Human Subjects Research: Successful Completion of an IRB Application

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Human Subjects Research: Successful Completion of an IRB Application. Jason A. Kaufman, Ph.D. Assistant Professor, Dept. of Anatomy Chair, MWU Glendale Institutional Review Board. - PowerPoint PPT Presentation

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Human Subjects Research: Successful Completion of an IRB ApplicationJason A. Kaufman, Ph.D.Assistant Professor, Dept. of AnatomyChair, MWU Glendale Institutional Review Board

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When submitting an application to an IRB outside of Midwestern, be sure to contact their IRB Chair for information on policies and procedures specific to that institution.ObjectivesTraining for Investigators:What is the function of the Institutional Review Board (IRB)?Does your project constitute human subjects research?Categories of human subjects research: where does your project fit?What are the elements of a complete IRB application?What elements are necessary in an Informed Consent Document?What are some common mistakes and how can they be avoided?What is the function of the Institutional Review Board?Responsibilities of the IRBAn Institutional Review Board (IRB) is a committee established to help protect the rights and welfare of human research subjects. Regulations require IRB review and approval for human subjects research.IRB review is guided by three basic ethical principles*Respect for personsBeneficenceJustice*(Belmont Report, 1979; 45 CFR 46)5Elements of your application that the IRB is mandated to reviewRespect for persons (autonomy)Ensure that subjects receive full disclosure and participate voluntarily: Informed ConsentEvaluate safeguards for privacy of subjects and confidentiality of dataAssure protections for individuals with diminished autonomyVulnerable populations: pregnant women, prisoners, children, mentally disabled, students 6Elements of your application that the IRB is mandated to reviewBeneficenceDetermine that research risks are minimizedVerify that risks are justified by benefitsConfirm that research design and methods are appropriate, scientifically valid, and therefore justify exposing subjects to research risksEnsure that investigators are qualified to perform procedures and handle adverse events7Elements of your application that the IRB is mandated to reviewJusticeEnsure that subjects are recruited equitably and free from coercion or undue influenceRecruitment methods for student subjects must minimize the potential for coercion or undue influence

8Does your project constitute human subjects research?Projects that meet federal definitions of both research and human subjects must be reviewed by the IRBResearch a systematic investigation . . . designed to develop or contribute to generalizable knowledgeHuman Subject A living individual* about whom an investigator obtains data through intervention, interaction, or the collection of identifiable private information* HIPAAs Privacy Rule extends research protections concerning private health information to the deceasedIntervention includes both physical procedures (e.g., venipuncture) and manipulations of the subjects environment

Intervention includes both physical procedures (e.g., venipuncture) and manipulations of the subjects environment

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Examples of activities that are not considered to be human subjects researchCase reports are not considered human subjects research if certain conditions are metCase report / case study form available on ORSP website

The case report draws conclusions only about that participant or group and only in that specific context

11Examples of activities that are not considered to be human subjects researchData gathered solely for internal campus use (e.g., course evaluation or institutional program development), or are part of classroom projects that will not be presented outside the classroom are not considered human subjects researchSubjects deserve protection regardless of whether the research is published or presented externally

If results of these studies will be disseminated publicly in any way (e.g., conference presentation or publication), then the study is considered to constitute research. If the possibility of future dissemination exists, submit the project for IRB review before initiating the research

12Examples of activities that are not considered to be human subjects researchResearch involving only coded (de-identified) biological specimens or private information is not considered human subjects research if: the coded specimens or private information were not collected specifically for the purpose of the proposed research, andthe investigator(s) cannot readily ascertain the identity of the individuals to whom the coded private information pertains

13Determination of whether a project does, or does not, constitute human subjects research should be made in consultation with the IRB Chair

Categories of Human Subjects Research

Categories of Human Subjects ResearchExemptExpedited reviewFull IRB review

16Categories of Human Subjects ResearchExemptExempt means that a project is exempt from review by the full IRB committeeIf investigations qualify as exempt they may be administratively reviewed and approved by the chair of the IRBOnce approved, exempt studies do not require continuing review (no annual reporting) as long as the protocol and sample size do not change

Research on vulnerable populations is never exempt (pregnant women & fetuses, children, prisoners)17

Anonymous pedagogical studiesCommon types of exempt research

Anonymous surveys or test instruments

Research on existing data, documents, records, or specimens if the information is recorded by the investigator in such a way that subjects cannot be identified18Categories of Human Subjects ResearchExpedited ReviewCertain types of research involving no more than minimal risk Minimal risk defined as those risks that are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or testsExpedited applications are reviewed by the IRB chair and two committee members

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Collection of blood samples; collection of biological specimens by noninvasive means; noninvasive procedures routinely employed in clinical practice (excluding x-rays or microwaves)Common types of expedited research

20Surveys, test instruments, or research on data, documents, records, or specimens if the information is recorded by the investigator in such a way that subjects can be individually identified either directly or indirectly.Common types of expedited research

21Categories of Human Subjects ResearchFull ReviewResearch involving more than minimal risk to human subjects must be reviewed by the full Institutional Review Board

22What are the elements of a complete IRB application?Elements of a complete IRB applicationNecessary documentsForm A summary of the proposal (background, literature review, hypotheses, and methodology), personnel involved and their qualifications, subject recruitment, inclusion and exclusion criteria, confidentiality, risks and benefitsInformed Consent Document (or application for waiver)Any recruitment materials including introductory lettersQuestionnaires, surveys and/or interview questionsCertificate of completion of the NIH training on human subjects research (for all persons listed on Form A) (http://phrp.nihtraining.com/users/login.php)Current signed & dated CV for the PILetters of permission from non-MWU performance sites24Letters of PermissionIf data collection will be performed outside of MWU, the application must include a letter of permission from the administrator of the siteAdministrator provides letter on performance sites letterhead. Must include:What administrator is allowing you to do (e.g., observation, intervention, access to patients, access to medical records)Statement that the administrator will accept MWUs IRB approval25Dual IRB ReviewAn MWU IRB will not require dual review if all of the following conditions are met:The research is conducted at an institution with a registered IRB that has approved the research (MWU retains the right to accept or reject the other institutions approval)The primary appointment of the PI is with the other institutionMWU is not the primary recipient of funding for the researchData collection is conducted entirely at the other institutionForm A

Principal Investigator must be MWU faculty memberIf data collection to be performed at locations other than MWU, submit letter of support from each location

Anticipated number of subjects = maximum number approved for protocol (can be amended later)

27Form ASelect Research Category if Exempt or Expedited

28Form A

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Summary of the proposalClearly explain what you plan to do, who you plan to do it on, and why you plan to do itDescribe in detail your proceduresDescribe comparisons (justify sample size)Describe hypotheses or expected outcomes

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PersonnelIdentify all individuals involved in the study and describe their qualifications

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Subject recruitmentDescribe and justify your subject populationDescribe recruitment methodsInclude recruitment materialsE-mail, flyers, survey introductions, etc.

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Informed ConsentDescribe how you will obtain informed consent, or include application for waiver

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ConfidentialityDescribe how you will protect individual privacy and confidentiality of dataDescribe how information will be stored, and how and when study records will be destroyedInvestigators must retain consent documents and research records for at least 3 years after the completion of research activityDescribe how anonymity will be maintained in published format

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Risks to subjectsDescribe risks associated with your researchPhysical risksPsychological risksSocial/Economic risksLegal risksBreach of confidentialityLoss of privacyEstimate the magnitude and probability of the risksDescribe procedures used to minimize risk

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BenefitsDescribe benefits (to subjects or to others)*Explain how benefits outweigh risks

*Basic science (pursuit of knowledge) is a perfectly valid benefit36Informed ConsentPurpose of StudyProceduresRisks/DiscomfortsBenefitsAlternativesFinancial Costs to SubjectsStatement on Compensation for Research InjuryPayments to ParticipantsConfidentialityVoluntary consent and the right to discontinue without penaltyContact information

38Informed Consent3 key principles of Informed ConsentFull disclosureExplain exactly what the subject will experienceAvoid the terms I agree to . . . or I understand . . .Use the second-personAdequate comprehensionWritten at a 7th grade reading levelVoluntary participationIndividuals may refuse to participate at any time without penalty or loss of benefitsExculpatory language is not permitted

39Informed ConsentAdequate comprehensionUse fewer wordsUse smaller wordsUse shorter, less complex sentence structureAvoid technical jargon or scientific termsUse second personThink about the education level of your subject population and their familiarity with research!Correction of inappropriate comprehension level in the Informed Consent is one of the most-commonly requested revisions by the IRB40

Informed ConsentResearch involving children or protected health information requires HIPAA-compliant consent form

41HIPAA Identifiers (Protected Health Information)Names (excluding initials)All geographic subdivisions smaller than a State, including ZIP codeAll elements of dates (except year), including birth, death, admission and discharge dates; all ages over 89 years (may include age 89 years)Telephone numbersFax numbersEmail addressesSocial security numbersMedical record numbersHealth plan beneficiary numbersAccount numbersCertificate/license numbersVehicle identification numbers and serial numbers, including license plate numbersDevice identifiers and serial numbersURLsIP addressesBiometric identifiers, including finger and voice printsFull face photographic images and any comparable imagesAny other unique identifying number, characteristic, or code

42Informed ConsentChildrenAdolescents (> 12 years but < 18 years). HIPAA-compliant consent/assent form signed by parent and adolescentChildren 4-12 years. Two forms: Description of experience for child to sign. HIPAA-compliant consent form parental permissionChildren < 4 years. Consent form signed by parent

43Informed ConsentSigned consent is not always requiredExample: survey researchSurvey may be preceded by an introductory letter containing the relevant elements of informed consentState that completion and submission of the survey indicates consent to participate in the research studyContact person must be MWU faculty with MWU phone number / email

44What are some common mistakes and how can they be avoided?Common mistakesIncomplete application (e.g., NIH training certifications not provided for all investigators)Check that application contains all necessary elementsApplication lacks required signatures PI and Department Chair must sign Form AThe PI on the IRB application is not an MWU facultyResearch is described as having no risksLoss of privacy and/or breach of confidentiality is always a risk and needs to be recognized as such

46Common mistakesNo justification for payment of subjectsMust provide justification for compensating subjectsA procedure is included without any justificationProvide justification for all procedures listed in protocolExclusion criteria are provided, but there is no questionnaire to screen potential subjectsProvide screening questionnaireNo justification of sample sizeJustify sample size with power analysis or reference to published studies47Common mistakesApplication contains spelling mistakes, grammatical mistakes, or is otherwise below the threshold of acceptable academic writingInformed Consent must be linguistically correctHave a colleague proofread your applicationPIs mentoring students should proofread applicationData collection initiated before IRB approvalAll research must be approved prior to initiating studyProject exceeds approved number of subjects Additional subjects requires an amendment request

48Youve been approved!!Investigators must retain consent documents and research records for at least 3 years after the completion of research activityExpedited and Full Review protocols must receive continuing review: PI submits annual report, and final report when completeExempt studies do not require continuing review as long as the protocol and sample size do not changeChanges in protocol or sample size require an amendment request

49Further Informationhttp://www.midwestern.edu/ORSP.html Forms, templates, policieshttp://www.hhs.gov/ohrp/Federal regulations and guidelinesContact informationJason Kaufman, MWU Glendale IRB Chairjkaufm@midwestern.edu623-572-3717Lindsay Goboly, ORSP Research Coordinatorlgobol@midwestern.edu623-572-3728

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