResearchHuman Subjects in Research

• An official review board must approve the proposed study procedures before any research begins.


• 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


• 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


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 subjectsNo 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

What about using animals for scientific research studies?

What about using animals for scientific research studies?

The Review Process for

Using Animals

as Research Subjects

Animal Subjects in ResearchAnimal 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.


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


• 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?


• To gain review board approval:• The animal species used in the study

must be appropriate.

Would a more primitive animal be just as good?


• 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?


• 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?


• 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?


• 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?


• To gain review board approval:• The actual experimentation on living

animals must be done by qualified, experienced people.

Are real scientists doing the 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?


• 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.

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.



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.

biomedical research using review boards to ensure ethical and appropriate scientific research

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