The Continual Cycle of Science

1. The Continual Cycle of Science Research question about the real world Research hypothesis Theory Interpretation Data gathering Statistical analyses

2. Research Methods in Psychology ■ The goals of psychology are to describe, explain, predict, change, prevent, increase, decrease, modify, shape, extinguish, cause, and control behavior. ■These goals are accomplished by using the scientific method, which is systematic and empirical . . . [that is] . . . based on observable and measurable events. Extracted from Prentice-Hall Ch. 1 PP Slide Show for Davis & Palladino Text, Psychology, 4th Edition. Dr. Vessels’ Additions are shown in brackets.

3. Case Studies & Naturalistic Observation • A case study is an in-depth analysis of a single person or event. • Although the findings of a case study may apply only to the person who was studied, they may provide direction for further study using other methods. • To study behavior in real-life settings, psychologists often use naturalistic observation. • This technique also may suggest research projects using more controlled approaches. • In using naturalistic observation, the onlooker must be unobtrusive and avoid influencing the behavior being studied. Extracted from Prentice-Hall Ch. 1 PP Slide Show for Davis & Palladino Text, Psychology, 4th Edition. Vessels’ additions are shown in brackets.

4. Correlational Research ● Correlational studies do not inform us about cause; [rather, they reveal relationships and help us form reasonable hypotheses (informed predictions) about whether or not one event or variable causes another]. ●Correlational research tells whether the values of two variables are related. Extracted from Prentice-Hall Ch. 1 PP Slide Show for Davis & Palladino Text, Psychology, 4th Edition. Dr. Vessels’ additions are shown in brackets.

5. Making Inferences about Causality • Hypothesis: Children who watch violence on television tend to be more aggressive toward their peers and siblings. • Question: Can we infer a causal relationship between these two variables? + Watching Violence on TV Violent Behavior

6. Inferences about Causality • Answer: not necessarily • Explanation: Although causality implies correlation, correlation does not necessarily imply causality. • Elaboration: There are at least three other ways to explain the correlation between TV viewing and aggressive behavior.

7. Three Plausible Alternative Inferences about Causality (1) Acting aggressively makes you want to watch more violent TV Watching Violent on TV + Violent Behavior

8. The 2nd Plausible Alternative Inference about Causality (2) Acting violent makes you want to watch more TV and watching TV makes you act more violently + Watching Violent on TV Violent Behavior +

9. The 3rd Plausible Alternative Inference about Causality (3) A “third variable” influences both variables, causing them to be correlated Watching Violence on TV Violent Behavior Living in a Violent Family + +

10. How do we choose from these possibilities? • One way to do so is to conduct an experiment. • In an experiment, at least one variable is manipulated (i.e. systematically varied) by a researcher in order to study its effects on another variable.

11. Experimental Research • Basic features: (a) At least one variable is manipulated or varied by the experimenter: independent variable(IV) (b) Another variable that is expected to be changed by the manipulation is called the dependent variable(DV) (c) Random assignment to two groups Watching Violent on TV + Violent Behavior IV DV

12. Experimental Research • Because it can . . . [support] cause-and-effect statements, . . . the experimental method is the most powerful . . . • By manipulating an independent variable (the possible cause), the researcher . . . [can determine with reasonable certainty] . . . . whether [or not] it influences the dependent variable (the effect). Extracted from Prentice-Hall Ch. 1 PP Slide Show for Davis & Palladino Text, Psychology, 4th Edition. Dr. Vessels’ additions are shown in brackets.

13. Possible Specifics of Experimental Study IV DV • The Independent Variable is watching violence on TV • Levels: • view an episode of the Sopranos • view an episode of the Sopranos in which the violent scenes have been edited The Dependent Variable is aggressive behavior Operational definition: The number of times the child punches his or her peers on the playground

14. Single Group or Within-Subject Designs Versus Multiple Group or Between-Subject Designs ● The former offers at least some control through pre-post testing. ● The latter offers control through random assignment of subjects, which makes the groups equivalent. Pre-post testing can still be used, which essentially incorporates a within-subject aspect that strengthens the study. ● When random assignment is not possible and intact groups must be used, control is only achieved through pre-post testing in both groups and using the same statistical test as with the random groups design with pre-post testing (ANCOVA), but with needed adjustments based on the reliability of measures used.

15. Threats to Internal Validity or Cause-Effect Inferences There are many threats to internal validity in single group or within-subject studies as seen below, and these are not removed with pretesting. There is only one threat to internal validity when using multiple-group or between-subject designs: the groups not being comparable before the study. This threat is called selection bias. A selection threat is anything other than the program that results in posttest differences between groups. Primary Source: Trochim, William M.K. (2005). Single Group Threats. Retrieved fromhttp://www.socialresearchmethods.net/kb/intsing.htm

16. There Are Two Major Types of Experimental Research (1) True experimental research design • Search for cause-and-effect relationships in a “manipulated environment” • Random assignment to groups • Independent variable manipulated

17. Two Major Types of Experimental Research Continued (2) Quasi-experimental research design • Search for cause-and-effect relationships in a “manipulated environment” • No random assignment to groups • Independent variable manipulated

18. Are subjects assigned randomly to experimental and control groups? YES NO Randomized or True Experiment Is there a comparison group? Are there pre-post measures? YES NO Quasi-Experiment Non-Experiment Source: Trochim, William M.K. (2005). Types of Designs. Retrieved from http://www.socialresearchmethods.net/kb/destypes.htm

19. Two-Group Posttest-Only Randomized Experiment ● This is the simplest experimental design. ● The experimental group gets the treatment or program or independent variable (X) and the controlgroup doesn't. ● Notice that a pretest is not required for this design because we assume that the two groups are equivalent to begin with. R X O R O Source: Trochim, William M.K. (2005). Two-Group Experimental Designs. Retrieved from http://www.socialresearchmethods.net/kb/expsimp.htm

20. The Analysis of Covariance Design (ANCOVA or ANACOVA) is simply a pretest-posttest randomized experimental design. The pre-program measure or pretest is called a "covariate" because we "covary" it with the outcome variable in order to remove variability or “noise.” The ANCOVA design is a "noise reduction" experimental design. It "adjusts" for the effects of one variable on another. You can use any continuous variable as a covariate. The pretest is usually best because it is the most highly correlated with the posttest. When you "remove' it, you remove extraneous variability from the posttest. R O X O R O O Source: Trochim, William M.K. (2005). Covariance Designs. Retrieved fromhttp://www.socialresearchmethods.net/kb/expcov.htm

21. Categorizing Other Experimental Designs We can divide all other experimental designs into two categories: signal enhancers and noise reducers. Enhancing the “signal” (effects) or reducing the “noise” (variability) improves the research. The signal-enhancing experimental designs are called factorial designs. Here the focus is on aspects of the program or treatment and how they are separated in the study plan. In a typical factorial design there are many different variations of the treatment or independent variable. There are two types of noise-reducing experimental designs: covariance designs and blocking. These designs use information about the makeup of the sample or about pre-program variables to remove some of the noise in your study. Primary Source: Trochim, William M.K. (2005). Classifying Experimental Designs. Retrieved from http://www.socialresearchmethods.net/kb/expclass.htm

22. The signal-enhancing experimental designs are called factorial designs. Here the focus is on aspects of the program or treatment and how they are set up in the study. In a typical factorial design there are many different variations of the treatment or independent variable. Source: Trochim, William M.K. (2005). Factorial Designs. Retrieved fromhttp://www.socialresearchmethods.net/kb/expfact.htm

23. Quasi-Experimental Research Designs The Non-Equivalent Groups Design (NEGD) is frequently used in social research. It is structured like a pretest-posttest randomized experiment but lacks random assignment. Intact treatment and comparisongroups are used instead. There are other quasi-experimental designs besides the NEGD. The NEGD is especially vulnerable to internal validity threats. Prior differences between the groups may affect the outcome of the study. This can lead to the conclusion that a program did not have an effect when in fact it did, or that it did have an effect when in fact it didn't. N O X O N O O Source: Trochim, William M.K. (2005). Quasi-Experimental Designs. Retrieved fromhttp://www.socialresearchmethods.net/kb/quasiexp.htm

24. Ethics A branch of philosophy in which we study and evaluate arguments about right and wrong actions. Research ethics A branch of philosophy in which we study and evaluate arguments about right and wrong actions in the search for generalizable knowledge, scientific theories and principles, and technological advancement.

25. Research Ethics Topics • Data acquisition, management, sharing, • and ownership • 2. Mentor / trainee responsibilities • 3. Publication practices and responsible • authorship • 4. Peer review • 5. Collaborative science • 6. Research involving human subjects • 7. Research involving animal subjects • 8. Research misconduct • 9. Conflict of interest and commitment • - NIH Core Instructional Areas

26. The Ethics of Human Research • Is About: • Doing valid research (using accepted scientific methods) • Appropriate sampling (to get valid results) • Respecting people and their communities • Protecting research participants • Benefiting individuals and society • Creating a basis for socially beneficial policies • Disseminating findings effectively • Facilitating the application of findings

27. Well Known Major Cases Involving Unethical Research in the U.S. • Tuskegee Syphilis Study 1932-1972 • U.S. Radiation Experiments 1940s • Willowbrook Study, NY 1956-1972 • Milgram Study, 1961 • Jewish Chronic Disease Hospital, 1963 • U.S. Army LSD studies/National Airport, 1963-4 • Stanford Prison Study, 1971

28. Nazi War Crimes - WWII Victims of Dr. Josef Mengele's medical experiments at Auschwitz-Birkenau. Poland, 1944. Nazi physician Carl Clauberg performed medical experiments on prisoners in Block 10 of the Auschwitz camp. Poland, between 1941 and 1944

29. Mid 20th Century Scandals • Willowbrook State School, Staten Island, NY, 1950s • Children at this institution for the retarded were fed extracts of stools from individuals infected with the hepatitis virus. • Justification by Willowbrook’s Research Director, Dr. Saul Krugman, was that children in the crowded facility would likely contract hepatitis anyway. • Parental “permission” was obtained through misleading them about lengthy admission process for non-participating children. • Jewish Chronic Disease Hospital Cancer Experiments - 1960s • Twenty two chronically ill, debilitated, non-cancer patients injected with live human cancer cells • They were not told about the cancer cells because doctors (researchers) "did not wish to stir up any unnecessary anxieties in the patients" who had "phobia and ignorance" about cancer. • Research funded by U.S.P.H.S. and American Cancer Society. • Two years later, the American Cancer Society elected the principal investigator to be their Vice-President.

30. Stanford Prisoner Study 1971 http://www.prisonexp.org/

31. PHS Syphilis StudyDisclosed 1972 1932, Public Health Service study, in collaboration with the Tuskegee Institute in Macon County, Alabama, undertook a study of untreated syphilis in hopes of justifying treatment programs for blacks. 600 black men (399 with syphilis, 201 without) were told they had "bad blood," a local term used to describe syphilis, anemia, and fatigue. Penicillin, treatment of choice, was discovered in 1940s but was withheld. In exchange for taking part in the study, the men received free medical exams, free meals, and burial insurance. Although originally projected to last 6 months, the study actually went on for 40 years.

32. PHS Syphilis Study To entice their continued participation, PHS doctors sent them a letter titled, “Last Chance for Special Free Treatment.” The men submitted to painful and dangerous spinal taps. The fact that autopsies would eventually be required was also concealed. The Surgeon General of the United States participated in enticing the men to remain in the experiment, sending them certificates of appreciation after 25 years in the study. By end of study in 1970s, 28 men were dead of syphilis, 100 were dead of related complications, 40 of their wives were infected, and 19 of their children were born with congenital syphilis.

33. Scientists Behaving BadlyBC Martinson, MS Anderson, & R de Vries. (2005). Nature, 435: 737-38 • NIH funded survey • 3,247 early/mid • career • (~47% rr) • Engaged in • Top 10 Behaviors • Early = 28% • Mid = 38% • Overall = 33% • plus expect an underreporting bias.

34. Nuremberg Code 1947 U.S. Scandals Henry Beecher: "Ethics and Clinical Research" Public Health Service Policy Adopting IRBs Declaration of Helsinki Stanford Prisoner Study (1971) PHS “Tuskegee Study” Revealed (1972) National Research Act & 45 CFR 46 Belmont Report (1979) Significant Events PHS Syphilis Study, formerly “Tuskegee Study” 1930 1940 1950 1960 1970 1980

35. Common Rule 1991 Nicole Wan dies at Rochester 1996 President Clinton apologizes to PHS Syphilis study survivors Jesse Gelsinger dies at U Penn OPRR shuts down LA VA Medical, Duke, U Ill, UC, U Penn OPRR shuts down VCU, UAB, U Okla OPRR reorganized as OHRP, moved to Cabinet level and Director replaced, June 2000 Ellen Roche dies at Johns Hopkins; OHRP suspends JH federally funded research Secretary's Advisory Committee on Human Research Protections replaces National Human Research Protections Advisory Committee Significant Events 1990 1996 1997 1999 2000 2001 2002

36. Ethical Framework P C Principles Consequences I Interests

37. FFP? • Fabrication is making up results and recording or reporting the fabricated results. • Falsification is manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record. • Plagiarism is the appropriation of another person's ideas, processes, results, or words without giving appropriate credit and without specific approval, including those obtained through confidential review of others' research proposals and manuscripts.

38. Belmont Report, 1979 • National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research • This report is the basis of all federal regulations regarding the protection of human subjects in research • http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm

39. Historical Review – Ethical Codes Belmont Report • 9/30/1978 the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research submitted its report entitled “The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research.” • The Report, named after the Belmont Conference Center at the Smithsonian Institution where the discussions were held, sets forth the basic ethical principles underlying the acceptable conduct of research involving human subjects.

40. Belmont Report, 1979 Articulates 3 Basic Ethical Principles: • Respect For Persons – Autonomy of the Individual • Beneficence – Risk Minimization • Justice – Burdens and Benefits of Research are Equitably Distributed

41. Historical Review – Ethical Codes Belmont Report • Respect for persons – informed consent which contains the three elements: information, comprehension and voluntariness • Beneficence– risk/benefits assessment: study is carefully designed so that the benefits are maximized and any potential harm is minimized (benefit is not monetary!) • Justice – requires all subjects be treated fairly: selection of research subjects must be the result fair selection procedures and fair selection outcomes

42. The Belmont Report • Respect for Persons • Recognition of personal dignity and autonomy • Special protection of those with diminished autonomy • Informed Consent • Information • Comprehension • Voluntariness

43. The Belmont Report • Beneficence • Obligation to protect persons from harm • Maximize anticipated benefit, minimize possible harm • Risk/benefit ratio • Risk – probability, magnitude • Benefit – subject, society

44. The Belmont Report • Justice • Fair distribution of research benefits and burdens • Inclusion/exclusion on scientific basis rather than convenience, availability • Two levels of justice • Social • Individual ** More information about the Belmont Report can be found in the UI Investigator’s Guide Chapter 2.

45. Federal Regulations • DHHS • Title 45 CFR Part 46 • FDA • Title 21 CFR Part 50, Protection of Human Subjects • Title 21 CFR Part 56, Institutional Review Boards

46. Federal Regulations for the Protection of Subjects from Research Risks (Based on Belmont Report)45 CFR Part 461981

47. 45 CFR 46 • Subpart A -- Basic Protections • Subpart B -- Pregnant Women, Neonates and Fetuses • Subpart C -- Prisoners • Subpart D -- Children

48. Oversight • Federal law requires the Department of Health and Human Services (DHHS) to issue regulations for the protection of human subjects in research projects [codified at Title 45, Part 46 of the Code of Federal Regulations, Protection of Human Subjects] • The Office of Human Research Protections (OHRP) is the unit within DHHS that implements the regulations for the protection of human subjects

49. Fundamental Provisions of45 CFR Part 46, Subpart A • Assurance of Compliance • IRB requirements • Legally effective informed • consent

50. Assurance of Compliance (1) Each institution engaged in research covered by 45 CFR part 46 and which is conducted or supported by HHS shall provide assurance satisfactory to the HHS Secretary that it will comply with the requirements set forth in 45 CFR part 46 [45 CFR 46.103(a)].