Human Participants Research at the University of Northern Iowa Information for Students, Faculty & Staff at UNI.
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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”). 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. Nazi Medical Experiments in WWII Concentration Camps 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 Tuskegee Syphilis Study (1932-72) 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. 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 Risks 45 CFR Part 46 Common Rule 1981/1991/2005 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: (1) (2) 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: 1. data through intervention or interaction with the individual or 2. identifiable private information Which projects need review? 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 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) Exempt from Continuing Review 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 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 Full Board Review 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! 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 Possible Risks Physical Psychological Social Emotional Economic Political 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. Protections Required: Informed Consent Informed Consent Respect for Persons or Autonomy Fundamental principle from Belmont Report Individuals empowered to make free decisions, and given adequate information to make good decisions Arguably, the most important ethical principle in research Informed Consent: Criteria for IRB Approval According to federal regulations …. 1. 2. Informed consent will be sought from each prospective subject (46.116) Informed consent will be appropriately documented (46.117) Informed Consent A process not a form! No coercion or undue influence (recruitment) Language understandable to the participant No exculpatory language 8 required elements of consent 6 additional elements, where appropriate What would you want to know if you were a research participant? Required Elements 1. Statement that the study is research and explanation of purposes and procedures 2. 3. 4. 5. Duration, location, procedures, etc. Reasonably foreseeable risks or discomforts Benefits which may be reasonably expected Alternative procedures or treatments Statement about confidentiality of data Required Elements (cont.) 6. If more than minimal risk … statement regarding compensation for injuries 7. Contact information Usually PI and IRB Administrator 8. Statement that participation is voluntary and one can withdraw at any time without penalty Informed consent documents should be on UNI letterhead or state that research is being conducted by faculty/students/staff at UNI. Types of Consent Various methods A written consent document or form Orally Electronically presented Presented in a letter Waiver of documentation of consent Consent information still provided Parental permission required for children No passive consent allowed Do I have to interact with the IRB again postreview? YES! When Further Contact with IRB is Required Changes to protocol Continuing approval Closure Adverse events Changes to Protocols Changes to all studies, even those exempt from continuing review, must be approved by IRB When risks or protections change Participant pool changes Procedures change Consent document changes Instrument changes Research sites change Email request to IRB Administrator Include original protocol # Attach any new/changed materials Forwarded to reviewer Continuing Approval Approval period no longer than 1 year PI must seek continuing approval No grace period Applies to Full Board or Expedited studies Use Annual/Update form Form and reminder email sent out by IRB office 30 days before expiration dates Project Closure Download form from IRB website Send in any time after completion of study Important for students to remember before they leave campus Adverse Events Federal regulations require PIs report to the IRB problems or adverse events that occur during course of study IRB required to report to OHRP Unanticipated problems Serious or continuing noncompliance by PI Suspension or termination of a study IRB Review Process Renewal/amendment or closure Start Changes as needed leading to final approval Initiate a complete application, with all supporting documents PI receives reviewer comments Administrative review Exempt, expedited or FB review IRB Forms Standard Application Survey Application Existing Data Application Annual Renewal/Update form Project Closure form Informed Consent Checklist Supplemental Materials May Include Recruitment letters/scripts Copies of instruments Consent documents Letters of cooperation Debriefing scripts Training certificates Required for all key personnel How to Find Us Office of Sponsored Programs www.uni.edu/osp - Click on Research Policies 213 East Bartlett Hall [email protected] or 273-6148 [email protected] or 273-2235 Questions? Thank You!