1. Institutional Review Board (IRB)
Nalinee D. Patin, CIP
IRB Administrator
Office of Research Compliance

2. IRB Institutional Review Board
committee of members with diverse backgrounds, experience, and expertise (includes non-scientist and community member)
conducts federally mandated, independent, objective, and ethical review of research involving human subjects
primarily tasked with the protection of human subjects in research
IRB
-discuss the composition of Clemson’s IRB (expertise, non-scientist, community member)
-also known as Research Ethics Board or Independent Ethics Committee.

3. Why Zimbardo Stanford Prison Study (1971)
World War II and Nazi / Japanese Scientists
Tuskegee Syphilis Study ( )
Zimbardo Stanford Prison Study (1971)
Facebook Mood Manipulation Experiment (2012)
Pavuluri Lithium Bipolar Study with Children ( )
-WWII ( ): experiments conducted by Nazi doctors and scientists on concentration camp prisoners during World War II; resulted in the Nuremberg Code, which outlined ten points for conducting ethical research with human subjects.
-Tuskegee syphilis study: U.S. Public Health Service (PHS) study in the 1940's, the Tuskegee syphilis study used disadvantaged, rural black men to study the untreated course of a disease that is by no means confined to that population. These subjects were deprived of demonstrably effective treatment in order not to interrupt the project, long after such treatment became generally available. led to the creation of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (National Commission or "the Commission"). The Commission was charged with establishing a code of research ethics for U.S. research involving human subjects. In 1979, the Commission issued the Belmont Report, the foundational document of the current system of U.S. human subjects protections. The Belmont Report, in turn, informed the U.S. Department of Health and Human Services (HHS) Code of Federal Regulations (45 CFR 46), which was created in 1974 and later revised.
-social sciences studies such as Milgram's Obedience to Authority study, Zimbardo's Stanford Prison Experiment, and Humphreys's Tearoom Trade study , made it clear that social and behavioral research may carry risks of harm related to psychological well-being , violations of autonomy and privacy, and reputational damage. Despite good intentions and best efforts, researchers are not always able to anticipate risks of harm. This module aims to bring human subjects protections into focus for researchers in the social and behavioral sciences, education, and the humanities, by examining the complex issues raised by research with human subjects and how these issues may be addressed using the ethical principles outlined in the Belmont Report.
-Laud Humphreys's study, detailed in his book Tearoom Trade: Impersonal Sex in Public Places, the researcher observed men meeting other men for casual sexual encounters in public restrooms. Humphreys, then a sociology graduate student, gained the confidence of the men by pretending to be a participant and acting as a lookout. While Humphreys eventually revealed himself as a researcher to some of the men and was able to interview them openly, he withheld his identity from many others, recording the license plate numbers of a subset of 100 other tearoom regulars in order to contact them for interviews at a later date.
A year after completing the observational part of the study, Humphreys followed up with these subjects, including them in a separate social health study that enabled him to conduct in-home surveys and gather data about their family relationships and religious background. In a 1970 article taken from his book, Humphreys maintained that the researcher's obligation to protect respondents from harm was a critical ethical assumption. To avoid being recognized by the interview subjects, Humphreys changed his appearance and the kind of car he drove.
the ethical concerns are invasion of privacy, lack of informed consent, and a failure to protect against deductive disclosure of identity.
-"The Stanford Prison Experiment," Philip Zimbardo's 1971 landmark psychological study of the human response to captivity, specifically prison life. Zimbardo assigned roles to normal male student volunteers to create groups of "prisoners" and "guards." The simulation became so intense that physical and psychological abuse of "prisoners" by "guards" escalated and several of the subjects experienced distress less than 36 hours after the study began. Zimbardo's study, like Humphreys's study, occurred in a different regulatory environment, before the advent of the Belmont Report. Zimbardo did submit his research plan to an ethics board, but the consent process contained no provisions allowing subjects to withdraw at will, and no risks of harm beyond loss of privacy were addressed. According to Zimbardo (2012), the consent form signed by the subjects only allowed them "to be released from participation for reasons of health deemed adequate by the medical advisers to the research project or for other reasons deemed appropriate by Dr. Philip Zimbardo." Zimbardo did not stop the experiment until six days had passed.
caused psychological and even physical distress
-Harvard University study, "Tastes, Ties, and Time (T3)" ( ). Sociologists at Harvard gleaned voluminous and detailed personal information from the Facebook profiles of an entire class of undergraduates and followed those students over four years. The research team created an extensive data set that included student gender, home state, major, political and group affiliations, friend networks, photographs, and tastes in music, books, and film. In 2008, the researchers made the data publicly available through the Dataverse Network Project. Although no students were identified by name, some data were specific enough to allow for re-identification of students by an outside researcher (Zimmer 2010, ; Parry 2011).
-Restaurant letter study (2001)
-Include some recent cases (2014 FB study, election study)
-Facebook mood manipulation experiment (2012): Facebook’s News Feed—the main list of status updates, messages, and photos you see when you open Facebook on your computer or phone—is not a perfect mirror of the world. But few users expect that Facebook would change their News Feed in order to manipulate their emotional state. We now know that’s exactly what happened two years ago. For one week in January 2012, data scientists skewed what almost 700,000 Facebook users saw when they logged into its service. Some people were shown content with a preponderance of happy and positive words; some were shown content analyzed as sadder than average. And when the week was over, these manipulated users were more likely to post either especially positive or negative words themselves. This tinkering was just revealed as part of a new study, published in the prestigious Proceedings of the National Academy of Sciences. Many previous studies have used Facebook data to examine “emotional contagion,” as this one did. This study is different because, while other studies have observed Facebook user data, this one set out to manipulate it. The experiment is almost certainly legal. In the company’s current terms of service, Facebook users relinquish the use of their data for “data analysis, testing, [and] research.” Is it ethical, though? Since news of the study first emerged, I’ve seen and heard both privacy advocates and casual users express surprise at the audacity of the experiment. Cornell professor co-author; no IRB review.
-Dr. Mani Pavuluri, a star pediatric psychiatrist at the University of Illinois at Chicago whose clinical trial studying the effects of the powerful drug lithium on children was shuttered for misconduct. Pavuluri’s study, which began in 2009 and was shut down in 2013, was designed to use imaging to look at how the brains of adolescents with bipolar disorder function during a manic state, and then again after eight weeks of treatment with lithium. The hope was that the results would provide new information to help identify the disease earlier, lead to treatment, and potentially even reverse how the disorder affects the brain. She violated research rules by testing the powerful drug lithium on children younger than 13 although she was told not to, failed to properly alert parents of the study’s risks, and falsified data to cover up the misconduct, records. University quietly paid a severe penalty for Pavuluri’s misconduct and its own lax oversight, after the National Institute of Mental Health demanded weeks earlier that the public institution — which has struggled with declining state funding — repay all $3.1 million it had received for Pavuluri’s study.

4. Belmont Report (published by “The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research” in 1979)
Ethical Principles
Practical Applications
Respect for Persons
Individuals be treated as autonomous agents
Persons with diminished autonomy are entitled to protection
Informed Consent
Adequate information
Comprehension
Voluntariness
Use legal authorized representative
Beneficence
First, do no harm: maximize possible benefits of the research and minimize possible harms to the research process
Assessment of Risks and Benefits
Nature and scope
Systematic assessment
Vulnerable populations
Informed consent process
Justice
Consistent and “fairness in distribution” of “burdens and benefits”
DHHS federal regulations (45 CFR 46), Protection of Human Subjects
Subpart A known as Common Rule
-Published by “The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research” in 1979 and identifies three basic ethical principles that underlie all human subjects research.
-respect for persons: no coercion or unduly influenced to engage in research activities for which they would not otherwise volunteer
-beneficence: decide when it is justifiable to seek certain benefits despite the risks involved, and when the benefits should be foregone because of the risks; A difficult ethical problem remains, for example, about research that presents more than minimal risk without immediate prospect of direct benefit
-justice: injustice occurs when some benefit to which a person is entitled is denied without good reason or when some burden is imposed unduly; selection of research subjects needs to be fair and not systematically selected simply because of their easy availability
-Common Rule adopted by other federal agencies funding research in the social and behavioral sciences

5. Definition of Research
A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
Definition of Human subject
A living individual about whom an investigator (whether professional or student) conducting research obtains (1) Data through intervention or interaction with the individual, or (2) Identifiable private information
Research:
-The researcher’s “intent” is key to whether or not a particular project falls within the definition of research; it was the researcher's intent to contribute to a body of knowledge or whether the results were replicable.
-derive general conclusions from particulars; contribute to a body of knowledge
Human subject:
-“about whom” – information collected is “about” a participant if it includes information from their experience or opinions; on their opinions, characteristics, or behavior of the individual
-“About what” asks about something; It is not “about” a participant if different people will consistently give the same answer to the question (e.g., “What is Clemson University’s policy on plagiarism?”, “How many times have the Cincinnati Reds won the World Series?”, “When did this company implement its new inventory system?”)
-Interactions include communication or interpersonal contact between the subject and the researcher. Communication does not have to be face to face, and may even exist entirely on paper or in electronic realms. Online surveys that do not ask for any identifying information about the subjects are considered interactions.
-Interventions include physical procedures through which data are gathered, such as (1) measuring brain function to supplement paper and pencil inquiries into the development of language, and (2) behavioral interventions such as experimental education programs or unproven psychosocial therapies. They also include manipulation of the subject or the subject's environment performed for research purposes, for example, studies investigating the effect of music on memory.
-private information includes: Information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place;
Information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a school record)

6. What is generalizable knowledge?
goal of the activity is to learn something for the purpose of benefiting other people or internal program
results of the study are presented and/or published in order to highlight some topic/issue within one’s field of study (clinical trials)
data is geared for scholars, practitioners, and/or researchers (expand study; results can be replicated)
Reference: Elizabeth Bankert and the University of Wisconsin-Stout

7. What Requires Review? Includes:
ALL projects that meet both the definitions of research and human subjects.
Includes:
Faculty, staff, and student researchers
Collaborations where CU researchers work with researchers at other institutions
Research conducted both on and off Clemson’s campuses; international projects
Funded and unfunded research

8. Review Levels and Timelines
Exempt
2 weeks
Requires review
Expedited
2 to 4 weeks
Full Board
4 weeks or more
Note: Exempt means exempt from continuing review not exempt from review
Timelines depend mostly on:
Level of review
Complexity of research study (international projects)
If researchers have completed the IRB forms and respond quickly to requests from the IRB

9. IRB Submission Application (PI assignment) Recruiting material(s)
Informed consent
Instruments
Site/ethics review
local cultural review
IRB
Submission

10. IRB Review Process
IRB notifies researcher of decision by
Reviewer assigned
IRB office screens packet (other regulations/policies/awards)
PI submits IRB forms to
IRB forms
IRB training
Researcher drafts proposal (consultation recommended)

11. Questions IRB website: http://www.clemson.edu/research/compliance/irbor
Phone: (864)
Office: 391 College Ave., suite 406
Questions