Presentation on theme: "University of Missouri Campus institutional review board"— Presentation transcript:
1University of Missouri Campus institutional review board IRB BasicsPresenter: Janelle Greening, M.B.A., C.I.P. Compliance OfficerRevised: April 2012
2Campus irb Websites Campus IRB Website: Online Electronic System: Online Electronic System:MU faculty, staff and students can login without creatingan account.Location: 485 McReynolds Hall
3IRB CERTIFICATION www.citiprogram.org Create an Account Associate with UMCCampus SBR – User GroupBasic Course: Select “Human Subject Research Course”Refresher Course*Do not complete the Responsible Conduct of Research modules – it will not count towards IRB trainingTraining is active for two years.
4Join our listserv Up-to-date IRB information Changes to policies and proceduresTraining opportunitiesSend an to and putting “SUBSCRIBE CIRB” in the body of the
6Topics to cover IRB Functions Ethical Principles Federal Definitions 3 Levels of ReviewSpecial Categories of ResearchVulnerable SubjectsRecruitment ProcessInformed ConsentInvestigator Reporting RequirementsIRB FormsCriteria for Approval
7Today’s objectivesBasic understanding of the federal regulations governing human subject researchBasic understanding the federal definition of “human subject” and “research”Understanding the importance of informed consent and respect for personsKnowing your reporting responsibilitiesMaintaining appropriate oversight of your research
8purposeSafeguard human subject research participants in accordance with the DHHS federal regulations 45 CFR 46Comply with the ethical principles outlined in the Belmont Report, released in 1979Comply with MU Institutional Policy Chapter 410: Research Involving HumansComply with the Federalwide Assurance AgreementComply with State or Local laws which provide additional protections for human subjects
9Irb Functions and operations Protect the rights and welfare of human subjectsReview, approve, require modifications, or disapprove all research activities involving human subjectsApprove changes in previously approved research (adding/removing components)Provide continuing review of all humans subject research activitiesAny other steps necessary to protect the human subject participants
10Ethical principles Belmont Report: A statement of the basic ethical principles to be used to resolve ethical problems that surround the conduct of research with human subjectsIdentifies three basic principles for conducting research with human subjectsProvides a foundation for the federal regulationsMU must comply with the Belmont Report as outlined in our Federalwide Assurance AgreementFocus on what is right or wrong
11Campus Irb membership At least 5 members Diverse membership 1 non-affiliated member1 scientific member1 non-scientific memberAdequate expertiseConsultants, if necessary
12Respect for personsRecognition of personal dignity and autonomy of individualsCreate a meaningful consent processProvide subjects with all necessary information to make a decision to participateAllow subjects to withdraw without penalty or adverse consequencesDemands that subjects enter into the research voluntarily and with adequate informationPersons with diminished autonomy are entitled to protection
13beneficence Minimize risks of harm and maximize the potential benefits Ensure the benefits justify the risks of harmRisks may include:PhysicalPsychologicalLegalSocialEconomic
14justiceFair procedures and outcomes in the selection of research subjectsSelection of research subjects needs to be scrutinized in order to determine whether some classes are being systematically selected simply because of their easy availability, their compromised position, or their manipulability, rather than for reasons directly related to the problem being studied.Participants should not be selected for research solely because:they are available;vulnerable; orthey cannot say no
15accountability Institution Investigator IRB We are all accountable for a successful local human subject protection programEach is expected to play a role
16Federalwide assurance A contractual agreement between MU and OHRP which guarantees this institution’s commitment that all human subject research complies with the regulations protecting human subject participants.
17EngagementAssess whether our institution is considered to be engaged in the research.Examples of being engaged (requires IRB review at MU):Consenting participantsIntervening or interacting with participantsObtaining identifiable private information or identifiable biological specimens from any source for the researchMU is the lead on a contract or grant, even when the research is conducted elsewhere
18Not engagedExamples of activities that would not require review by MU’s IRB:Inform subjects about the availability of the research;Provide subjects with information about the research but do not obtain subjects’ consent or act as representatives of the investigators;Provide subjects with information about contacting investigators for information or enrollment; and/orSeek or obtain the subjects’ permission for investigators to contact them.Permit use of our facilities.Release to investigators at another institution identifiable private information or identifiable biological specimens pertaining to the subjects of the research.Obtain coded private information or human biological specimens from another institution , but cannot readily ascertain the identity of the subjects.
19Research Human Subject Minimal Risk Federal definitionsResearchHuman SubjectMinimal Risk
20researchA systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledgeInternal MU Definitions:Systematic Investigation: A "systematic investigation" is an activity that involves a prospective plan that incorporates data collection, either quantitative or qualitative, and data analysis to answer a question.Generalizable Knowledge: Investigations designed to develop or contribute to generalizable knowledge are those designed to draw general conclusions, inform policy, or generalize findings beyond a single individual or an internal program (e.g., publications or presentations.) However, research results do not have to be published or presented to qualify the experiment or data gathering as research. The intent to contribute to "generalizable (scholarly) knowledge" makes an experiment or data collection research, regardless of publication.
21Human subject A living individual about whom an investigator obtains: Data through intervention or interactions with the individual; ORIdentifiable private information
22Human subject continued Intervention: Includes both physical procedures by which data are gathered and manipulations of the subject or the subject’s environment that are performed for research purposesInteraction: Includes communication or interpersonal contact between investigator and subject
23private informationIncludes information about behavior that occurs in a context in which:An individual can reasonably expect:That no observation or recording is taking place, ANDThe information will not be made public.Private information must be individually identifiable (i.e. the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.
24Minimal riskThe probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those encountered in daily life or during the performance of routine physical or psychological examinations or tests.
25Exempt Expedited Full Board 3 levels of irb reviewExemptExpeditedFull Board
26exempt Determination must come from the IRB Projects involving minimal riskMust fall under 1 of the 6 categories in the federal regulations 45 CFR 46Cannot involve prisoners or childrenInvestigators must complete the Exempt Application for initial reviewModifications: Exempt Amendment FormContinuing Review: Annual Exempt Certification FormComplete Applications: ~1 business day turnaround time
27Exempt categoriesResearch conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.
28Exempt categories cont… Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (b)(2) of this section, if: (i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.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, directly or through identifiers linked to the subjects.
29Exempt categories cont… Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine: (i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
30expedited Projects involving minimal risk Minor changes to approved researchMust fall under 1 of the 7 categories of initial review or 1 of the 2 categories of continuing reviewInvestigators must complete the Expedited/Full Board Application for initial reviewModifications: Amendment FormContinuing Review: Continuing Review Status ReportComplete Applications: ~5-10 business day turnaround time
31Full boardProjects not meeting the criteria for Exempt or Expedited reviewProjects involving greater than minimal riskInvestigators must complete the Expedited/Full Board Application for initial reviewModifications: Amendment FormContinuing Review: Continuing Review Status ReportDeadline: 1st of every month or the following business day
32Continuing reviewAn IRB shall conduct continuing review of research covered by this policy at intervals appropriate to the degree of risk, but not less than once per year.PURPOSE: Ensure the research remains justified and the rights and welfare of the participants continue to be fully protected.Failure to provide the annual report could lead to study suspension, a loss of funding and/or publication possibilities, or reporting of noncompliance to sponsors or funding agencies.
33Special categories of research to discuss Internet ResearchInternational ResearchEthnographic ResearchSurvey ResearchQualitative ResearchCollaborative ResearchDeception StudiesAny others you would like to discuss?
34Research that may not be subject to irb review Research using de-identified secondary datasetsQuality improvement/program evaluation only studiesClassroom research only submitted for a grade – not disseminated outside the classroom
35Vulnerable populations Vulnerable as defined by the federal regulationsPregnant Women: 45 CFRPrisoners: 45 CFRChildren: 45 CFRWards: 45 CFRPossible other vulnerable subjectsStudentsLow-IncomeEmployeesElderly
36prisonersConstraints could affect their ability to make a truly voluntary and uncoerced decision whether or not to participatePrisoner representative will review the studyMust fall under one of the categories for research involving prisonersParole boards will not take into account a prisoner’s participation in researchAdditional duties of IRBs where prisoners are involved
37childrenResearch must fall under one of the four categories for research involving childrenCannot be ExemptChild assent and parental permission must be obtained unless waivedDescribe for the IRB how child assent will be documented if not written
38wardsGreater than minimal risk studies where there is no direct benefit:Research is related to their status as wards; orConducted in schools, camps, hospitals, institutions, or similar settings in which the majority of children involved as subjects are not wards.
40Subject recruitment The four Cs of Recruitment from an IRB perspective Consent (ongoing)CoercionConfidentiality and PrivacyCompleteness (accuracy as well as truthfulness versus deception)
41advertisementsThe advertisement is limited to the information the prospective subjects need to determine their eligibility and interest, such as:The name and address of the investigator or research facilityThe condition under study or the purpose of the researchIn summary form, the criteria that will be used to determine eligibility for the studyA brief list of participation benefits, if anyThe time or other commitment required of the subjectsThe location of the research and the person or office to contact for further information
42COMPENSATION Describe the amount, method, and timing of disbursement Compensation is not contingent upon completing the entire studyAny amount of compensation as a bonus for completion is reasonable and not so large as to unduly induce subjects to stay in the study when they would otherwise have withdrawnCourse/Extra Credit: The alternative assignment is comparable in time and effortAccounting Services Approval is required when the investigator proposes to use internal or external funding, and offering cash or non-cash items to their subjects
43Informed consentInformed consent is a process that enables persons to voluntarily decide whether or not to participate as a research subject
44Respect for personsConsent is a fundamental mechanism to ensure the basic ethical principle of respect for persons is met through a provisional process of thoughtful consent for a voluntary act.Consent is a procedure designed to educate the subject population in terms that they can understand.
45Issues to considerWho is obtaining consent and do they have proper training and oversight?Is it coercive?Is it voluntary?Does the subject have time to consider participation?Does the subject understand the alternatives?Do they have the legal and mental capacity to consent or is a Legally Authorized Representative required to consent on their behalf?
46Basic Elements of consent (1) A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental;(2) A description of any reasonably foreseeable risks or discomforts to the subject;(3) A description of any benefits to the subject or to others which may reasonably be expected from the research;(4) A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;(5) A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;(6) For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;(7) An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject; and(8) A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
47Additional elements of consent (1) A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable;(2) Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent;(3) Any additional costs to the subject that may result from participation in the research;(4) The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject;(5) A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject; and(6) The approximate number of subjects involved in the study.
48Types of consent Written Consent Short Form Waiver of Documentation (no signature)Waiver of ConsentA copy of the consent document must be provided to the subject unless waived by the IRB
49Short formFor the occasional and unanticipated non-English-speaking subject, an alternative "short form" method is allowedUsed because no consent form in the subject's language was preparedRoutine use of the "short form" for obtaining informed consent is strongly discouragedThe short form consent process cannot be used for vulnerable subject populationsThere will be a witness to the oral presentationContact the IRB for additional requirements
50Criteria for waivers Waiver or Alteration of Consent No more than minimal risk to subjectsWould not adversely affect the rights and welfare of subjectsCould not practicably be carried out without the waiver or alteration; andWhen appropriate, debriefing session is availableWaiver of Documentation That the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern; or That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.
51Comprehension/Readability Does the subject understand the information provided?It is your responsibility to enhance each subject’s comprehension of the informationAvoid complex terms and sentencesNo exculpatory language (waiving legal rights)The investigator must consider:The nature of the subject populationThe type of information conveyedThe circumstances under which the consent process will take placeThe primary language of the participant
52Template language Contact our office for template language: Certificates of confidentialityUse of electrodesStudies involving alcohol consumptionIRB contact informationInjury statement (greater than minimal risk studies)Etc.
53Non-english speakingTranslated documents shall be prepared after IRB review and approval of the English versionMinimal Risk Studies: The qualifications of the individual performing the translation will be assessed by the IRB. A letter from the translator describing their qualifications must be provided with the translation documents.Greater than Minimal Risk Studies: A certified translation is one that has been formally verified by a licensed translator or translation company for use in official purposes.
54Parental and youth assent The parental consent process must contain all elements of consent unless a waiver is approved by the IRBConsent may need to be obtained from one or two parents (greater than minimal risk studies with no direct benefit)The IRB shall determine that adequate provisions are made for soliciting the assent of children.Are the children capable of providing assent?Is a waiver appropriate?Take into consideration age, maturity, and psychological state
55Consent approvalsThe Campus IRB will save a revised copy of your consent document(s) to the document storage of eIRB. We will place a footer in the document with the approval date and IRB number.You must use this copy when obtaining consent.
57Reporting requirements ChangesDeviationsUnanticipated ProblemsConflicts of InterestSubject ComplaintsKnown or suspected noncomplianceFunding Source / Personnel changesSuspension or closure of approved projectsAny issue that arises that could impact the adequate protection of human subjects involved in research
59Campus irb forms Exempt Application Expedited/Full Board Application Exempt AmendmentAmendment Form (Expedited/Full Board)Annual Exempt Certification FormContinuing Review Status ReportEvent ReportSite Additions FormProject Personnel Change FormCompletion/Withdrawal Report
60supportive documentation Exempt Research:Permission LettersAccounting ServicesCover LetterFunding ProposalInstrumentsInterview QuestionsSurvey QuestionsFocus Group QuestionsInformation provided to subjects about the researchExpedited & Full Board Research:Permission LettersRecruitment MaterialsConsent DocumentsAccounting ServicesInstrumentsFunding ProposalsAny other documents to support the research application
61Document storage: new feature The IRB now marks approved documents.You must use the documents we mark approved in document storage.Go to the upper right hand corner and select approved documents from the drop-down list.Use the IRB approved consent documents stamped with our approval footer
62Data storageThe research plan makes adequate provision for monitoring the data collected to ensure the safety of the subjectsThere also must be adequate provisions to protect the privacy of subjects and to maintain the confidentiality of the data.All research records must be retained for at least seven years after completion of the research – including audio, video, and photographsInspectionCopyingRecords must be retained at MU
63Criteria for irb approval of research Risks to subjects are minimizedRisks to subjects are reasonable in relation to anticipated benefitsSelection of subjects is equitableInformed consent will be sought from each prospective subjectsInformed consent will be appropriately documentedWhen appropriate, the research plan makes adequate provisions for monitoring the data collected to ensure the safety of the subjectWhen appropriate, the research plan makes adequate provisions to protect the privacy of subjects and to maintain confidentiality
64Every effort must be made to protect human subjects from harm. conclusionEvery effort must be made to protect human subjects from harm.