Request For The Approval For The Use Of Human Subjects in ResearchHealth and Biological Sciences

Institutional Review BoardVersion 2/2001

Project Title: DRIVING SIMULATOR FOR PERSONS WITH IMPARIED COGNITION     

Principal Investigator:Including middle initial and highest earned degree

WILLIAM K DURFEE, PHD

Telephone Number: 612-625-0099

Pager or Cell Phone:      

Fax: 612-625-4344Department Name: University Fairview Other:      

MECHANICAL ENGINEERINGMailing Address: 1100 MECHE

E-mail Address: WKDURFEE@UMN.EDU

Name, phone number, and E-mail address of person preparing this form:WILLIAM DURFEE, 612-625-0099, WKDURFEE@UMN.EDU

As Principal Investigator of this study, I assure the IRB that the following statements are true: The information provided in this form is correct. I will seek and obtain prior written approval from the IRB for any substantive modifications in the proposal, including changes in procedures, co-investigators, funding agencies, etc. I will promptly report any unexpected or otherwise significant adverse events or incidents that may occur in the course of this study. I will report in writing any significant new findings which develop during the course of this study which may affect the risks and benefits to participation. I will not begin my research until I have received written notification of final IRB approval. I will comply with all IRB requests to report on the status of the study. I will maintain records of this research according to IRB guidelines. The grant that I have submitted to my funding agency which is submitted with this IRB submission accurately and completely reflects what is contained in this application. If these conditions are not met, I understand that approval of this research could be suspended or terminated.

PROFESSOR      Original Signature of PI Title of PI Date

If Principal Investigator is faculty or staff, a Department head signature is required. As Department Head, I acknowledge that this research is in keeping with the standards set by my department and I assure that the Principal Investigator has met all departmental requirements for review and approval of this research.PETER MCMURRY      Typed Name of Department Head, or Director of Research Fairview Date

     Original Signature of Department or Fairview Official Date

Co-Investigators responsible for, or working on this project should be listed below. Include any individual who will have responsibility for the consent process, direct data collection from subjects, or follow-up. If there are more than two Co-Investigators, please attach additional pages containing the following information.Co-Investigator:Including middle initial and highest earned degree

SEE ATTACHED PAGES

Telephone Number:       Pager or Cell Phone:      

Fax:      Department Name: University Fairview Other:      

     Mailing Address:      

E-mail Address:      

     Original Signature of Co-Investigator Date

Co-Investigators responsible for, or working on this project should be listed below. Include any individual who will have responsibility for the consent process, direct data collection from subjects, or follow-up. If there are more than two Co-Investigators, please attach additional pages containing the following information.Co-Investigator:Including middle initial and highest earned degree

     

Telephone Number:       Pager or Cell Phone:      

Fax:      Department Name: University Fairview Other:      

     Mailing Address:      

E-mail Address:      

     Original Signature of Co-Investigator Date

Research Staff are any personnel you wish to be included in correspondence related to

this study e.g. study coordinators.Name:      Department Name: University Fairview Other:      

     Address:      Telephone Number:      E-mail:      

Check here if this is Fairview System Research (not University faculty/staff/student).

Student Research requires the approval of an Academic Advisor. As Academic Advisor to the Student Investigator, I assume responsibility for ensuring that the student complies with University and Federal Regulations regarding the use of Human Subjects in research.Advisor’s Name:      University Department:

     

Address:      Telephone Number:      E-mail:      

     Original Signature of Academic Advisor Date

Length of StudyHow many months do you anticipate this study will last from the time final approval is granted? 36 MONTHS

FundingIs this research funded by an internal or external

agency? Yes

Attach Appendix A No

Peer ReviewIs this research subject to review by another Committee?

(If so complete the requested information)It is the responsibility of the PI to secure the appropriate approval from these

Committees and document that approval to the IRB.Committee Date of

SubmissionInstitutional Animal Care and Use Committee (IACUC)      Cancer Protocol Review Committee (CPRC)      All University Radiation Protection Committee      Conflict Management Committee      Nursing Research Committee      General Clinical Research Center      Other IRB (name)(i.e., if you are participating in a multicenter trial which requires the approval of other IRB’s)

1. COURAGE CENTER2. SISTER KENNY INSTITUTE3. NATIONAL REHAB HOSP

PENDING

Other (specify)            

Conflict of InterestFederal Guidelines have been revised to require IRBs to assure that there are no conflicts of interest in research projects which could affect human subject participation. If this study involves or presents a potential conflict of interest, additional information may need to be provided to the IRB. Examples of conflicts of interest may include, but are not limited to: 1) A researcher or family member participating in research on a technology owned by a business in

which the faculty member holds a financial interest2) A researcher participating in research on a technology developed by that researcher3) A researcher or family member assuming an executive position in a business engaged in

commercial or research activities4) A researcher or family member serving on the Board of Directors of a business from which that

member receives University-supervised Sponsored Research SupportUniversity of Minnesota Researchers, please refer to the Web site for further information: http://www.ospa.umn.edu/policy/respolcy.htm#RegentsFairview Health System Researchers, please refer to the Web site for further information: http://www.fairview.org/prof/research

Do any of the Investigators or personnel listed on this study have a conflict of interest associated with this study?

Yes. Continue on with the next question. No. If yes, has this conflict of interest been disclosed as per the relevant policy?

Yes. Is there a management plan in place?

No. Please contact your department head for further instructions. The IRB cannot review a study before a conflict has been disclosed to the appropriate department head.

Yes. Please provide a copy of the plan for IRB review.

No. Please contact your department head about developing a management plan.

The IRB may require disclosure of the potential conflict of interest in the consent documentation for study participants.

1. What is your research question? (Hypothesis). Please note that the following questions must be answered in lay language or language understood by a person unfamiliar with your area of research. Area-specific jargon should be avoided or explicitly explained. Do not say “see protocol”.

***Note: See attached "Supplement" for additional information on this project

Brain injury frequently results in cognitive impairment, reducing an individual’s ability to judge driving situations accurately. Rehabilitation professionals use clinical and on-the-road tests to

determine whether an individual is safe to drive. The on-the-road tests are typically conducted under calm conditions and offer little information regarding an individual’s response to real-life driving challenges. The lack of valid and reliable driving assessments leaves rehabilitation teams ill-equipped to recommend whether patients should be allowed to drive.

Driving simulators offer an option to on-road training and assessment for indivuals with cognitive disabilities. Until recently, driving simulators were too expensive or too unsophisticated for widespread clinical application. Recent advances have improved performance and reduced cost.

In this project, we are evaluating the efficacy of STISIM, a driving simulator made by System Technology, Inc., for use in assessing the driving ability of individuals with cognitive impairment. In particular, we are interested in (1) seeing if STISIM can distinguish between people with varying driving ability, (2) determining if driving performance on the STISIM simulator matches on-road driving performance, and (3) determining whether driving on STISIM changes a person's self-awareness of their driving abilities.

Through a multi-center clinical trial, we intend to answer four key questions that will help determine simulator efficacy as an assessment tool in a clinical setting. These questions are:

2.1 Test-retest reliability: Do you get similar simulator session results for time 1 and time 2 when the test is repeated a second time on the same subject with a 2 week delay between test sessions? Favorable results will enable clinicians to determine how patient performance changes over time.

2.2 Discriminant validity: Can the simulator discriminate between the driving ability of subjects with different cognitive impairments? That is, are scores from simulator runs consistent with other test methods used to categorize the severity of cognitive impairment?

2.3 Concurrent validity: Is performance on the driving simulator similar to on-road performance? This experiment requires both simulator and on-road tests

2.4 Face validity: Do clients who drive the simulator accept that simulator driving is similar to real, on-road driving?

In addition, we are conducting a pilot study to determine if the simulator can be used therapeutically to change a driver’s self-awareness of driving ability. This study will show whether feedback given by the simulator and by the driving evaluator can improve the accuracy of self-appraisal of driving skills. We suspect that the

simulator will have the most value as a therapeutic tool in a rehabilitation clinic setting and we are eager to see if use of the simulator with feedback can indeed impact self-awareness for brain-injured persons.

The study will be conducted by having individuals with mild to moderate cognitive impairments, as well as non-impaired subjects, drive the simulator. Some of the subjects will also participate in on-road tests in a real car, under the supervision of a professional rehabilitation driving evaluator.

2. What research methods will you use? (How will you ask the question?) Attach a protocol if applicable.

Summary: There are three protocols for this study. In Protocol A, subjects only drive the simulator. In Protocol B, subjects drive the simulator and drive a real car. In Protocol C, subjects only drive the simulator, but are given feedback on their driving performance.

Simulator drives use STISIM, a driving simulator made by Systems Technology, Inc. STISIM has a 3-screen visual display and a realistic car seat, steering wheels and pedals for control. Speakers provide simulations of car and road noise. A description and photograph of STISIM is posted at http://www.systemstech.com/stidrsm1.htm.

Detailed protocol descriptions follow for (1) subject evaluation tests, (2) simulator trial, (3) on-road trial.

Subject evaluation tests: Cognitive level is determined by administering the Neurobehavioral Cognitive Status Examination (COGNISTAT, although sometimes referred to as NCSE) instrument from The Northern California Neurobehavioral Group, Inc. We exclude the language component (language skills are not related to driving ability) and score subjects on the 8 remaining COGNISTAT categories: level of consciousness, orientation, attention, constructions, memory, calculations, similarities reasoning and judgment reasoning. Subjects also are given the Trails A and B paper and pencil test from the Halstead-Reitan Neuropsychological Battery. These are tests of psycho-motor skills that measure ability to connect a

sequence of numbered and lettered circles while being timed, and can be more discriminating than the COGNISTAT.

To control for motor impairments, subjects will undergo a Dynavision test (www.dynavision2000.com) to measure upper limb reaction time, and a brake pedal response test on STISIM Drive to measure lower limb reaction time.

Visual attention and visual processing speed will be measured by the Useful Field of View (UFOV) test. The UFOV is a computer administered, computer scored test that determines the size of a driver's perceptual window and has been used to identify at-risk drivers among older adults.

All subjects, including the non-disabled, will be assessed using COGNISTAT, Trails A&B, reaction time and UFOV tests. Scores from these tests will be used in the data analysis for several of the clinical research questions addressed by the study.

Simulator session protocol:

Prior to the simulator drive, the Simulator Sickness Questionnaire is administered. The SSQ is a multi-symptom questionnaire where 16 effects such as sweating and nausea are rated on a 4-point scale and a composite score is calculated based upon the results. Pre- and post-simulator experience SSQ scores are compared to determine whether the simulator caused driver sickness. The SSQ is rapidly becoming the standard for determining simulator sickness and has been normed on thousands of flight simulator experiences.

Subjects are then seated in the STISIM simulator and the seat and steering wheel adjusted to a comfortable driving position. The researcher orients the subject to the physical controls of the machine, then starts the subject on the familiarization scenario. The researcher guides the subject through the route offering feedback as required to maximize the subject’s comfort with the simulator. The familiarization route may be stopped and started several times, and can be rerun as needed until the subject expresses a basic familiarity and readiness to continue with the main, data collection scenario. The familiarization process takes 10 to 15 minutes.

When ready, the subject drives the main scenario. Automatic voice prompts are provided by STISIM Drive instructing the subject where to turn. During the drive, the researcher silently records observed driving performance on the Drive Log.

After completing the first half of the scenario, which contains simple driving challenges and takes about 20 minutes, the subject

is invited to rest. During the rest period, no feedback on driving performance is provided to the subject.

The subject then completes the second half of the scenario containing complex driving challenges that takes another 20 minutes to complete. Simulations are taken to completion unless the subject can’t finish or there is a major simulation error.

Immediately following the simulated drive, the SSQ is administered again to determine whether driving on STISIM Drive caused the subject to feel sick. The researcher fills out the Driver Rating Form, which includes assessing behavioral driving skills and entering a Global Driving Score (GDS) for the run. The GDS is a 3-point scale where 0 means unsafe to drive, 1 means marginal and 2 means safe to drive. This type of scale is commonly used in traditional driver rehabilitation and testing programs. All research staff in all clinical centers who will be scoring drives will be instructed on how to anchor the GDS scale. Finally, the Driver Face Validity Questionnaire is given to assess whether the subject viewed STISIM Drive as a valid representation of their driving ability and to draw out what specific aspects of the simulation undermined or supported the perceived validity.

At the conclusion of the session, the subject is thanked and dismissed.

On-road testing protocol (with a subset of subjects and at Courage Center site only):

On road and simulator experiments will be performed at the Courage Center with the on-road test under the supervision of the Courage Center professional driving evaluation staff. Only subjects with mild cognitive impairment will participate in the on-road experiments, no non-impaired subjects. It is important to note, that the on-road tests are not tied to licensing nor to formal driving evaluation process for the subject, and indeed the on-road route will be especially created for the study. The length of the on-road drive will be approximately 40 minutes if all traffic signs and signals are obeyed.

The standard Courage Center pre-driving assessment is performed prior to the on-road session to check that vision, visual information processing, physical strength and coordination, reaction time and cognitive functioning of the subject is appropriate for a safe, on-road evaluation session.

During the drive, the professional driving evaluator sits in the front passenger seat of the dual control vehicle and provides route instructions keyed to landmarks and read from a prepared script to

avoid bias. Deviations from the script are permitted only if the evaluator senses conditions where safety might be compromised. The researcher sits in the back seat and records observed driver activity on the Drive Log, exactly as done in the simulation run. Missed turns and signals are also recorded in the Drive Log. During the drive, GPS location and velocity data and braking event data is logged on the laptop computer while a camcorder logs a visual record of the drive. These instruments are also manipulated by the researcher from the rear seat.

Following the drive, the professional driving evaluator completes the Courage Center Driving Assessment Summary Form that includes assigning a grade of Pass, Pass with Restrictions or Fail for the subject. Independently the researcher fills out the Driver Rating Form and assigns a GDS, just as with the simulator run. The researcher then conducts the Face Validity interview with the driver. The Simulator Sickness Questionnaire is administered before and after the drive as a check to see if the subject is prone to sickness when driving real cars.

Self-awareness study protocol:

Some subjects will participate in an experiment to determine if use of the simulator increases their self-awareness of driving ability. Only subjects with mild or moderate cognitive impairments will participate. The self-awareness study will take place at the Sister Kenny site only.

The protocol follows the standard simulator trials protocol described above, except that feedback is given by the researcher to the subject about his or her driving. Feedback can take the form of verbal commentary during the run (“You missed that stop sign, you might want to pay more attention because another one is coming up in a bit”), can be delivered during a simulator pause (“Let’s pause the drive for a bit and discuss what just happened”) or after the run (“Let’s review how you did"). Feedback can also be delivered post-drive in the form of charts or graphs of driving performance (“Here is a plot of how the car moved during a straight section of the road. Do you see how much you were wobbling from side to side?”), or in replay form (“Let’s play back on the monitor what was going on when you ran into that pedestrian”). Because of the many possible variations in content, style and format of the feedback, a full, statistically validated study on the use of feedback to increase driver awareness is not possible.

The measurement of awareness will be the Self-Awareness of Deficits Interview (SADI) that will be administered by the researcher. In addition, we will pilot a new interview instrument designed to measure self-awareness of driving performance

(SADPI).

3. What will the subjects be asked to do?

Subjects will be asked to do the following activities:

1. All subjects will undergo the screening tests described above. These will be done at the first experiment session, prior to the first drive on the simulator.

2. Subjects in the simulator-only protocol (Protocol A) will participate in two simulator session, spaced by approximately two weeks.

3. Subjects in the simulator plus drive protocol (Protocol B) will participate in one simulator session and one on-road session, spaced by one to 14 days.

4. Subjects in the simulator self-awareness protocol (Protocol B) will participate in one simulator session.

4. Subject Population

4. a)

Number of SubjectsHow many subjects will you enroll?

Male: 45 Female: 45 Total: 90 (see Supplement)

If this is a clinical trial, how many people do you estimate you will need to take through the consent process (but not necessarily enroll) to get the data sets you need?Male: 60 Female: 60 Total: 120

4. b)

Age Range(Check all that apply)

0-7 (Submit parental consent form and Appendix B)

8-17 (Submit child’s assent form, parental consent form and Appendix B)

18-65 65 and older

4. c)

Location of Subjects During Research Data Collection(Check all that apply)

Elementary/Secondary Schools Community

Clinic Specify:      

Prisons/Halfway houses Fairview University Medical Center Fairview Southdale Hopital Fairview Ridges Hospital Other Fairview

Facilities Specify:      

Other Hospitals Specify       University Campus (nonclinical) Other Special Institutions Specify 1. Sister Kenny

Institute, Minneapolis2. Courage Center, Minneapolis3. National Rehabilitation Hospital, Washington D.C.

4. d)

Subject Characteristics(Check all that apply)

Inpatients

Outpatients

Normal Volunteers

Controls

4. e)

Inclusion and Exclusion of Subjects in this Research StudyIt is necessary that the inclusion and exclusion of minors be scientifically justified. Provide justification in Appendix C. It is also necessary to provide scientific justification for uneven gender enrollment.

List criteria for inclusion and exclusion of subjects in this study

Inclusion Criteria:

For impaired subjects:

1. 21 to 65 years of age2. Dx: CVA, BI with mild to moderate cognitive impairment3. At least one of the eight subsection scores on the COGNISTAT shows a maximum of mild impairment. (Note: lower scores indicate more impairment)4. Three or more months post injury5. Active driver at time of accident: (drove at least 5,000 miles per year)6. Competent to give informed consent7. Expressed interest in driving as a goal8. Functional literacy in English adequate for driving (read signs, etc.)9. Deemed appropriate for a driving evaluation by their physician10. Currently, a non-driver

For non-impaired subjects:

1. 21 to 65 years of age5. Active driver (drives at least 5,000 miles per year)6. Competent to give informed consent7. Expressed interest in project8. Functional literacy in English adequate for driving (read signs, etc.)

Exclusion Criteria:

For impaired subjects:

1. Dx: progressive disease process (MS, Dementia, etc)2. More than 2 severe and/or more than 4 moderate scores on the COGNISTAT subsections. 3. Sensory or motor impairment that requires adaptive driving equipment

For unimpaired subjects:

1. Moving traffic violation in past 12 months.2. Involved in two or more traffic accidents in the past 24 months, no matter who was at fault.

4. f)

Special Populations To Be Included In This Study(Check all that apply)

Minors under age 18 Appendix B must be attached Patients Mentally/Emotionally/Developmentally Disabled Persons.

Minority Group(s) and Non-English Speakers Specify:       Pregnant Women Appendix C must be attached Fetus/Fetal Tissue Elderly Subjects (65 and over)

Provide rationale for using special populations These groups are considered “vulnerable” or require special consideration by the federal regulatory agencies and by the IRB. Suggestion: Researchers should not select subjects on the basis of discriminatory criteria. Selection criteria that exclude one sex or racial group require a clear scientific rationale for the exclusion (See Appendix C).Rationale: Subjects with mild or moderate cognitive impairments

resulting from brain injury will be used in this project. Some of this population may be in or out patients at the various clinics involved in the study. Others may not be patients, but rather clients of the clinics. Because the project is specifically interested in the efficacy of driving simulators for use in the rehabilitation of individuals with cognitive impairments, this group must be included in the subject population

5. Recruitment

5. a) Describe how subjects will be identified and recruited. Attach a copy of any and all recruitment materials to be used e.g. advertisements, bulletin board notices, e-mails, letters, or phone scripts.

Subjects with impairments will be recruited from the in and out-patient populations of the clinics involved in the study (Sister Kenny Institute, Courage Center, National Rehabilitation Hospital). Prospects will be solicited by

publicizing the study to clinical staff and by posted fliers.

Subjects without impairments will be recruited by word of mouth and by flyers among the community population associated with the study clinics or with the University of Minnesota.

5. b) Initial ContactDescribe who will make initial contact, and how it will be made. If subjects are chosen from records, indicate who gave approval for use of the records. If records are “private” medical or student records, provide the protocol, consent forms, letters, etc. for securing consent of the subjects of the records. Written documentation for the cooperation/permission from the holder or custodian of the records should be attached. (Initial contact of subjects identified through records search must be made by the official holder of the record, i.e. primary physician, therapist, public school official.)

Initial contact will be made either by a therapist associated with the study, or by subjects calling the study researcher from a telephone number given in the flyer.

A phone script that will be used in the initial screening interview is attached.

5. c) Is the study sponsor offering any incentive connected with subject enrollment or completion of the study (i.e. finders fee, recruitment bonus, etc.) that will be paid directly to the research staff?

No Yes. If yes describe.

     

5. d) Will subjects receive inducements before or rewards after the study?

No Yes. If yes, please describe.

Please note that this information must be included in the consent form, under the heading “Compensation”, and not in the “Benefits” section. Also, payments for multiple visits should be prorated.

Subjects will be paid $50 per experiment session. For subjects who participate in Protocols A and B with two sessions, the

maximum payment will be $100. For those in Protocol C with one session, the maximum payment is $50.

5. e) Will the subjects be charged for research related procedures? If yes, explain charges, including estimated amounts. This information must be specified in the consent document.

No Yes. If yes, please describe.

     

6. Risks and Benefits

6. a)

Does the Research Involve:(Check all that apply)

Any surgical process Administration of drugs, chemical, or biological agents, or devices. Attach

Appendix E Use of controlled substances Use of radioisotopes or other sources of ionizing radiation (including X-rays) Administration of physical stimuli (beyond what is described on the Social and

Behavioral Sciences form) Major changes in diet or exercise Use of private records (medical or educational records) Possible invasion of privacy of subject or family

Deprivation of physiological requirements such as nutrition or sleep Manipulation of psychological or social variables such as sensory deprivation,

social isolation, psychological stresses Any probing for personal or sensitive information in surveys or interviews

Use of a deceptive technique, e.g., placebo, double-blind, etc. (suggestion: if deception is part of the experimental design, the protocol must include a debriefing procedure, which will be followed upon completion of the study or upon withdrawal of a subject. Attach a description of the debriefing protocol and any related materials.)

Presentation of materials which subjects might consider offensive, threatening,

or degrading Other risks Specify: For subjects who drive on the simulator,

there is the risk of simulator sickness. Simulator sickness is an experience that can produce the feeling of mild to moderate nausea similar to sea sickness.

For subjects who participate in the on-road trials, there is the normal risk of automobile accidents.

6. b) Describe the precautions that will be taken to minimize the risk to the subjects.

The familiarization run acclimates subjects to the simulator and for many subjects will reduce or eliminate the incidence of simulator sickness.

Subjects will be told that if they start to feel sick while driving the simulator, they should immediately stop driving. The simulator run will also be halted if the investigator determines the subject is sick.

Non-impaired subjects will be asked to refrain from driving a real car for at least 30 minutes following a simulator drive to minimize the risk of simulator disorientation carrying over to real driving. (Subjects with impairments are non drivers.) If the subject feels they are too sick to drive their car, the study will provide them with cab fare to get home.

Risk of accidents in the on-road test will be minimized by driving only with a certified rehabilitation driving instructor in a dual-control car. The driving instructor is trained and experienced in assessing driving abilities of individuals with mild and moderate cognitive impairment. The driving instructor will determine if a subject is appropriate for a safe, on-road session based upon the same criteria used in clinical driving programs.

6. c) Why are the risks and inconveniences mentioned above reasonable?What is the expected scientific yield from the project? Please justify the risks

in relation to the anticipated benefits to the subjects, and in relation to the importance of the knowledge that may reasonably be expected to result from the research.

The risk of simulator sickness and on-road accidents are small. The benefit to be gained from the project, however, is significant. If it can be shown that driving on the simulator is approximately the same as driving on the road, or if it can be shown that driving on

the simulator improves ones self-awareness of driving skills, then simulators can be used effectively in clinical rehabilitation programs. Increased use of simulators should then reduce the overall risk to drivers with disabilities and to others on the road by eliminating from the road drivers who are not ready to drive.

6. d) Benefits of ParticipationList any anticipated direct benefits to participation in this research project. If none, state that fact here and in the consent form. The benefit of receiving treatment is not necessarily a benefit to participation in the research project. That distinction is central to the informed consent process.

Other than the subject payment, there are no direct benefits for participating in the study. In particular, the study is not tied in any way to clinical evaluations, nor to a clinical decision of when those with impairments are deemed ready to return to driving.

7. Biological Samples

7. a) Blood drawing, marrow biopsy sampling, biopsy of other tissues, etc.If samples of body fluids or tissues are taken as part of this research project, state how much and how often the samples are taken. The consent form must include lay term equivalents for the amounts, e.g. teaspoons etc. Please distinguish procedures that are diagnostic from procedures that are performed solely for research.

n/a

7. b) Will DNA be collected?

No Yes. If yes, attach Appendix D.

7. c) Will tissue/blood samples be stored with identifiers?

No Yes. If yes, attach Appendix D.

8. Care of subjects in case of an accident

Select from one of the following compensation options listed below. This language must be included in the consent form. If a special contract to pay for research related injuries exists, attach documentation for IRB record.

Non-sponsor-funded compensation

In the event that this research activity results in an injury, treatment will be available, including first aid, emergency treatment and follow-up care as needed. Care for such injuries will be billed in the ordinary manner, to you or your insurance company. If you think that you have suffered a research related injury let the study physicians know right away.

Sponsor funded compensation:

In the event that this research activity results in an injury, treatment will be available, including first aid, emergency treatment and follow-up care as needed. Care for such injuries will be billed in the ordinary manner, to you or your insurance company. The sponsor of the study has some funds available to pay for care for injuries resulting directly from being in this study. If you think that you have suffered a research related injury and that you may be eligible for reimbursement of some medical care costs, let the study physicians know right away.

If the preferred injury compensation language is unacceptable to the study sponsor, the following alternative language may be used:

Under some circumstances the sponsor of the study will pay for care for injuries resulting directly from being in the study. If you want information about those circumstances or if you think you have suffered a research related injury let the study physicians know right away.

9. Confidentiality of Data

9. a) Describe provisions made to maintain confidentiality of the data.

Data will be accessed only by study-investigators, data entry personnel and statisticians involved with this study. In the data, subjects will only be referred to by subject number. The information tying subject number to name will be kept only on one record, separated from the subject data. When results are reported, subjects identities will not be revealed.

9. b) Where will the data be kept and for how long will it be kept?

Data will be kept on a computer in secure locations at each study site. Data will be kept for a minimum of three years following the completion of the study.

9. c) What security provisions will be used? Who will have access to the collecteddata?

Computers containing data will be areas of the clinic not open to the public. Data will only be accessible by study personel.

9. d) Will data identifiying the subjects be made available to anyone other than the Principal Investigator, e.g., FDA, study sponsor?

No Yes. Please explain below and in the consent form.

     

9. e) Will the data be part of the medical chart or other permanent record?

No Yes. Please explain below and in the consent form.

     

10. Expedited Review

Expedited Review RequestAfter careful consideration of risks and review of the expedited review categories it has been determined that this research fits the precise requirements of category # ___ of the “Expedited Review” provision of 45 CFR 46, (see page vii.). The research could be considered of “minimal risk” to participants based on those guidelines. (Note: Most research will not fit the categories for expedited review.) The decision to route the study via expedited review process will be determined upon review of the completed application by the IRB.

11. Informed Consent Process

11. a) Prepare and attach a consent form for IRB review.Please see the sample consent form and follow it carefully. Do not submit sponsor prepared forms without editing the form to include IRB standard language. See the IRB Web site for the informed consent tutorial: www.research.umn.edu/subjects.htm.

11. b) Describe what will be said to the subjects to introduce the research.Do not say “see consent form”. Write the explanation in lay language. If you are using telephone surveys, telephones scripts are required.

Subjects will be informed that:

* The study is designed to understand the suitability of driving simulators for use in driving rehabilitation programs.

* Their performance driving a simulator will be measured. And, for those subjects in Protocol B, their performance driving a real car will be measured.

* Participation in the study involves one or two sessions that will be approximately three hours for the first and approximately two hours for the second. Subjects in Protocol A will have two simulator sessions, those in Protocol B will have one simulator and one on-road session (order is randomized), and those in Protocol C will have one simulator session. The first session is longer because standard tests to measure cognition, reaction time, and visual attention will be administered.

* That we would like them to participate in both sessions (except for those in Protocol C) because otherwise the study results will be compromised.

* There is the risk of simulator sickness and for those in the on-road trial, risk of an automobile accident. The steps taken to minimize risks will be described.

* The study is in no way tied to clinical evaluation and recommendations of their suitability to return to driving.

* If they are interested in a clinical driving program, that a driving assessment program similar to that used by the study is available via referral to occupational therapy at Sister Kenny Institute, the Driving Program of Courage Center, or the Driving Program at National Rehabilitation Hospital. These programs are not connected to the study and it is up to the subject to proceed further.

* They will be paid $50 per session, but that there are no other direct benefits to participating.

* They have a right to participate not participate or stop participating any time they wish.

We will also repeat the inclusion and exclusion criteria to ensure that only target subjects are enrolled.

11. c) What questions will be asked to assess the Subjects’ understanding?Please answer how you will assess subjects’ understanding of the consent process. Questions requiring “yes/no” answers do not do that very well. Please ask subjects to explain the purpose of the study to you along with the

risks and the benefits to themselves as participants. Their answers to these questions should allow you to determine if they understand the study and their part in it. If they do not understand, informed consent has not been achieved even if the subjects signed the consent document.

Subjects will be asked:

* "What is the purpose of this study?"

* "What are you agreeing to do if you participate?"

* "What are the risks associated with participating in the study?"

* "What do you expect to get out of participating in the study?"

* "What are your rights regarding starting or ending your participation in the study?"

11. d) In relation to the actual data gathering, when will consent be discussed and documentation obtained? (e.g., pre-operatively, or several days before?) Be specific.

Consent will be obtained at the start of the first session, before the subject evaluation tests.

Prior to attending the first session, subjects will be pre-screened by telephone or in person for inclusion/exclusion criteria. (see attached script)

11. e) Will the investigator(s) be securing all of the informed consent?

Yes No. If no, please name the specific individuals who will obtain informed consent and include their job title and a brief description of your plans to train these individuals to obtain consent and answer subjects’ questions.

     

You have reached the end of this form. Please make sure that you have responded to every question on this application (even if your response is “not applicable”). Submit 12 copies plus the original for Full Review, and 3 copies plus the original if you are requesting Expedited Review. Please send the application to:

Research Subjects’ Protection ProgramsIRB

D528 Mayo Memorial BuildingMMC 820

420 Delaware Street S.E.Minneapolis, MN 55455

See the meeting “Meeting Dates and Deadlines” page on the Research Subjects’ Protection Programs’ Web page: http://www.research.umn.edu/subjects/index.html to find out the date of the meeting at which your application will be reviewed. If you have any questions, please call us at 612-626-5654.