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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 the university of northern iowa

Human Participants Research at theUniversity of Northern Iowa

Information for Students, Faculty & Staff at UNI


Objectives
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
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
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

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
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.

Tuskegee Syphilis Study (1932-72)


Guatemalan syphilis study 1946 48
Guatemalan Syphilis Study 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.(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
US National Research Act of 1974 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.

  • 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
Basic Principles of Belmont Report 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.

  • 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
Federal Regulations and Policy Research Risks

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
Federalwide Assurance (FWA) Research Risks

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
Definition of Research Research Risks

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
Definition of Human Research RisksParticipant

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
Which projects need review? Research Risks

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 review1
Which projects need review? Research Risks

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


Which projects need review2

Examples of projects needing review: Research Risks

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?


Which projects need review3

Examples of projects Research Risksnot 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
Does this project require IRB review? Research Risks

  • 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 review1
Does this project require IRB review? Research Risks

  • 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 review2
Does this project require IRB review? Research Risks

  • 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 review3
Does this project require IRB review? Research Risks

  • 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 review4
Does this project require IRB review? Research Risks

  • 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
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 review!

Disapproving a study at UNI is very rare, but modifications are common


What is the irb
What is the IRB? review!

  • 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
IRB Composition review!

  • 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
The UNI IRB review!

  • 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
UNI’s Full Board review!

  • 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
Criteria for IRB Approval review!

  • 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
Additional Protections for Vulnerable Populations review!

  • 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
Types of IRB Review review!

  • Exempt from Continuing Review

  • Expedited

  • Full Board

  • Modifications to Approved Protocols

  • Continuing Review (Annual)


Exempt from continuing review

Minimal risk review!

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
Expedited review!

  • 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 review!

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 review!

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

Protections Required: review!

Recruitment


Recruitment issues
Recruitment Issues review!

  • 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 review!

  • 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
Students as Participants review!

  • 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
Action, ethnographic, and qualitative research review!

  • 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 required1

Protections Required: review!

Risks Minimized


Possible risks

Physical review!

Psychological

Social

Emotional

Economic

Political

Possible Risks

Invasion of privacy

Loss of confidentiality

Embarrassment

Financial

Stress/discomfort

Other


Risks to participants
Risks to Participants review!

  • 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 required2

Protections Required: review!

Confidentiality/Privacy


Privacy and confidentiality
Privacy and Confidentiality review!

  • “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
Confidentiality review!

  • 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
Confidentiality on the Internet review!

  • 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 required3

Protections Required: review!

Informed Consent


Informed consent
Informed Consent review!

  • 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
Informed Consent: review!Criteria for IRB Approval

  • According to federal regulations ….

    • Informed consent will be sought from each prospective subject (46.116)

    • Informed consent will be appropriately documented (46.117)


Informed consent1
Informed Consent review!

  • 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



Required elements
Required Elements participant?

  • Statement that the study is research and explanation of purposes and procedures

    • 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
Required Elements (cont.) participant?

  • If more than minimal risk … statement regarding compensation for injuries

  • Contact information

    • Usually PI and IRB Administrator

  • 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
Types of Consent participant?

  • 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



When further contact with irb is required
When Further Contact with IRB is Required participant?

  • 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

Changes to Protocols


Continuing approval

Approval period no longer than 1 year review, must be approved by IRB

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

Continuing Approval


Project closure

Download form from IRB website review, must be approved by IRB

Send in any time after completion of study

Important for students to remember before they leave campus

Project Closure


Adverse events
Adverse Events review, must be approved by IRB

  • 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
IRB Review Process review, must be approved by IRB

Changes as needed

leading to final approval

Initiate a

complete application,

with all supporting

documents

Exempt, expedited or FB

review

Renewal/amendment or closure

Start

PI receives reviewer comments

Administrative review


Irb forms
IRB Forms review, must be approved by IRB

  • Standard Application

  • Survey Application

  • Existing Data Application

  • Annual Renewal/Update form

  • Project Closure form

  • Informed Consent Checklist


Supplemental materials may include
Supplemental Materials May Include review, must be approved by IRB

  • Recruitment letters/scripts

  • Copies of instruments

  • Consent documents

  • Letters of cooperation

  • Debriefing scripts

  • Training certificates

    • Required for all key personnel


How to find us
How to Find Us review, must be approved by IRB

  • 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

Questions? review, must be approved by IRB

Thank You!


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