uiuc institutional review board - university of illinois - irb administration

10
8/21/2015 UIUC Institutional Review Board University of Illinois IRB Administration http://oprs.research.illinois.edu/?q=formsandinstructions/tipsheet.html 1/10 IRB1 Application Tipsheet Section of IRB1 Application Form Tips 1. Responsible Project Investigator * Name and contact information of the Responsible Project Investigator. * Must be UIUC faculty or staff. Cannot be a student, post doc or visiting faculty 2. Project Title * Do not use the same title for more than one project. 3. Investigators * List everyone who will be responsible all aspects of the research. This includes individuals who are not affiliated with UIUC.� * Provide all contact information for all researchers, attach additional sheets if necessary. * Provide complete contact information 4. Research Staff * Provide the contact information for anyone else who is involved in the protocol as a research staff person (responsible for data collection, analysis, recruitment, etc.) Attach additional sheets if necessary. 5. A. Funding Status * Indicate whether this project will be supported by internal or external funding. 5.B. Source(s) * Indicate the source(s) of the funding 5.C. Proposal * Attach a copy of the proposal or contract. * Provide the title of the proposal or contract if different from the title of this project.

Upload: nina-howard

Post on 25-Jan-2016

4 views

Category:

Documents


2 download

DESCRIPTION

UIUC Institutional Review Board - University of Illinois - IRB Administration (image only)

TRANSCRIPT

Page 1: UIUC Institutional Review Board - University of Illinois - IRB Administration

8/21/2015 UIUC Institutional Review Board ­ University of Illinois ­ IRB Administration

http://oprs.research.illinois.edu/?q=forms­and­instructions/tipsheet.html 1/10

IRB­1 Application ­ Tipsheet

Section ofIRB­1ApplicationForm

Tips

1. ResponsibleProjectInvestigator

* Name and contact information of the Responsible Project Investigator.

* Must be UIUC faculty or staff. Cannot be a student, post doc or visiting faculty

2. Project Title * Do not use the same title for more than one project.

3.Investigators

* List everyone who will be responsible all aspects of the research. This includesindividuals who are not affiliated with UIUC.�

* Provide all contact information for all researchers, attach additional sheets ifnecessary.

* Provide complete contact information

4. ResearchStaff

* Provide the contact information for anyone else who is involved in the protocol as aresearch staff person (responsible for data collection, analysis, recruitment, etc.)Attach additional sheets if necessary.

5. A. FundingStatus

* Indicate whether this project will be supported by internal or external funding.

5.B. Source(s) * Indicate the source(s) of the funding

5.C. Proposal * Attach a copy of the proposal or contract.

* Provide the title of the proposal or contract if different from the title of this project.

Page 2: UIUC Institutional Review Board - University of Illinois - IRB Administration

8/21/2015 UIUC Institutional Review Board ­ University of Illinois ­ IRB Administration

http://oprs.research.illinois.edu/?q=forms­and­instructions/tipsheet.html 2/10

*Protocols funded generally be start­up funds for faculty or be departmental fundingtypically do not require formal funding proposals (so none needs to be supplied).

NOTE: � Grants & Contracts does not forward copies of submitted proposals to theIRB office.

5.D. FundingOfficial To beNotified of IRBApproval

6. Conflict ofInterest

* Indicate whether you or any of the other project investigators (or families) has anyconflict of interest by checking any of the four different types of financial conflict ofinterest listed in section 6, and by indicating whether this conflict has been disclosed toUIUC.

* NOTE: This section refers to financial conflicts of interest only.

7. Summarizethe Research

Examples

* The reviewers need to understand what you are doing and why.

* Avoid using technical jargon. Not all reviewers are conversant in your discipline.

8.PerformanceSites

* List exactly where the research project will take place.

* If conducted at another institution (completely or in part) IRB approval will beneeded from that institution as well if that institution requires it. This includesresearch conducted at institutions outside the U.S.

*For protocols with collaborators at other institutions requiring IRB approval, pleasesubmit a copy of that IRB�s approval letter once obtained.

* If a research site does not have an IRB, a letter of permission may be required.

Page 3: UIUC Institutional Review Board - University of Illinois - IRB Administration

8/21/2015 UIUC Institutional Review Board ­ University of Illinois ­ IRB Administration

http://oprs.research.illinois.edu/?q=forms­and­instructions/tipsheet.html 3/10

9. A.SecondaryData

* Indicate the proposed research involves data that has already been collected byanother investigator who is willing to share the data (which was presumably acquiredwith IRB approval from UIUC or another institution). This would also apply for UIUCresearchers who move here from another institution and wish to analyze data theycollected with IRB approval from their former institution

9. B. Materialsof HumanOrigin

* If any human biologicals are involved indicate so and complete a BiologicalMaterials Form

9.C.Anticipatednumbers

* How many subjects will be part of this project in total? Include the number of ALLindividuals who will contribute data to this project.

* Break the numbers down by gender and performance sites.

* Be sure total lines are correct.

9.D. AgeRange

* Select as many age ranges as needed.

**Common Problems: age range is inconsistent throughout the application form.

NOTE: If the project involves minors (under age 18) and more than minimal risk,document the benefits on a separate sheet.

9.E. Special ofVulnerablePopulations

* Select as many of the boxes as necessary. If there are no special or vulnerablepopulations, check <None>.

*If there are special/vulnerable populations checked, clarify in the text box for 9e whatspecial precautions are taken to protect their rights and welfare (e.g., if UIUC studentsare involved, do the investigators only recruit in classes that they are not affiliatedwith as an instructor)

10.A.RecruitingProcedures

* Clearly describe how you will recruit subjects; attach everything you will use torecruit including: flyers; newspaper ads, scripts used to telephone people or to speakthem, text of e­mail recruiting, radio and television announcements.

Page 4: UIUC Institutional Review Board - University of Illinois - IRB Administration

8/21/2015 UIUC Institutional Review Board ­ University of Illinois ­ IRB Administration

http://oprs.research.illinois.edu/?q=forms­and­instructions/tipsheet.html 4/10

Examples **Common Problems:

��� ­ Language in recruiting materials is inconsistent with the rest of the IRB 1form.

��� ­ attachments not included

10.B. WithheldInformation

Examples

* If you plan to withhold any information from the participants about their role in theresearch project, mark �Yes� and justify your reasons for withholding theinformation.

NOTE: In most cases you will be required to debrief the volunteers once theirparticipation is completed. Please attach the document or script you will use to fullyinform the subjects after participation has ended.

10.C.ProtectedHealthInformation

* There is no UIUC �HIPAA Compliance Form.� Researchers who will obtainprotected health information (PHI) from a covered entity should use the formrecommended by that entity. In cases where the covered entity does not have aHIPAA form, HIPAA language may be added to the consent form. Additionalinformation about PHI and HIPAA language can be found on the IRB Web site.

10.D. SchoolsBasedresearch

* Indicate whether or not you will be using participants from Illinois schools.

* All research projects proposed for Illinois schools must ALSO be approved of by UIUCOffice of School­University Research Relations [(217) 244­0515]

11. Inclusionand ExclusionCriteria

Examples

* Explain why you are selecting these persons.

* Justify the exclusion vulnerable populations (children, prisoners, persons withcognitive impairment, etc.) or other groups.

*When inclusion/exclusion criteria exist, clarify who will be making the determination(e.g., investigators, by participant self­report, participant�s physician, etc.)

* Be specific with the criteria.

Page 5: UIUC Institutional Review Board - University of Illinois - IRB Administration

8/21/2015 UIUC Institutional Review Board ­ University of Illinois ­ IRB Administration

http://oprs.research.illinois.edu/?q=forms­and­instructions/tipsheet.html 5/10

*If allowing audio taping or videotaping is a requirement for participation, pleaseindicate that in this section.

12. ResearchProcedures

Examples

* Describe exactly how the research will take place.� It is helpful to the reviewer todetail the process in a step­by­step fashion (number each step).

* Include location, duration of each related activity.

*For studies involving examination of existing data, clarify how that data was collected.

* Note the number of sessions subjects will be asked to complete, and describe anyaudio/video taping or photography procedures.

13. Equipment

Examples

* Attach a Research Equipment Form for research involving any physical orphysiological data acquisition equipment. A copy of this form is available on the IRBWeb site at:

14. Drugs,Devices,Biologics

* Attach a Drugs, Agents, and Devices Form for research involving any drugs,devices, or chemical or biological agents. A copy of this form is available on the IRBWeb site.

15. MRI at BIC *Check appropriate boxes only if the study involves magnetic resonance imaging doneat the BIC (Biomedical Imaging Center) at UIUC.

16. Measures * List and attach copies of all questionnaires, survey forms, tests, interview questions,inventories, psychological measures, and other instruments or measures that will beused.

* A copy of the measures is required even in research involving open­ended, informalinterview procedures.

* The IRB cannot approval a project without a copy of all measures.

*The IRB needs complete measures rather than just examples (e.g., all pictures being

Page 6: UIUC Institutional Review Board - University of Illinois - IRB Administration

8/21/2015 UIUC Institutional Review Board ­ University of Illinois ­ IRB Administration

http://oprs.research.illinois.edu/?q=forms­and­instructions/tipsheet.html 6/10

reacted to by the participants, all scenarios they are responding to, etc.) The exceptionmight be that lengthy published tests may not have to be supplied in their entirety,please check with the IRB.

17. SubjectRemuneration

* Will subjects receive compensation in terms of money, course credit, extra points,gifts, gift certificates, etc?

* If subjects do not complete the study explain if and how they can receive partialcompensation

* If participants receive a �lottery ticket� for a prize, indicate the number of prizesavailable, the value of the prize, the odds of winning, the dates of the drawing(s), andhow winners will be notified. (This information should also be included on the consentform).

18. SubjectOutlay

* Do the subjects incur any costs or expenses due to participating in the research suchas parking or mileage?

19.Confidentialityof Data

* These questions center on whether or not the data collected will remainconfidential.� Confidentiality is required unless specifically waived by the participantin the informed consent document.

19.A. (datarecordingcheckboxes)

* Indicate whether any data will be recorded on tapes or other imaging.

19. B. DataCollection

Examples

* Provide a detailed description of how confidentiality will be maintained during thedata collection.

* Outline how the data will be coded and indicate whether an identity key linkingsubjects� names to their ID code will be maintained.

**Common Problem: Failure to explain clearly how the investigator will collect the datawithout being able to trace the data to the participant.

19.C. DataSecurity

* Indicate where the data (e.g., audio/video tapes, photos, imaging, completedmeasures, consent forms, etc.) will be stored. �

* Data should be stored on campus. If not justify why they will be kept elsewhere.

Page 7: UIUC Institutional Review Board - University of Illinois - IRB Administration

8/21/2015 UIUC Institutional Review Board ­ University of Illinois ­ IRB Administration

http://oprs.research.illinois.edu/?q=forms­and­instructions/tipsheet.html 7/10

Examples * Indicate that data key (if any), informed consent documents, and the data itself willall be stored separately at the research site (or when data is in transit).

19.D. StaffTraining

Examples

* Describe the type of human subjects research training or experience theinvestigators have relating to this project (e.g., ethics training, IRB workshops, pasthuman subjects research experience, etc.).

* Describe the methodology training or experience researchers have relating to thisproject (e.g., qualitative methods courses).

19.E.DataRetention

Examples

* Indicate how long the data will be retained. Note: Consent forms must be securelystored (separate from the data) for three years (e.g., locked file cabinet or desk inoffice).

19. F.Disseminationof Results

Examples

* Describe all methods anticipated for distributing the results of the research (journals,presentations, annual reports, classroom project, thesis, dissertation, etc.)

19. G. Privacy *privacy refers to the �individuals right to control access to themselves (note:privacy concerns people, whereas confidentiality concerns data). For example, personsmay not want to be seen entering a place that might stigmatize them, such as apregnancy counseling center that is clearly identified as such by signs on the front ofthe building. Any plans related to this issue should be detailed in this section.� Inaddressing privacy, issues that may be of concern include the methods used to identifyand contact participants, appropriateness of each research staff person being presentin research activities, etc.

19. H.IndividuallyIdentifiableInformation

* State whether or not individually identifying data will be revealed in disseminatingthe results. �(If photos audio or video clips will be disseminated, answer �Yes�to this question.)

Page 8: UIUC Institutional Review Board - University of Illinois - IRB Administration

8/21/2015 UIUC Institutional Review Board ­ University of Illinois ­ IRB Administration

http://oprs.research.illinois.edu/?q=forms­and­instructions/tipsheet.html 8/10

NOTE: If data cannot be kept confidential, this must be stated on the informedconsent document.

20. InformedConsent

* This section�

Attach all consent forms to be used including any consent scripts that are read toparticipants, plus any children assent forms.

SEE ALSO: ELEMENTS of INFORMED CONSENT

20. A. Type ofConsent

* Indicate what types of consent will be used for ALL participants.

* Written consent/assent is recommended for individuals who are at least eight yearsof age.

*If written consent is not feasible, please justify the use of alternative methods toobtain consent. The alternatives are Waiver/Alteration of Informed Consent andWaiver of Documentation. Check the appropriate boxes for either option in 20a andsupply the appropriate waiver form.

Both forms are available under Forms and Instructions on the IRB web site.

­­Waiver/alteration of informed consent � form is used to justify having no consentprocess/form at all, or altering the usual elements of consent in some way (e.g.,parents only sign form if they DON�T want their children to participate in a study,study involves deception so exact purpose can�t be detailed, etc.)

­­Waiver of documentation ­ this form is for when the consent document includes allelements of consent, but there will be no signature (documentation). This type ofconsent could be online consent, an unsigned �informational sheet� typeconsent, or oral consent done over the phone as long as all the elements of consentare on the form that is read to the participants and a copy was sent to thembeforehand.

20.B and 20.C.Use of a Proxy

* In the case of adults indicate if someone else is authorizing consent in 20b and addjustification in 20c.

Page 9: UIUC Institutional Review Board - University of Illinois - IRB Administration

8/21/2015 UIUC Institutional Review Board ­ University of Illinois ­ IRB Administration

http://oprs.research.illinois.edu/?q=forms­and­instructions/tipsheet.html 9/10

20.D. ConsentProcess

* Describe the consent process for each type of consent listed in 20.A.

**Common problem: the description of the consent process is not detailed enough.Please review the questions supplied in 20d.

21.A. Risks

Examples

* Do not state that there is no risk. Risk can be physical, psychological, social, andeconomic. At minimum state that there are no risks beyond those that exist in dailylife (if such is judged to be the case).

21 B. RiskLevel

* Indicate the risk level. Minimal risk is defined to be: the probability and magnitude ofharm or discomfort anticipated in the proposed research are not greater, in and ofthemselves, than those ordinarily encountered in daily life or during the performanceof routine physical or psychological examinations or tests.

21 C.�OngoingMonitoring for�More thanMinimalRisk�Studies

*Elaborate on data protection plans and ongoing monitoring plans that are in place toinsure that data is protected and that the benefits continue to outweigh the risks for�more than minimal risk� studies. Please address the specific questions posed onthe IRB­1 in this section; note that this section is ONLY required if the study is codedas being �more than minimal� risk.

22. Benefits

Examples

* Describe the anticipated benefits the research will have on the subjects and tosociety.

**Common Problem: Participant compensation, course credit, etc.� is NOT a benefit� these issues should be mentioned in section 17 (subject remuneration).

23 RiskBenefitAssessment

Examples

* Weigh the risks and benefits as described above and show that the benefits outweighany risk.

* Feel free to copy and paste statements from sections 21 and 22 when completingthis section as appropriate.

Page 10: UIUC Institutional Review Board - University of Illinois - IRB Administration

8/21/2015 UIUC Institutional Review Board ­ University of Illinois ­ IRB Administration

http://oprs.research.illinois.edu/?q=forms­and­instructions/tipsheet.html 10/10

24. Multi­sitestudy

*Respond to the yes­no question here regarding whether there are other universitiesor research sites involved with the study with UIUC acting at the lead (UIUC is themain funding awardee with subcontracts awarded to other institutions).

25.InvestigatorAssurances

* The signature of the RPI and all participating investigators assures that they knowthe UIUC policy on human subjects research and that the proposed research will becarried out in accordance with these policies.

**Common Problem: IRB­1 is submitted without original signature.

25.DepartmentalAssurance(Optional)