IRB 101: Human Subjects PROTECTION PROGRAM

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IRB 101: Human Subjects PROTECTION PROGRAM. September 6, 2014 Graduate Development Conference Hila Berger, MPH, CIP Research Compliance Officer. Objectives. What is the IRB responsible for? And why? What is Human subjects research? What do we look for when reviewing a protocol? - PowerPoint PPT Presentation

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Human Subjects PROTECTION PROGRAM FOR THE RESEARCH ADMINISTRATOR

IRB 101:Human Subjects PROTECTION PROGRAM

September 6, 2014

Graduate Development Conference

Hila Berger, MPH, CIPResearch Compliance Officer

11ObjectivesWhat is the IRB responsible for? And why?What is Human subjects research?What do we look for when reviewing a protocol?Document requirements for submissionApproval designations: Full, Expedited, ExemptIRB 101 TOP TIPS22So Why BotherPrimary objective is to protect human participantsBound by law (45 CFR Part 46) under our FWA Federal Wide assuranceThus, we report to U.S. Department of Health & Human Services; Office of Human Research Protection (OHRP)OHRP will take corrective actions for non-complianceIncluding stopping all research projects related or un-related to the study in question

IT IS ETHICAL!

33IRB Missionto support faculty, staff, students to complete their research in compliance with federal and state laws and MSU policy. As such, the IRB is charged to review, approve initiation of, and conduct periodic reviews of research projects that involve human participants.4COVERED ENTITIES 4

IRB Committee and Staff12 Faculty/1 community membersAmy Krenzer, CIP, IRB coordinatorMylka Biascochea, IRB Program AssistantRaja Gounder, IRB Grad Student Assistant

5

Definition of human subjects researchHuman subject means a living individual about whom an investigator conducting research obtains(1) data through intervention or interaction with the individual, or(2) identifiable private information

Research is defined as a systematic investigation that is hypothesis driven with the intent to develop knowledge that can be generalized.6The following are examples of criteria to consider that would generally distinguish whether an activity is research:

The activity is designed, that is involves a predetermined method to study some phenomenon to answer a question and generate new knowledge. Research typically involves a fixed protocol, goal, methodology, population and time period.

The intent is that the activity is undertaken to contribute to generalizable knowledge, not to provide immediate and continuous improvement and feedback in the local setting. Generalizable knowledge applies beyond a specific time and location.

intervention, interaction and identifiable private information ("about whom"): Intervention: Includes both physical procedures by which data are gathered (for example, venipuncture, administration of a drug, administration of a survey or interview) and manipulations of the subject or the subject's environment that are performed for research purposes.Interaction: Includes communication or interpersonal contact between an investigator and subject.Private Information: Includes information about behavior that occurs in a context in which an individual can reasonable expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, medical records, school grades, height and weight measurements). Private information must be individually identifiable (i.e., the identity of the subject is or may be ascertained by the investigator or associated information) in order for obtaining the information to constitute research involving human subjects.

6Human Subjects research (HSR)?Survey of MBA students in NJ on their use of LinkedIn. Results to be generalizable to MBA students in NJ and published in NJ Business Education magazine

A - yes HSR

B - no HSR

C I dont know7

Student surveys others students in their class on their use of LinkedIn for a class project. Will use results to interpret the groups tendencies on social media and to advise the group in class only on how to improve their use of social media in business.

A - yes HSR

B - no HSR

C I dont know

8

Human Subjects research (HSR)?Human Subjects research (HSR)?Faculty surveys and interviews students about their experience with her online teaching vs. classroom teaching for self-improvement purposes9

A - yes HSR

B - no HSR

C I dont knowHuman Subjects research (HSR)?MSU Childrens Center conducting surveys after workshops and would like to present program as a model to other Centers on how to provide a particular service to parents. 10YES Program Evaluation can be HSR too!

A - yes HSR

B - no HSR

C I dont knowNot sure if what you are doing is human subjects research?Submit a Research determination form (RDF)Available at: http://www.montclair.edu/provost/institutional-review-board/forms/To reviewboard@mail.montclair.eduCall or email the IRB for further clarificationIRB Chair or designated member will get back to you within 7 business days to determine if you need to submit an IRB application11IRB submission process, REVIEW PROCEDURES and categories1212OVERALL STEPS in Process

ResearcherResearcher develops protocol and research plan

Researcher completes online Human Subjects training course (CITI)

Researcher completes IRB application form

Form and attachments submitted to IRB (reviewboard@mail.montclair.edu)Committee / Committee member review and category assignment (timeline anywhere from 3-7 weeks)Decision in writingStudent Researcher

1a) Student reviews research protocol with faculty sponsor

2a) Student & Faculty Sponsor completes online Human Subjects training course

3a) Student has Faculty Sponsor review and sign off on completed IRB application form before submitting

13How many IRB applications does the IRB review annually (new and continuing)?A ~50-75B ~100-150C ~200-250D ~300-35014

Application Forms & Templates15

Please update to the most recent Adobe Reader & do not fill out in the browserTHE IRB APPLICATION

16General themes involved in the IRB review (45 CFR 46.111)how participants are recruited to be in the studyhow the privacy of participants will be protectedthe physical, psychological, and sociological risks to participantsany discomfort and stress to participantsbenefits outweigh the risksconsent process (45 CFR 46.116)accurately reflect the studyConsent form written in simple lay language appropriate to the participant pool(language)

17SHOW F&D17THE IRB APPLICATION

18THE IRB APPLICATION

Example Only19THE IRB APPLICATION

Example Only20Checklist: Documents for IRB submissionCITI training completedApplication completed with signaturesConsent formTranslated consent forms if applicableSite agreements for any and all off-campus research sitesRecruitment material (flyer, ads, emails, brochures etc.)Scripts (e.g. in person pleas)Grant proposalData collection instrument (survey, interview questions etc.)

21PI sends submission to IRBIRB office processingIs the submission complete?Sent to a reviewerScheduled for Full Board, Expedited or Exempt in accordance with regulationsReview Performed either Full Board or by designated reviewerDoes the Submission Meet Criteria for Approval?Yes, Approval Processing Approval letter and stamped documents sent to PINo, Modifications required.Email sent to PI with clarifications and revisions. PI must respond within 30 daysCommon ProblemsMissing documentsDocuments incompletePersonnel not completed CITINo faculty sponsor signatureProvided information is not consistent among all documents

Email sent to PI identifying problems with submission. PI asked to re-submitYesNoYesNo

22Example of requested revisions from a reviewerApplication#4 - List yourself and all research team members.#7D - Change response to 'No' since you cannot access SONA participant pool (only for Psychology dept.)#16D - Left blank. Even though you may not anticipate an adverse event - you need to verify your understanding of the process for reporting an adverse event or unanticipated problem to the MSU IRB. #17B - MSU IRB policy as stated under #17 "All research data must be maintained for at least four years after the project is closed out or results published whichever occurs last." Please revise your answer. (ALSO correct in #18H)#17J-K - Please revise your process to indicate how you will make use of 3rd party recruiting and data collection in any classes in which you are the professor (also update in question #18 for all steps involved)Consent Form - Please submit, follow the template on our webpageScript and Information Sheet mentions an envelope for results, nothing is indicated in question #18H involving how finished surveys are handed in. 23How to make changes in Initial Application:Non-Mac UsersDelete the signatureMake changesSign and send

Mac Users Electronically signing application locks it foreverAlways save an unsigned application in latest versionUse unsigned application to make changes on save again as latest versionSign and save as another file so it can be sent into IRB

2424Three categories (45 CFR 46.109)Exempt (subcategories 1-6)Expedited(subcategories 1-9)Full Board(subcategories 1-10)

2525Criteria for exemptResearch activities that (1) present no more than minimal risk to human subjects and (2)involve only procedures listed in one or more of the government categories (1-6)Example: data analysis with de-identified existing data setExample: regular classroom activity where results are now intended for research

Exempt Review- Goal: 3 to 4 weeks

26authorized by 45CFR46.110 and 21 CFR 56.110

26Criteria for expeditedResearch activities that (1) present no more than minimal risk to human subjects and (2)involve only procedures listed in one or more of the government categories (1-9)At MSUExpedited: Collection of data through non-invasive procedures (e.g., weight)Expedited: Curriculum program evaluation involving surveys Most research on individual or group characteristics or behavior (including motivation, identity, social behavior, cultural beliefs) and research using survey, interview, focus group, program evaluationExpedited Review - Goal: 4 to 6 weeks

27authorized by 45CFR46.110 and 21 CFR 56.110

27

Criteria for full boardResearch activities that present greater than minimal risk to human subjectsTriggersAny disclosure of illegal activities, sexual attitudes, genetics, religious beliefs, mental health that could place participants at risk of criminal or civil liability, be damaging to the participants financial standing, employability, insurability, reputation, or be stigmatizingDepression and mental health disordersViolent crimesOpinion about employerCoercionDeception or incomplete disclosurePopulation involves persons with cognitive disabilitiesPregnant womenMedically invasive, e.g., clinical trial Full Review- Goal: 6 to 8 weeks (involves review of entire committee)

28authorized by 45CFR46.110 and 21 CFR 56.110

28IRB Deadlines29

(all applications are accepted on rolling basis; deadlines will apply for Full Board studies)A - 5%B - 20%C - 40%D - 60%E - I dont know what full board isWhat percent of IRB research at MSU is Full Board/greater than minimal risk?30

IRB 101 TOP TIPS TO IRB SUBMISSION3131IRB 101: TIP #1 Complete submissionObtain all signatures

Answer every question

Attach your grant proposal and match the title (if applicable)

Use mail.montclair.edu email address for submissionsFill in Subject Line and Body of Email next slide

32Emailing the IRB33

IRB 101: TIP #2 Clear research designWhat will you do? In simple and clear termsParticipant observationSurveysInterviewsInterventionDeception or Incomplete disclosureClearly describe your benefitsDo not copy and paste your entire grant proposal, thesis, or manuscript

34Instrument Design for Online SurveysMSU IRB does not require use of one survey toolSurvey toolsMSU survey https://surveys.montclair.edu/survey/login.jsp?r=1Only one screen; difficult to consent unless you create 2 surveysMSU limesurvey https://msusurveys.montclair.edu/admin/admin.php Data stored in-house; similar features to survey monkeyOther survey tools:http://idealware.org/articles/fgt_online_surveys.phpFor consent use the template for implied consent for online surveys35IRB 101: TIP #3 Proper Informed consent Understand Consent vs. AssentAssent form with Parent/Guardian Consent if research is with minorsTemplate available online only to be used as outlineThe consent should clearly and succinctly tell people what your study is about; including any screening proceduresReadability levelAdults 6th-8th grade reading level for general publicAsk for help!36CONSENT Example explaining the studyPoorThis survey is about cervical cancer and screeningScreening what?Cervical cancer risk?Cervical cancer symptoms?

BetterThis survey will ask you questions about perception of cervical cancer risk and screening behaviors of college aged female students. I hope to learn about what young women know about cervical cancer and risk factors, how they perceive risk, and how that effects whether or not they have been screened for cervical cancer.37IRB 101: TIP #4 RecruitmentDetermine who your study population isJustify inclusion or exclusion criteria in screeningIf you are using your own students or staff then you must adjust your data collection to avoid undue coercionFAQs online provide optionsUsing SONA (Psychology department)SONA is a course requirement for certain psych courses; 1 SONA credit=30 minutes of research timePopulation is accessible to Psych faculty and psych graduate researchers onlyIf you are using SONA you cannot also pay your subjects

38Recruitment Example This study will be recruiting at MSUThis study will recruit 30 students and 30 staff members at MSU. Students: We will be soliciting students outside the student center. Students agreeing to be involved will be given contact information to the study coordinator. The coordinator will email the consent form to interested participants. Only students that return the signed consent form will receive a link to the survey.Staff: Staff will be solicited through the for sale listserv accessible to all students and staff. The email plea is attached with this application.

I am recruiting my own studentsThe faculty member will leave the room 15 minutes prior to the end of class. The GA will enter the room explain the study and hand out consent forms. Students can choose to complete the consent form and survey or leave the class with no obligation. The GA will collect the signed consent form and completed survey in separate envelopes. Results will only be available to the PI after grades are submitted.

39IRB 101: TIP #4 Be consistentConfidential vs. anonymousOnly anonymous if researcher and others cannot identify the participant (i.e. online survey)Participation time should be the same in application and in your consent formUse of data in the futureIf you ask for permission to use data in future studies then include this on the consentCompensationCompensation noted in the application...

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