• Share
  • Email
  • Embed
  • Like
  • Save
  • Private Content
Allenjcochran 08 irbprelimproposal
 

Allenjcochran 08 irbprelimproposal

on

  • 420 views

 

Statistics

Views

Total Views
420
Views on SlideShare
420
Embed Views
0

Actions

Likes
0
Downloads
0
Comments
0

0 Embeds 0

No embeds

Accessibility

Categories

Upload Details

Uploaded via as Adobe PDF

Usage Rights

© All Rights Reserved

Report content

Flagged as inappropriate Flag as inappropriate
Flag as inappropriate

Select your reason for flagging this presentation as inappropriate.

Cancel
  • Full Name Full Name Comment goes here.
    Are you sure you want to
    Your message goes here
    Processing…
Post Comment
Edit your comment

    Allenjcochran 08 irbprelimproposal Allenjcochran 08 irbprelimproposal Document Transcript

    • For office use only APPLICATION FOR EXEMPTION FROM REVIEW BY THE INSTITUTIONAL REVIEW BOARD PROTOCOL NUMBER: The Ohio State University, Columbus OH Name: Peter Kwok Chan Phone: 614.247.4271 Principal Investigator University Title: Department or College: Department of Design E-mail: chan.179@osu.edu Professor Associate Professor Campus Address (room, building, street address): Assistant Professor 128 N Oval Mall, Hopkins Hall, Rm 375B Instructor Other. Specify: (may OSU ID: require prior approval.) Signature: Date: Fax: Name: Allen J Cochran Phone: 513.549.1554 Co-Investigator University Status: Campus Address (room, building, street address) or E-mail: Faculty Mailing Address: cochran.291@osu.edu Staff 128 N Oval Mall, Hopkins Hall, Rm. 368 Graduate Student Undergraduate Student Other. Specify: OSU ID: 200017001 Signature: Date: Fax: Name: Phone: Key personnel University Status: Campus Address (room, building, street address) or E-mail: Faculty Mailing Address: Staff Graduate Student Undergraduate Student OSU ID: Other. Specify: Fax: Additional Co-Investigators or Key Personnel  Complete Appendix A1 Key personnel are defined as individuals who participate in the design, conduct, or reporting of human subjects research. At a minimum, include individuals who recruit or consent participants or who collect study data. PROTOCOL TITLE Co-Creation Case Study SOURCE OF FUNDING Non-funded EDUCATION Have all investigators and key personnel completed the required web-based course (CITI) in the Yes No protection of human research subjects? Educational requirements must be satisfied prior to submitting the application for review. See CITI Training or contact ORRP for more information.Version 2.4 Page 1 of 5 Approved by the Policy Coordinating IRB 05/18/00 Revised 01/20/10
    • FINANCIAL CONFLICT OF INTEREST Does any OSU investigator (including principal or co-investigator), key personnel, or their immediate Yes No family members have a financial interest (including salary or other payments for services, equity interests, or intellectual property rights) that would reasonably appear to be affected by the research, or a financial interest in any entity whose financial interest would reasonably appear to be affected by the research? All OSU investigators and key personnel must have a current COI disclosure form (updated as necessary for the proposed research) filed before review. Examples of financial interests that must be disclosed include (but are not limited to) consulting fees or honoraria; stocks, stock options or other ownership interests; and patents, copyrights and royalties from such rights. For more information, see Office of Research Compliance COI Overview and COI Forms . EXEMPT CATEGORY Please check the categories of exemption for which you are applying (IRB Exemption Categories). You may check more than one box. For more information, see the OSU HRPP Policy Exempt Research. 1 2 3 4 5 6 SCREENING QUESTIONS • Does any part of the research require that subjects be deceived? Yes No • Will research expose human subjects to discomfort or harassment beyond levels encountered in Yes No daily life? • Could disclosure of the subjects’ responses outside the research reasonably place the subjects at Yes No risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation? • Will individuals involuntarily confined or detained in penal institutions be subjects of the study? Yes No • For research proposed under category 2, will research involve surveys, interview procedures, or Yes No observation of public behavior with children? • For research proposed under category 4, will any of the data, documents, records, pathological Yes No specimens, or diagnostic specimens be collected or come into existence after the date you apply for exemption? • For research proposed under category 4, will any of the information obtained from data, Yes No documents, records, pathological specimens, or diagnostic specimens that come from private sources be recorded by the investigator in such a manner that subjects can be identified directly or through identifiers linked to the subjects? If you checked YES to ANY of the questions above, your research is NOT EXEMPT. Do not complete this application. Submit an IRB Application for Initial Review of Human Subjects Research for review. If you have checked NO to ALL of the questions above, your research may be exempt. Please complete the remainder of the exempt application. If you have questions about the application or review process, please contact: Office of Responsible Research Practices (614) 688-8457 / Fax: (614) 688-0366 exemptinfo@osu.eduVersion 2.4 Page 2 of 5 Approved by the Policy Coordinating IRB 05/18/00 Revised 01/20/10
    • GENERAL QUESTIONS REGARDING THE PROPOSED RESEARCH Please describe your study clearly and completely, using a style of language that can easily be understood by someone who is not familiar with your research. If the research involves protected health information (PHI) and you are requesting a  Complete Appendix N waiver of authorization - If the research will be performed at an international site -  Complete Appendix U 1. Describe the purpose of the research activity to be undertaken. Describe how it involves human subjects. Attach a copy of the research protocol. I will be interviewing in-house designers at OSU to discuss their workflow and to show me previous samples of work. Additionally, I will be utilizing anonymous surveys to ask questions concerning work habits. I aim to understand how designers work and collaborate by reviewing these items. 2. Provide a brief description of the subjects you plan to recruit and the criteria used in the selection process. Indicate whether subjects are adults or children. The adult participants (all above the age of 18) of this study are to be designers currently employed by The Ohio State University. The selection process will start with recommendations from Department of Design faculty. From there, I’ll ask those participants for recommendations and each subsequent study member will come from the previous. 3. Describe how the proposed research meets the criteria for exemption from IRB review and oversight (refer to the exempt categories). As outlined in Exemption Category 2, the interviews and surveys in this study will not identify any participant by name or connect them by name through any identifiers. Additionally, information acquired in this study and disclosed in any report will not jeopardize any participant to any point that may put them at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation. All interviews and surveys will be held on individual basis unless the prior consent of each participant is gained through a consent form. The approval of study member will determine their participation throughout each part of this study. Information used in writing after interviews, surveys and sessions will be completely anonymous; each participant will be assigned a number and referred to as such throughout documentation. 4. Will your subjects be recruited through schools, employers, and/or community agencies or organizations, and/or are you required to obtain permission to access data that is not publicly available? If the answer is yes, provide a letter of support from the person authorized to give you access to the subjects or to the data in question. More than one letter may be required. Does not apply Letter(s) attached Comments: 5. Describe the means you will use to obtain data. Check all boxes that apply. Surveys or questionnaires distributed by mail or in person. I am attaching a copy of the instrument(s). Surveys distributed through the Internet, listservs, or E-mail. I am attaching a copy of the instrument(s). Provide the Internet address: Interviews. I am attaching a copy of the interview questions. Focus groups. I am attaching a copy of the questions that will shape the discussion.Version 2.4 Page 3 of 5 Approved by the Policy Coordinating IRB 05/18/00 Revised 01/20/10
    • Observation of public behavior. Observation of activities in school classrooms. Audiotapes. I will obtain consent from the subjects to tape their responses. Videotapes. I will obtain consent from the subjects to tape their activities or responses. Review of existing records, including databases, medical records, school records, etc. I am attaching a copy of the data collection sheet. I am recording information in such a manner that subjects cannot be identified directly or through identifiers linked to the subjects. All of the information in the records to be reviewed exists as of the date of submission of this application. Tissue specimens. All of the specimens have already been collected and are “on the shelf.” I am recording information in such a manner that subjects cannot be identified directly or through identifiers linked to the subjects. 6. Indicate the date when you plan to begin research, and the date when you anticipate that data analysis will be complete. Begin date: 2010 09 01 End date: 2011 06 01 CONFIDENTIALITY • Investigators are required to protect the confidentiality of the information obtained during research, unless the subjects (a) explicitly agree to be identified or quoted, and/or (b) explicitly agree to the release of material captured on audiotapes or videotapes for use in presentations or conferences. 7. Provide a brief description of the measures you will take to protect confidentiality. Please describe how you will protect the identity of the subjects, their responses, and any data that you obtain from private records or capture on audiotape or videotape. Describe the disposition of the data and/or the tapes once the study has been completed. All participants’ personal information (name and position at OSU) will be kept completely confidential. To keep track of participants, I will keep one password-protected spreadsheet that lists name and participant number. Besides that, all references to the participant will be through their number. Interview notes will be titled and saved with the participant’s number. Audio recordings and transcripts will be similarly titled with the participant’s number. Everything will be kept digitally; there will be no physical audio or videotapes. Once I’ve finished working with one record it will be backed up on an external, password-protected hard drive until the end of the research and writing. Again the only connection from information participant will be through one protected spreadsheet. INFORMED CONSENT • In most cases, investigators are required to obtain informed consent from their subjects before collecting data. Respond to questions #8 and #9 to indicate how you will inform your subjects about the research and how you will obtain and document their consent. • Subjects must be told what they will be asked to do if they agree to participate in research, how long it will take, and how you will protect the confidentiality of the information they provide. • Subjects must be told that their participation is voluntary, they can refuse to answer questions that they do not wish to answer, and they can refuse to participate or they can withdraw at any time without penalty or repercussion. • With few exceptions, written consent of the child’s parent(s) or guardian(s) is required if subjects are children. In addition, older children should generally be asked to give written assent (agreement) to participate. Younger children unable to provide assent in writing should generally be asked to give verbal assent (agreement) to participate. • Provide a means for subjects to contact the investigator(s) if they have questions or concerns about the research. Make it clear to the subjects that you are affiliated with The Ohio State University. 8. What information do you plan to give to your subjects before you ask for their consent? Use a style of language that simply and clearly explains the research to your subjects. Respond in the space provided here, or attach a copy of the information you plan to provide to your subjects and/or their parents or guardians. (Note: if you use more than one method of recruitment, you may check more than one box)Version 2.4 Page 4 of 5 Approved by the Policy Coordinating IRB 05/18/00 Revised 01/20/10
    • Letter(s) attached. I will give each of the subjects a copy of this letter. I will be contacting subjects by phone or in person. I am attaching a script that contains the information I will give them. Does not apply. My data analysis is limited to existing records or tissue specimens. Response: See attached 9. How do you plan to document informed consent? Read all of the options before checking the appropriate boxes. The subjects are adults. Before collecting data, I will ask them to sign a written consent form. I am attaching a copy of the consent form. The subjects are adults. Before collecting data, I will ask them to give verbal consent to participate in this research study. The subjects are adults. I am distributing a survey or questionnaire to the subjects. They can choose whether or not they want to respond. I am requesting a waiver of written consent. The subjects are children. I am attaching a copy of the consent form that I will use to obtain consent from their parents or guardians and assent (agreement) from subjects who are capable of providing written assent. Some of the subjects are adults, and some are children. I have checked more than one box above to reflect the methods I will use to document informed consent. Does not apply. My data analysis is limited to existing records or tissue specimens. Other. Please explain and provide justification for your request: Comments:Version 2.4 Page 5 of 5 Approved by the Policy Coordinating IRB 05/18/00 Revised 01/20/10