Susan Bailey, PhDFall 2010

Lecture 1

Learning ObjectivesUnderstand components of the syllabus

My ResponsibilitiesCourse ObjectivesMaterialsYour Responsibilities

Assignments Preparation and Participation Academic Honesty Special Needs

GradingCourse Outline

Learning Objectives

Understand the need for human subjects protection

Realize the investigator’s and the IRB’s responsibilities

Learn the guidelines for protectionDevelop an IRB applicationDevelop an informed consent form

The Need for Human Subjects Protection

Unethical researchNazi Germany – criminal and unscientific behavior of physicians in concentration camps Joseph Mengele (1911-1979) Injected dye into children’s eyes to change color Sterilizations, amputations, shock treatments Murder to perform dissections Sewed two children together to form conjoined twins

1936 U.S. – Public Health Service began a study of the effects of untreated syphilis in Tuskeegee, AL long after effective treatment of disease was known

Human Subjects ProtectionUnethical Research (cont.)

1963 U.S. – Jewish Chronic Diseases Hospital – 22 elderly patients injected with cancer cells without their knowledge to test immunological response

Willowbrook State Hospital, NY – retarded children deliberately infected with viral hepatitis to study natural history

Response1947 – Nuremberg Code – research ethics for human research

1974 – congress establishes the National Commission for the Protection of Biomedical and Behavioral Research – established Institutional Review Boards (IRB)

1996 – Health Insurance Portability and Accountability Act (HIPPA) – protect individual’s health information

10 Questionable Practices1. Involving people without their knowledge or

consent2. Coercing people to participate3. Withholding information about the true nature

of the research4. Otherwise deceiving the participant5. Inducing participants to commit acts

diminishing their self-esteem6. Violating rights of self-determination7. Exposing individuals to physical or emotional

stress8. Invading privacy9. Withholding benefits10.Not treating participants with respect

(Kimmel, 1998)

Institutional Review Board (IRB)Purpose – an IRB shall review and have authority to approve, require modification in, or disapprove all research activities covered by this policy

Membership – at least 5 members with expertise appropriate to safeguard the rights and welfare of human subjectsMixed in terms of gender, race, and cultural background

One member not affiliated with the institutionOne member with and one without scientific expertise

No member with a conflict of interest

Risk-Benefit RatioMinimal Risk - the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

Benefits – may be for the subjects, their family, and/or the common good

Ratio – risks to subjects are reasonable relative to benefits, if any

Informed Consent

RequirementsDisclosure of relevant information to prospective subjects about the research

Subjects’ comprehension of the information

Subjects’ voluntary agreement, free of coercion and undue influence

OHSR information sheet

Learning Objectives

Understand the history of inquiryLearn different approaches to inquiryDefine the modern scientific method

Traditional Scientific MethodMethod of inquiry of phenomena, new knowledge, or evaluation of existing knowledge that is based on gathering observable, empirical, and measurable evidence subject to specific principles of reasoning

Collect data through observation or experimentation in order to formulate and test hypotheses

Hypotheses are building blocks for theoriesMethod must be value free

Hippocrates (B.C. 460-377)First to base his conclusions on observation – rational approach

Rejected superstitions, legends and beliefs that credited supernatural or divine forces with causing illness

Four humours – fluids that are balanced in healthBloodBlack bileYellow bilePhlegm

PositivismPhilosophy that postulates that the only authentic knowledge is that which is based on actual sense experienceSeparate facts from valuesRely on strict rules and procedures, rejecting common sense

Purpose is to develop universal causal lawsAssumptions and methods of natural science can be applied to social science

Has been rejected in social science as being too strictNot all phenomena can be physically observedReality can be defined subjectively

RelativismPhilosophy that maintains that there is no external reality independent of human consciousnessReality is represented through the eyes of the observer

Research process generates “working” hypotheses rather than universal causal laws

All points of view are equally valid

RealismScientific approach which avoids both positivism and relativismKnowledge is a social and historical product

Task of science is to invent theories to explain the real world, and to test these theories by rational criteria

Science should be understood as an ongoing process in which scientists improve the concepts they use to understand the mechanisms that they study

Realistic Explanation

Gunpowder example

mechanism

action outcome

context

Example in EpidemiologyStudy by Bradbury (1933) of the incidence and causes of tuberculosis in north EnglandThree mechanisms

Poor housing conditions – overcrowding Poor nutrition – compromising resistance Being Irish – less generational exposure

Language of ResearchEmpirical – based on observations and measurements of reality

Operationalization – the act of translating the idea you want to measure into a real measurement

Methodology – specific ways or methods used to try to understand phenomena

Theory – analytic structure intended to explain a set of empirical observations

Hypothesis – proposed explanation for an observable phenomenon – it must be testable to be scientific

Leading Causes of Death in the US (2006)

Heart diseaseCancerStroke (cerebrovascular diseases)Chronic lower respiratory diseasesAccidents (unintentional injuries)DiabetesAlzheimer's diseaseInfluenza and PneumoniaNephritis, nephrotic syndrome, and nephrosis

Septicemia

Stages of a StudyFormulate the Research Question

May or may not test a hypothesisReview the LiteratureChoose/Design Measures and InstrumentsIdentify the Sampling FrameObtain IRB ApprovalConduct the SamplingCollect DataProcess DataAnalyze DataReport Results