Social and Behavioral Sciences Application Form

THE GEORGE WASHINGTON UNIVERSITY Office of Human Research- Institutional Review Board [email protected] Phone: 202-994-2715 humanresearch.gwu.edu IRB APPLICATION (HRP-200)IRB # (if already assigned, otherwise leave blank--will be assigned upon submission): STUDY TITLE: YOUR ASSIGNED VERSION DATE (required): Minimal Risk: Please review the exempt categories to determine if your research qualifies for exempt status. If you believe your research is exempt, you may complete the questions in orange only. Otherwise, you must complete all questions and required supplements or state why a question is not applicable. If it is determined by OHR that your research does not qualify for exempt status, the application will be returned to you to complete the remaining questions. Greater Than Minimal Risk1.0 PRINCIPAL INVESTIGATOR AND PRIMARY CONTACT INFORMATION NOTE: If the study includes team members other than the PI and Primary Contact, training, responsibilities, and COI information for the PI and Primary Contact should be provided on the RESEARCH PERSONNEL FORM (HRP-201) instead of on this page. Please submit training certificates for all research personnel with this submission.1.1 PRINCIPAL INVESTIGATOR LAST FIRST NAME: DEGREE: NAME: PHONE: EMAIL: GWID: SCHOOL: DEPARTMENT: ADDRESS: PROFESSOR ASSOCIATE PROFESSOR ASSISTANT PROFESSORRESEARCH SCIENTIST RESEARCH PROFESSOR OTHER: Do you have any outside interests related to this research (ex: personal stock/equity in the company sponsoring the research, receipt of income, including royalties and entitlement to royalties, from the sponsor of this research for purposes other than this research, etc.) that could possibly be perceived as introducing bias into the research or as a conflict of interest? (y/n): If yes, submit an explanation of how this will be managed and provide supporting documentation. Date of expiration of GW CITI BIOMEDICAL Basic/Refresher Course for Human Subjects: (training is valid for two years) Date of expiration of GW CITI SOCIAL/BEHAVIORAL Basic/Refresher Course for Human Subjects: (training is valid for two years) Date of completion of CITI Health Information, Privacy & Security (HIPS) or Skillport HIPAA Training if accessing PHI or PII: Date of completion of CITI ICH-GCP Training, if clinical trial: If any training taken under another name, provide other name: 1.2PRIMARY CONTACT (IF OTHER THAN THE PI) TO RECEIVE IRB CORRESPONDENCE IRB Application (HRP-200) V. 01/13/16THE GEORGE WASHINGTON UNIVERSITY Office of Human Research- Institutional Review Board [email protected] Phone: 202-994-2715 humanresearch.gwu.edu IRB APPLICATION (HRP-200) LAST NAME: FIRST NAME: DEGREE: PHONE: EMAIL: GWID: FACULTY STAFF UNDERGRADUATE STUDENT MASTERS STUDENT DOCTORAL STUDENT RESIDENT POST-DOC OTHER: Role/research responsibilities: Do you have any outside interests related to this research (ex: personal stock/equity in the company sponsoring the research, receipt of income, including royalties and entitlement to royalties, from the sponsor of this research for purposes other than this research, etc.) that could possibly be perceived as introducing bias into the research or as a conflict of interest? (y/n): If yes, submit an explanation of how this will be managed and provide supporting documentation. Date of expiration of GW CITI BIOMEDICAL Basic/Refresher Course for Human Subjects: (training is valid for two years) Date of expiration of GW CITI SOCIAL/BEHAVIORAL Basic/Refresher Course for Human Subjects: (training is valid for two years) Date of completion of CITI Health Information, Privacy & Security (HIPS) or Skillport HIPAA Training if accessing PHI or PII: Date of completion of CITI ICH-GCP Training, if clinical trial: If any training taken under another name, provide other name: 1.3 Is this a student-initiated research project? Yes  Complete the STUDENT INVESTIGATOR’S RESPONSIBILITIES FORM (HRP- 290) No1.4 Research Team Members: Additional research team members must be added via the RESEARCH PERSONNEL FORM (HRP-201). Please include the PI and Primary Contact on this form so that all study team members are listed in one place. Please note that a modification form is no longer required for changes in team members (unless a change in PI); instead you may just submit the updated study roster to OHR. No research team members other than the PI and Primary Contact2.0 EFFORT AND FUNDING2.1 What percentage of the PI’s total professional effort is devoted to the study and/or paid for by the sponsor? Note: this question applies to all research regardless of funding. For student research, please estimate the amount of time the PI will supervise the student. 2.2 Is this study funded? Yes  please complete a Funding Source Supplement (HRP-220) and submit it along with a copy of the grant, contract, or other funding documentation with this application. No IRB Application (HRP-200) V. 01/13/16THE GEORGE WASHINGTON UNIVERSITY Office of Human Research- Institutional Review Board [email protected] Phone: 202-994-2715 humanresearch.gwu.edu IRB APPLICATION (HRP-200)3.0 GW’S ROLE3.1 Select GW’s Role in the Project (select one) Sole Site (GW is the only IRB involved in this study) Lead Site (Lead researcher is GW-based, other IRBs are also evaluating) Other participating institutions: Status of review by other institutions: Participating Site (Lead researcher is not GW-based, other IRBs also evaluating) Lead institution: Status of review by lead institution: Data Coordinating Site (GW researchers role limited to data analysis, other IRBs also evaluating) Lead institution: Status of review by other institutions: 4.0 OBJECTIVES AND JUSTIFICATION 4.1 Provide a brief summary of the study using lay language (200 words or less). 4.2 Describe the objective(s) of the study including purpose, research question, hypothesis and relevant background information etc. 4.3 Provide the scientific justification for the research. 4.4 Describe how the research results/findings will be used and will contribute to generalizable knowledge (publishing, establishing national standards, etc.)? 4.5 How will the data be analyzed to answer the research question? Briefly describe statistical tests, thematic analysis, and the factors to be compared. 4.6 Provide an account of any preliminary studies conducted by the PI or other research team members that establish the scientific need to pursue the proposed project, if applicable. Please attach references as an appendix, if applicable. 5.0 STUDY DETAILSIRB Application (HRP-200) V. 01/13/16THE GEORGE WASHINGTON UNIVERSITY Office of Human Research- Institutional Review Board [email protected] Phone: 202-994-2715 humanresearch.gwu.edu IRB APPLICATION (HRP-200) 5.1 Provide a step-by-step description of the research procedures and/or and interactions with human subjects. Provide a study schedule or describe the frequency and duration of procedures, psychological tests, educational tests, specimen collection, and experiments, including screening, intervention, follow-up etc. Attach surveys, instruments, interview questions, focus group questions, etc. to this submission and label them clearly. If the study includes the collection or analysis of biological specimens for research purposes, describe and explain whether results will be provided to subjects. 5.2 Will participants be audio-recorded, or video-recorded, or photographed? Describe when recordings will be transcribed and if recordings be used in presentations or for any reason other than data analysis. Describe how and when they will be destroyed. This should also be stated in the consent document. If you wish to use recordings or other materials for presentation purposes, please justify and be sure to include audio/video release information in your consent document. 5.3 Please describe appropriate alternatives to the study procedures or course of treatment (ex: not to participate, standard care, same treatment offered off study). 5.4 Describe how long individual participants will be in the study. 5.5 Describe how long the entire study is expected to last, including data analysis. 6.0 PARTICIPANT POPULATION: 6.1 List locations where subjects will participate in GW IRB supervised activities or from which data is retrieved. If you will be conducting research at an organization or institution outside of GW, you must obtain a letter of permission from the external organization or institution and include it with this application, or state where in the process you are in obtaining permissions. If you need to list more than two organizations, please submit a memo detailing each name and their list of activities.Organization/Facility/Location Research Activities Performed (recruitment, consenting, subject/researcher interaction or data retrieval):6.2 Provide the maximum number of participants to be enrolled. For a multi-center study, both local and total accrual numbers must be provided if GW is acting as the IRB of Record. If this study does not involve multiple sites or the number of participants at other sites is unknown, complete IRB Application (HRP-200) V. 01/13/16THE GEORGE WASHINGTON UNIVERSITY Office of Human Research- Institutional Review Board [email protected] Phone: 202-994-2715 humanresearch.gwu.edu IRB APPLICATION (HRP-200) only the local accrual rows. Participants are considered to be enrolled and count towards your total number of participants once they begin study procedures, but excluding screening procedures. A list of participants who sign the informed consent document but did not meet inclusion criteria should be kept for your files.MAXIMUM NUMBER OF PARTICIPANTS TO BE ENROLLED Annually Entire Study Locally (by GW researchers) Study-wide 6.3 Please provide justification of how the maximum number of participants was chosen. 6.4 Please provide the age range of participants. 6.5 List the study’s Inclusion Criteria for subjects. These are the characteristics that a participant must meet in order to be eligible to participate in the study. 6.6 Indicate where, how, and from whom information regarding inclusion criteria will be accessed, obtained or otherwise determined. 6.7 List the study’s Exclusion Criteria for subjects. These are the characteristics that a participant must NOT have in order to be eligible to participate in the study. 6.8 If excluding a population or group that may benefit from the research, please provide justification. 6.9 Indicate any special populations to be involved in the research. N/A Pregnant Women, Fetuses or Neonates Prisoners Complete PRISONER CERTIFICATION CHECKLIST FOR INVESTIGATOR (HRP-291) Children Complete CHILDREN SUPPLEMENTAL CHECKLIST (HRP-292) and attach assent form and parental permission form Employees Students Educationally Disadvantaged Economically Disadvantaged Mentally Ill Decisionally-Impaired Illiterate Non-English speaking and/or Research conducted internationally Complete INTERNATIONAL/NON-ENGLISH SPEAKERS SUPPLEMENT (HRP-293)IRB Application (HRP-200) V. 01/13/16THE GEORGE WASHINGTON UNIVERSITY Office of Human Research- Institutional Review Board [email protected] Phone: 202-994-2715 humanresearch.gwu.edu IRB APPLICATION (HRP-200) Other (specify): 7.0 PARTICIPANT RECRUITMENT7.1 Describe the recruitment process to be used for each group of subjects. Explain who will approach potential subjects to take part in the research study, where participants will be approached, and what will be done to protect individuals’ privacy in this process. State if email, flyers, other print media, social media, verbal announcements, snowball recruitment or other techniques will be used. Attach a copy of any and all recruitment materials to be used e.g. advertisements, bulletin board notices, e-mails, letters, phone scripts, or URLs to this submission. 7.2 What steps will be taken to avoid coercion or undue influence in the recruitment of research participants? 7.3 Will subjects be recruited through the access of records, such as medical, student, employment, prisoner, health and human services, financial, etc.? If yes, how will access to records be obtained? Are the records private? If yes, written documentation indicating the cooperation or permission from the record custodian should be included. 7.4 If obtaining, viewing, or collecting records or data from medical or clinical settings to support subject selection, will any potential subjects currently be under treatment by a member of the research study team? If yes, identify team member and explain treatment relationship. 7.5 If the study involves retrospective analysis, please state the exact date range (DD/MM/YYYY) from which data will be accessed. Please note that all data accessed for this research must be in existence at the time of the initial IRB application in order to meet the definition of “retrospective.” 8.0 INFORMED CONSENT PROCESS8.1 Indicate the consent method being requested for the study. Check all that apply and describe the population for which being requested. If being requested for all participants, write “all”. Include the applicable consent documents with your submission.Written consent document with signature (obtaining subject or Legally Authorized Representative signature). Study population: IRB Application (HRP-200) V. 01/13/16THE GEORGE WASHINGTON UNIVERSITY Office of Human Research- Institutional Review Board [email protected] Phone: 202-994-2715 humanresearch.gwu.edu IRB APPLICATION (HRP-200) Waiver of documentation of consent (will obtain consent but subjects will not physically sign a hard copy of the consent document):  Complete a REQUEST FOR WAIVER/ALTERATION FOR CONSENT SUPPLEMENT (HRP-294) , Section 1. Waiver of the informed consent process (typically only granted when study involves data analysis of existing data only or when the research is performed in an emergency use)  Complete a REQUEST FOR WAIVER/ALTERATION FOR CONSENT SUPPLEMENT (HRP-294) , Section 2. Waiver or alteration of some of the elements of Consent (such as in research involving deception):  Complete a REQUEST FOR WAIVER/ALTERATION FOR CONSENT SUPPLEMENT (HRP-294) , Section 3.8.2 Give a detailed description of your informed consent process, assent process, and parental permission process, when applicable. If requesting a waiver of consent, please state. Your narrative should include the below elements (3-5 paragraphs). Do not leave this blank. Required  Who will consent/assent the subjects  When consent will occur relative to recruitment and research activities  Where or through what communication channels (telephone, email, etc.) it will occur  How privacy and confidentiality will be assured for the subject throughout the process  How subjects will be given a chance to ask questions and opt out prior to research  Who will answer the subject’s questions  How you will assess the subject’s understanding of the information presented  How subjects will receive a copy of signed consent formIf applicable  Special considerations for children (assent procedures, etc.), pregnant women, newborns, fetuses, prisoners, illiterate, non-English-speaking (see Federal Guidelines )  Include an assent process for children aged 7 years or older, and include how parental permission will be obtained  How undue influence will be minimized in authoritative relationships (professor-student, doctor-patient).  Use of Evaluation to Consent or other measures for decisionally-impaired subjects  Methods/amount of compensation  Use of deceptive or withheld information and plan for subject debriefing  Foreign-language translation measures8.3 Describe how and where signed consent documents will be securely maintained and for how long they will be maintained. If requesting a waiver of documentation or a waiver of consent, please state. Do not leave this blank. IRB Application (HRP-200) V. 01/13/16THE GEORGE WASHINGTON UNIVERSITY Office of Human Research- Institutional Review Board [email protected] Phone: 202-994-2715 humanresearch.gwu.edu IRB APPLICATION (HRP-200) 9.0 RISKS AND BENEFITS9.1 Describe the possible risks and likelihood of these risks to subjects. Please note that all research study have some risk. Examples of risk include: possible loss of confidentiality; discomfort due to asking for personal information in surveys or interviews; risks resulting in social rejection or stigmatization; financial hazards associated with actual incurred costs, or loss of income; legal risk if asking questions about participation in illegal activities; physical risk. Be sure to include all risks in the consent form. 9.2 Explain the steps that will be taken to minimize risks and to protect subjects’ welfare, including special protections for vulnerable populations. 9.3 Describe the anticipated benefits of this research for individual subjects and/or each subject group. Note: compensation is not a benefit. 9.4 Describe the anticipated benefits of this research for society. 9.5 Is any deception (withholding of complete information) required for the validity of this study? No Yes  Please be sure your response to Consent Question is selected, and complete a REQUEST FOR WAIVER/ALTERATION FOR CONSENT SUPPLEMENT (HRP-294) indicating for which elements of consent you are requesting a waiver. Please explain why the deception is necessary and submit a copy of the debriefing procedure to be used at the conclusion of the study to inform the participant of the deception. 9.6 Is there a data and safety monitoring plan or board (DSMB) for this study? No  Please explain: Yes  Please attach the plan or describe the plan for monitoring, reporting, and analyzing unanticipated problems, serious adverse events (SAEs), and other adverse events (AEs). The plan must include a description of the events or problems that will be tracked and analysis plan for monitoring interim results. 10.0 PRIVACY AND CONFIDENTIALITY10.1 Which personal or demographic data will be collected? Check all that apply.Name Race/Ethnicity SSN GenderIRB Application (HRP-200) V. 01/13/16THE GEORGE WASHINGTON UNIVERSITY Office of Human Research- Institutional Review Board [email protected] Phone: 202-994-2715 humanresearch.gwu.edu IRB APPLICATION (HRP-200) Medical Record # (MRN) Employer/School Name DOB or Age Department/Division Phone # Disease Status Home Address City Email State/other Date of medical procedures Zip Code Biological samples (describe): 10.2 Describe how the information selected in the previous question will be collected. Will any of it be obtained from the medical record or other existing record? Will it be obtained via self-report? 10.3 Will you retain a link between study code numbers (such as subject #1, #2, #3) and direct identifiers (such as name, date of birth, phone number, medical record number, etc.)? If yes, explain the code being used, why a code is necessary, how will the link be kept, and by whom. Describe the security measures used to protect the link. 10.4 Describe in detail the protections that will be implemented to maintain the confidentiality of consent forms, data, and specimens. Where and how will data and specimens be stored? How long will the data and specimens be stored? Who will have access to all study materials? How will study materials be destroyed? How will data and specimens be transported and who is responsible for receipt or transmission of the data or specimens? Will specimens be used for future research? Where will data analysis take place and how will data security be maintained during analysis? All applicable information should also be included in the consent form.10.5 Describe whether data will be aggregated/summarized in publications and presentations, or whether individual results will be communicated. If individual results are to be communicated, this should be clearly described to the participant in the consent document, or the participant should have the option to opt out of having their individual results presented. 10.6 Will you retain identifying information for purposes of another research project (e.g., keeping participants’ contact information to recruit them for future research projects)? No Yes  please describe what information will be retained. This must be described in the Informed Consent document. 10.7 If the study will collect information that, if disclosed, could have significant negative consequences to the participants such as damage to their financial standing, employability, insurability or reputation (e.g., HIV, AIDS, other STDs; use of alcohol, drugs, or other addictive products, illegal behaviors, etc.), will a Federal Certificate of Confidentiality (CoC) be obtained for this research?? N/A no sensitive information is being collected No  justify why you are not obtaining a CoC: Yes  submit documentation of application with this application form. Visit the NIH Certificates of Confidentiality Kiosk for information about obtaining a Federal Certificate of Confidentiality (http://grants.nih.gov/grants/policy/coc/contacts.htm IRB Application (HRP-200) V. 01/13/16THE GEORGE WASHINGTON UNIVERSITY Office of Human Research- Institutional Review Board [email protected] Phone: 202-994-2715 humanresearch.gwu.edu IRB APPLICATION (HRP-200)11.0 USE OF PROTECTED HEALTH INFORMATION (PHI): HIPAA REQUIREMENTS 11.1 Will this study involve access to, or use of, any participants’ 18 identifiable pieces of protected health information (PHI) defined under HIPAA (45 CFR 164.514(A)(2)) from a covered entity? Visit http://www.hhs.gov/ocr/privacy/for more information about the Health Insurance Portability and Accountability Act (HIPAA). No  HIPAA does not apply  Proceed to Section 12 Yes  Create a HIPAA Authorization to be included in the consent document. Yes  Requesting a HIPAA PARTIAL WAIVER (HRP-281)* (for recruitment purposes only) Yes  Requesting a HIPAA FULL WAIVER (HRP-280)* (to be used when viewing PHI or collecting PHI without consent)*Be advised that the HIPAA waiver request must be approved by the Privacy Officer of the covered entity in addition to the IRB before the research may begin. In addition, all research personnel must complete HIPAA training.12.0 COMPENSATION AND COST12.1 Will subjects be given payments/compensation, gift cards, travel expense reimbursement, gifts, incentives to enroll, raffles, or extra credit? If yes, please explain. Please describe the payment schedule and also include this information in the Informed Consent document. Note that compensation is not considered a benefit of research. Note: GW Investigators may be required to obtain the Social Security Number (SSN) for each research participant to track amounts paid to the participant. Contact Accounts Payable Office for more information and to determine whether a Form 1099-MISC is required. If the data being collected in the study is highly confidential and disclosure and/or identification of the subject's or subject's name, address and social security number for purposes of financial reimbursement will pose risk for the subject, please submit REQUEST FOR VERIFICATION OF CONFIDENTIAL NATURE (HRP-297) with this application.12.2 What components of the study are provided free of charge to the participant (e.g., drugs, procedures, etc.), and what components will be the participants responsibility? Will subjects incur any additional costs associated with study participation? If yes, please explain. Note that any costs that will be or may be incurred by subjects (including, but not limited to insurance claims or out of pocket prescription expenses) must be detailed in the consent document and presented to the subject prior to enrollment. 12.3 Who will be financially responsible for research related injuries? Please check all that apply and include this information in the Informed Consent document:IRB Application (HRP-200) V. 01/13/16THE GEORGE WASHINGTON UNIVERSITY Office of Human Research- Institutional Review Board [email protected] Phone: 202-994-2715 humanresearch.gwu.edu IRB APPLICATION (HRP-200) Study Sponsor Research participant or participant’s insurance / third party payerPI’s compensation planMinimal risk research with no risk for research related injuriesOther, please describe: 13.0 MEDICAL, THERAPEUTIC, OR OTHER DIAGNOSTIC STUDIES 13.1 Does this study involve drugs, devices, or biologics? No Yes Submit DRUG SUPPLEMENT (HRP-295) OR DEVICE SUPPLEMENT (HRP- 296)14.0 ANCILLARY REVIEWS14.1 Radiation Safety Committee Review: Will radioactive materials (e.g., nuclear medicine, radio- immune therapy) or an ionizing radiation producing machine (e.g., CT, X-ray, Accelerator, DEXA scanner) be used as part of the study and result in a study participant or a healthy volunteer receiving a radiation dose they would not otherwise receive as part of their standard clinical care? No Yes  If yes, explain in detail including maximum number of subject exposures over the course of a 12 month period, distinguishing between standard of care and research. For research, please specify the type of device and make/model. Submit a copy of the RSC approval letter(s). If approval is pending, enter “pending” in the approval date field. Date approved: 14.2 Institutional Biosafety Committee Review: Will this study involve the deliberate transfer/administration of recombinant DNA, DNA/RNA derived from recombinant DNA, or synthetic DNA into one or more study participants? No Yes  Institutional Biosafety Committee (IBC) review and approval is required prior to enrolling any study participants. Please check one of the check boxes below: IBC and NIH RAC have approved the study: Please submit the IBC approval documents outlining the Appendix M items, and submit approval documents from NIH RAC review. IRB Application (HRP-200) V. 01/13/16THE GEORGE WASHINGTON UNIVERSITY Office of Human Research- Institutional Review Board [email protected] Phone: 202-994-2715 humanresearch.gwu.edu IRB APPLICATION (HRP-200) IBC and/or NIH RAC review is pending. Status of IBC and NIH RAC review: Note: For multicenter studies where GW is the IRB of record for an external clinical trial site, please include a copy of the clinical trial site’s IBC review and approval with this application. 14.3 Institutional Stem Cell Research Oversight: Does this study involve the use or destruction of embryonic stem cells? No Yes  Provide information about where the stem cells are obtained (e.g., NIH approved line). Provide the location and approval date of the ISCRO committee review and submit a copy of the ISCRO approval letter. 15.0 SUBMITTED DOCUMENTS Please select the additional documents that are being submitted and PROVIDE THE TITLE AND VERSION DATE FOR THE DOCUMENTS. All items may not apply to your study.Protocol: Grant Proposal and Application: Recruitment Materials: Data Collection Tools, including Case Report Forms, Surveys, Questionnaires, Interview or Focus Group Guides, Variable Codebooks, and Other Relevant Measures: Written Informed Consent Forms/Scripts: Assent Forms/Scripts: Site Permission Letters: External IRB Approvals: Other: 16.0 SIGNATURESIRB Application (HRP-200) V. 01/13/16THE GEORGE WASHINGTON UNIVERSITY Office of Human Research- Institutional Review Board [email protected] Phone: 202-994-2715 humanresearch.gwu.edu IRB APPLICATION (HRP-200) Principal Investigator:  My signature indicates that I have reviewed this IRB Application form and supporting documents.  I will respect and protect the rights and welfare of individuals enrolled in this research project. I will also carry out my responsibilities as Principal Investigator as outlined in Federalwide Assurance of Protection for Human Subjects, for which GW is registered with OHRP/DHHS, and as detailed in GW HRPP Policies & Procedures. I will be guided by the principles contained in the Bel mont Report and The Code of Federal Regulations governing research with human subjects (45CFR46 and 21CFR50).  I have verified that all members of the research team have agreed to accept the responsibilities required of their roles and I provide my assurance that all will be kept fully briefed on the details of the study.  I have queried all members of the research team to determine if they have a conflict of interest in this study as defined by GW policies. PI Signature: Date:Department Chair:  My signature indicates that this project has been reviewed by the appropriate departmental parties who have judged that 1) there is a scholarly and scientific justification for the protocol, that the study is feasible, and that the proposed methods are scientifically valid, 2) the PI is sufficiently qualified by training and experience to conduct the research, 3) that the department has made the space and time commitment necessary to carry out the project, 4) that the financial implications of the research have been considered and deemed acceptable to the department. Department Chair Signature: Date: FOR MFA STUDIES ONLY: Date: Office of Clinical Research Signature: Date: Gary Simon, MD, PhD, Signature: Alan G. Wasserman, MD, Signature: IRB Application (HRP-200) V. 01/13/16

Social and Behavioral Sciences Application Form

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