Section of IRB-1 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.

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

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

5.D. Funding Official To be Notified of IRB Approval

6. Conflict of Interest

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

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

7. Summarize the 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.Performance Sites

* List exactly where the research project will take place.

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

*For protocols with collaborators at other institutions requiring IRB approval, please submit 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.

9. A. Secondary Data

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

9. B. Materials of Human Origin

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

9.C. Anticipated numbers

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

* Break the numbers down by gender and performance sites.

* Be sure total lines are correct.

9.D. Age Range

* 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 of Vulnerable Populations

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

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

10.A. Recruiting Procedures

Examples

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

**Common Problems:

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

��� - attachments not included

10.B. Withheld Information

Examples

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

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

10.C. Protected Health Information

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

10.D. Schools Based research

* 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 UIUC Office of School-University Research Relations [(217) 244-0515]

11. Inclusion and Exclusion Criteria

Examples

* Explain why you are selecting these persons.

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

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

* Be specific with the criteria.

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

12. Research Procedures

Examples

* Describe exactly how the research will take place.� It is helpful to the reviewer to detail the process in a step-by-step 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 any audio/video taping or photography procedures.

13. Equipment

Examples

* Attach a Research Equipment Form for research involving any physical or physiological data acquisition equipment. A copy of this form is available on the IRB Web 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 IRB Web site.

15. MRI at BIC

*Check appropriate boxes only if the study involves magnetic resonance imaging done at 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 be used.

* A copy of the measures is required even in research involving open-ended, informal interview 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 reacted to by the participants, all scenarios they are responding to, etc.) The exception might be that lengthy published tests may not have to be supplied in their entirety, please check with the IRB.

17. Subject Remuneration

* 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 partial compensation

* If participants receive a �lottery ticket� for a prize, indicate the number of prizes available, the value of the prize, the odds of winning, the dates of the drawing(s), and how winners will be notified. (This information should also be included on the consent form).

18. Subject Outlay

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

19. Confidentiality of Data

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

19.A. (data recording checkboxes)

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

19. B. Data Collection

Examples

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

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

**Common Problem: Failure to explain clearly how the investigator will collect the data without being able to trace the data to the participant.

19.C. Data Security

Examples

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

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

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

19.D. Staff Training

Examples

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

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

19.E.Data Retention

Examples

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

19. F. Dissemination of 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, persons may not want to be seen entering a place that might stigmatize them, such as a pregnancy counseling center that is clearly identified as such by signs on the front of the building. Any plans related to this issue should be detailed in this section.� In addressing privacy, issues that may be of concern include the methods used to identify and contact participants, appropriateness of each research staff person being present in research activities, etc.

19. H. Individually Identifiable Information

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

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

20. Informed Consent

* This section�

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

SEE ALSO: ELEMENTS of INFORMED CONSENT

20. A. Type of Consent

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

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

*If written consent is not feasible, please justify the use of alternative methods to obtain consent. The alternatives are Waiver/Alteration of Informed Consent and Waiver of Documentation. Check the appropriate boxes for either option in 20a and supply 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 consent process/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 all elements of consent, but there will be no signature (documentation). This type of consent could be online consent, an unsigned �informational sheet� type consent, or oral consent done over the phone as long as all the elements of consent are on the form that is read to the participants and a copy was sent to them beforehand.

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

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

20.D. Consent Process

* 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, and economic. At minimum state that there are no risks beyond those that exist in daily life (if such is judged to be the case).

21 B. Risk Level

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

21 C.� Ongoing Monitoring for �More than Minimal Risk� Studies

*Elaborate on data protection plans and ongoing monitoring plans that are in place to insure 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 on the IRB-1 in this section; note that this section is ONLY required if the study is coded as being �more than minimal� risk.

22. Benefits

Examples

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

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

23 Risk Benefit Assessment

Examples

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

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

24. Multi-site study

*Respond to the yes-no question here regarding whether there are other universities or research sites involved with the study with UIUC acting at the lead (UIUC is the main funding awardee with subcontracts awarded to other institutions).

25. Investigator Assurances

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

**Common Problem: IRB-1 is submitted without original signature.

25. Departmental Assurance (Optional)