Research ethics video notes

Nuremberg code

After world war 2 in 1947, rulebook of ethical guidelines for human research. 

• Voluntary consent is critical

■ The study should benefit society

■ You better have a good reason to believe that the study

will work

■ No unnecessary pain or suffering

■ If there is a decent chance someone might die or

become disabled, don't do it

■ Keep risks low and proportional to the benefit

■ Take every possible safety precaution

■ Only let qualified professionals run the study

■ Let participants leave whenever they want

■ If things go bad stop the study immediately

^ guidelines, at this time no one was legally required to follow at the time.

Henry Beecher

Exposes studies where people are doing shady research

● Not getting consent, etc

Published an article in the new england journal of medicine about ethics and clinical research

^ wake up call paper

Tuskegee experiment

• Conducted by the US public health service from 1932 to 1972

• Sharecroppers were unknowing subjects in the study

• They were not told they had syphilis not were they offered effective treatment when it became available in 1947 with the availability of penicillin

• Found to be “ethically unjustified”

^breaking point. whos watching the researchres?!

What other experiments pushed boundaries 

Other experiments that pushed boundaries

• Milgram experiment

• Thought they were shocked with increasing voltage when wrong answers were given

■ Stanford prison experiment

● Power trips that escalated quickly between guards and prisoners but all were research subjects and not actually either

■ Both technically legal, but just because you CAN doesnt mean that you should

National research act

• Established a commission to identify basic ethical principles necessary for human subject research

• Established the IRB for human subject research (all federally funded research gose through them)

  • All federally funded studies must go through this

^ after tuskegee

The belmont report

The Belmont report

    ■ 3 golden rules for ethical research

           ● Respect for persons

              ○ People are autonomous

              ○ They decide what happens to them

              ○ If someone isnt fully capable (children or people with certain disabilities) they need extra protection

            ● Beneficence

               ○ Maximize benefits

               ○ Minimize harm

               ○ Dont just avoid hurting people, aim to do good

            ● Justice

               ○ Be fair in how you select research participants

               ○ Dont exploit certain groups because it is cheaper or easier

IRB

IRB: INSTITUTional REVIEW BOARD

• Thing where there was minimal funding and they were overworked but then it got straightened out and they are taken seriously

• A review committee established to help protect the rights and welfare of human research participants

• Regulations require IRB review and approval for research involving human subjects if it is funded or regulated by the federal government

• Minimal risk where the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater in and of themselves than those ordinarily encountered in daily life or in routine physical/psychological exams or tests

• Type of irb review

• ● Exempt (ex: anonymous ssurvey, itnerview w/o identifier, wathcing ppl in public space, cant do anything with voulnerable population (children, prisoners)

  • ○ Lowest possible level of risk

  • ○ Anonymity

• ● Expedited (more personal research, every life or routine checkup) (using patient or person identifiers)

  • ○ Minimal level of risk

  • ○ No anonymity

• ● Full board/committee (working w voulnerable populations, collecting tissue high risk groups etc).

  • ○ More than minimal level of risk

  • ○ No anonymity

VULNERABLE POP: disabilities, children, econmically or educatinoal disadvantage, prisoners, etc. SPECIAL ATTENTION WHEN THEY ARE INVOLVED