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Human Participants Research at the University of Northern Iowa. Information for Students, Faculty & Staff at UNI. Objectives. Understand the historical context in which the ethical principles of research evolved. Know the ethical principles governing human research (the “Belmont principles”).
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Human Participants Research at theUniversity of Northern Iowa Information for Students, Faculty & Staff at UNI
Objectives • Understand the historical context in which the ethical principles of research evolved. • Know the ethical principles governing human research (the “Belmont principles”). • Understand how to apply the ethical principles to one’s own research. • Understand the role of the IRB and how to navigate the IRB review process.
International Response Nuremburg War Trials German doctors were charged with crimes against humanity for “performing medical experiments upon concentration camp inmates and other living human subjects, without their consent, in the course of which experiments the defendants committed murders, brutalities, cruelties, tortures, atrocities, and other inhuman acts.”
Nuremberg Code - 1947 • As part of the verdict, the Court enumerated ten rules for “Permissible Medical Experiments”, now known as the “Nuremberg Code”. Among others, the rules include: • Voluntary consent is absolutely essential • Benefits outweigh risks • Ability of the subject to terminate participation
Did the Nuremberg Code Impact the behavior of American scientists who did research on humans? No
Well Known Cases Involving Unethical or Questionable Research in the U.S. • Tuskegee Syphilis Study: 1932-1972 • Guatemalan Syphilis Study: 1946-1948 • U.S. Radiation Experiments: 1944-1974 • Willowbrook Study: 1956-1972 • Milgram Authority/Conformity Study: 1961 • Jewish Chronic Disease Hospital: 1963 • Zimbardo’s Stanford Prison Study: 1971 • Tearoom Trade Study: 1970
American medical research project conducted by the U.S. Public Health Service from 1932 to 1972 examined the natural course of untreated syphilis in black men. The subjects, impoverished sharecroppers from Macon County, Alabama, were unknowing participants in the study; they were not told that they had syphilis, nor were they offered effective treatment after a cure was found. Tuskegee Syphilis Study (1932-72)
Guatemalan Syphilis Study (1946-48) U.S. Public Health employees purposefully infected over 1300 prostitutes, prisoners, mental patients, and soldiers in Guatemala with STDs without their knowledge. Only some were treated, and 83 may have died as a result of the diseases.
US National Research Act of 1974 • Revelations of Tuskegee Study resulted in Senate investigation into research activities • Led to passage of National Research Act • Established National Commission for the Protection of Human Subjects • Belmont Report – 1979 • Ethical Principles and Guidelines for the Protection of Human Subjects of Research • Code of Federal Regulations – 45 CFR 46 • Creation of IRBs
Basic Principles of Belmont Report • Respect for persons • Proclaims individuals capable of self-determination; thus voluntary consent is essential (autonomy) • Beneficence • Obligates researchers to maximize potential benefits and minimize possible harm • Justice • Requires the benefits and burdens of research be fairly distributed
Federal Regulations for the Protection of Subjects from Research Risks45 CFR Part 46Common Rule1981/1991/2005
Federal Regulations and Policy Additional Protections Included in 45 CFR 46: • Subpart B - Additional Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research (revised December 13, 2001) • Subpart C - Additional DHHS Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects • Subpart D - Additional DHHS Protections for Children Involved as Subjects in Research
Federalwide Assurance (FWA) What is an Institutional Assurance? • Issued by the Office for Human Research Protections (OHRP) … the federal agency regulating research involving humans • Documentation of institutional commitment to comply with the Common Rule • Certifies that all research with human participants conducted at UNI will be reviewed for approval by the IRB in accordance with federal regulations
Definition of Research A systematic investigation, including research development, testing and evaluation, designed to contribute to generalizable knowledge Generalizable knowledge is interpreted to include research findings or data intended for public dissemination or presentation in any form, including via the Internet, poster presentation, scholarly paper, or report to external sponsor. The definition also includes research undertaken by students for the purpose of independent research papers, theses or dissertations.
Definition of Human Participant A human participant is a living individual about whom an investigator (whether professional or student) conducting research obtains: • data through intervention or interaction with the individual, or • identifiable private information Thus, the scope of “human participant" is interpreted broadly. If you are interviewing people, testing individuals, looking at records, or conducting a survey, you are involving human participants in your research.
Which projects need review? CRITERIA 1 Is it research? • Systematic data collection • Intended to contribute to generalizable knowledge • Results will be made public (e.g., presentation, research article, Internet, report)
Which projects need review? CRITERIA 2 Is it research with human subjects? • A living individual about whom an investigator … conducting research obtains: • data through intervention or interaction with the individual or • identifiable private information
Examples of projects needing review: Mailed survey to ascertain opinions on a topic Action research project in a local school Testing athletes’ physiological response to running Conducting interviews of Postville residents to obtain opinions of economic climate following the ICE raid An investigator obtains individually identifiable information on the treatment outcomes of patients and records data in a coded manner Teacher utilizes student artifacts and test results collected the previous semester Which projects need review?
Examples of projects not needing review: Program evaluation or quality improvement projects for internal use only Class research projects (results not shared outside of class) No more than minimal risk Adults not from a vulnerable population Data collection about organizations No personal opinions/data Surveys performed as contracted services to inform business decisions in which results are not made public Observations of public behavior in which there is no interaction with those being observed Which projects need review?
Does this project require IRB review? • The Department of Residence at UNI conducts activities on campus during the summer for incoming students. DOR asks participants to complete a satisfaction survey at the end of each session. This information is used by the director in planning future orientation sessions. • NO – it is intended to evaluate the orientation program and is not collecting data that will contribute to generalizable knowledge
Does this project require IRB review? • A staff member wishes to know whether UNI students are committed to the university by wearing clothing with the UNI name or logo on it. She positions herself in a prominent location at the Union and counts the number of students wearing UNI clothing for an hour • NO – it is observation of public behavior. The staff member is not interacting with subjects, nor is she obtaining private information.
Does this project require IRB review? • An investigator hopes to understand business outcomes for individuals who lost their businesses to the floods of 2008. To do this, PI conducts interviews with a sample of business owners from Cedar Rapids. • YES – it is a systematic investigation designed to contribute to generalizable knowledge. Further, it involves interaction with the subjects and gathers private information.
Does this project require IRB review? • A faculty member wishes to understand more about attitudes of patrons of a local business regarding Christmas shopping. With the permission of the store owner, the researcher stands on the public sidewalk outside the store and asks customers to complete a short survey. • YES – it is a systematic investigation designed to contribute to generalizable knowledge. Further, it involves interaction with the subjects and gathers private information.
Does this project require IRB review? • For a senior thesis, a student has access to an existing dataset from a local business s/he is assisting. The dataset contains individual-level private information pertaining to company employees. • YES – such projects require review. Several questions relate. Is the dataset publically available? Can personal identities be established? Is the data coded? Special application for projects involving existing data. If any questions, contact the IRB.
What if you aren’t sure if the project requires IRB review! • IF … • there is a question • a project might become research • there is potential to publish or present • THEN … • submit to the IRB • at least ask!
Institutional Review Board: Role and Responsibilities Disapproving a study at UNI is very rare, but modifications are common
What is the IRB? • Authorized by federal regulations • A committee charged with the review of human participants research to assure that the participants’ rights and welfare are adequately protected • Researchers are responsible for obtaining IRB review and approval before their research commences
IRB Composition • At least 5 members • Scientific and Nonscientific Members • At least 1 Non-affiliated Member • Collective Expertise • Sensitivity to Community Standards • Diversity of Perspectives • Knowledge of Vulnerable Subjects
The UNI IRB • In Office of Sponsored Programs (OSP) • Institutional Official – Christy Twait • Assistant Provost for Sponsored Programs • IRB Administrator – Anita Gordon • Interdisciplinary Committee • Chair, Helen Harton
UNI’s Full Board • Bunker, Dr. Matthew P. -- UNI Department of Marketing (2009-2014) • Clohesy, Dr. William W. -- UNI Philosophy & World Religions (2008-2014) • Creighton-Smith, Belinda -- Prisoner Advocate (2009-2012) • Downs, Dr. William R. -- UNI Department of Social Work (2010-2014) • Etscheidt, Dr. Susan K. -- UNI Special Education (2009-2012) • Evans, Dr. Todd -- UNI HPELS-Athletic Training (2009-2012) • Gordon, Anita, M.S.W. -- UNI IRB Administrator (Ongoing) • Harton, Dr. Helen C. -- UNI Psychology (2007-2013) (Chair) • Hensley, Dr. Larry D. -- Community Member (2010-2013) • Larimer, Dr. Christopher -- UNI Political Sciences (2011-2013) • Ophus, Dr. John -- UNI Biology & Science Education (2011-2013) • Roth, Dr. Ronald R. -- Community Member (2008-2014) • Stalp, Dr. Marybeth – UNI Sociology, Anthropology & Criminology (2011-2013)
Criteria for IRB Approval • Risks to participants are minimized • Risks are reasonable in relation to anticipated benefits • Selection of participants is equitable • Informed consent is sought from each prospective participant • Informed consent is appropriately documented • When appropriate, data are monitored to ensure safety of participants • When appropriate, privacy and confidentiality of participants is protected
Additional Protections for Vulnerable Populations • Children • Parent/guardian permission is generally required for people under age 18 • Prisoners • Pregnant women • Mentally disabled persons • Economically or educationally disadvantaged persons • Others
Types of IRB Review • Exempt from Continuing Review • Expedited • Full Board • Modifications to Approved Protocols • Continuing Review (Annual)
Minimal risk Often includes anonymous surveys and archival observations Review usually takes less than 2 weeks Does not require continuing approval Changes to protocol DO require prior approval Review IS required Exempt from Continuing Review
Expedited • Minimal risk • May include surveys/measures in which participant is identified • Review usually takes about 2 weeks • DOES require closure/continuing review forms (usually 1 year period) • Changes to protocol DO require prior approval
More than minimal risk studies Often includes vulnerable populations May include deception Reviewed by full committee at monthly meeting Investigators may attend but not required (is recommended) Plan ahead - review will take longer for these! Full Board Review
Minimal Risk Minimal risk means that 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.
Protections Required: Recruitment
Recruitment Issues • Equitable selection of participants • Minimize possibility of coercion or undue influence: “an offer you can’t refuse” • Indirect recruitment, third party recruitment, assurances • Participants’ relationship to PI • Compensation
Compensation • Compensation ≠ benefits • Payment to participants for the time, inconvenience, and expenses involved in participating in a research project • Monetary, gift cards, property … t-shirts, books, etc • Considered a recruitment incentive • Total payments ≥ $600 reported to IRS • Individual payments > $74 requires PI to record name, SSN, address and report to OBO • UNI employees or students – all compensation must be submitted to OBO (and possibly financial aid) • Implications for informed consent
Students as Participants • Same issues related to employees, patients, or those subordinate to the researcher • Because of potential for coercion or undue influence, there is possibility that agreement to participate will not be freely given • Whenever possible, PIs should avoid using their own students or employees as research subjects
Action, ethnographic, and qualitative research • Practitioner researchers do not have right to demand or compel participation in research (Pritchard, 2002) • Qualitative research requires sustained, on-going negotiation to informed consent and participation
Protections Required: Risks Minimized
Physical Psychological Social Emotional Economic Political Possible Risks Invasion of privacy Loss of confidentiality Embarrassment Financial Stress/discomfort Other
Risks to Participants • Risks must be reasonable in relation to the benefits • IRB must weigh the benefits of the research against the potential risks to subjects • No risks vs. No foreseeable risks
Protections Required: Confidentiality/Privacy
Privacy and Confidentiality • “When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data” • Breaches of privacy and/or confidentiality are the main risk in social-behavioral research or research that is no greater than minimal risk.
Confidentiality • Maintain confidentiality of research data • Methods may include: • Coding identifiers, limiting access to research data, storing data safely throughout the study, destroying data upon completion of the study, encryption, and training the research team on the importance of confidentiality • Remember that several “vague” identifiers (e.g., gender and race) together may individually identify participants
Confidentiality on the Internet • Application to Internet-based research and online surveys • Statement on consent document should advise participants that no absolute guarantee can be made about the confidentiality of data sent via the Internet.