Social and Behavioral Research and the IRB: History and Guidelines
Behavioral Research and the Belmont Report
• “It is important to distinguish between biomedical and behavioral research.”
• “The general rule is that if there is any element of research in an activity, that activity should undergo review for the protection of human subjects.”
Behavioral Research and 45 CFR 46
Definition of a “Human Subject” Individuals whose physiologic or behavioral
characteristics and responses are the object of study in a research project. Under federal regulations, they are defined as: living individual(s) about whom an investigator conducting research obtains: (1)data through intervention or interaction with the individual; or (2)identifiable private information.
What is research?
• Research is a systematic investigation (i.e., the gathering and analysis of information) designed to develop or contribute to generalizable knowledge.
What is ethics?
• Ethics is the “science of moral values and duties; the study of ideal human character, actions and ends.”
(Webster’s New Collegiate Dictionary, Cambridge, MA, G & G Merriam Co., 1961).
What is research ethics?
• Research ethics is therefore synonymous with both “values science and scholarship” and “standards of conduct and practice in science.”
• Clearly, one is in agreement with the definition when one exhibits honesty and reliability, designs and performs experiments with skill and thoroughness, and is fair in dealing with students, co-workers and competitors, and assumes responsibility to people and institutions.
Why should we be concerned about research ethics?
• You will do better science.• You may know what to do if an ethical problem
arises.• Other scientists depend on your trustworthiness.• Scientific progress depends on it.• Public Welfare depends on it.• Your scientific reputation and career depend on it.• Science cannot work otherwise.• It is the right thing to do!
Nazi War Crimes WWII
• Voluntary informed consent absolutely essential• Research should yield useful results• Base research on prior work• Avoid physical and mental suffering• No expectation of death or disabling injury• Risk must be outweighed by importance• Subjects must be protected from injury• Qualified scientists, adequate facilities• Subject free to stop at any time• Investigator must be ready to withdraw subject
NUREMBERG CODE1947
DECLARATION of HELSINKI World Medical Association, 1964
updated in 2000• Consent should be in writing• Research should build on previous work• Research must follow written protocol.• Review by an independent committee• Caution if subject is in dependent relationship with
investigator• Subjects must receive best proven diagnostic and
therapeutic methods
revised 1975, 1983, 1989, 1996, 2000
Tearoom Trade StudyLaud Humphreys, 1970
Sociological study of homosexual encounters• Several stages involving
deception...• Observation in public restrooms• Obtaining names and addresses
through license plates• In-home interviews
Milgram Shock Experiment• Involved deception of subjects• Subjects told to shock actors (unknown to subjects) • Study on obedience to authority
Stanford Prison Experiment• One group of subjects were “guards”; the other were
“prisoners”• Principal Investigator acted as warden• Situation deteriorated quickly; prisoners abused by
guards.• Long-term emotional distress by subjects especially
prisoners.
“The study continues to cast a long shadow over the relationship between African Americans and the bio-medical professions; it is argued that the study is a significant factor in the low participation of African Americans in clinical trials, organ donation efforts, and routine preventive care.”
Legacy of Tuskegee
• US National Research Act July 1974• Established National Commission for the
Protection of Human Subjects of Biomedical and Behavioral Research (1974-1978)
• The Belmont Report (1979)• Code of Federal Regulations (1981)• Institutional Review Boards (IRBs)• Informed consent• Common Rule (1991)
Charge to the National Commission
• Identify the basic ethical principles which should underlie the conduct of biomedical and behavioral research involving human subjects
• Develop guidelines to assure that such research is conducted in accordance with those principles
National Research Act, 1974 (PL 93-348)
Belmont ReportEthical Principles and Guidelines for the Protection of Human Subjects of
Research• Respect for Persons• Beneficence• Justice
National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979
What are the main ethical issues in human subjects research?
• The primary concern of the investigator and the IRB should be the safety of research participants. This is accomplished by carefully considering the risk/benefit ratio and continually monitoring the research as it proceeds.
• The investigator must obtain informed consent. This must be obtained in writing (although sometimes oral consent is acceptable).
What are the main ethical principles governing research with human
subjects?
• The first ethical principle noted in the Belmont Report is autonomy.
• The second principle is beneficence.
• The third principle invoked is justice.
Translating Ethical Principles Into Regulations
Regulatory requirements stem directly from ethical principles
Social & Psychological Risk
Social and psychological risks are real risks.
Identifying Risks
• Why IRBs do not rely solely on investigators to identify risks– No one can be objective about their own work– People underestimate the risks involved in things
they are very familiar with– People overestimate the benefit of things that are
important to them
Identifying Risks
Examples of Social and Behavioral risk
– Emotional Distress– Psychological Trauma– Invasion of Privacy – Embarrassment– Loss of Social Status– Loss of Employment
Identifying Risks
The Primary source of social risk results froma breach of confidentiality.
• Confidentiality and anonymity are not the same• Names are not the only identifiers• Subjects’ participation in the research may need to
be kept confidential as well as their data
Role of the Institutional Review Board (IRB)
21 CFR 56.109 and 45 CFR 46.109
According to federal mandate “An IRB shallreview and have authority to approve,require modification in (to secure approval),or disapprove all research activities coveredby this policy”
So, What Is the IRB’s Purpose?
The IRB’s Purpose and Responsibility Is to Protect the Rights and Welfare of Human Subjects.
The IRB Reviews and Oversees Such Research to Ensure That It Complies With Federal Regulations, That Pertain to Human Subject Protection.
Federal Regulations
• According to federal regulations, the activities that require IRB review include:
• Any activities involving the collection of data through intervention or interaction with a living individual
• Any activities involving identifiable private information regarding a living individual
Minimizing RiskThere are three ways to minimize risk• Alternatives
– Are there other procedures or methods that are less risky?
• Precautions– Has the researcher included procedures to
decrease the likelihood that harms will occur?• Safeguards
– Are there procedures included to deal with harms if they occur?
Informed Consent
• Consent process should empower subjects to make their own determination about risk
• Risks should be explained in terms that the subjects can relate to - everyday life experiences
• Consent process should not do more harm than the research
Common Rule
The Common Rule provides sufficient flexibility forIRBs to effectively and efficiently review non-biomedical research
• Exempt Research• Expedited Review• Waiver of Consent and/or documentation
of informed consent
Expedited ReviewResearch that may meet expedited review criteria include minimal risk studies and only those which fall under those categories :
• Eleven specific categories most of which relate to medical samples.
• The study of existing data, documents, records, pathological specimens or diagnostic specimens
• Research on individual or group characteristics of individuals, such as studies of perception, cognition, game theory, or test development, where the investigator does not manipulate subjects’ behavior and the research will not involve stress to subjects
Exempt Categories
• Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as:
• Research on regular and special education instructional strategies, or
• Research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
Exempt Categories Cont’d
• Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), if information taken from these sources is recorded in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
Exempt Categories Cont’d
• Research involving survey or interviewing procedures, except where all of the following conditions exist:
• Responses are recorded in such a manner that the subjects can be identified, directly or through identifiers linked to the subject,
• The subject’s responses, if they became known outside the research, could reasonably place the subject at risk of criminal or civil liability or be damaging to the subject’s financial standing or employability,
Exempt Categories Cont’d
• The research deals with sensitive aspect of the subject’s own behavior, such as illegal conduct, drug use, sexual behavior, or use of alcohol.
• All research involving survey or interview procedures is exempt, without exception, when the respondents are elected or appointed public officials or candidates for public office.
Exempt Categories Cont’d
• Research involving the observation (including observation by participants) of public behavior, except where all of the following conditions exist:
• Observations are recorded in such a manner that the subjects can identified, directly or through identifiers linked to the subjects,
• The observations recorded about the individual, if they became known outside the research, could reasonably place the subject at risk of criminal or civil liability or be damaging to the subject’s financial standing or employability, and
Exempt Categories Cont’d
• The research deals with sensitive aspects of the subject’s own behavior such as illicit conduct, drug use, sexual behavior, or use of alcohol.
• Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified
Exempt Categories Cont’d
• directly or through identifiers linked to the subjects. (Investigators must include with the IRB application a letter of approval for use or supply of the information material or specimens.)
Consent Requirements
• Institutions are free to set their own consent requirements for exempt research.
• All consent requirements must be met in expedited review.
Research In Schools
• The provisions of the Common Rule, Part A of 45 CFR 46, apply to all subjects regardless of age or circumstance, including public school students.
• There are three direct references to children in the common rule, all of which identify children as vulnerable subjects.
• Researchers and IRB members must be aware that there are vulnerabilities unique to school based research.
Vulnerabilities of Children in Research
• Children may be vulnerable to undue influence and/or coercion.
• When considering children as subjects researcher must take into account the purpose of the research and the setting in which it takes place.
Strategies to Minimize Undue Influence in School-Based Research
• Researchers can provide attractive alternatives to participation for children who do not want to participate – not just time to do schoolwork.
• Enlist Principals to identify classrooms where students are encouraged to make choices, rather than expected to participate in all activities.
• If there is direct benefit, every effort should be made to enroll those students who will be most benefited by the research.
Exemptions in School-Based Research
The following activities with school children do notqualify for exemption under 45CFR 46 Subpart D:
1. Research involving surveys.2. Research involving interviews.3. Observation of public behavior when the researcher
participates in the activities being observed.
Exemptions in School-Based ResearchIn contrast, the following research activities inschools may qualify for exemption:1. Research conducted in established or commonly
accepted educational settings involving normal educational practices. For example, research on regular or special education instructional strategies or research on the effectiveness of or comparison among instructional techniques, curricula, or classroom management methods
2. Research using educational tests, unless the disclosure of identifiable information would create the potential for harm.
Exemptions in School-Based Research
3. Observation of public behavior in which the researchers do not participate in the activities being observed.
4. Research involving the collection of study or existing data or records, if the data is publicly available or are recorded without identifiers.
5. Some food and taste studies.
What You Need to Know About School-Based Research
1. All research, including school-based research requires either a signed informed consent or waiver of informed consent or documentation of informed consent
2. All research using children as subjects requires parental consent and child assent .
3. Chicago Public Schools (CPS) has it’s own research review system, before designing your study check the CPS website for their requirements. Website: http://research.cps.k12.il.us/cps/accountweb/Requests/index.html
What You Need to Know About School-Based Research
4. Other school districts may have a similar process. Check district websites for research requirements.
5. When your proposal requires access to student records, review the following for requirements and compliance
a. Family Educational Rights and Privacy Act (FERPA) http://www.ed.gov/policy/gen/guid/fpco/ferpa/index.html
b. Illinois School Student Records Act (105 ILCS) at http://www.ilga.gov
Application of the Common Rule
The effective and efficient application of theCommon Rule to non-biomedical researchrequires that an institution must have:
• An IRB that has sufficient expertise in social & behavioral research
• An IRB that understands and utilizes the flexibility in the Common Rule
• Investigators that understand the potential for social & psychological risk in their research
Reporting Requirements
As part of the Institutional Review Board’srequirements, which are mandated by theregulations during the approval year, researchersare required to report to the IRB in the event of anyof the following: • significant adverse reactions, (Yes, Social and
Behavioral research can have adverse reactions)• Any changes to the study protocol, • Termination or closure of the study.
Investigator: Where Do I Begin?
• I have an idea for research. • So, what do I do?
First Steps
• Discuss your research idea with a colleague or a faculty member/mentor.
• Develop your research hypothesis.• Determine your study group(s)
► Who will you be studying?► What do you want to know?► Start Early!!! Plan! Plan! Plan!
There is Help? Yes, You are not alone!
• The IRB Administrative Staff ( the Office of Sponsored Programs) are committed to assisting researchers, student researchers and others. So, when in doubt, call the OSP.
• Visit the OSP website www.neiu.edu/~sprogram for on-line training and forms
Full Board Review
• Any study that doesn’t fall under the Exempt or Expedited categories
• No regular schedule of meetings so one must be called as needed
• Principal Investigator requested to attend• Need to plan for additional time to obtain
approval• May need to obtain expert assistance which
would require additional time
Conclusion
• Start Early• Plan Ahead• There is help to assist you• If you don’t know, don’t assume, ask someone• REMEMBER, all human subject research
must be reviewed by the IRB.• Don’t jeopardize your project. SUBMIT!
NEIU OSP IRB Forms
• Full Institutional Review Board/Human Subjects Committee
• Exempt Application
• Informed Consent Checklist
Human Subjects On-Line Training
Mandatory training for researchers using human subjects can be accessed at:https://www.citiprogram.orgThis is a link to the Collaborative IRB Training Initiative's Course in The Protection of Human Research Subjects. You will need to register for a free account to access the training module.
