* Project Classification: Provide an appropriate description (e.g., Research Project, Dissertation, Thesis, etc.) SAMPLE

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1 (300) UTK IRB Submission * Project Classification: Provide an appropriate description (e.g., Research Project, Dissertation, Thesis, etc.) * Please indicate the correct status of this submission: I am requesting initial approval for research. I am registering research that was originally approved on paper by the UTK IRB. (415) UTK Key Project Study Contact Information * For the Principal Investigator and all Study Contacts (as listed in section 3.3 above) provide the following contact information: office address; office phone number; cell number; pager; address; degree; rank; whether he/she will obtain consent from subjects; and whether he/she will have access to research records of subjects. ALL OTHER key study personnel (as listed in section 3.2A & B) must be added to the chart below if they will obtain consent or have access to research records; however, you do not have to complete any other columns for those persons (except the last 2 columns). Note: All imedris correspondence will be sent automatically to your UT account. You may contact the HELP Desk at (865) to have your UT forwarded to another account. revised 09/24/2014 Name Office Address Office Phone No record has been added Add a new row Copy existing row(s) Delete selected row(s) Cell Phone (417) UTK KSP Credentials Obtain Page Address Degree Rank Informed consent Access to researc h records Please list the names and credentials and ROLES for all KSP on this study. (Examples include John Smith, PhD-Statistician; Mary Jones, MD-Surgeon; Jane Doe, MD-Patient Recruitment) Note: Investigators must specify their relevant qualifications and those of other investigators involved in this project to perform the proposed research. Include qualifications of personnel working on portions of the research where special training, certification, or licensing is required for the performance of their tasks. Experience and expertise is required when involving participants' classifed as vulnerable, such as children, pregnant women, prisoners, cognitively impaired or institutionalized individuals. Add a new row Copy existing row(s) Delete selected row(s) KSP Name KSP Credentials and Roles No record has been added (420) Review Board Routing Questions

2 * Additional Research Compliance. Does this research involve animal subjects? Yes No * Check All of the following items that apply to this study. below: Radioactive Materials Potential Biological Hazards (viruses, recombinant DNA, etc.) Chemical Hazards (poisons, explosives, reagents, flammables, carcinogens, etc.) Use of Botulinum Neurotoxins, Botulinum Neurotoxin Producing Species of Clostridium, Preparations, or Pharmaceuticals Containing Botulinum Neurotoxins Not Applicable (468) Funding Source * Is there a funding source associated with the study/project? Yes No (470) Funding Source Please designate your funding sources: Federal or Foreign Government; Sponsor Company; Medical Center or University; Not-for-Profit Organization If applicable designate source (475) Contract Information * Select the office or institution that is processing the grant or contract for this study/project. If there is no grant or contract for this study/project, enter "Not Applicable." --none-- If you selected "Other" please list the office or institution that is processing the grant or contract for this study/project: Where is the project/proposal in the funding process? Not submitted (seeking IRB approval as first step) Submitted but not awarded Awarded Is the proposal title different from this IRB project application? Yes No If different list

3 List the following information (if applicable): Note: Please contact the office processing the contract/grant for the appropriate information. UTK - PAMS number or other Institution Log Number / Proposal Number Protocols for which the contract is handled by UTK Sponsored Programs require the PAMS number be entered here. If you have not yet routed the contract you may generate a PAMS number by filling out and saving the first page in PAMS. You will be assigned a PAMS number and may return to complete the routing when you are ready. Sponsor Award Number Institution Award Number Account Number (485) Study/Project Information * Are you requesting Full Board, Expedited or Exempt review by the IRB? Full Board Expedited Exempt Not Sure * Please indicate the type of study/project: No drug/biologic or device is being administered and evaluated as part of study/project procedures. A device is being administered and evaluated as part of the study/project procedures. A drug/biologic is being administered and evaluated as part of the study/project procedures. A drug/biologic AND a device is being administered and evaluated as part of the study/project procedures. (490) Drug, Biologics, and Device Information and Administration List the names of all of the drugs and biologics being evaluated in this study/project as well as those that are being used as comparators. If this is a drug or biologic being used under the emergency, treatment, or compassionate use provisions of the FDA regulations, answer all applicable questions below.

4 Device Information: Provide the name of each device, the person(s) who will be authorized to administer each device, and explain how each individual is qualified by training and experience to administer each device: Add a new row Copy existing row(s) Delete selected row(s) Name of Authorized Qualifications Device Person explained No record has been added (590) Exempt Screening Questions * Check ALL of the following items that describe your study: My project is a case study or series of NO MORE THAN 5 (five) cases and only involves the review of records. The study is an internal evaluation of an institutional program or academic course. The results of my study may be presented or published. The only subjects of this study are persons who are deceased. I am NOT able to identify the persons whose information or specimens are being analyzed in the study, either directly or through identifiers linked to the subjects. All documents or records used in this research are publicly available. The study involves the review of more than five records and ALL the data to be used in the project are in existence AT THE TIME THIS APPLICATION IS SUBMITTED. Once my study is complete, linkage to the identity of subjects will be deleted. The study involves the administration of tests, surveys, interviews or focus groups, or observation of public behavior. All subjects doing tests, surveys, interviews or focus groups will be 18 or older. The study involves public observation of children without the investigator being involved in the activities observed. All survey/interview subjects are public officials. The research involves evaluating educational practices in a typical educational setting. The research involves evaluation of a public benefit or service program. The evaluation of the public benefit or service program is authorized by law. The study involves taste, food quality, or consumer acceptance testing. (638) Not Exempt Based on your answers to the questions for Determination of Exempt Status, your project does not fall under Exempt status according to the Federal Regulations. Please go back to (485) Study/Project Information, and change your answer to "Expedited." Once you save, you will receive the expedited questions. You may also call the IRB for assistance (865) if you believe your study is exempt. (639) Exempt

5 Based on your answers to the questions for Determination of Exempt Status, your project does falls under Exempt status according to the Federal Regulations. (640) Exempt - Not Sure Please go back to (485) Study/Project Information, and change your answer to "Exempt." Once you save, you will continue with the exempt questions. (652) Begin Exempt Application: Purpose of Research * Please briefly describe the background and rationale for this study/project. * What is the purpose of the study/project? (653) Studies Involving Records, Data, Documents, Specimens 45CFR46.101(b)(4) * Describe the defining features of the records, data, documents, or specimens to be examined, such as the presenting problem, diagnosis, or types of treatment being investigated. * Indicate the name and location of the institution in which the records, data, documents, or specimens are housed. * Specify the start date AND the end date for the records, data, documents, or specimens to be reviewed. * Describe in general terms the types of information that will be abstracted from the records, data, documents, or specimens to be examined.

6 (658) Survey or Interview 45CFR46.101(b)(2) or (b)(3) * Describe the characteristics of the subject population that will be involved in the survey /interview. * Explain the circumstances or conditions under which the survey or interview will be conducted. * Briefly describe the content of the survey or interview: (At the end of the application, you will be asked to attach a copy of the survey or interview.) (660) Informed Consent Indicate which procedure will be used to secure and document the informed consent of prospective subjects involved in survey or interview. Please note that you may use an informed consent statement for survey studies in lieu of a signed consent form. You can choose this option by answering yes to option #2. Yes No * 1) An informed consent interview will be conducted with subjects and they will be asked to sign a consent form to document their agreement to participate in the study/project.

7 * 2) A brief informed consent statement will be presented orally to subjects (for survey or interview) or will be attached (for survey only). Subjects will not provide written documentation of consent. Their willingness to respond to the survey or interview will constitute documentation of their consent. If you answer "Yes," at the end of the application, you will be asked to attach a copy of the informed consent statement prepared in accord with the IRB guidelines for informed consent to survey research (these guidelines should also be followed for interviews, focus groups, etc.) Yes No (662) Exempt Research (other than or in addition to: Survey /Interview or Records/Data/Documents/Specimens) * Describe the subject population and explain how the subjects will be selected or recruited. * Describe the procedures used in the study/project for collecting, retrieving, and/or analyzing data. (663) Secure Informed Consent * Will you secure the informed consent of subjects? Provide details of storage of signed informed consent form and retention for three years: Yes No (665) Informed Consent Process * Please describe the process that you will use for securing informed consent. You will be asked at the end of the application to attach your informed consent document(s). (667) Informed Consent Not Possible * Please explain why it is not possible to secure informed consent:

8 (675) Informed Consent * Can the study/project practicably be conducted if informed consent is required? Yes. The study/project can be carried out even if informed consent is required. No. The study/project cannot be carried out without a waiver of informed consent. If you answered "Yes," please describe the plan to secure and document the informed consent of the subjects: (At the end of the study/project application, you will be asked to attach a copy of the informed consent statement or form.) (685) Waiver of Informed Consent * Why can the research not be practicably carried out without the waiver of consent? Funds and personnel do not exist to contact all potential subjects to secure their consent. Failure to include all potential subjects might result in skewed analysis of the results of the study/project. Other reason. If you answered "Other reason," please explain: (701) Define "Expedited" and Minimal Risk "Expedited Review" is a speedier process than "Full Board Review." Proposals that may qualify for Expedited Review include: Research activities that 1) present no more than minimal risk to human subjects AND 2) involve only procedures listed in one or more of seven Expedited Review Categories. By answering the following questions, you will assist the IRB in determining if your proposal will be granted Review. an Expedited

9 Please hit "Save and continue..." in the upper right corner. * Do the Research activities present no more than minimal risk to human subjects? Yes. The research activities present no more than minimal risk to human subjects. No. The research activities DO present more than minimal risk to human subjects. * Would identification of the subjects and/or identification of their responses reasonably place them at risk of criminal or civil liability or be damaging to the subjects financial standing, employability, insurability, reputation, or be stigmatizing? Yes. Identification of subject or subject responses could place the subject at risk. No. Identification of subject or subject responses would not place subject at risk. (703) Minimal Risk * Will reasonable and appropriate protections be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal? Yes. Protections will be implemented. No. Protections will not be implemented. (706) Classified Research * Is this project considered to be "classified" research? Yes. This research is considered classified. No. This research is NOT considered classified. (715) Significant Risk * Is it possible that this research will significantly increase the risk or decrease the acceptability of the risks associated with the use of the drug? Yes. Risk may increase significantly or acceptability of risk may decrease significantly. No. Risk will not increase significantly and acceptability of risk will not decrease significantly. (720) Category 2: Blood Collection * Does this research involve the collection of blood? Yes. This study/project does involve the collection of blood. No. This study/project DOES NOT involve the collection of blood. (722) Mode of Blood Collection * Will the collection of blood samples be solely by finger stick, heel stick, ear stick, and/or venipuncture? Yes. Blood will be collected ONLY by the methods listed above.

10 No. Blood may be collected by other methods that do not meet requirements for expedited review. (723) Study/Project Population * Does the study/project population include the following? Check all that apply. Healthy, NON-pregnant adults who weigh at least 110 pounds Unhealthy adults, pregnant females, children, AND/OR persons who weigh less than 110 pounds (Click on the question mark in the right margin to review the definition of 'Children.' (724) Healthy, Non-Pregnant Adult Blood Collection * Please check the amount of blood that will be collected from the healthy, non-pregnant adults who weigh at least 110 pounds: NO MORE than 550 ml of blood will be collected in an 8 week period. MORE than 550 ml may be collected in an 8 week period. * Please check the frequency of blood collection for the healthy, non-pregnant adults who weigh at least 110 pounds: Blood will be collected NO MORE than 2 times per week. Blood will be collected MORE THAN 2 times per week. (726) Vulnerable Population Blood Collection * Please check the amount of blood that will be collected from the unhealthy adults, pregnant women, children, and persons who weigh less than 110 pounds: NO MORE than the lesser of: [50 ml] OR [3-ml-per-kg] of blood will be collected in an 8 week period. MORE than the lesser of: [50 ml] OR [3-ml-per-kg] of blood will be collected in an 8 week period. * Please check the frequency of blood collection for the unhealthy adults, pregnant women, children, and persons who weigh less than 110 pounds: Blood will be collected NO MORE than 2 times per week. Blood may be collected MORE THAN 2 times per week. (730) Category 3: Biological Specimen Collection * Does this research entail biological specimen collection other than blood? Yes. This research includes biological specimen collection other than blood. No. This research DOES NOT include biological specimen collection other than blood. (732) Prospective/Retrospective Specimen Collection * Please indicate the type of specimen collection to be used in this research: Retrospective specimen collection means the specimens were "previously collected." "Previously collected" means collected prior to the date that this research is initiated.

11 Prospective specimen collection means the specimens will be collected during the course of the research. Retrospective Biological Specimen Collection Only Prospective Biological Specimen Collection Only Both Retrospective and Prospective Biological Specimen Collection (734) Non-Invasive Specimen Collection Expedited Review criteria allow the prospective collection of biological specimens through non-invasive means. Please click on the question mark in the right margin for a list of example procedures that represent noninvasive means of specimen collection. * Are the procedures in this study/project no more invasive than the procedures in the examples listed? Yes. Specimen collection procedures in this research are NO MORE invasive than the examples listed. No. Spec collection procedures in this research are MORE invasive than the examples listed. (740) Category 4: Non-Invasive Procedures * If this study/project involves physical diagnostic and/or monitoring procedures, is it true that ALL are NON-INVASIVE and do not include general anesthesia, sedation, x-rays or microwaves? Yes. The study/project involves physical diagnostic and/or monitoring procedures, all of which are non-invasive and do not include general anesthesia, sedation, x-rays or microwaves. No. The study/project involves physical diagnostic and/or monitoring procedures, some of which are invasive or include general anesthesia, sedation, x-rays or microwaves. Not applicable. The study/project does not involve physical diagnostic and/or monitoring procedures. (742) List of Non-Invasive Procedures Expedited Review criteria allow procedures for the collection of data that are NO MORE INVASIVE than the following procedures: physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subject's privacy weighing or testing sensory acuity magnetic resonance imaging electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual * Are the procedures in this research MORE INVASIVE than the procedures above? Yes. The procedures are MORE invasive than the example procedures listed above. No. The procedures are NOT MORE invasive than those listed above. (750) Category 5: Use Non-Research Materials * Does this proposal involve using materials (data, documents, records, or specimens) that have been collected solely for non-research purposes?

12 Yes. This proposal involves using materials (data, documents, records, or specimens) that have been collected solely for non-research purposes. No. This proposal does not involve using materials (data, documents, records, or specimens) that have been collected solely for non-research purposes. (760) Category 6: Recordings * Does this proposal involve the collection of data from voice, video, digital or image recordings made for research purposes? Yes. This proposal does involve data from recordings as noted above. No. This proposal does NOT involve data from recordings as noted above. (765) May Be Exempt Based on your answers to the questions for Determination of Expedited Status, your project may qualify for Exempt status if you are using materials (data, documents, records, or specimens) that have been collected solely for non-research purposes, AND all of these materials are already in existence at the time you submit this application to the IRB. If this is true, then please go back to (485) Study/Project Information, and change your answer to "Exempt." Once you save, you will receive the exempt questions. You may also call the IRB for assistance ( ) if you have any questions. If this is not true, simply save and continue answering the expedited application questions. (770) Category 7: Characteristic, Behavioral, Methodology Research * Is this research on individual or group characteristics or behavior (including but not limited to research on perception. cognition, motivation, identity, language, communication, cultural beliefs or practices and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies? Yes. This research is on characteristics, behaviors and/or involves one of the specified methodologies. No. This research does not fall into the behavior, characteristic or methodology categories above. (775) May Be Exempt Based on your answers to the questions for Determination of Expedited Status, your project may qualify for Exempt status if you are using materials (data, documents, records, or specimens) that have been collected solely for non-research purposes, AND all of these materials are already in existence at the time you submit this application to the IRB. If this is true, then please go back to (485) Study/Project Information, and change your answer to "Exempt." Once you save, you will receive the exempt questions. You may also call the IRB for assistance ( ) if you have any questions. If this is not true, simply save and continue answering the expedited application questions. (780) Not Expedited Based on your answers to the questions for Determination of Expedited status, your project does not fall under Expedited status and should be submitted for Full Board Review according to the Federal Regulations.

13 Please go back to (485) Study/Project Information, and change the chosen option to Full Board. You may also call the IRB for assistance ( ) if you believe your study is expedited. (925) Study/Project Synopsis * Click on the bar below and provide a synopsis of the research study/project addressing the following SIX items USING these numbered subheadings: 1. Purpose, 2. Rationale, 3. Study/Project Population, 4. Research Design, 5. Study/Project Procedures, and 6. Outcome Measures. Click here to access the text editor. (1050) Purpose * State concisely the objectives of the study/project. (1075) Background & Current Status of Work in the Field * Provide a discussion of the background and current status of work in the field. (1200) Site Information * Please list sites and procedures where the study/project will occur. * Is this a multicenter study/project? Yes. This is a multicenter study/project No. This is NOT a multicenter study/project Not applicable * Are any of the locations listed above non-utk facilities?

14 If a project is to be conducted in a non-ut Facility, an original letter of permission to use the non-ut facility must accompany the submission. Letters of permission must be on the letterhead of the organization and signed by authorized officials. If public school or school system facilities are to be used, letters of permission from authorized officials in the superintendent of schools office, and possibly from school principals must accompany the submission. Yes No If Yes, then what is the status of the other IRB s review? Future plans In process Ready to process Describe the research setting (e.g. classroom, clinic, laboratory, office, park, personal computer). (1400) Subject Population Please state the anticipated number and age range of the subjects to be studied. Overall number of subjects for sponsored multi-center studies [This is the total number of subjects that the protocol states will participate in the study across all centers.]: * Number of subjects to be accrued locally [This is the total number of subjects you expect to accrue (consent), including anticipated screen failures and withdrawals. For studies that have been approved for a waiver of consent, subjects are considered accrued at the time ANY study interventions are performed, including medical record abstraction and screening procedures.]: * Age range of subjects to be accrued locally: Is any racial/ethnic group excluded? Yes No Provide an explanation if any racial/ethnic group is excluded. (1488) Vulnerable Subjects * Does your study require the inclusion of (i.e., are you targeting) any of the following categories of vulnerable subjects? Check all that apply.

15 Children (0-17 years) Who Are Not Wards of the State Children (0-17 years) Who Are Wards of the State Pregnant Females and Their Fetuses Neonates Who Are Nonviable or of Uncertain Viability Prisoners Developmentally Disabled Persons (who are not institutionalized) Developmentally Disabled Persons Who Are Institutionalized Persons Who Are Mentally Ill (but who are not institutionalized as mentally ill) Persons Who Are Institutionalized as Mentally Ill International Populations Students of a School Associated with this Project Employees of an Institution/Agency Associated with this Project Other Vulnerable Population Not Identified Above Vulnerable Not Applicable Subjects not Classified as Vulnerable Might any of the following categories of vulnerable subjects be incidentally included in your study, even though their inclusion is not necessary? Check all that apply. Children (0-17 years) Who Are Not Wards of the State Children (0-17 years) Who Are Wards of the State Pregnant Females and Their Fetuses Neonates Who Are Nonviable or of Uncertain Viability Prisoners Developmentally Disabled Persons (who are not institutionalized) Developmentally Disabled Persons Who Are Institutionalized Persons Who Are Mentally Ill (but who are not institutionalized as mentally ill) Persons Who Are Institutionalized as Mentally Ill International Populations Students of a School Associated with this Project Employees of an Institution/Agency Associated with this Project Please explain how a certain category of vulnerable subjects might be incidentally included:

16 (1494) Study/Project Duration * What is the anticipated duration of a single subject's participation in the study/project? * How long will the entire study last locally? (1500) Inclusion Exclusion Criteria Identify inclusion criteria. Identify exclusion criteria. (1600) Subject Selection and Recruitment How will subjects be selected? Check all that apply. Subjects identified through medical record screening Subjects recruited from among students and/or employees Telephone pre-screening Website pre-screening Advertising Other If you selected "Other," please explain: * Recruitment Materials At the end of this application, you are required to attach all recruitment materials which you intend to use for this study/project. No recruitment materials will be used in this research. Recruitment materials to be used in this research will be attached at the end of this application.

17 Recruitment materials will be submitted at a later date. If you selected the 2nd option above, describe how/where EACH of your recruitment materials (by name) will be used, in the text box below; e.g., on a website, sent to an ing list, posted on campus, in a newspaper, etc. (1710) Study/Project Procedures * Describe the study/project design: * Describe the procedures that will be performed to determine whether prospective subjects satisfy inclusion/exclusion criteria for study/project participation. * Do the study/project procedures involve administration of a drug, device or other intervention to determine its efficacy, safety, and/or tolerability for treatment purposes? Yes. The study/project procedures involve administration of a drug, device or other intervention to determine its efficacy, safety, and/or tolerability for treatment purposes. No. The study/project procedures DO NOT involve administration of a drug, device or other intervention to determine its efficacy, safety, and/or tolerability for treatment purposes. (1720) Procedures for Treatment * Describe the procedures for the administration of treatment. (1730) Procedures Other Than Treatment Describe all procedures, other than treatments, that will be performed. For studies/projects that involve multiple study/project visits, specify the timing of each visit, and in chronological order, list what will be done at each visit. Click on "Add a new row" to list each procedure of each visit.

18 If you do not wish to use the table, click on the Text Editor and type in the information (specify the timing of each visit and list in chronological order, using bullet points, what will be done at each visit). Also use the Text Editor to further describe any procedures that are not self-explanatory. Visit Name Visit Timing Procedur e No record has been added Add a new row Copy existing row(s) Delete selected row(s) (1735) Discontinuations, Endpoints, Analyses * Describe the criteria for discontinuation of treatment and withdrawal of the subject from the study/project. * Describe the endpoints or outcomes being assessed in the study/project, such as efficacy and safety endpoints. * Describe the statistical analysis that will be used. (2000) Risks & Benefits * Describe the possible risks to participants (including psychological harm, economic harm, social stigmatization, legal harm and physical harm if applicable). Include justification of those known risks. Describe ways in which this risk, if any, will be minimized.

19 Is there potential for direct benefit to the subject? Yes No Will there be benefit to the class of subjects? Yes No Is there societal benefit? Yes No If yes to any of the last three questions, explain: (2210) AE's and Data Monitoring * Has an independent data and safety monitoring board (DSMB) been established for the conduct of the study/project? Yes. An independent data and safety monitoring board (DSMB) HAS been established for the conduct of the study/project. No. An independent data and safety monitoring board (DSMB) HAS NOT been established for the conduct of the study/project. * Please explain so that the IRB understands the data and safety monitoring arrangements that are in place for this research, or indicate that it is explained in the sponsor protocol: (2730) If Subjects Were Not to Participate * List all of the procedures (including those such as medical record abstraction or survey administration) that will be performed ONLY because the subject is in this study/project. This means even listing how many additional blood draws, visits, etc., would occur beyond the number of standard of care blood draws, visits, etc. If all procedures are being performed solely for research purposes, you may simply state this.

20 (2800) Confidentiality 1 "n/a." * Will all paper research records containing data from individual subjects be locked and stored and be accessible only to research personnel? Yes. All paper research records containing data from individual subjects will be locked and stored and will be accessible only to research personnel. No. Not all paper research records containing data from individual subjects will be locked and stored and will be accessible only to research personnel. Not applicable. There will be no paper research records containing data from individual subjects. * If you answered "No," please explain: Otherwise, type "n/a." * Will all electronic research records containing data from individual subjects be computer password protected and be accessible only to research personnel? Yes. All electronic research records containing data from individual subjects will be computer password protected and accessible only to research personnel. No. Not all electronic research records containing data from individual subjects will be computer password protected and accessible only to research personnel. Not applicable. There will be no electronic research records containing data from individual subjects. * Will biological specimens from individual subjects maintained at the local investigative site be labeled with a code? Explanatory note: "Labeled with a code" means that identifying information (such as a name or social security number) which would permit easy identification of an individual has been replaced with a number, letter, symbol, or some combination thereof. Yes. Biological specimens from individual subjects maintained at the local investigative site during the study/project will be labeled with a code. No. Biological specimens from individual subjects maintained at the local investigative site will not be labeled with a code. Not applicable. There are no biological specimens being collected in this study/project. Not applicable. Biological specimens are being collected, but they are not being maintained at the local investigative site. * If you answered "No," please explain: Otherwise, type

21 * Will any research records containing data on individual subjects or any specimens from individual subjects be transmitted to an external site during the study/project? An external site is any site not listed in section (1200) Site Information, and this includes ing data to yourself or to another party. Yes. Research records containing data on individual subjects or specimens from individual subjects may be transmitted to an external site. No. Neither research records containing data on individual subjects nor specimens from individual subjects will be transmitted to an external site. (2810) External Records/Specimens * Will all research records or specimens transmitted to the external site(s) during the study/project be coded? Explanatory note: "Coded" means that identifying information (such as a name or social security number) which would permit easy identification of an individual has been replaced with a number, letter, symbol, or some combination thereof. All research records and specimens transmitted to the external site(s) will be coded. Some research records or specimens transmitted to the external site(s) will not be coded. All research records or specimens transmitted to the external site(s) will not be coded. * If the second or third choice is selected, please explain: Otherwise, type "n/a." (2814) Coded External Records/Specimens * For coded research records or specimens sent to the external site(s) during the study, will the master key linking the names of subjects with the codes be maintained only at the local investigative site? Yes. The master key will be maintained only at the local investigative site. No. The master key may NOT be maintained only at the local investigative site. * If you answered "No," please explain: Otherwise, type "n/a." (2820) Confidentiality 2 * Will information obtained from procedures performed only for research purposes be placed in the medical record of subjects? Yes. Information obtained from procedures performed only for research purposes MAY Be placed in the medical record of subjects. No. Information obtained from procedures performed only for research purposes WILL NOT BE placed in the medical record of subjects.

22 Not applicable: There will be no procedures performed only for research purposes. Not applicable: This project does not include access to or use of the medical record of the subjects. * If "Yes," please explain what information will be placed in the medical record: Otherwise, type "n/a." * Will documentation of the participation of the subject in the research study, such as a copy of the consent form or other notation, be placed in the medical record of the subject? Yes. Documentation of the participation of the subject in the research study, such as a copy of the consent form or other notation, MAY BE placed in the medical record of the subject. No. Documentation of the participation of the subject in the research study, such as a copy of the consent form or other notation, WILL NOT BE placed in the medical record of the subject. Not applicable: This project does not include access to or use of the medical record of the subjects. * For studies/projects that involve a repository: Is it true that specimens or data from the repository will not be labeled in a manner that allows individual investigators to whom the specimens or data are distributed to identify individual subjects? This is not a repository study/project. True. Specimens or data from the repository WILL NOT BE labeled in a manner that allows individual investigators to whom the specimens or data are distributed to identify individual subjects. False. Specimens or data from the repository WILL BE labeled in a manner that allows individual investigators to whom the specimens or data are distributed to identify individual subjects. (2825) Confidentiality 3 * Will a federal Certificate of Confidentiality be obtained for this study/project? Yes. A federal Certificate of Confidentiality WILL be obtained for this study/project. No. A federal Certificate of Confidentiality WILL NOT be obtained for this study/project. (3045) Payment * Will any type of payment (money, gift card, or other item) be provided to the subject for participation? Yes No (3050) Describe Payment * Indicate the AMOUNT of money to be paid (including reimbursement pay) per visit AND total maximum payment, the TYPE of payment (check, cash, gift card and value), as well as the monetary worth of any OTHER tangible item provided as payment for study/project participation.

23 * To whom will the payment [money, gift certificate, other items] be paid/given? The subject The subject's legally authorized representative Mixed arrangement, depending on the age of subjects * If you answered "Mixed arrangement," please explain: Otherwise, type "n/a." * How will the actual amount of money received by the subjects or their legally authorized representative be determined? Lump sum payment will be made at completion of the study/project (Note: if paying per visit, the payment must not be held until the end of the study because of potential undue inducement; the same applies if a rather large sum of money will be paid only at the end of the study.) Prorated payments will be processed or issued at the time specific visits and/or procedures are completed Prorated payments will be processed or issued at the time specific visits and/or procedures are completed, plus a bonus will be paid for completing the entire study/project Course Credit Not applicable; no money will be paid to the subjects * If your answer is the second option, "Prorated payments for...procedures," please describe the schedule of payments for specific visits and/or procedures. If your answer is the third option, "Prorated payments... plus a bonus for completing the entire study," please describe the schedule of payment for specific visits and/or procedures, as well as the bonus for completing the entire study/project. Otherwise, type "n/a." (3100) Financial Obligations * Will any drug/biologic, device or intervention being administered and evaluated as a diagnostic, monitoring or treatment procedure in this study/project be provided free of charge? Not Applicable. No drug/biologic, device or other intervention is being evaluated as treatment study/project. in the

24 Yes. The drug/biologic, device or other intervention being evaluated as treatment WILL be provided free of charge. No. The drug/biologic, device or other intervention being evaluated as treatment WILL NOT be provided free of charge. * If you answered "Yes," please explain which drug/biologic, device or other treatment intervention is being provided free of charge: Otherwise, type "n/a." (3200) Research Injuries * Does the research include procedures that have the potential to cause physical injury to the subjects? Yes. The research includes procedures that have the potential to cause physical injury to the subjects. No. The research DOES NOT include procedures that have the potential to cause physical injury to the subjects. (3210) Potential Injuries * Who will be responsible for the costs of treating research-related physical injuries? Write the subject & his/her insurance or the subject & his/her insurance, and the sponsor below, regarding who will be responsible for the costs of treating research-related physical injuries, or specify any other arrangements. * Will research personnel provide treatment or referral for research-related physical injuries as needed or requested by the subject? Research personnel will provide acute care for research-related physical injuries. Research personnel will refer subjects for appropriate care for research-related physical injuries. Research personnel will provide acute care for research-related physical injuries and will refer subjects for appropriate care. Other, please explain below. If you answered "Other," please explain. * Will compensation be available to subjects for any ancillary expenses incurred as the result of researchrelated physical injuries, such as additional hospital bills, lost wages, travel expenses, etc.? Yes. Compensation will be available to subjects for any ancillary expenses incurred as the result of research-related physical injuries, such as additional hospital bills, lost wages, travel expenses, etc.

25 No. Compensation will NOT be available to subjects for any ancillary expenses incurred as the result of research-related physical injuries, such as additional hospital bills, lost wages, travel expenses, etc. (3220) Physical Injury: Who Provides Compensation * Who will provide compensation for these ancillary costs associated with research-related physical injuries? Write the sponsor or not provided in the text box below regarding who will provide compensation for the ancillary costs associated with research-related physical injuries, or specify any other arrangements. (3230) Compensation for Non-Physical Injuries * Will compensation be available to subjects for any non-physical injuries that may be incurred as a result of research participation, such as exposure to criminal or civil liability, or damage to their reputation, financial standing, or employability? Yes. Compensation will be available to subjects for any non-physical injuries that may be incurred as a result of research participation, such as exposure to criminal or civil liability, or damage to their reputation, financial standing, or employability. No. Compensation will NOT be available to subjects for any non-physical injuries that may be incurred as a result of research participation, such as exposure to criminal or civil liability, or damage to their reputation, financial standing, or employability. (3240) Non-Physical Injury: Who Provides Compensation * Who will provide compensation for non-physical injuries associated with research participation? Write the sponsor or not provided in the text box below regarding who will provide compensation for non-physical injuries associated with research participation, or specify any other arrangements. (3300) Conflict of Interest * For publically traded entities, have any individuals among the key research personnel (including their spouses, parents, and children) received salary for services or any other payments (e.g., consulting fees, honoraria, paid authorship) from the sponsor of the research during the previous 12 months, and/or hold equity interest in the sponsor, where the value, when combined, exceeds $5,000? Yes. Key study personnel (or their spouses, parents, or children) have received remuneration from the sponsor and/or hold equity interest in the sponsor, that when aggregated, exceeds $5,000. No. Key study personnel (or their spouses, parents, or children) will NOT receive remuneration from the sponsor and/or do not hold equity interest in the sponsor, that when aggregated, exceeds $5,000. Not Applicable. There is no commercial sponsor for this research study/project. * For non-publically traded entities, have any individuals among the key research personnel (including their spouses, parents, and children) received salary for services or any other payments (e.g., consulting fees, honoraria, paid authorship) from the sponsor of the research during the previous 12 months which exceeds $5,000, or hold any equity interest in the sponsor of the research?

26 Yes. Key study personnel (or their spouses, parents, or children) have received remuneration from the sponsor during the previous 12 months, which exceeds $5,000, or hold equity interest in the sponsor of the research. No. Key study personnel (or their spouses, parents, or children) have NOT received remuneration from the sponsor during the previous 12 months, which exceeds $5,000 or hold equity interest in the sponsor. Not Applicable. There is no commercial sponsor for this research study/project. * Do any individuals among the key research personnel (including their spouses, parents, and children) have intellectual property rights (patents, trademarks, or copyrights) in the medical entity being evaluated in the research and received income related to such rights and interests? Yes. Key study personnel or their spouses, parents, or children do have intellectual property rights related to the medical entity being evaluated and received income related to such rights and interests. No. Key study personnel (or their spouses, parents, or children) do not have intellectual property rights related to the medical entity being evaluated. Not Applicable. (3329) Informed Consent * Check each of the following that apply to your study/project: Informed consent will be secured from adult subjects who are able to consent for themselves. Informed consent will be secured from legally authorized representatives for adult subjects who are not able to consent for themselves. Permission will be secured from legally authorized representatives for children who are subjects. Assent will be secured from children 7 years of age and older who are subjects. A request is being made to waive or alter consent for some or all of the subjects. (Note: Informed consent normally requires the use of a consent form prepared according to the IRB format and the conduct of an individual in-person interview with the prospective subject. WAIVER of consent is a request to forego consent entirely. ALTERATION of consent is a request to alter the normal process, e.g., by using a shorter consent statement or conducting consent over the phone.) Consent will be secured from the subjects, but a request is being made to NOT obtain a signed consent form for some or all of the subjects. (For example, you are conducting an online survey study.) Non-English speaking subjects will be included in the study population. (3350) Waiver and/or Alteration of Consent * Are you requesting a waiver and/or alteration of consent? Note: Informed consent normally requires the use of a consent form prepared according the IRB format and the conduct of an individual in-person interview with the prospective subject. WAIVER of consent means that a request is being made to forego consent entirely. ALTERATION of consent means that a request is being made to alter the normal process, e.g., by using a shorter consent statement, speaking with the prospective subject by phone, or securing consent from subjects as a group. A request is being made for a general waiver of informed consent. A request is being made for an alteration of informed consent. (3352) Subjects Under Waiver and/or Alteration of Consent * Describe the group(s) of subjects for which the waiver and/or alteration of consent is being requested. If you have requested both a waiver and an alteration of consent, please describe the subjects for each request.

27 (3360) Describe Alteration of Consent * Describe the nature of the alteration in consent being requested. For example, will you be using the survey consent elements instead of a full consent form for a survey study, or will you be mailing a consent form and conducting the informed consent interview over the phone and asking the subject to mail the signed consent form back to you? (3365) Practicality Without Alteration of Consent * Why can the research not be practicably carried out without the alteration of consent? Prospective subjects cannot be contacted in person to secure their consent, but can be contacted by other means, such as telephone. Achieving the objectives of the research requires that the consent disclosure not include some key elements of information about the study. The research is minimal risk, the number of subjects is large, and funds and personnel do not exist to conduct the consent interview utilizing a full consent form. Other reason. * If you answered "Other," please explain: Otherwise, type "n/a." (3370) Practicality Without Waiver of Consent? * Why can the research not be practicably carried out without the waiver of consent? Funds and personnel do not exist to contact all potential subjects to secure their consent. Failure to include all potential subjects might result in skewed analysis of the results of the study. Other reason. (3380) Waive Signed Consent Form Requirement * Describe the group of subjects for which a request is being made to NOT obtain a signed consent form.

28 (3385) Risk/Consent * Does the research involve more than minimal risk? Yes. The research involves more than minimal risk. No. The research does NOT involve more than minimal risk. (3390) Consent Outside Research * Does the research involve any procedure for which separate, written consent is normally required outside the research setting? Yes. The research does involve procedures for which separate, written consent is normally required outside the research context. No. The research does NOT involve procedures for which separate, written consent is normally required outside the research setting. (3393) Consent Summary * Will the subject be provided with a written consent summary about the research study? Yes. The subject will be provided with a written consent summary about the research study. No. The subject will NOT be provided with a written consent summary about the research study. (3440) Consent Process * Briefly explain when and where informed consent, permission and/or assent will be sought. (3442) Non-English Speaking * Will a consent form (or survey with consent elements) in the primary language of non-english speaking subjects and/or non-english speaking legally authorized representatives be attached to the application? NOTE: You may NOT enroll non-english speaking subjects until you have a consent form translated into their primary language. Yes. A consent form (or survey with consent elements) in the primary language of non- English speaking subjects and/or legally authorized representatives will be attached to the application. No. After the English consent form (or survey with consent elements) is approved by the IRB, we will obtain a translation. The translation will be submitted at a later date. Not Applicable. You may ONLY check this button if you are NOT using survey consent elements or any type of consent form or written document during the informed consent process.