Purpose: To provide policy and guidelines and helpful information for conducting research at Brooks

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1 [BRCRC 01] Research: Conducting Research at Brooks (Application for Research) Purpose: To provide policy and guidelines and helpful information for conducting research at Brooks Responsible Party: All Investigators and Brooks employees wishing to initiate or engage in research activities conducted at Brooks Policy: (1) All research conducted within the Brooks Rehabilitation ("Brooks") or any entity or facility bearing the Brooks name, including the Brooks Rehabilitation Clinical Research Center must be conducted in accordance with the study Institutional Review Board policies, Brooks policies, HIPAA regulations for research, and federal, state and local rules and regulations governing clinical research and human subject protections. (2) All research conducted at Brooks Rehabilitation or any entity or facility bearing the Brooks name, including the Brooks Rehabilitation Clinical Research Center, must have prior Brooks' administrative approval, and documented Institutional Review Board (IRB) approval and continuing oversight as required. [See Research Policy: Institutional Review Board (IRB) Review and Oversight} to determine if proposed research may qualify for exempt status from this policy] (3) Any Brooks employee or contract employee planning to engage in research as a principal investigator, co-investigator, sub-investigator, or all other key research personnel conducting research at Brooks must have approval from their manager/supervisor before entering into any research related contracts or agreements. (4) There are situations that arise when Brooks physicians, scientists and other professional or clinical staff will be involved in research projects here at Brooks or as partners in collaborative research projects with investigators at other institutions. Brooks intends to coordinate its research efforts, clinical research projects, research awards and sub awards through the Brooks Rehabilitation Clinical Research Center. Any exceptions must be approved by a member of the Brooks Executive team. Procedures: (1) Service and support prior to an approved protocol may include consultation, planning and protocol development with the Investigator to determine feasibility, utilization, availability and cost of resources requested; however all Investigators who wish to conduct research at Brooks or the Brooks Rehabilitation Clinical Research Center must submit an Application for Research. (2) Initiation of any Brooks-approved research project will also require additional administrative requirements such as documentation of final 1RB approvals of the protocol, consent form(s) and recruitment material, verification of human subject protections training for key research personnel and completion of the Conflict of Interest disclosure form if applicable. Other study requirements may apply, depending on project specific details. (3) Since Brooks does not have its own IRB, the protocol must be reviewed and approved by an IRB that is registered with the Office of Human Research Protections. If the proposed IRB for the project is not already listed on Brooks Federal Wide Assurance agreement, contact the Brooks Research Director to determine if an IRB Authorization Agreement is required. [See Research Policy: Terms of the Federal Wide Assurance] (4) The Principal Investigator for any research project conducted at or involving Brooks or the Brooks Rehabilitation Clinical Research Center retains primary responsibility to ensure the safe and appropriate conduct of the research. This includes, but is not limited to, monitoring protocol compliance, reporting any major protocol violations and any serious adverse events and sharing this information with the 1RB of record and Brooks research administration. The Investigator will commit to maintain IRB oversight, to

2 comply with IRB and Brooks policies, and to provide required documentation and updates to the Brooks research administration throughout the study. [See Research Policy: Investigator Responsibilities] (5) After Administrative approval and during the course of the study, if there are any changes to the project that will affect funding or utilization of Brooks or Brooks Clinical Research Center resources, the Investigator will provide written notification of proposed changes to Brooks research administration. If the changes result in amendment or modification of the protocol, consent form, or recruitment materials, the Investigator will forward the new IRB approved copies to Brooks research administration. Awlication for Research Requirements All Investigators proposing to conduct research involving human subjects at or in affiliation with Brooks and/or the Brooks Rehabilitation Clinical Research Center must submit the following documents electronically to the Research Manager at Brooks Rehabilitation at (Telephone Contact: ^. 1. Application for Research Online form available at Attach a copy of the proposed study budget, if available. 2. Copy of protocol, if available 3. Copy of Informed Consent(s), if available 4. Curriculum Vitae for Principal Investigator, if not previously submitted within the last 12 months 5. IRB Approvals, if available. If the project has been submitted and is pending approval, provide date of submission. Contact information for questions regarding the application process or conducting research at Brooks or the Brooks Rehabilitation Clinical Research Center: Research Manager Brooks Rehabilitation Clinical Research Center brooks.research@brooksrehab.org

3 [BRCRC 02] Research: Policies and Procedures for Research Purpose: Brooks Rehabilitation Clinical Research Center (BRCRC) research policies and procedures (including Standard Operating Procedures for research) are written instructions based on best practices to ensure consistency, compliance and accountability of all personnel engaged in research at Brooks Rehabilitation or through the BRCRC. The BRCRC seeks to provide comprehensive and practical policies in order to assist the research team: to achieve maximum safety and efficiency; to achieve uniformity of procedures; to ensure data reliability and integrity; and to ensure compliance with Good Clinical Practice, FDA and HHS regulations and guidelines (as applicable) for conducting research studies and clinical trials at Brooks. Responsible Party: Principal Investigators, key research personnel and all those engaged in clinical research at Brooks Rehabilitation or through the BRCRC. Policy: All those engaged in clinical research at Brooks Rehabilitation or through the Brooks Rehabilitation Clinical Research Center (BRCRC) are required to read, review and adhere to BRCRC policies prior to and during the conduct of any research activity involving human subjects. Procedure: The BRCRC will maintain written policies for research. All research policies will be reviewed and updated annually by the Research Director. BRCRC approved research policies will be available in a designated Brooks Policy and Procedure Manual which can be accessed internally via the network ("ebrooks"). They will also be published externally through a link at the Brooks Rehabilitation Clinical Research Center website located at httd:// All policies for research must be reviewed and approved by the Research Director, before they can be published.

4 [BRCRC 03] Research: Statement of Ethical Principles and Guidelines for Research Purpose: To ensure ethical conduct of research at Brooks Responsible Parties: Principal Investigators, Co-lnvestigators, Sub-lnvestigators and all other key research personnel conducting research at Brooks Policy: All of Brooks Rehabilitation's human subject research activities, regardless of funding source, will be guided by the basic ethical principles and guidelines set forth in The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. These ethical principles remain the basis for human subject protection regulations. Procedures: Brooks recommends that all research personnel read "The Belmont Report" prior to conducting any research at Brooks. The Belmont Report may be accessed at: Research is guided by three fundamental ethical principles when involving human subjects: (1) Respect for Persons: all volunteers are treated as individuals and are entitled to protection; protecting the autonomy of all people and treating them with courtesy and respect and allowing for informed consent; Informed Consent: Each subject to the degree they are capable, is given the opportunity to choose what shall or shall not happen to them. Information: The extent and nature of the information should be such that persons can decide whether they wish to participate in the furthering of knowledge. That is to say, consenting individuals are aware that the procedure is neither necessary for their care nor perhaps fully understood, and they understand clearly the range of the risks. Comprehension: The ability of a subject to understand is a function of intelligence, rationality, maturity and language and therefore it is necessary to adapt the presentation of the information to the subject's capacities. Investigators are responsible for ascertaining that the subject has comprehended the information. Voluntariness: The agreement to participate in research is considered a valid consent, if and only if voluntarily given under conditions free of coercion and undue influence. *The challenges in applying the Belmont principle of respect for persons are in making sure that potential participants comprehend the risks and potential benefits of participating in research, while avoiding influencing potential participants' decisions either through explicit or implied coercion or through excess/ve undue influence. (2) Beneficence: maximizing benefits for the research project while minimizing risks to the research subjects; Do not harm Maximize possible benefits and minimize possible harms Assessment of Risks and Benefits *The challenges inherent in applying the Belmont principle of beneficence is how to determine when potential benefits outweigh considerations of risks and vice versa.

5 (3) Justice: ensuring reasonable, non-exploitive and well-considered procedures are administered fairly (the fair distribution of costs and benefits.) To each person an equal share To each person according to individual need To each person according to individual effort To each person according to societal contribution To each person according to merit Justice requires that individuals and groups be treated fairly and equitably in terms of bearing the burdens and receiving the benefits of research. The principles of justice may arise in decisions about inclusion and exclusion criteria for participation in research and requires investigators to question whether groups are considered for inclusion simply because of their availability, their compromised position, or their vulnerability - rather than for reasons directly related to the problem being studied. *The challenge of applying the Belmont principle of justice is how to decide which criteria should be used to ensure that harms and benefits of research are equitably distributed to individuals and populations. References/Regulations Belmont Report:

6 [BRCRC 04] Research: Terms of the Federal Wide Assurance for Protection of Human Subjects Purpose: To ensure that human subjects research conducted at Brooks is in compliance with Brooks Federal Wide Assurance of Compliance (FWA) and human subjects protections regulations. Definition: The Federal Wide Assurance is a written document submitted by an institution (not an Institutional Review Board) that is engaged in non-exempt human subjects research conducted or supported by the Department of Health and Human Services (HHS). Through this assurance, Brooks commits to comply with the Federal Policy known as the Common Rule: Title 45 Code of Federal Regulations Part 46 (45 CFR 46) for the Protection of Human Subjects. Brooks FWA # Expires: 02/16/2021 Signatory Official: Douglas M. Baer Human Protections Administrator: Raine Osborne The following IRB entities have been designated and approved to review research conducted at Brooks: University of Florida IRB 01 (Gainesville) University of Florida IRB 02 (Gainesville) University of Florida IRB 03 (Jacksonville) University of North Florida IRB #1 Western IRB (WIRB) Jacksonville University IRB Schulman IRB Responsible Parties: This policy applies to all on-going and future human participant research projects conducted by Brooks Investigators, employees, staff, students, volunteers, or anyone conducting any research activity supported by Brooks or on property maintained by Brooks. Policy: Brooks and any designated IRB entities that provide oversight to research conducted at Brooks will comply with the FWA Terms of Assurance. Terms of Assurance: In signing the FWA, Brooks and its IRB components have agreed to the following Terms: (1) All of Brooks human subject research activities regardless of funding source, will be guided by the ethical principles in The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. [See Research Policy: Statement of Ethical Principles and Guidelines for Research] (2) The Terms apply whenever Brooks' employees or agents intervene or interact with living individuals for purposes of research; or the institution's employees or agents obtain, release, or access individually identifiable private information for purposes of conducting human subject research; or the institution receives a direct Federal award to conduct human subject research, even where activities involving human subjects are carried out by a subcontractor or collaborator. (3) Brooks and its designated IRBs agree to comply with the Terms of Assurance. Brooks ensures that all institutions and investigators collaborating in human subject research operate under an appropriate

7 Assurance of Protection for Human Subjects. All institutions engaged in such research, including subcontractors and subgrantees, must hold their own Assurance. (4) Except for research exempted or waived, all human subject research will be reviewed, prospectively approved, and subject to continuing oversight by a designated IRB. The IRB will have authority to approve, require modifications in, or disapprove the covered human subject research. Brooks and/or its designated IRBs have established written procedures for IRB initial and continuing review, and ensuring prompt reporting to the IRB and other required agencies for serious and unanticipated problems involving risks to subjects or others in any covered research; serious or continuing noncompliance with Federal, institutional, or IRB requirements; and suspension or termination oflrb approval of research projects. [See Research Policies: IRB Review and Oversight; Reporting Unanticipated Problems and Adverse Events Involving Human Subjects; Reporting Research Concerns and Complaints] (5) Except where specifically waived or altered by the IRB, all human subject research will require written informed consent, presented in language understandable to the subject (or the subject's legally authorized representative). [See Research Policy: The Informed Consent Process] (6) The Brooks designated Signatory Official and Human Protections Administrator will personally complete the relevant OHRP basic educational modules, or comparable training approved by OHRP. (7) Brooks will establish education and oversight mechanisms (appropriate to the nature and volume of its research) to verify that research investigators and key research personnel have knowledge of relevant Federal regulations, State and local law, and institutional policies for the protection of human subjects, as well as being cognizant of OHRP and other applicable guidance. Brooks will require documentation of such training from Brooks Key Personnel as a condition for conducting human subject research. [See Research Policy: Training Requirements for the Protection of Human Subjects in Research] (8) The activities of individual research investigators who are not employees or agents of Brooks and who are not covered under their own organization's Assurance may be covered under Brooks Assurance only in accordance with a formal, written agreement of commitment to relevant human subject protection policies and IRB oversight. (9) Information provided under this Assurance will be updated by the Brooks Research Director as required and at least every 36 months in order to maintain an active Assurance. References/ReguIations Office for Human Research Protections (OHRP) website on Assurances: Terms of the Federal Wide Assurance (FWA) for Institutions within the United States: httd://

8 [BRCRC 05] Research: Institutional Review Board (IRB) Review and Oversight Purpose: To provide information and guidance on Brooks policy regarding Institutional Review Board (IRB) review and oversight requirements for research conducted at Brooks. This policy also outlines what types of activities are considered human subjects research or clinical investigations, subject to regulations and requirements for IRB review and approval. Responsible Parties: Investigators wishing to conduct research at Brooks Institutional Review Boards (IRBs) are specialized committees required by HHS regulations that safeguard the rights and welfare of human subjects. IRBs determine "the acceptability of proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice" (45 CFR ). The major roles of IRBs in the oversight of research are: - Initial review and approval or disapproval of the proposed research activity - Ensuring that the proposed informed consent process meets ail of the requirements of 45 CFR Providing continuing oversight for progress reports and protocols for ongoing research studies Policy: (1) Except for research exempted or waived * all human subject research conducted at Brooks will be reviewed, prospectively approved, and subject to continuing oversight by an Institutional Review Board (IRB). It is the responsibility of the Investigator to communicate with the IRB to determine if the proposed research project meets the definition for "human subjects research" and whether it is subject to regulatory requirements and IRB review and oversight. (2) All human subjects research conducted at Brooks must have IRB oversight from an IRB that is registered with the Office of Human Research Protections (OHRP). A signed IRB Authorization Agreement between Brooks and the IRB will be in place before research begins. [See Research Policy: Terms of the Federal Wide Assurance for Protection of Human Subjects] (3) IRB policies may vary among institutions. It is the responsibility of the Investigator to contact and understand the needs and requirements of the designated IRB for review and approval of a proposed research study and the ongoing submission and reporting requirements. (a) Investigators are responsible to ensure that changes or revisions to the approved research are reported promptly to the IRB and are not initiated without IRB approval, except when necessary to eliminate apparent immediate hazards to the subject. (b) Investigators must conform to the reporting timelines, formats and requirements of the designated IRB (and any other entities to which they are responsible), but at a minimum those events that must be reported are those that are: related to study participation, unexpected, serious or involve risks to subjects or others. [See Research Policy: Reporting Unanticipated Problems and Adverse Events Involving Human Subjects] (4) Investigators must maintain documentation of all IRB communications and ensure that the Brooks Research Director has a current copy of IRB approvals for the protocol, consent form(s) and recruitment materials.

9 *The federal regulations outline six categories of low risk projects that may qualify as 'exempt' studies. Only an IRB may determine if a research project qualifies for exempt status. "Exempt" means that informed consent is not required and annual review is not required. The following six categories are considered "Exempt" from the regulatory requirements: (1) Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods. (2) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation. (3) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior, if: (i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter. (4) Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects. (5) Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine: (i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs. (6) Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or

10 approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture. References/Regulations Office of Human Research Protections: 21 CFR CFR CFR CFR CFR

11 [BRCRC 06] Research: Independent Investigator Agreements Purpose: To ensure compliance with the Brooks Federal Wide Assurance (FWA) Terms and that Independent Investigators engaged in or conducting human subjects research at Brooks operate under an appropriate OHRP-approved assurance for the protection of human subjects. Responsible Parties: Applies only to those investigators who are NOT otherwise affiliated with Brooks or one of its Federal Wide Assurance (FWA) approved entities but who wish to conduct research under Brooks FWA. (This policy does not apply to investigators who are covered by another OHRP-approved entity listed on the Brooks FWA, such as University of Florida.) Policy: (1) All investigators engaged in research at Brooks must operate under an appropriate Office of Human Research Protections (OHRP) approved assurance for the protection of human subjects. (2) The activities of independent research investigators who are not employees or agents of Brooks may be covered under Brooks Federal Wide Assurance (FWA # ) only in accordance with a formal, written Independent Investigator Agreement which represents acknowledgement, responsibility and commitment to protect the rights and welfare of human research subjects and to comply with all applicable provisions of this Assurance. Definition: "Independent Investigator" is defined as any external investigator that wishes to conduct research at Brooks but is not employed by Brooks and not affiliated with one of Brooks FWA approved entities. Procedures: The Independent Investigator Agreement form is available electronically and may be obtained by contacting the Brooks Rehabilitation Clinical Research Center at (904) or Brooks.Research(%brooksrehab.ora. The Principal Investigator and each named sub-investigator(s) and/or co-investigator(s) for the research protocol will prepare and sign the Independent Investigator Agreement form and submit with the Application for Research. An Independent Investigator Agreement will only apply to the specified protocol. A new agreement is required for each protocol conducted at Brooks. If there are any relevant protocol modifications or amendments naming any new Investigator(s), sub-investigator(s) or co-investigator(s), then a new Independent Investigator Agreements) will be required. Reference/Regulations: [See Research Policy: Terms of the Federal Wide Assurance for Protection of Human Subjects]

12 [BRCRC 07] Research: Administrative Approval for Conducting Research Purpose: To define the review process for new clinical research applications and proposals to be conducted at Brooks Rehabilitation. Responsible Parties: All Investigators wishing to conduct research at Brooks Rehabilitation or the Brooks Rehabilitation Clinical Research Center. Policy: All research activity involving human subjects, conducted at Brooks Rehabilitation or the Brooks Rehabilitation Clinical Research Center or at any Brooks Rehabilitation facilities, must have administrative approval from the Chief Operating Officer, the Executive Director of Research, the Local Scientific Advisory Committee, the UF/PHHP Director of Research if under the Brooks/UF Memorandum of Understanding, the appropriate management personnel involved in the patient population, facility and resources to be utilized. Procedures: Investigators wishing to conduct research at Brooks Rehabilitation or the Brooks Rehabilitation Clinical Research Center need to submit a fully completed Application for Research. [See Research Policy: Conducting Research at Brooks (Application for Research)]. New applications will be reviewed by the Executive Director of Research and/or the UF PHHP Director of Research as indicated. The Director of Research will prepare a summary for approval as may be needed for further administrative approval process. 1. The purpose of the review and approval process is: To review submitted protocols for consistency with and importance to the Brooks Center mission and strategic plan for research; To evaluate the requests for resources from Brooks Rehabilitation and the Brooks Rehabilitation Clinical Research Center To evaluate the impact on each organization's operations; and To render professional judgment about the quality and importance of each project application. 2. The potential review committee or administrative approval process shall include any or all of the following: the COO, the Executive Director of Research, committee members appointed by the COO. The committee members would be comprised of individuals whose goals are consistent with the Brooks Rehabilitation Clinical Research Center and who can broker resources, coordinate research opportunities for patients across sites, and to ensure quality projects. All Nursing research protocols will require that an internal or external nurse with research and/or administrative experience approve nursing research protocols. 3. The Chief Operating Officer will have the final approval which must be obtained before an investigator may begin to conduct research. The approval process may seek additional expertise when issues arise, by appointing ad hoc reviewers as necessary. 4. Protocol Review and Approval Process: The Executive Director of Research will make every attempt to review projects in a timely manner. The Chief Operating Officer and Executive Director of Research may give preliminary approval to the Investigator, The Executive Director of Research will provide written notice of approval or deferral to the Investigator with feedback and rationale for the decision.

13 The Executive Director of Research may extend approval of the project to recognize the project's merit and issue a Letter of Support; however, the approval may be conditional and ask that the Investigator meet additional conditions before initiating the study. A Notice of Deferral indicates that the project has not been approved and an explanation will be provided to the Investigator. 5. Initiation of any approved research project will require additional administrative documentation, including current IRB approvals of the protocol, consent form(s) and recruitment materials and completion of required training and documentation for Key Research Personnel.

14 [BRCRC 08] Research: Training Requirements for the Protection of Human Subjects in Research Purpose: The purpose of this policy is to ensure that researchers understand their responsibilities to research subjects, and to reflect Brooks Rehabilitation's (Brooks) commitment to the protection of the rights and welfare of human subjects participating in research. Responsible Parties: This policy applies to all individuals, investigators, clinicians, Brooks employees, students, visitors, volunteers, subcontractors, or any other individuals who work with human subjects under the auspices of Brooks, whether at Brooks facilities or at another location, and regardless of their institutional affiliation or source of funding. In the event that individuals from other institutions conduct research under the auspices of Brooks Rehabilitation or in affiliation with the Brooks Rehabilitation Clinical Research Center (BRCRC), they must complete the necessary training, but may do so at their home institution. Policy: Brooks Rehabilitation requires that all its employees designated as "Key Research Personnel" complete a human subjects training program. Training must be completed before any research activity may be initiated or conducted at Brooks or in affiliation with the BRCRC. This requirement applies to all research projects, regardless of the project's sponsorship or funding source. Key Research Personnel should submit a copy of the certificate to verify completion of human subjects training to the BRCRC before engaging in any research activity involving human subjects. Copies of certificates may be ed to Brooks.ResearchO.Brooksrehab.org or delivered directly to BRCRC. Key Research Personnel, for purposes of this training requirement, means all individuals, including investigators, staff, clinicians, coordinators, students, volunteers, subcontractors and consultants, who: design research, direct research or serve as the principal investigator or co-investigator, enroll research subjects (including obtaining subjects' informed consent or screening potential subjects) or make decisions related to eligibility to participate in research, conduct study procedures, have direct involvement with research participants as related to the study, collect, analyze or report research data, analyze or report adverse events, or author manuscripts concerning the research for publication. Procedures: (1) Before initiating any new research project involving human subjects at Brooks, the Principal Investigator (Pl) will identify Brooks "key research personnel" who will be responsible for the design and/or conduct of the study. The Pl is responsible for assuring these key personnel and all others working with human subjects on the project complete the necessary training. Brooks requires a one-time completion of human subjects training. However, individual IRB's may have different requirements. All key research personnel working on a project affiliated with the BRCRC must comply with the requirements set by the IRB overseeing the study. It is the investigators' responsibility to maintain a current knowledge of developments in human subjects protection. (2) Individual IRBs may have specific requirements regarding the particular human subjects training they will accept. The principal investigator is responsible for ensuring that all key personnel have met the specific requirements of the IRB overseeing the study. Page 1 of 2

15 The BRCRC recommends that key research personnel complete the human subjects training provided by the Collaborative Institutional Training Initiative (CITE). An alternative training is through NIH Office of Extramural Research. Instructions on how to access the specific trainings are provided below. The Human Subjects Training provided by the Collaborative Institutional Training Initiative (CITI) may be accessed at the following link: Instructions for registration can be found on the Brooks Clinical Research Center ebrooks page or by contacting the research staff at or Brooks. ResearchSp.Brooksrehab.org. The NIH tutorial may be accessed at the following link: Protecting Human Research Participants or httr://i3hrp.nihtraininci.com/users/lociin.php The NIH Training Site requires the user to complete a registration form for a new account before proceeding. Registration is free. The course contains a total of 7 modules, 4 of which are followed by quizzes. The entire course may take up to 3 hours to complete, but does not need to be completed all at one time. After finishing all sections and quizzes, the user will have the opportunity to print a completion certificate. (3) The Brooks Research Director will maintain records to show that Brooks employees serving as key research personnel have completed the human subjects training. References/Regulations Required Education in the Protection of Human Research Participants, National Institutes of Health, (Link) Federal Policy for the Protection of Human Subjects, 45 CFR 46 ("The Common Rule") NIH Office of Extramural Research Protecting Human Research Participants Training Course httd://dhrd.nihtrainina.com/users/login.php NIH Training Course FAQ's Page 2 of 2

16 [BRCRC 09] Research: Investigator Responsibilities Purpose: To outline the responsibilities of the Principal Investigator and key research personnel who are engaged in research involving human participants. Responsible Parties: Applies to all Principal Investigators, Co-lnvestigators and Sub-investigators conducting research at Brooks Rehabilitation (Brooks) or in affiliation with the Brooks Rehabilitation Clinical Research Center (BRCRC). Policy: The Principal Investigator accepts responsibility for conduct of the study and protecting the rights, safety and welfare of research participants. Principal Investigators are obligated to design and conduct human participant research in accordance with the ethical principles of the Belmont Report, federal and state law and regulations, IRB policies, and Brooks/BRCRC institutional policies. Procedures: Investigators must comply with all applicable provisions of the Brooks Federal Wide Assurance (FWA), Institutional Review Board (IRB), Brooks policies as well as all applicable federal, state, and local laws governing research involving human subjects, including, but not limited to, the following: 1. Obtaining IRB approval prior to involving any human subjects (including their data or tissue) in research studies. Note: Only the IRB may determine if research is exempt from Federal regulations (investigators may not make the final determination of exemption); 2. Reporting progress of approved research to the appropriate IRB, as often as and in the manner prescribed by the IRB on the basis of risks to subjects, but not less than once per year. This includes submitting a closure report to the IRB once the research is completed; 3. Ensuring that Brooks research administration is provided with current IRB approval documents (copies), and updating Brooks on the status of the project on a regular basis and at least annually; 4. Ensuring that only qualified personnel conduct the study according to the approved Protocol, and in compliance with each individual's scope of practice; 5. Ensuring that anyone obtaining informed consent has read the protocol and has sufficient knowledge of all information provided in the informed consent document; 6. Completing required education and training as required by the Institutional Review Board and Brooks; also ensuring that all key research personnel have completed required education and training, before conducting any study activity; 7. Adhering to the IRB approved protocol as well as the approved informed consent procedures and promptly reporting proposed changes in previously approved human subject research activities to the IRB. The proposed changes will not be initiated without IRB review and approval, except where necessary to eliminate apparent immediate hazards to the subjects. Changes made to eliminate apparent immediate hazards to research subjects must be reported to the IRB promptly in accordance with established IRB procedures; 8. Ensuring the rights and welfare of each research subject, and that the subject's rights and welfare take precedence over the goals and requirements of the research; 9. Obtaining legally effective informed consent from human subjects or their legally authorized representative before any research-related screening or intervention commences and using only the currently approved, stamped Informed Consent Form, when applicable; 10. Providing each subject enrolled in the study a copy of the IRB-approved informed consent document at the time of the consent, unless the IRB has specifically waived this requirement;

17 11. Promptly reporting any serious adverse events or unanticipated problems to the IRB in writing within 5 working days of occurrence or discovery of occurrence, or sooner as required by the protocol or IRB of record; 12. Maintain appropriate research-related records. All research records must be available for inspection by authorized representatives of federal regulatory agencies, sponsors, Brooks, and the IRB. Unless specified otherwise, all research related documents should be retained throughout the study and for an additional three years after the study is completed/closed with the IRB (OHRP regulation). This responsibility continues even if the investigator leaves Brooks. The Investigator will maintain the following records, as appropriate: A list of qualified persons to whom the Principal Investigator has delegated significant research-related duties Signed and dated consent forms Research authorization and privacy forms All records submitted to the IRB with evidence of approval All data collection forms (documentation of electronic databases kept and location) All adequate records of the disposition of the drug or device Participant enrollment log Signed and dated CVs for all Principal Investigators, Co-lnvestigators, and/or Sub- Investigators, if applicable (if required by the sponsor) Signature sheet documenting signatures and initials of all persons authorized to make entries or corrections on data collection forms, if applicable (if required by the sponsor) Monitoring reports, if applicable 13. Maintain and protect the privacy and confidentiality of all personally identifiable information of all human subjects participating in research, except as required by law or released with the written permission of the subject; 14. If conducting research involving products regulated by the Food and Drug Administration (FDA), the investigator will comply with all applicable FDA regulations and fulfill all investigator responsibilities (or investigator-sponsor responsibilities, where appropriate), including those described at: 21 CFR 312: Investigational New Drugs 00/21cfr312 QOjTtml 21 CFR 812: Investigational Device Exemptions 00.html 15. If unavailable to conduct or direct this research personally, as when on sabbatical, leave, or vacation, to: (1) arrange for a co-investigator to assume research related responsibilities in the researcher's absence, and (2) to notify the IRB in writing of this change prior to the absence;and 16. In the event that employment with Brooks is discontinued, Investigator will do one of the following with each approved/active study prior to leaving: (1) transfer the study to a new principal investigator or (2) close the project. These changes must be sent in writing to the IRB by submitting either a formal revision or a Continuing Review/Study closure report. This notification must be submitted in advance (prior to the termination of employment). References/Regulations OHRP Investigator Responsibility Frequently Asked Questions

18 [BRCRC 10] Research: The Informed Consent Process Purpose: To provide guidance in obtaining and documenting informed consent when enrolling subjects in research. Responsible Parties: For Principal Investigators and other research personnel authorized to obtain informed consent. Policy: (1) Except where specifically waived, Investigators must obtain written informed consent of prospective subjects (or the subject's legally authorized representative) using an IRB-approved consent form before they include these subjects in research. (2) Informed consent should be considered an ongoing educational process rather than a legal protection for an institution. It is not intended to be a one-time act of having a participant sign a form. Informed consent is designed to inform research subjects about the purpose, risks, potential benefits and alternatives to the research that allows people to make a decision about whether or not to participate based on their own goals and values. This exchange of such information should occur at enrollment and throughout the study. (3) The informed consent process must be delivered in language that is understandable to the subject. (4) In most cases, federal regulations require documentation of the informed consent process. In certain circumstances, the federal regulations allow a waiver of the informed consent process. Procedures: 1. The IRB of Record will be responsible for reviewing and approving the Investigator's proposed informed consent document to ensure that all applicable requirements are met. 2. The IRB affixes an approval stamp to the approved informed consent document, indicating approval and expiration dates. Investigators may only enroll subjects using informed consent/assent forms which have a valid "IRB approval" stamp unless the IRB grants a waiver from the requirement for informed consent or documentation. 3. The investigator is responsible for ensuring that informed consent is obtained from each research subject or his/her legally authorized representative after the subject or the subject's legally authorized representative has had an adequate opportunity to read the form and before that subject participates in any part of the research study, using the process and form approved by the IRB. 4. Consent should be obtained in person and documented in writing (no verbal or telephone or or online consents unless specifically approved by the IRB); however, the investigator (or other IRB approved research personnel) may obtain written consent via a faxed or electronically scanned copy of the informed consent form in cases where the person providing consent is unable to be present. The investigator must be satisfied that true informed consent can be obtained without a face-to-face discussion with the person providing consent. It is recommended that a copy of the consent form be mailed, ed, or faxed to that person prior to any extensive explanation of the study so that he/she can review it before the study is explained via telephone. The person should then sign and fax or a scanned copy of the consent form back to the investigator if he/she agrees to the subject's participation and before any research activity is initiated with the subject. 5. The subject or the subject's legally authorized representative and the person providing the information to the subject will sign and date the informed consent document at the time of consent. 6. If the legally authorized representative provides consent, the relationship of the consenter to the subject should be documented in the subject's medical record or research file. 7. Only individuals authorized by the IRB to obtain informed consent should sign on the line entitled "Name of [authorized] person obtaining consent from the subject."

19 8. The researcher's signature on the informed consent document verifies that the person who explained the study and obtained informed consent is qualified and that the IRB has approved him/her to do so. 9. The subject or legally authorized representative signing on behalf of the subject receives a copy of the signed form. 10. For Research Involving Decisionally Impaired/Challenged: the researcher may obtain consent by a Legally Authorized Representative only in situations where the prospective subject is incompetent or has impaired decision-making capacity, as determined and documented in the person's medical record in a signed and dated progress note. The determination that a subject is incompetent or has an impaired decision-making capacity must be made by a legal determination or a determination by the physician after appropriate medical evaluation that the prospective subject lacks decision-making capacity and is unlikely to regain it within a reasonable period of time. Legally Authorized Representative: an individual or judicial or other body recognized under Florida Law, who has legal authority to consent on behalf of a prospective participant to that individual's participation in the procedure(s) involved in the research. Under Florida law, several classes of persons can consent for incapacitated/incompetent adults. Consent should be sought from the following individuals and in the order presented. If the first reasonably available person refuses consent, that refusal is final. 1. Surrogate (competent adult expressly designated by the patient/individual to make health care decisions on behalf of the patient). Designation should be in writing. 2. Court Appointed Guardian (in the absence of a Surrogate, or where a court revokes the authority of the Surrogate). All persons who have been adjudged incompetent should have a judicially appointed guardian. 3. A person holding a valid power of attorney (durable POA) which contains language giving the right to make health care decisions from a patient: 4. A proxy (in the event the patient is incompetent or incapacitated) Pursuant to Section a proxy may consent (where the patient has not executed an advance directive, or designated a Surrogate to make heath care decisions) to experimental treatment, provided, the experimental treatment has been approved by and IRB, and the proxy reasonably believes that the patient would have made the decision under the circumstances. What is a proxy? A substitute, competent decision maker in the following order of priority: Patient's spouse An adult child, or if the patient has more than 1 child, a majority of the adult children reasonably available for consultation A parent of the patient The adult sibling of the patient (if more than 1, then a majority of such adult siblings) An adult relative of the patient who has exhibited special care and concern for the patient and maintained regular contact with the patient A close friend of the patient A clinical social worker

20 11. For Research Involving Children: The consent process for research involving children requires that parents or legal guardians give permission for their children to become research subjects. The children, as appropriate for their developmental stage, provide Assent. Assent is an individual's voluntary, affirmative agreement to participate in research. A participant's failure to object cannot be construed as assent. As with all consent processes, the parental permission and child assent processes must include all of the information that potential participants need to make an informed decision. Permission and assent forms/materials must be presented in the appropriate language and reading level and the voluntary nature of participation must be made clear. In Florida, the legal age of consent for research is 18 years of age. Usually, children aged seven (7) or above have the ability to read a simple assent form, adjusted for developmental stage, to agree to participate in a research project. A verbal script is permitted by the IRB whenever children are involved, as appropriate. Assent scripts should be brief, to the point, and at a language level appropriate to the participant. 12. For Research Involving Non-English Speaking Subjects: Investigators must deliver all information regarding informed consenvassent to potential subjects or their legally authorized representatives in the subject's native language(s) or one that the subject understands. The investigator must use an IRB approved version of the translated consent/assent form. 13. Waivers of Informed Consent: The HHS regulations (45 CFR (c)) allow institutional review boards (IRBs) to waive or alter some or all of the required elements of informed consent if all of the following conditions are met: "The research or demonstration project is to be conducted by or subject to the approval of state or local government officials and is designed to study, evaluate, or otherwise examine: (i) public benefit service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; (iv) possible changes in methods or levels of payments for benefits or services under those programs, and the research could not practicably be carried out without the waiver or alteration." 14. Documentation and Recordkeeping of Informed Consent Unless specifically waived by the IRB, regulations require that informed consent be documented. The investigator is responsible to keep the original signed copy of the consent/assent document in his/her research records in accord with the IRB-approved protocol. For studies conducted at Brooks Rehabilitation hospital (inpatient setting), the investigator is responsible for placing a copy of the signed consent form and the assent form, if applicable, in the medical record. For studies conducted in other settings (i.e., outpatient, home health, community), the investigator is responsible for keeping the original signed informed consent form but is not required to place a copy in the medical chart. References: 45 CFR (c) 45CFR46.116(c) 21 CFR 50.3(1) 45 CFR (e) Florida Statute Florida Statute

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