Carnegie Mellon University

Transcription

1 Carnegie Mellon University For CMU s IRB Office Use: IRB No. APPLICATION FOR IRB REVIEW OF RESEARCH INVOLVING HUMAN SUBJECTS Research Project Title: Motion Capture Data Base Anticipated Start Date: July 1, 2008 Anticipated End Date: July 1, 2009 Source of Funding (Sponsor): Internal: External: National Science Foundation Grant Title: Data-Driven Animation of Skin Deformations Grant or SPEX #: ccf Principal Investigator (PI): Jessica Hodgins PI Title/Degree: Professor PI s Department: Robotics PI s Phone: PI s jkh@cs.cmu.edu PI s Building & Room No: 4103 If student, please complete: Faculty Advisor: CMU s Co-Investigators: (3) Nancy Pollard (1) Moshe Mahler (4) Lillian Chang (2) Justin Macey (5) Concise Statement of Proposed Research with Details of Human Use Aspect Describe within the space below, in layman's terms, what is to be done so that a realistic estimate of the risks to the subject and the benefits of the project can be assessed. The inclusion of females and members of minority groups and their sub-populations must be addressed in the development of the research design appropriate to the scientific objectives of the study. The research plan should describe the composition of the proposed study population in terms of gender and racial/ethnic group. Provide a rationale for selection of such subjects. Your proposal should contain a description of the proposed outreach programs for recruiting females and minorities as participants. The procedure involves participating in a study of human motion. The subject will be asked to perform tasks such as walking, running and gesturing. The subject will be wearing athletic attire (biker shorts or a lycra dance suit) and will be dressed in a motion capture suit. The suit will consist of small reflective markers that are applied to clothing or skin with hypoallergenic tape. Motion will be recorded in two ways: through the sensors of the motion capture equipment (limb orientations and/or locations of markers) and by one or more video cameras. Both the motion capture data and the video data will be stored on the web for use by other researchers. The study continues for about two hours. The subject may be asked to participate in multiple sessions on a volunteer basis. If at any time the subject is not comfortable with a task, or the subject would like to discontinue the task, the subject has the right to do so without penalty and can inform the experimenter of their concerns. 1

2 CMU IRB REVIEW APPLICATION 1. Regarding the human subjects involved in the proposed study: (a) What is the age range of the subjects? yrs (If subjects are minors, assent forms may be required.) (b) How many subjects are needed for this study? NA_ (c) Of the subjects studied, what will be the ratio of males to females? _50_% males to _50_% females (d) Of the subjects studied, what percentage will be from minority groups? 20_% (e) Are the subjects capable of understanding the nature of the study and the consenting process? YES [X ] NO [ ] (f) Indicate how subject recruitment will be performed: (Check appropriate boxes) [ ] CMU directory listing [ X ] External advertising (postings) [ ] or web-based solicitations [ ] Participant Pool [ X ] Other: Talent based captures for actors, dancers, and other skilled movements will be sought out. (Please elaborate) 2. Will any of the following classes of vulnerable subjects be involved in the proposed study? YES NO Comments Minors [] [X ] Subjects with Compromised Mental Status [ ] [X ] Pregnant Women/ Fetuses [ ] [X ] Prisoners [ ] [X ] Subjects requiring certificate of confidentiality [ ] [X ] 3. Will the subjects receive intangible benefit from the study? [ ] [X ] (a) Are the subjects compensated for the study? [ X] [ ] If yes, what is the amount and source of the funds? $ max of $50/hr Amount Source NSF (b) Are other inducements planned to recruit subjects? [ ] [X ] If yes, describe other inducements planned: 5. Is subject s confidentiality/anonymity in the project protected? [ ] [X ] 6. Are consent forms to be used? [X ] [ ] 7. Indicate degree of research s physical or psychological risk to subject: _X_Minimal Greater than Minimal High Minimal Risk: A risk is minimal where 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. Greater than Minimal Risk: A risk is greater than minimal where the probability and magnitude of harm or discomfort anticipated in the proposed research are greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. High Risk: A risk is high when a moderate-to-high probability of serious adverse effects might occur as a result of participation in a research study. 10. Do you or any individual who is associated with or responsible for the design, the conduct, or the reporting of this research have an economic or financial interest in or act as an officer or a director for any outside entity whose interests could reasonably appear to be affected by this research project? YES [ ]* NO [X ] (*if yes, please provide detailed information to permit the IRB to determine if such involvement should be disclosed to potential research subjects.) The Investigator(s) must also report any Adverse Event to the IRB through RCA. 2

3 I am familiar with and agree to comply with the CMU s policies on the responsible conduct of research. 07/07/08 Investigator Date Co-Investigator (1) Date Co- Investigator (2) Date Co-Investigator (3) Date Above signatures may be obtained after submission to IRB for review, but completed signatures are needed before final approval can be granted (faxed copies accepted). Faculty signatures are not required if already on file with the RCA office (see investigator signature page). Please submit each of the following with this IRB Review Application form (electronic submission preferred: 1. A draft or an abstract of the proposal. 2. A clear definition of how the subjects will be utilized, how the experimental treatment will be administered or the methodology. 3. A copy of the consent form(s) that the subjects or parent/guardian will be required to sign or justification if none will be used. 4. A description of how confidentiality/anonymity will be protected. 5. The name(s) and address(es) of official(s) authorizing access to any subjects in cooperating institutions not affiliated with CMU. 6. A description of the benefits and risks to the subjects and how they will be managed. 7. A copy of any recruitment document (include advertisement flyers/invitation letters/invitation s) to be used. 8. A copy of your on-line training certificate ( unless already on file. For assistance or answers to questions, call CMU s Research Compliance Administration (RAC) at ; WH 413; fax:

4 Carnegie Mellon University Institutional Review Board Federalwide Assurance No: FWA IRB Registration No: IRB Certification of IRB Approval IRB Protocol Number: HS Title: Motion Capture Data Base Investigator(s): Jessica Hodgins, Moshe Mahler, Nancy Pollard, Lillian Chang, Justin Macey Department(s): Robotics Institute Date: July 29, 2009 Carnegie Mellon University Institutional Review Board (IRB) reviewed the renewal above referenced research protocol in accordance with the requirements of Public Law as implemented by 45 CFR 46 and CMU s Federalwide Assurance. The research protocol has been given APPROVAL by Expedited Review on July 29, This APPROVAL expires on July 30, 2010, one year from the renewal date, unless suspended or terminated earlier by action of the IRB. All untoward or adverse events occurring in the course of the protocol must be reported to the IRB within three (3) working days. Any additional modifications to this research protocol or advertising materials pertaining to the study must be submitted for review prior to their being enacted. Please refer to the above referenced protocol number in all correspondence. Federal regulations require that all records relating to this research protocol be maintained for at least three (3) years after completion of the research, and be accessible for inspection and copying by authorized representatives at reasonable times and in a reasonable manner. The Investigator(s) listed above in conducting this protocol agree(s) to follow the recommendations of the IRB and the Office of the Provost of any conditions to or changes in procedure subsequent to this review. In undertaking the execution of the protocol, the investigator(s) further agree(s) to abide by all CMU research policies including, but not limited to the policies on responsible conduct research and conflict of interest. The IRB maintains ongoing review of all projects involving humans or human materials, and at continuing intervals, projects will require update until completion. At the end of the current approval, a progress report and current consent form must be submitted to the IRB summarizing progress on the protocol during that period. Please be advised that the progress report requests information pertaining to women and minorities; therefore, this information should be tracked with your participants data. The Public Health Service (PHS) has guidelines for the inclusion of women and minorities as research participants. These guidelines require that women and minorities be represented in research, and if not, justification as their exclusion. Listed below are the racial categories of participant to be reported as defined by PHS: American Indian or Alaska Native: A person having origins in any of the original peoples of North, Central, or South America, and who maintains tribal affiliations or community attachment. Asian: A person having origins in any of the original peoples of the Far East, Southeast Asia, or the Indian subcontinent including, for example, Cambodia, China, India, Japan, Korea, Malaysia, Pakistan, the Philippine Islands, Thailand, and Vietnam. Black or African American: A person having origins in any of the black racial groups of Africa. Terms such as Haitian or Negro can be used in addition to Black or African American. Native Hawaiian or Other Pacific Islander: A person having origins in any of the original peoples of Hawaii, Guam, Samoa, or other Pacific Islands. White: A person having origins in any of the original peoples of Europe, the Middle East, or North Africa. Please call the Research Regulatory Compliance Office at if you should have any questions regarding this certification. Thank you. David Danks, Ph.D., Chair, IRB

5 Carnegie Mellon University Consent Form for Participation in Research Study Title: Motion Capture Database Principal Investigator: Professor Jessica K Hodgins Other Investigator(s): Professor Nancy Pollard, Lillian Chang, Justin Macey, Moshe Mahler Purpose of this Study: We are studying basic human motions to better understand how people move and why they move in the ways that they do. We are interested in these questions primarily to understand how to better construct systems for computer animation. Procedures The procedure involves participating in a study of human motion. You will be asked to perform simple tasks such as jogging, running and gesturing. You will be wearing athletic attire (biker shorts or a lycra dance suit) and will be dressed in a motion capture suit. The suit will consist of small reflective markers that are applied to clothing or skin with hypoallergenic tape. Your motion will be recorded in two ways: through the sensors of the motion capture equipment (limb orientations and/or locations of markers) and by one or more video cameras. Both the motion capture data and the video data will be stored on the web for use by other researchers. The study continues for about two hours and you may be asked to participate in multiple sessions on a volunteer basis. If at any time you are not comfortable with a task, or want to discontinue the task, you have the right to do so without penalty and you should inform the experimenter of your concerns. Expected Duration & Location One session lasts 1-2 hours and will take place at Carnegie Mellon University, Pittsburgh PA. Participant Requirements Participants must be years old. Risks The risks and discomfort associated with participation in this study are no greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. You may experience a small amount of discomfort when the optical markers are removed (equivalent to removing a bandaid from the skin). Rights Your participation is voluntary. You are free to stop your participation at any point. Refusal to participate or withdrawal of your consent or discontinued participation in the study will not result in any penalty or loss of benefits or rights to which you might otherwise be entitled. The Principal Investigator may at his/her discretion remove you from the study for any of a number of reasons. In such an event, you will not suffer any penalty or loss of benefits or rights which you might otherwise be entitled. IRB No: page 1 Approved: Expires: Modified:

6 Carnegie Mellon University Consent Form for Participation in Research Benefits There may be no personal benefit from your participation in the study but the knowledge received may be of value to humanity. Compensation & Costs You will receive up to $200 total for completion of this study. This is for your time and travel costs related to the study. The compensation is based on an hourly rate and will generally be much less than the full amount. There will be no cost to you if you participate in this study. Confidentiality By participating in the study, you understand and agree that Carnegie Mellon may be required to disclose your consent form, data and other personally identifiable information as required by law, regulation, subpoena or court order. Otherwise, your confidentiality will be maintained in the following manner: Your data and consent form will be kept separate. Your consent form will be stored in a locked location on Carnegie Mellon property and will not be disclosed to third parties. By participating, you understand and agree that the data and information gathered during this study may be used by Carnegie Mellon and published and/or disclosed by Carnegie Mellon to others outside of Carnegie Mellon. However, your name, address, contact information and other direct personal identifiers in your consent form will not be mentioned in any such publication or dissemination of the research data and/or results by Carnegie Mellon. I understand that the following procedures will be used to maintain my anonymity in analysis and publication/presentation of any results: (1) Each participant will be assigned a number, names will not be recorded. (2) The researchers will save the data file and/or any video or audio recordings by participant number, not by name. The data and video clips will be stored on the web and free access will be granted to researchers and others. The videotape may be of sufficient quality for someone to recognize me. I may request to see my data visualized and may request that particular trials from a session be deleted if I prefer that my performance not be included in the database. I may request that the researchers remove the video clips from the web database at any time in the future. Optional Permission I understand that the researchers may want to use a short portion of any video or audio recording for illustrative reasons in presentations of this work in the classroom or at professional meetings. I give my permission to do so provided that my name will not appear. YES NO (Please initial here ) IRB No: page 2 Approved: Expires: Modified:

7 Carnegie Mellon University Consent Form for Participation in Research Right to Ask Questions & Contact Information If you have any questions about this study, you should feel free to ask them now. If you have questions later, desire additional information, or wish to withdraw your participation please contact: Professor Jessica K Hodgins Robotics Institute, Carnegie Mellon University 5000 Forbes Ave, Pittsburgh, PA Phone: jkh@cs.cmu.edu If you have questions pertaining to your rights as a research participant; or to report objections to this study, you should contact: IRB Chair Regulatory Compliance Administration Carnegie Mellon University 5000 Forbes Avenue Warner Hall, 4th Floor Pittsburgh, PA irb-review@andrew.cmu.edu (412) or (412) The Carnegie Mellon University Institutional Review Board (IRB) has approved the use of human participants for this study. Voluntary Consent By signing below, you agree that the above information has been explained to you and all your current questions have been answered. You understand that you may ask questions about any aspect of this research study during the course of the study and in the future. By signing this form, you agree to participate in this research study. PARTICIPANT SIGNATURE DATE I certify that I have explained the nature and purpose of this research study to the above individual and I have discussed the potential benefits and possible risks of participation in the study. Any questions the individual has about this study have been answered and any future questions will be answered as they arise. SIGNATURE OF PERSON OBTAINING CONSENT DATE IRB No: page 3 Approved: Expires: Modified:

8 CARNEGIE MELLON UNIVERSITY For IRB Office Use IRB No: Rec d: REQUEST FOR CONTINUING REVIEW OF IRB APPROVED HUMAN SUBJECT RESEARCH Requests for continuing review should be submitted to the IRB four (4) weeks prior to the expiration date of the study. The following items must be submitted for Continuing Review to be completed: 1. Completed Request for Continuing Review form. 2. Copy of the original application or updated application that includes all modifications previously approved. 3. Consent form if applicable. If requesting a modification as well as a renewal, please complete and submit the CMU IRB Request for Modification form. Please all documents to irb-review@andrew.cmu.edu. For assistance call CMU Research or irb-review@andrew.cmu.edu. Additional information and templates are available at 1. Protocol Title: Motion Capture Data-Base IRB Number: HS Expiration Date: 7_30_09 Principal Investigator: Jessica Hodgins jkh@cs.cmu.edu Other person to correspond with regarding mmahler@andrew.cmu.edu continuing review: Moshe Mahler I am a student. If so, please provide information about your faculty advisor below. Name: Level of risk: Minimal risk Greater than Minimal Risk 2. Review Type check the one that applies Continuing review and progress report for study still recruiting participants and/or collecting data Continuing review for study closed to accrual but still analyzing data Final report for study that is completed 3. Protocol Progress Report How many study participants have been enrolled in this review period? 10 How many study participants have been enrolled since the inception of the study?365 Estimate the ethnic origin of participants enrolled in the study as follows: Caucasian59% African American6% Hispanic0% Asian35% Native American0% Other 0% Have any participants withdrawn from the study? Yes No If yes, how many? Please explain. Have any participants have been removed from the study by the Investigator? Yes No If yes, how many? Please explain. 1 version 1/2009

9 CARNEGIE MELLON UNIVERSITY For IRB Office Use IRB No: Have there been any complaints about the study? Yes No If yes, have these been reported to the CMU IRB? Yes No If no, please describe. Have there been any unanticipated problems with the study? Yes No If yes, have these been reported to the CMU IRB? Yes No If no, please describe. Have there been any adverse events? Yes No If yes, have these been reported to the CMU IRB? Yes No If no, please describe. Has literature relevant to the research been published during this review period? Yes No If yes, please summarize or attach. Has anything happened that may affect the risk benefit ratio for the study? Yes No Have there been any changes related to the conflict of interest disclosure information or are there conflict of interest issues now relevant to the review of this protocol? Yes No Has funding for the study changed? Yes No Are you requesting a change to the informed consent document? Yes No Please attach a copy of the current approved consent document and if applicable a new consent document. Is there anything else you would like the IRB to know about this study? Yes No 4. Principal Investigator s Assurance I certify that the information provided in this request is complete and accurate. 7/17/09 PI Signature Date NOTE: If ed from the PI s CMU account, a hand written signature is not needed. Please type in name and date. Rec d: Please all documents to irb-review@andrew.cmu.edu Comments: 2 version 1/2009

10 CARNEGIE MELLON UNIVERSITY For IRB Office Use IRB No: Rec d: REQUEST FOR CONTINUING REVIEW OF IRB APPROVED HUMAN SUBJECT RESEARCH Requests for continuing review should be submitted to the IRB four (4) weeks prior to the expiration date of the study. The following items must be submitted for Continuing Review to be completed: 1. Completed Request for Continuing Review form. 2. Copy of the original application or updated application that includes all modifications previously approved. 3. Consent form if applicable. If requesting a modification as well as a renewal, please complete and submit the CMU IRB Request for Modification form. Please all documents to irb-review@andrew.cmu.edu. For assistance call CMU Research or irb-review@andrew.cmu.edu. Additional information and templates are available at 1. Protocol Title: Motion Capture Data-Base IRB Number: HS Expiration Date: July 30, 2010 Level of risk: Minimal risk Greater than Minimal Risk 2. Principal Investigator (PI) Principal Investigator: Jessica Hodgins Telephone: jkh@cs.cmu.edu I am a student. If so, please provide information about your faculty advisor below. Faculty Advisor Name: Other person to correspond with regarding continuing review: Moshe Mahler Telephone: mmahler@andrew.cmu.edu Business Manager for your department: 3. Co-Investigators Name:Justin C Macey Name:Nancy Pollard Name:Lillian Chang Name:Moshe Mahler 4. Funding Unfunded research External Funding Internal Funding Grant Title: Data-Driven Animation of Skin Deformations maceymade@aol.com npollard@andrew.cmu.edu lillianc@ri.cmu.edu mmahler@andrew.cmu.edu Sponsor/Source: National Science Foundation SPEX Proposal #: ccf Oracle String: If you don t know the funding/grant information, please get it from your department s business manager. 5. Review Type check the one that applies Continuing review and progress report for study still recruiting participants and/or collecting data Continuing review for study closed to accrual but still analyzing data Final report for study that is completed 1 version 8/2009

11 CARNEGIE MELLON UNIVERSITY For IRB Office Use IRB No: 6. Protocol Progress Report How many study participants have been enrolled in this review period? 8 How many study participants have been enrolled since the inception of the study?363 Estimate the ethnic origin of all participants enrolled in the study since its inception as follows: Caucasian87% African American0% Hispanic0% Asian13% Native American0% Other 0% Answer the following questions as they relate to this renewal period. Have any participants withdrawn from the study? Yes No If yes, how many? Please explain. Have any participants have been removed from the study by the Investigator? Yes No If yes, how many? Please explain. Have there been any complaints about the study? Yes No If yes, have these been reported to the CMU IRB? Yes No If no, please describe. Have there been any unanticipated problems with the study? Yes No If yes, have these been reported to the CMU IRB? Yes No If no, please describe. Have there been any adverse events? Yes No If yes, have these been reported to the CMU IRB? Yes No If no, please describe. Has literature relevant to the research been published during this review period? Yes No If yes, please summarize or attach. Has anything happened that may affect the risk benefit ratio for the study? Yes No Have there been any changes related to the conflict of interest disclosure information or are there conflict of interest issues now relevant to the review of this protocol? Yes No Has funding for the study changed? Yes No Are you requesting a change to the informed consent document? Yes No Please attach a copy of the current approved consent document and if applicable a new consent document. Is there anything else you would like the IRB to know about this study? Yes No 7. Final Report If this is the final report for the study, please provide a description of any findings. Describe the overall success of the study. You may attach a copy of the final report to the sponsor if you prefer. 8. Principal Investigator s Assurance I certify that the information provided in this request is complete and accurate. 5/5/2010 PI Signature Date NOTE: If ed from the PI s CMU account, a hand written signature is not needed. Please type in name and date. Please all documents to irb-review@andrew.cmu.edu Rec d: Comments: 2 version 8/2009

12 CARNEGIE MELLON UNIVERSITY For IRB Office Use IRB No: Rec d: 3 version 8/2009