Social and Behavioral Research and the IRB: History and Guidelines

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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. - PowerPoint PPT Presentation

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Accreditation: Panacea or Pain?

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.

4What is ethics?Ethics is the science of moral values and duties; the study of ideal human character, actions and ends.

(Websters New Collegiate Dictionary, Cambridge, MA, G & G Merriam Co., 1961).5What 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.6Why 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!7Nazi War Crimes WWII

8Voluntary informed consent absolutely essentialResearch should yield useful resultsBase research on prior workAvoid physical and mental sufferingNo expectation of death or disabling injuryRisk must be outweighed by importanceSubjects must be protected from injuryQualified scientists, adequate facilitiesSubject free to stop at any timeInvestigator must be ready to withdraw subjectNUREMBERG CODE19479DECLARATION of HELSINKI World Medical Association, 1964 updated in 2000Consent should be in writingResearch should build on previous workResearch must follow written protocol.Review by an independent committeeCaution if subject is in dependent relationship with investigatorSubjects must receive best proven diagnostic and therapeutic methodsrevised 1975, 1983, 1989, 1996, 2000 10Tearoom Trade StudyLaud Humphreys, 1970Sociological study of homosexual encounters

Several stages involving deception... Observation in public restrooms Obtaining names and addresses through license plates In-home interviews

11Milgram Shock ExperimentInvolved deception of subjectsSubjects told to shock actors (unknown to subjects) Study on obedience to authority

Stanford Prison ExperimentOne group of subjects were guards; the other were prisonersPrincipal Investigator acted as wardenSituation 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

14US National Research Act July 1974Established 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 consentCommon Rule (1991)15Charge to the National CommissionIdentify the basic ethical principles which should underlie the conduct of biomedical and behavioral research involving human subjectsDevelop guidelines to assure that such research is conducted in accordance with those principlesNational Research Act, 1974 (PL 93-348)16Belmont ReportEthical Principles and Guidelines for the Protection of Human Subjects of ResearchRespect for PersonsBeneficenceJustice

National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 197917What 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).18What 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.19Translating Ethical Principles Into Regulations

Regulatory requirements stem directly from ethical principles20Social & Psychological Risk Social and psychological risks are real risks.Identifying RisksWhy IRBs do not rely solely on investigators to identify risksNo one can be objective about their own workPeople underestimate the risks involved in things they are very familiar withPeople overestimate the benefit of things that are important to them

Identifying RisksExamples of Social and Behavioral risk

Emotional DistressPsychological TraumaInvasion of Privacy EmbarrassmentLoss of Social StatusLoss of Employment

Identifying RisksThe Primary source of social risk results froma breach of confidentiality.

Confidentiality and anonymity are not the sameNames are not the only identifiersSubjects 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 policy25So, What Is the IRBs Purpose?The IRBs 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 RegulationsAccording 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 individualMinimizing RiskThere are three ways to minimize riskAlternativesAre there other procedures or methods that are less risky?PrecautionsHas the researcher included procedures to decrease the likelihood that harms will occur?SafeguardsAre there procedures included to deal with harms if they occur?Informed ConsentConsent 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 RuleThe Common Rule provides sufficient flexibility forIRBs to effectively and efficiently review non-biomedical research

Exempt ResearchExpedited ReviewWaiver of Consent and/or documentation of informed consentExpedited 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 specimensResearch 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 CategoriesResearch conducted in established or commonly accepted educational settings, involving normal educational practices, such as:Research on regular and special education instructional strategies, orResearch on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.Exempt Categories ContdResearch 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 ContdResearch 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 subjects 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 subjects financial standing or employability,

Exempt Categories ContdThe research deals with sensitive aspect of the subjects 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 ContdResearch involving the observation (including observation by participants) of public behavior, except wher