Module 4

Question 1

Formal experiments

Answer 1

allows the researcher to manipulate one factor and observe the result

Question 2

Tuskegee study

Answer 2

The study initially involved 600 Black men – 399 with syphilis, 201 who did not have the disease. Participants’ informed consent was not collected. Researchers told the men they were being treated for “bad blood,” a local term used to describe several ailments, including syphilis, anemia, and fatigue. In exchange for taking part in the study, the men received free medical exams, free meals, and burial insurance. By 1943, penicillin was the treatment of choice for syphilis and becoming widely available, but the participants in the study were not offered treatment.

Question 3

Principles and policies developed in response to the Tuskegee study

Answer 3

1. informed consent (must know what they are volunteering for and the risks involved)
2. Non-corecsive enrollment and retention (You can leave a study at any time with no concequences)
3. avaliability of intervention (no participants should be denied standard care

Question 4

Common rule

Answer 4

federal policy outlining the protection of human research participants

Question 5

Neremberge code

Answer 5

set of principles guiding medical experiments

Question 6

Belmont report (4)

What it is and what it sets out

Answer 6

a foundation document for today’s ethic guidelines
- sets out 3 important principles of ethical research with human participants
1. respect for person
2. beneficence
3. Justice

Question 7

Belmont report: Respect for person (5)

Answer 7

• individuals have the right to make their own desicion
• extra protection for vulnerable population such as elders and children
• careful informed consent
• lack of coercion to participate
• privacy

Question 8

Belmont report: Benefience

Answer 8

• benefits to participants should be max and risk should min
• seek procedure with the lowest risk
• risk are resonable relative to the benefit of the study

Question 9

Belmont report: Justice (3)

what it is+ avoid…+ex

Answer 9

benefit and burden of research is distributed fairly
- avoid exploitation of a particular population:
- ex testing risky drug on one population

Question 10

human subject

Answer 10

a living individual who a researcher obtains data either through interaction or through identifiable private info

Question 11

IRB (2)

what they are and what power they have

Answer 11

comiitee charged with reviewing research involving human participants at their institutions for compliance with ethical standards
- power to approve/disprove/ terminante or suspen approval for research,

Question 12

Limited review

Answer 12

research that is otherwise exempt but might compromise ocnfidentiality. When exempt status is granted, the PI will be excused from complying with certain regulations: documentation of informed consent and continuing review on an annual basis. However, if changes are made to the project, a modification MUST be submitted through HawkIRB for review.

Question 13

expediate review (2)

what study qualifies and what happens?

Answer 13

• studies that involve minimal risk which is defined as daily risk we have normally
• a procedure through which certain kinds of research may be reviewed and approved without convening a meeting of the IRB

Question 14

studies that involve more than minimal risk need to be

Answer 14

reviewed by full IRB

Question 15

under the revised common rule, studies eligible for expedited review or limited review no longer need

Answer 15

continouing review

Question 16

exempt review

Answer 16

research not covered by IRB

Question 17

7 principle of common rule

Answer 17

Question 18

passive consent

Answer 18

will participate unless proactively taken out

Question 19

Expedited review:

Answer 19

Review by an IRB of research that involves minimal risk or is specifically identified as suitable for expedited review by federal regulations.