TITLE PAGE FLORIDA DEPARTMENT OF HEALTH DOH 15-062 REQUEST FOR PROPOSALS (RFP) FOR Institutional Review Board (IRB) Application Management System Respondent Name: Respondent Mailing Address: City, State, Zip: Telephone: ( ) Fax Number: ( ) E-Mail Address: Federal Employer Identification Number (FEID): BY AFFIXING MY SIGNATURE ON THIS PROPOSAL, I HEREBY STATE THAT I HAVE READ THE ENTIRE RFP TERMS, CONDITIONS, PROVISIONS AND SPECIFICATIONS AND ALL ITS ATTACHMENTS, INCLUDING THE REFERENCED PUR 1000 AND PUR 1001. I hereby certify that my company, its employees, and its principals agree to abide to all of the terms, conditions, provisions and specifications during the competitive solicitation and any resulting contract including those contained in the Standard Contract. Signature of Authorized Representative: Printed (Typed) Name and Title: *An authorized representative is an officer of the Respondent s organization who has legal authority to bind the organization to the provisions of the Proposals. This usually is the President, Chairman of the Board, or owner of the entity. A document establishing delegated authority must be included with the Proposal if signed by anyone other than the authorized representative.
TABLE OF CONTENTS SECTION 1.0: Introductory Material....3 SECTION 2.0: Procurement Process, Schedule & Constraints..5 SECTION 3.0: Scope of Services.......8 SECTION 4.0: Instructions for Proposal Submittal.....20 SECTION 5.0: Contract Special Terms and Conditions....... 24 SECTION 6.0: Proposal Evaluation Process and Criteria.......28 ATTACHMENT A: Cost Proposal.. 31 ATTACHMENT B: Experience Form.... 33 ATTACHMENT C: Sample Program Forms...35
SECTION 1.0: INTRODUCTORY MATERIALS 1.1 Statement of Purpose The Florida Department of Health (Department) is seeking proposals from qualified respondents for a web-based software solution to manage applications submitted to the IRB for review. 1.1.1 Programmatic Authority 1.2 Definitions The program is authorized in section 381.96, Florida Statutes, and review is conducted according to Department of Health and Human Services regulations at 45 CFR 46, and Food and Drug Administration regulations at 21 CFR 50, 56, 312 and 812, and the Privacy Rule at 45 CFR 160, 162, and 164. Business hours: 8 a.m. to 5 p.m. Eastern Time on all business days. Calendar days: All days, including weekends and holidays. Contract: The formal agreement that will be awarded to the successful Respondent under this RFP, unless indicated otherwise. Contract Manager: An individual designated by the Department to be responsible for the monitoring and management of the Contract. IRB: Committee composed of at least five persons with appropriate qualifications and expertise to review research to ensure adequate protections for research participants and the ethical conduct of research as required by section 381.86, Florida Statutes and Department of Health and Human Services regulations at 45 CFR 46, and Food and Drug Administration regulations at 21 CFR 50, 56, 312 and 812, and 45 CFR 160, 162, and 164. IRB review using the expedited procedure: Review by one member of the IRB outside of a convened meeting to determine that criteria for approval of the application are met. IRB review by the convened IRB: Review by a committee of the IRB, where two or more members serve as primary reviewers and evaluate the entire application, and all other members review a portion of the application and then discuss the application in a public meeting to determine that criteria for approval are met. IRB System: Software solution including the workflow and forms used by researchers to apply for review; forms used by Department staff; forms used by IRB reviewers; and the series of steps and processes to receive applications, conduct staff review and conduct IRB review of initial applications, modifications and amendments to open studies, continuing review of open studies, review of problems in research, and process study closures. The system must manage committees, including agendas and minutes, maintain complete records of the IRBs determinations, and include standard reports and the ability for staff to create ad hoc reports. Institutional Review Board (IRB) Application Management System Page 3
Minor Irregularity: As used in the context of this solicitation, indicates a variation from the RFP terms and conditions which does not affect the price of the Proposal, or give the Respondent an advantage or benefit not enjoyed by other respondents, or does not adversely impact the interests of the Department. Proposal: The complete written response of the Respondent to the RFP (technical and cost proposals), including properly completed forms, supporting documents, and attachments. Respondent: An entity that submits a Proposal in response to this RFP and also may refer to the entity awarded a contract by the Department in accordance with terms of this RFP. Vendor Bid System (VBS): refers to the State of Florida internet-based vendor information system at http://vbs.dms.state.fl.us/vbs/main_menu Institutional Review Board (IRB) Application Management System Page 4
SECTION 2.0 PROCUREMENT PROCESS, SCHEDULE & CONSTRAINTS 2.1 Procurement Officer The Procurement Officer assigned to this solicitation is: Florida Department of Health Attention: Blake McGough 4052 Bald Cypress Way, Bin B07 Tallahassee, FL 32399-1749 Email: blake.mcgough@flhealth.gov 2.2 Restriction on Communications 2.3 Term Respondents to this solicitation or persons acting on their behalf may not contact, between the release of the solicitation and the end of the 72-hour period following the agency posting the notice of intended award, excluding Saturdays, Sundays, and state holidays, any employee or officer of the executive or legislative branch concerning any aspect of this solicitation, except in writing to the procurement officer or as provided in the solicitation documents. Violation of this provision may be grounds for rejecting a response. Section 287.057(23), Florida Statutes It is anticipated that the Contract resulting from this RFP will be for three years beginning by July 1, 2016 or the Contract execution date, whichever is later, and is subject to renewal as identified in Section 5.2. The contract resulting from this RFP is contingent upon the availability of funds. 2.4 Timeline EVENT DUE DATE LOCATION RFP Advertised / Released April 27, 2016 Posted to the Vendor Bid System at: http://myflorida.com/apps/vbs/vbs_www.main_menu Questions submitted in writing Must be received PRIOR TO: May 10, 2016 2:00 PM ET Submit to: Florida Department of Health Central Purchasing Office Attention: Blake McGough Suite 310 4052 Bald Cypress Way, Bin B07 Tallahassee, FL 32399-1749 E-mail: blake.mcgough@flhealth.gov Answers to Questions (Anticipated Date) May 12, 2016 Posted to Vendor Bid System at: http://myflorida.com/apps/vbs/vbs_www.main_menu Institutional Review Board (IRB) Application Management System Page 5
Sealed Proposals and Cost Proposals Due (Must be Sealed) Technical Proposals Opened Evaluation of Proposals (Anticipated Date) Cost Proposals Opened Must be received PRIOR TO: May 24, 2016 3:00 PM ET May 24, 2016 3:00 PM ET May 26, 2016 May 31, 2016 3:00 PM ET PUBLIC MEETING (either by HAND DELIVERY OR MAIL) Submit to: Florida Department of Health Central Purchasing Office Attention: Blake McGough Suite 310 4052 Bald Cypress Way, Bin B07 Tallahassee, FL 32399-1749 DO NOT SEND PROPOSAL TO AGENCY CLERK PUBLIC MEETING Florida Department of Health 4052 Bald Cypress Way Suite 310 Tallahassee, FL 32399 Evaluation Team Committee to begin evaluations individually PUBLIC MEETING Florida Department of Health 4052 Bald Cypress Way Suite 310 Tallahassee, FL 32399 Posting of Intent To Award (Anticipated Date) June 6, 2016 Posted to Vendor Bid System at: http://myflorida.com/apps/vbs/vbs_www.main_menu 2.5 Addenda If the Department finds it necessary to supplement, modify, or interpret any portion of the specifications or documents during the solicitation period a written addendum will be posted on the MyFlorida.com Vendor Bid System, http://vbs.dms.state.fl.us/vbs/main_menu. It is the responsibility of the Respondent to be aware of any addenda that might affect their Proposal. 2.6 Questions This provision takes precedence over General Instruction #5 in PUR1001. Questions related to this solicitation must be received, in writing (either via U.S. Mail, courier, e-mail, fax, or hand-delivery), by the Procurement Officer identified in Section 2.1, within the time indicated in the Timeline. Verbal inquiries or those submitted after the period specified in the Timeline will not be addressed. Institutional Review Board (IRB) Application Management System Page 6
Answers to questions submitted in accordance with the RFP Timeline will be posted on the MyFlorida.com Vendor Bid System web site: http://vbs.dms.state.fl.us/vbs/main_menu. 2.7 Identical Tie Proposals Where there is identical pricing or scoring from multiple respondents, the Department will determine the order of award in accordance with Florida Administrative Code Rule 60A- 1.011. Institutional Review Board (IRB) Application Management System Page 7
SECTION 3.0: SCOPE OF SERVICES 3.1 Background The IRB is responsible for oversight of research involving human participants and the Department. IRB members, including but not limited to, scientists and persons who can represent the general perspective of research participants, review these applications to ensure human research participants are protected and that provisions are in place to protect the confidentiality of private data in state public health registries used for research. The goal is to obtain a web-based software solution and other necessary supporting services to manage the IRB system. Review must comply with regulatory requirements, Department policies, and meet standards and practices of the Department s accreditation by the Association for Accreditation of Human Research Protection Programs (AAHRPP) as defined in the Evaluation Instrument for Accreditation, which is located at: http://www.aahrpp.org. 3.2 Scope of Services The Department is seeking a web-based software solution and necessary services to implement workflows and configure forms necessary for researchers to provide information necessary for IRB review, for the Department to conduct programmatic review, and allow for review by IRB members. The system must allow the Department to manage committee meeting agendas, and record meeting attendance and the decisions of the IRB and meeting minutes. The system must allow the Department to assign research studies to specific reviewers or entire committees of the IRB, and monitor the status of reviews. The system must provide researchers updates on the review process. The system must maintain records of applications and review in a manner that enables the Department to reconstruct a complete history of application submission and review in compliance with regulatory and accreditation requirements. Respondent will, in consultation with the Department, implement workflows, configure forms for application submission and review, configure user roles and permissions, and ensure proper workflow for researchers to submit applications and obtain review by the IRB, and implement standard reports for application status and provide for ad hoc reporting. The Department s intent is to establish a contract with a Respondent able to deliver a solution and provide these services. 3.2.1 Task List At a minimum, Respondent must implement the following tasks in consultation with the Department. 3.2.1.1 Implement and maintain through the entire course of the contract a workflow and configure forms to allow creation of user accounts with different user permissions defined by different roles, including at a minimum: researcher, research staff, Department staff, IRB members, local health department directors and other Department roles, auditors and compliance monitors (read only access), and members of the public (read only access). The workflow and forms must include the ability for researchers to create their own accounts and assign other persons on the Institutional Review Board (IRB) Application Management System Page 8
same research study to certain roles, including but not limited to other researchers, study coordinators, and other personnel such as statisticians. Users must be able to re-set their own passwords without intervention by the Department. 3.2.1.2. Implement and maintain through the entire course of the contract a workflow and forms to allow the Department to configure the IRB member roster for each committee; specify the specific roles in which members serve including committee chairs, scientific reviewers, non-scientific reviewers, and reviewers who represent the general concerns of research participants; specify the expertise of each member; specify whether each member is qualified to review research involving vulnerable populations including children, pregnant women, prisoners, and adults unable to consent; assign alternate members who can serve in the absence of committee members, and assign ad hoc consultants to review research studies. Department staff must be able to revise committee membership documents within the IRB system. The system must maintain a record of rosters of members, including changes over time. (See Attachment C Member Roster for example) 3.2.1.3. Implement and maintain through the entire course of the contract a workflow to allow the Department to schedule meetings of at least two IRB committees; assign studies to one or more members of an IRB committee; to create meeting agendas that include a description of each study, for example the title, researcher, location of the research, a summary of the study, and the names of two primary reviewers. The system must inform IRB members of decisions made using the expedited review procedure, such as including the record of reviews on meeting agendas that list a history of all studies approved by members of the committee since the time of the previous meeting of the committee, including the study title, researcher, and location of the research. (see Attachment C, Agenda for example) 3.2.1.4. Implement and maintain through the entire course of the contract a workflow and forms to create meeting minutes, specifying for each study whether the convened IRB approved the study, required changes to secure approval, or disapproved the study, and documenting a summary of the IRB s discussion of controverted issues, and indicating the approval period, e.g., one year, or six months and the date of expiration of IRB approval (see Attachment C, Minutes for example) 3.2.1.5. Implement and maintain through the entire course of the contract a workflow and forms to allow researchers to determine whether a fee is required for IRB review, and automatically send researchers an invoice Institutional Review Board (IRB) Application Management System Page 9
via email, and notify the Department via email that a fee is required for a study, and notify the researcher when payment has been received by the Department. (see Attachment C, Invoice for example) 3.2.1.6. Implement and maintain through the entire course of the contract a workflow and configure forms to allow researchers and research staff to request a determination of whether review by the Department's IRB is required, by filling out web-based forms and uploading supporting documentation in standard business file formats such as pdf or Word (see Attachment C, Form 500-00 for example) 3.2.1.7. Implement and maintain through the entire course of the contract a workflow and configure forms to allow researchers and research staff to apply for initial review by the IRB, by filling out web-based forms and uploading supporting documentation in standard business file formats such as pdf or Word. The system must allow researchers to create and edit applications, route for approval, and make revisions based on Department review and review by the IRB. These requirements apply to: 3.2.1.7.1 Applications for initial review to conduct research. (see Attachment C, Forms 500-01 and 500-02 for example) 3.2.1.7.2 Applications to modify or amend existing ongoing approved research. (see Attachment C, Form 500-30 for example) 3.2.1.7.3 Applications to obtain periodic review for authorization ton continue ongoing research studies. (see Attachment C, Form 500-40 for example) 3.2.1.7.4 Applications for review of unanticipated problems that occur during approved ongoing research. (see Attachment C, Form 500-50 for example) 3.2.1.7.5 Applications notifying the Department that research will close or is complete. (see Attachment C, Form 500-60 for example) 3.2.1.8 Implement and maintain through the entire course of the contract a workflow and configure forms to allow researchers and research staff to provide additional information to the IRB when the research involves additional requirements in regulation or Department policy by filling out web-based forms and uploading supporting documentation in standard business file formats such as pdf or Word: 3.2.1.8.1 Waiver of consent and waiver of documentation of consent 3.2.1.8.2 Children (see Attachment C, Form 500-10 for example) Institutional Review Board (IRB) Application Management System Page 10
3.2.1.8.3 Pregnant women (see Attachment C, Form 500-12 for example) 3.2.1.8.4 Prisoners (see Attachment C, Form 500-14 for example) 3.2.1.8.5 Adults who are unable to consent (see Attachment C, Form 500-16 for example) 3.2.1.8.6 When following United States Food and Drug Administration regulations, additional questions about drugs and devices, allowing researchers to list all drugs used in a study, including approved and unapproved or investigational drugs. (see Attachment C, Forms 500-20, 500-22, and 500-26 for example) 3.2.1.8.7 When following certain specific Florida laws, such as laws for research involving state data, additional questions specific to these requirements. For example, this applies to research involving Florida s Cancer Registry Data System or Vital Statistics 3.2.1.8.8 When following the Privacy Rule, additional questions specific to these requirements. 3.2.1.8.9 Research involving human biological materials (see Attachment C, Form 500-24 for example) 3.2.1.8.10 When following United States Environmental Protection Agency regulations, additional questions specific to these requirements. 3.2.1.8.11 When following United States Department of Defense regulations, additional questions specific to these requirements 3.2.1.9 Implement and maintain through the entire course of the contract a workflow and configure forms to allow the Department to review requests for whether IRB review is required or is exempt; to return applications to researchers if additional information is required to make a determination; to automatically communicate the Department s determination via email to researchers and research staff; and to maintain a record of the application and determination and any correspondence with researchers. When the application is returned to the researcher, the workflow must provide automatic reminders to researchers that action is required by the researcher to complete the application. (see Attachment C, Form 600-10 for example) Institutional Review Board (IRB) Application Management System Page 11
3.2.1.10 Implement and maintain through the entire course of the contract a workflow and configure forms to allow the Department to determine whether a researcher or research staff conflict of interest exists and whether a management plan is needed, and to return the application to researchers for additional information or assign to one or more IRB members and a committee for review. When the application is returned to the researcher, the workflow must provide automatic reminders to researchers that action is required to complete the application (see Attachment C, Form 700-50 for example) 3.2.1.11 Implement and maintain through the entire course of the contract a workflow and configure forms to allow the Department to determine whether applications for initial review, modifications, continuing review, and problem reports are complete, and to return applications to researchers when additional information is required; and when the application is complete, to assign to one or more IRB members and a committee for review; and maintain a record of any correspondence between the Department and the researcher. When the application is returned to the researcher, the workflow must provide automatic reminders to researchers that action is required to complete the application (see Attachment C, Forms 600-01, 600-03, 600-20, 600-22, 600-70, and 600-90 for examples) 3.2.1.12 Implement and maintain through the entire course of the contract a workflow and configure forms to assign the study to an agenda, assign to one or more members for review using the expedited procedure, or to one or more primary reviewers for review by the convened IRB, once the Department determines an application is complete. The workflow must provide automatic notification to the IRB members assigned as an expedited reviewer or primary reviewer, and provide automated reminders of the date when the review is due. The workflow must automatically notify the Department when the IRB member using the expedited procedure or primary reviewer has completed a review, and indicate whether the IRB member has approved, required changes to secure approval, or denied approval of the application. When changes are required to secure approval, the Department must be able to notify researchers of the changes require for approval, and the system must maintain a record of communication with the researcher. 3.2.1.13 Implement and maintain through the entire course of the contract the capacity to maintain a complete set of materials relevant to the Institutional Review Board (IRB) Application Management System Page 12
review of the research protocol in sufficient detail to allow a reconstruction of a complete history of IRB actions related to the review and approval of the research protocol or plan, including the following information: 3.2.1.13.1 Application creation date, submission date, and record of the user account that edited and submitted the application. 3.2.1.13.2 Protocols or research plans. 3.2.1.13.3 Investigator brochure, if any. 3.2.1.13.4 Scientific evaluations, when provided by an entity other than the IRB. 3.2.1.13.5 Recruitment materials. 3.2.1.13.6 Consent documents. 3.2.1.13.7 Progress reports submitted by researchers. 3.2.1.13.8 Reports of injuries to participants. 3.2.1.13.9 Records of continuing review activities. 3.2.1.13.10 Data and safety monitoring reports, if any. 3.2.1.13.11 Modifications to previously approved research. 3.2.1.13.12 Unanticipated problems involving risks to participants or others. 3.2.1.13.13 Documentation of non-compliance. 3.2.1.13.14 Significant new findings. 3.2.1.13.15 All correspondence between the IRB and researchers. 3.2.1.13.16 When using the expedited procedure, the justification for using the expedited procedure and actions taken by the reviewer 3.2.1.13.17 The justification for exempt determinations and non-research determinations 3.2.1.13.18 Date assigned to IRB reviewer, date review completed Institutional Review Board (IRB) Application Management System Page 13
3.2.1.14 Implement and maintain through the entire course of the contract a workflow and configure forms to allow one or more IRB members to conduct review of research studies. The system must allow IRB members to complete forms and answer questions based on the type of research (for example, if research involves drugs, or confidential data, then the IRB reviewer forms must display the additional questions necessary to review these types of studies). The workflow must allow IRB members to provide comments for researchers, and additional comments that are just viewable by the Department. When the research study has previously been reviewed by the IRB, the system just display the complete history of prior IRB reviews of research, including the documents reviewed and approved at each prior review and all correspondence with the research. These requirements apply to: 3.2.1.14.1 Applications for initial review to conduct research. (see Attachment C, Forms 700-01 and 700-07 for example) 3.2.1.14.2 Applications to modify or amend existing ongoing approved research. (see Attachment C, Form 700-10 for example) 3.2.1.14.3 Applications to obtain periodic review for authorization ton continue ongoing research studies. (see Attachment C, Forms 700-01 and 700-08 for example) 3.2.1.14.4 Applications for review of unanticipated problems that occur during approved ongoing research. (see Attachment C, Forms 700-51 for example) 3.2.1.15 Implement and maintain through the entire course of the contract a workflow and configure forms to allow IRB members to make additional determinations required by regulation and policy, including the ability for IRB members to provide text descriptions of required protocol-specific determinations for each question, when applicable. The workflow must allow IRB members to provide comments for researchers, and additional comments that are just viewable by the Department. 3.2.1.15.1 Waivers of consent and waiver of documentation of consent (see Attachment C, Form 700-05 for example) 3.2.1.15.2 Children (see Attachment C, Form 700-10 for example) 3.2.1.15.3 Pregnant women (see Attachment C, Form 700-12 for example) 3.2.1.15.4 Prisoners (see Attachment C, Form 700-14 for example) Institutional Review Board (IRB) Application Management System Page 14
3.2.1.15.6 Adults who are unable to consent (see Attachment C, Form 700-16 for example) 3.2.1.15.7 When following United States Food and Drug Administration regulations, additional determinations about drugs and devices (see Attachment C, Forms 700-20, 700-22, and 700-06 for example) 3.2.1.15.8 When following United States Environmental Protection Agency regulations, additional determinations specific to these requirements 3.2.1.15.9 When following United States Department of Defense regulations, additional determinations specific to these requirements 3.2.1.15.10 When following HIPAA and HITEC, additional determinations specific to these requirements 3.2.1.15.11 When following GCP guidelines, additional questions 3.2.1.15.12 When following DHHS or FDA regulations, additional questions for planned emergency research 3.2.1.15.13 Emergency use of a test article 3.2.1.15.14 Conflicts of interest management plans (see Attachment C, Form 700-02 for example) 3.2.1.16 Implement and maintain through the entire course of the contract business logic and configure web-based forms based on questions and forms provided by the Department in Word format. Forms must include the following question types, as needed to implement questions provided by the Department: 3.2.1.16.1 Text Response 3.2.1.16.2 Checkbox 3.2.1.16.3 Multiple choice 3.2.1.16.4 Dropdown 3.2.1.16.5 Date and Time 3.2.1.16.6 Text Response (short and long text boxes) 3.2.1.16.7 File uploader (to upload file attachments including but not limited to files in pdf, MS Word, and MS Excel.) Institutional Review Board (IRB) Application Management System Page 15
3.2.1.16.8 Questions that can be marked as required, and others that are optional. 3.2.1.16.9 Questions that may be skipped based on answers to earlier questions 3.2.1.17 Implement and maintain through the entire course of the contract a system to allow researchers and auditors to determine the current approved documents and materials, and materials that were approved at a given point in the protocol s history. For example, documents could be stamped with a visual watermark or other mechanism that allows researchers to demonstrate they are using the current approved documents for auditing purposes. The system must allow applicants to obtain the status of their applications online, and review historical information about their research studies such as record of applications submitted, approvals of initial applications, approvals of modifications, approvals of continuing reviews, records of problem reports and their disposition, and record of closure of research studies. Researchers and auditors must be able to reconstruct a complete history of the research at a given time, including which documents were approved at a given time. 3.2.1.18 Implement maintain through the entire course of the contract, a series of standard pre-configured reports and the ability for the Department to create ad hoc reports. At a minimum the Department must be able to run the following reports, and save data in commonly used formats such as csv, Excel, Word and HTML and the following: 3.2.1.18.1 Number of IRB applications submitted, organized by date, researcher, and researcher organization. Reports must be able to include data specified in the application, including type of study (such as social behavioral or biomedical), and if the information is included in the application, other information such as Florida Congressional and House of Representative district. 3.2.1.18.2 When following United States Department of Defense regulations, additional determinations specific to these requirements 3.2.1.18.3 Number of studies submitted from a university or research institute in a defined period of time, such as month and year, organized by organization, date and year, researcher, and type of research. 3.2.1.18.4 IRB applications that have not submitted a required invoice in a defined period, such as month and year. Institutional Review Board (IRB) Application Management System Page 16
3.2.1.18.5 Number of new IRB applications. 3.2.1.18.6 Number of applications reviewed using the convened IRB, using the expedited procedure, and determined to be exempt, or determined to be not research or not research involving human participants. 3.2.1.18.7 Time from submission of IRB applications to approval, including time from submission to staff review, time from submission to review by the IRB or reviewer using the expedited procedure, and time from submission to final approval. 3.2.1.18.8 Number of unanticipated problems involving risks to participants or others, number of adverse events and noncompliance, and non-compliance determined to be serious or continuing. 3.2.1.18.9 Number of protocol deviations. 3.2.1.18.10 For open studies under IRB review, the number of publications, books, theses, patents, copyrights, trademarks, and commercial products during the prior year. 3.2.1.18.11 IRB staff workload, including number of studies, time from assignment to completion of staff review. 3.2.1.18.12 IRB member workload, including reviews by the convened IRB and expedited procedure. 3.2.1.18.13 Reasons for returning studies to the researcher, organized by staff and IRB member. 3.2.1.18.14 Number of funded studies, organized by federal agency or industry sponsor. 3.2.1.18.15 Demographic information about researchers conducting research involving DOH, including location, organization, professional expertise, and type of research (e.g., industry sponsored study, investigator-initiated study, study involving department data systems such as the cancer registry research). 3.2.1.18.16 Complete history of actions on an IRB application (including but not limited to date of submission and person or user account who submitted the application, date of administrative review and person or user account of staff, Institutional Review Board (IRB) Application Management System Page 17
date returned to researcher, date re-submitted, date assigned to reviewer, date returned to researcher, date resubmitted and returned to the reviewer, date of approval, date of suspension or termination, and date of submission of documentation of prisoner research to federal regulators.) For each action, the system must show the person who conducted the task. 3.2.1.19 Implement and maintain through the entire course of the contract a webbased system with the following capabilities: 3.2.1.19.1 Respondent must host solution, and provide support, maintenance, and upgrades. 3.2.1.19.2 Solution must incorporate at least 256 bit encryption to protect confidential information over the unprotected internet, and must comply with Department security standards. 3.2.1.19.3 The solution must demonstrate being compliant with section 508 of the Americans with Disability Act. 3.2.1.19.4 The solution must support various web browsers and versions, including but not limited to Internet Explorer, Edge, Firefox, and Safari. 3.2.1.19.5 Respondent must establish and set-up the software solution for the Department s use within one month. Respondent must establish roles and access permissions for researchers and research staff, Department staff, IRB members, and auditors. 3.2.1.20 Respondent must create an implementation plan within 10 days of contract execution. 3.2.1.21 The system must be available from 7:00 a.m to 6:00 p.m Monday through Friday for Department processing functions, and 7:00 a.m to 11:00 p.m. seven days a week for public access functions. The system must be available 99.9 percent of the time, not including planned times for system upgrades. The respondent must provide prior notice of at least 48 hours for planned upgrades, and notice as soon as possible in advance for emergency updates prior to upgrading systems. The solution must perform acceptably, with response times between screen pages not to exceed five seconds. The Respondent must maintain a help desk to Institutional Review Board (IRB) Application Management System Page 18
receive calls concerning system problems, with problems being addressed within 24 hours. The Respondent must maintain daily backups that store off-site. The Respondent must maintain a disaster plan that is testing at least twice annually. Plan and test results must be made available to DOH within five business days of request. 3.2.1.22 The Respondent must develop and implement an ongoing training plan to ensure that all Department staff is educated on the use of the system. 3.2.1.23 The Respondent must be capable of performing enhancements to the system at the request of the Department. 3.2.2 Certifications, Licenses, Permits, Taxes and Equipment Respondent must pay for all licenses, permits, certificates and taxes required to operate in the State of Florida. Also, Respondent must comply with all applicable federal, state, and local laws, ordinances, codes, regulations, action transmittals, program instructions, and other requirements at no cost to the Florida Department of Health. Respondent will supply all necessary equipment to perform contract. 3.2.3 Minimum Qualifications The Successful Respondent must have a minimum of three years of experience in the following areas: 1. Providing online forms and workflows for IRB review. 2. Training staff at client organizations on how to use the vendor s system. 3. Maintaining an online system. Institutional Review Board (IRB) Application Management System Page 19
Section 4.0: INSTRUCTIONS FOR PROPOSAL SUBMITTAL 4.1 General Instructions to Respondents (PUR1001) This section explains the General Instructions to Respondents (PUR 1001) of the solicitation process, and is a downloadable document incorporated into this solicitation by reference. This document should not be returned with the Proposal: http://dms.myflorida.com/content/download/2934/11780 The terms of this solicitation will control over any conflicting terms of the PUR1001. 4.2 Proposal Format The Department discourages lengthy Proposals. Respondents are asked to use the following format: 4.2.1 Proposals should be on paper that is 8.5 by 11 inches. 4.2.2 The font size and style is at the discretion of the Respondent but should be at least 11 point. 4.2.3 The pages should be numbered and one-inch margins should be used. 4.2.4 Technical Proposals should include an index identifying the page number/section where information can be located in the Proposal. 4.3 Copies of Proposals 4.2.4.1. Separation of Technical and Cost Proposals (Mandatory Requirement): Respondents must separate the technical proposal from the cost proposal and ensure labeling as described in Section 4.4. Respondents must submit the following copies: 4.3.1 Technical Proposal One original and five paper copies of the Technical Proposal must be submitted no later than the date and time set forth in the Timeline. In addition, the original should contain an electronic version of the Proposal as submitted, including all supporting and signed documents, on a flash pen or jump drive. Refer to Section 4.7 for information on redacting confidential information, if applicable. The original paper copy of the Technical Proposal must be considered the authority if there are any differences between the paper and electronic copies. Respondents must not disclose cost information in the body of the Technical Proposal. Including cost information may cause the Proposal to be disqualified (Mandatory Requirement, see Section 4.10) Institutional Review Board (IRB) Application Management System Page 20
4.3.2 Cost Proposal One original copy of the Cost Proposal (Mandatory Requirement, refer to Section 4.5) must be submitted using Attachment A: Cost Proposal, no later than the date and time set forth in the timeline. No copies are requested. The Cost Proposal must be in a separate sealed envelope and must be identified in accordance with Section 4.5. 4.4 Proposal Labeling 4.4.1 Technical Proposal The Technical Proposal should be sealed and identified as follows: 4.4.2 Cost Proposal DOH 15-033 Request for Proposal for Institutional Review Board (IRB) Application Management System Due: May 24, 2016 @ 3:00 PM ET Respondent s Name: TECHNICAL PROPOSAL It is mandatory that the Respondent s Cost Proposal be in a separate sealed envelope and identified as follows: DOH 15-033 Request for Proposal for Institutional Review Board (IRB) Application Management System Due: May 24, 2016 @ 3:00 PM ET Respondent s Name: COST PROPOSAL 4.4.3 All Proposals must be sent or delivered to the Department of Health, Central Purchasing Office, 4052 Bald Cypress Way Bin B07, Tallahassee, Florida 32399. 4.5 Instructions for Submittal 4.5.1. Respondents are required to complete, sign, and return the Title Page with the Proposal submittal. (Mandatory Requirement) 4.5.2. Respondents are required to complete, sign, and return the Cost Proposal in a separate sealed envelope with the Proposal submittal. (Mandatory Requirement) 4.5.3. Respondents must submit all technical and cost data in the formats specified in the RFP. 4.5.4. Proposals may be sent by U.S. Mail, courier, overnight, or hand delivered to the location indicated in the Timeline. Institutional Review Board (IRB) Application Management System Page 21
4.5.5. Proposals submitted electronically will not be considered. 4.5.6. The Department is not responsible for improperly marked Proposals. 4.5.7. It is the Respondent s responsibility to ensure its submittal at the proper place and time indicated in the RFP Timeline. 4.5.8. The Department s clocks will provide the official time for Proposal receipt. 4.5.9. Materials submitted will become the property of the State of Florida and accordingly, the State reserves the right to use any concepts or ideas contained in the response. 4.6 Cost of Preparation Neither the Department of Health nor the State is liable for any costs incurred by a Respondent in responding to this solicitation. 4.7 Public Records and Trade Secrets Notwithstanding any provisions to the contrary, public records must be made available pursuant to the provisions of the Public Records Act. If the Respondent considers any portion of its Proposal to this solicitation to be confidential, exempt, trade secret or otherwise not subject to disclosure pursuant to Chapter 119, Florida Statutes, the Florida Constitution or other authority, the Respondent must segregate and clearly mark the document(s) as CONFIDENTIAL. Simultaneously, the Respondent must provide the Department with a separate redacted paper and electronic copy of its Proposal and briefly describe in writing the grounds for claiming exemption from the public records law, including the specific statutory citation for such exemption. This redacted copy must contain the solicitation name, number, and the name of the Respondent on the cover, and must be clearly titled REDACTED COPY. The Redacted Copy must be provided to the Department at the same time the Respondent submits its Proposal and must only exclude or redact those exact portions which are claimed confidential, proprietary, or trade secret. The Respondent will be responsible for defending its determination that the redacted portions of its Proposal are confidential, trade secret or otherwise not subject to disclosure. Further, the Respondent must protect, defend, and indemnify the Department for any and all claims arising from or relating to the determination that the redacted portions of its Proposal are confidential, proprietary, trade secret or otherwise not subject to disclosure. If the Respondent fails to submit a redacted copy with its Proposal, the Department is authorized to produce the entire documents, data or records submitted by the Respondent in answer to a public records request for these records. Institutional Review Board (IRB) Application Management System Page 22
4.8 Cost Proposal Each Respondent must provide their proposed cost utilizing Attachment A: Cost Proposal. The proposed cost should not be carried more than two places to the right of the decimal point. 4.9 Special Accommodations Any person who requires special accommodations at DOH Purchasing because of a disability should call the DOH Purchasing Office at (850) 245-4199 at least five work days prior to any pre-proposal conference, Proposal opening, or meeting. If hearing or speech impaired, contact Purchasing by using the Florida Relay Service, at 1-800-955-8771 (TDD). 4.10 Responsive and Responsible Respondents must complete and submit responses according to the following mandatory information or documentation as a part of the Proposal and comply with mandatory requirements. Any Proposal which does not meet the below requirements or contain the specified information will be deemed non-responsive. a. Proposals must be received by the time specified in the Timeline (Section 2.4). b. The Title Page of this RFP must be completed, signed, and returned with the Technical Proposal. c. Cost Proposal (Attachment A) must be completed, signed, and returned in a separate sealed envelope with RFP submittal. Cost information must not be contained in Respondent Technical Proposals. 4.11 Late Proposals The Procurement Officer must receive Proposals pursuant to this RFP no later than the date and time shown in the Timeline (Refer to Section 2.4). Proposals that are not received by the time specified will not be considered. Institutional Review Board (IRB) Application Management System Page 23
SECTION 5.0: CONTRACT TERMS AND CONDITIONS (not exclusive) 5.1 General Contract Conditions (PUR1000) The General Contract Conditions (PUR 1000) form is a downloadable document incorporated in this solicitation by reference, that contains general contract terms and conditions that must apply to any contract resulting from this RFP, to the extent they are not otherwise modified. This document should not be returned with the Proposal. http://dms.myflorida.com/content/download/2933/11777 The terms of this solicitation must control over any conflicting terms of the PUR1000. Paragraph 31 of PUR 1000 does NOT apply to this solicitation or any resulting Contract. 5.2 Renewal The Contract resulting from this solicitation may be renewed. Contracts may be renewed for a period that may not exceed three years or the term of the original Contract, whichever is longer. Renewals must be in writing, subject to the same terms and conditions set forth in the initial Contract and any written amendments signed by the parties. Renewals are contingent upon satisfactory fiscal and programmatic performance evaluations as determined by the Department and are subject to the availability of funds. 5.3 Conflict of Interest Section 287.057(17)(c), Florida Statutes, provides A person who receives a contract that has not been procured pursuant to subsections (1)-(3) to perform a feasibility study of the potential implementation of a subsequent contract, who participates in the drafting of a solicitation or who develops a program for future implementation, is not eligible to contract with the agency for any other contracts dealing with that specific subject matter, and any firm in which such person has any interest is not eligible to receive such contract. However, this prohibition does not prevent a vendor who responds to a request for information from being eligible to contract with an agency. The Department considers participation through decision, approval, disapproval, recommendation, preparation of any part of a purchase request, influencing the content of any specification or procurement standard, rendering of advice, investigation, or auditing or any other advisory capacity to constitute participation in drafting of the solicitation. 5.4 Certificate of Authority All corporations, limited liability companies, corporations not for profit, and partnerships seeking to do business with the State must be registered with the Florida Department of State in accordance with the provisions of Chapters 607, 608, 617, and 620, Florida Statutes, respectively prior to Contract execution. The Department retains the right to ask for verification of compliance before Contract execution. Failure of the selected Respondent to have appropriate registration may result in withdrawal of Contract award. Institutional Review Board (IRB) Application Management System Page 24
5.5 Respondent Registration Each Respondent doing business with the State of Florida for the sale of commodities or contractual services as defined in Section 287.012. Florida Statutes must register in the MyFloridaMarketPlace system, unless exempted under Florida Administrative Code Rule 60A-1.030. State agencies must not enter into an agreement for the sale of commodities or contractual services as defined in Section 287.012 Florida Statutes, with any Respondent not registered in the MyFloridaMarketPlace system, unless exempted by rule. The successful Respondent must be registered in the MyFloridaMarketPlace system within 5 days after posting of intent to award. Registration may be completed at: http://dms.myflorida.com/business_operations/state_purchasing/myflorida_marketplace/vendors. Respondents lacking internet access may request assistance from MyFloridaMarketPlace Customer Service at 866-352-3776 or from State Purchasing, 4050 Esplanade Drive, Suite 300, Tallahassee, FL 32399. 5.6 Subcontractors Respondent will not be authorized to enter into subcontracts for performance of services under the Contract resulting from this solicitation. Respondents may not propose subcontract agreements as part of their Proposal. 5.7 Commercial General Liability Insurance Respondent must secure and maintain, at its sole expense and for the duration of the contract, term insurance policies to protect himself, any subcontractor(s), and the State of Florida. Respondent must save and hold harmless and indemnify the Department against any and all liability, claims, judgments or costs of whatsoever kind or nature for injury to, or death of any person or persons and for loss or damage to any property resulting from the use, service operation, or performance of work under the terms of this contract, resulting in whole or in part from the negligent acts or omissions of Contract, his subcontractor, or any of the employees, agents, or representatives of the contractor or subcontractor. A. Workers Compensation in accordance with applicable state laws and regulations. B. General Liability Insurance covering all operations and services under the contract in amounts sufficient to protect the Department. C. Commercial Automobile Liability Insurance in amounts sufficient to protect the Department. Certificates of insurance coverage described above must be furnished by the Respondent on request of the Department. No insurance will be acceptable unless written by a company licensed by the State of Florida Department of Financial Services, Division of Insurance Agent and Agency Services to do business in Florida, where the work is to be performed at the time policy is issued. Institutional Review Board (IRB) Application Management System Page 25
5.8 Performance Measures Pursuant to Section 287.058(1)(e), Florida Statutes, the resulting contract must contain performance measures which specify the required minimum level of acceptable service to be performed. These will be established based on final determination of tasks and deliverables. 5.9 Financial Consequences Pursuant to Section 287.058, Florida Statutes, the contract resulting from this solicitation must contain financial consequences that will apply if Respondent fails to perform in accordance with the Contract terms. The financial consequences will be established based on final determination of the performance measures and contract amount. 5.10 Standard Contract Respondents must become familiar with the Department s Standard Contract which contains administrative, financial, and non-programmatic terms and conditions mandated by federal law, state statute, administrative code rule, or directive of the Chief Financial Officer. Use of the Standard Contract is mandatory for Departmental contracts and the terms and conditions contained in the Standard Contract are non-negotiable. The Standard Contract terms and conditions are located at: http://www.floridahealth.gov/about-the-department-ofhealth/about-us/administrative-functions/purchasing/_documents/doh-standard-contract.pdf. 5.11 Conflict of Law and Controlling Provisions Any contract resulting from this RFP, plus any conflict of law issue, will be governed by the laws of the State of Florida. Venue must be Leon County, Florida. 5.12 Records and Documentation To the extent that information is utilized in the performance of the resulting Contract or generated as a result of it, and to the extent that information meets the definition of public record as defined in section 119.011(12), Florida Statutes, said information is hereby declared to be and is hereby recognized by the parties to be a public record and absent a provision of law or administrative rule or regulation requiring otherwise, must be made available for inspection and copying by any interested person upon request as provided in Chapter 119, Florida Statutes, or otherwise. It is expressly understood that the respondent s refusal to comply with Chapter 119, Florida Statutes, will constitute an immediate breach of the Contract resulting from this RFP and entitles the Department to unilaterally cancel the Contract agreement. The Respondent will be required to promptly notify the Department of any requests made for public records. Unless a greater retention period is required by state or federal law, all documents pertaining to the program contemplated by this RFP must be retained by the Respondent for a period of six years after the termination of the resulting Contract or longer as may be required by any renewal or extension of the Contract. During the records retention period, the Respondent agrees to furnish, when requested to do so, all documents required to be retained. Submission of such documents must be in the Department s standard word Institutional Review Board (IRB) Application Management System Page 26