ECONOMIC DEVELOPMENT: Establishes the Louisiana Clinical Trial Competitiveness and Patient Access Act

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2026 Regular Session
HOUSE BILL NO. 1223
BY REPRESENTATIVE MCFARLAND
ECONOMIC DEVELOPMENT: Establishes the Louisiana Clinical Trial Competitiveness
and Patient Access Act
1 AN ACT
2 To enact Chapter 70 of Title 51 of the Louisiana Revised Statutes of 1950, to be comprised
3 of R.S. 51:3301 through 3306, relative to creating the Louisiana Clinical Trial
4 Competitiveness and Patient Access Act; to provide for purpose; to provide for
5 definitions; to provide for responsibilities of Louisiana Economic Development; to
6 provide for the participation of certain entities; to provide for the sharing of
7 information; to provide relative to external institutional review boards; to provide for
8 reporting; to provide for rulemaking authority; to provide for funding; and to provide
9 for related matters.
10 Be it enacted by the Legislature of Louisiana:
11 Section 1. Chapter 70 of Title 51 of the Louisiana Revised Statutes of 1950,
12 comprised of R.S. 51:3301 through 3306, is hereby enacted to read as follows:
13 CHAPTER 70. LOUISIANA CLINICAL TRIAL COMPETITIVENESS AND
14 PATIENT ACCESS ACT
15 §3301. Purpose
16 A. The purpose of this Chapter is to make Louisiana more competitive for
17 clinical trials by supporting sponsor-facing readiness, speed-to-trial information,
18 external central institutional review board reliance, avoidance of unnecessary
19 duplicate institutional review board ethical review, patient access, role-based
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1 collaboration, and statewide visibility of confirmed clinical-trial capabilities, while
2 preserving patient choice, institutional clinical authority, lawful local review, direct
3 sponsor relationships, confidential business information, and protected health
4 information.
5 B. Nothing in this Chapter shall be construed to designate any research
6 entity, healthcare system, academic medical center, cancer program, clinical partner,
7 affiliate, or other person as the exclusive or preferred statewide provider, gateway,
8 broker, coordinator, sponsor-facing representative, or patient-referral destination for
9 covered clinical projects.
10 C. Nothing in this Chapter shall be construed to designate, deny, confer,
11 limit, or impair any research entity's status, role, application, partnership, eligibility,
12 or recognition with respect to National Cancer Institute designation, National Cancer
13 Institute-supported networks, federal grant requirements, accreditation standards,
14 cancer-center designation standards, or other federal or private designation programs.
15 §3302. Definitions
16 For purposes of this Chapter, the following terms have the following
17 meanings:
18 (1) "Confidential business information" means nonpublic trade secret,
19 proprietary, competitively sensitive, commercially sensitive, sponsor-specific,
20 contract-research-organization-specific, research-entity-specific,
21 investigator-specific, or project-specific information, including trial pipelines,
22 feasibility, recruitment, referral strategy, contracts, budgets, rates, pricing,
23 intellectual property, commercialization strategy, site-selection strategy, sponsor
24 strategy, or market strategy.
25 (2) "Contract research organization" means an organization that provides
26 clinical research services to a sponsor or trial manager.
27 (3)(a) "Covered clinical project" means an industry-sponsored interventional
28 clinical trial, or a federally supported interventional clinical trial designated by rule
29 or voluntary written election by the research entity, involving a drug, biologic,
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1 medical device, radiopharmaceutical, diagnostic, combination product, or other
2 product regulated by the United States Food and Drug Administration and conducted
3 or proposed to be conducted at a site located in this state. A Phase IV clinical trial
4 is included only if interventional and designated by rule or voluntary written election
5 by the research entity.
6 (b) The term does not include a purely observational study, retrospective
7 chart review, registry-only study, quality-improvement activity, or expanded-access
8 treatment outside a clinical trial unless voluntarily included by the research entity or
9 designated by rule for a limited implementation purpose.
10 (4) "Department" means Louisiana Economic Development.
11 (5) "Designee" means a public or private entity, organizational unit,
12 contractor, or other person lawfully designated by the department to assist with
13 administrative, technical, market-facing, or implementation functions pursuant to this
14 Chapter. A designee shall be subject to the limitations, confidentiality restrictions,
15 patient-data restrictions, no-gatekeeper provisions, no-forced-routing provisions,
16 no-steering provisions, and antitrust-related limitations of this Chapter.
17 (6) "External central institutional review board" means an institutional
18 review board that serves as the single institutional review board or institutional
19 review board of record for a covered clinical project pursuant to a federally
20 compliant reliance arrangement, is registered in accordance with applicable federal
21 requirements, is not subject to an active federal restriction, suspension,
22 disqualification, or enforcement action that prohibits or materially limits review of
23 the covered clinical project, and is not the local institutional review board of the
24 research entity conducting the covered clinical project.
25 (7) "Patient-identifying information" means information that identifies or can
26 reasonably be used to identify a patient, research participant, or potential research
27 participant, including health, biological specimen, genomic, imaging, referral,
28 eligibility, or clinical information associated with that person.
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1 (8) "Protected health information" has the same meaning as provided in 45
2 CFR 160.103.
3 (9)(a) "Research entity" means a hospital, academic institution, institutional
4 healthcare provider, healthcare system, private clinical research site, research
5 organization, cancer research program, academic medical center platform,
6 community oncology program, pediatric research program, translational research
7 program, or other institutional entity serving as a trial site or otherwise exercising
8 institutional responsibility for a covered clinical project at a site located in this state.
9 (b) The term does not include an individual healthcare provider acting solely
10 in an individual professional capacity and not on behalf of an institutional trial site.
11 (10) "Sponsor" means a pharmaceutical company, biotechnology developer,
12 medical device manufacturer, diagnostic developer, radiopharmaceutical developer,
13 academic sponsor, federal sponsor, foundation sponsor, or other entity advancing an
14 investigational product.
15 §3303. Department role; voluntary participation; limitations
16 A. The department may administer this Chapter and may act through a
17 designee.
18 B. The department may coordinate, verify, aggregate, and market voluntarily
19 provided or verified Louisiana clinical-trial capabilities to sponsors, contract
20 research organizations, federal partners, site-selection teams, and other persons
21 involved in clinical-trial development, site selection, patient access, or
22 economic-development activities in a neutral, nonexclusive, and capability-based
23 manner.
24 C. Department-coordinated marketing, capability-presentation,
25 sponsor-facing, site-identification, pilot, cooperative endeavor agreement, or other
26 implementation activity is voluntary and nonexclusive. No research entity, sponsor,
27 contract research organization, patient, or referring provider shall be required to use
28 or route communications through the department or its designee, or participate in
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1 such activity, as a condition of conducting, considering, referring to, contracting for,
2 or participating in a covered clinical project.
3 D. A research entity may voluntarily provide capability, contact,
4 site-readiness, speed-to-trial, or role-based collaboration information to the
5 department or its designee for statewide clinical-trial marketing.
6 E. The department may enter into confidentiality agreements and other
7 lawful agreements to support implementation of this Chapter, to the extent permitted
8 by law. Nothing in this Chapter shall require a research entity, sponsor, or contract
9 research organization to provide the department or its designee with
10 patient-identifying information, protected health information, confidential business
11 information, feasibility information, trial-pipeline information, patient or referral
12 information, contract or budget terms, recruitment strategy, market strategy, or other
13 competitively sensitive information except pursuant to law or voluntary written
14 agreement.
15 F. Nothing in this Chapter shall authorize the department or its designee to
16 approve or disapprove a protocol, contract, budget, local operational determination,
17 site activation decision, patient referral, sponsor selection, contract research
18 organization selection, site-selection decision, clinical judgment, credentialing
19 decision, licensure determination, coverage determination, or federal research
20 determination.
21 G. Nothing in this Chapter shall transfer ownership of research programs,
22 clinical operations, faculty governance, medical judgment, licensure standards,
23 credentialing authority, contracting authority, budget authority, institutional review
24 authority, or clinical decision-making authority from a research entity to the
25 department or its designee.
26 H. A designee affiliated with a research entity, healthcare provider,
27 healthcare system, academic medical center, clinical partner, affiliate, or other
28 person that competes with a research entity shall not receive, collect, access, store,
29 transmit, or control another research entity's confidential business information,
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1 patient-identifying information, protected health information, feasibility information,
2 trial-pipeline information, patient or referral information, contract or budget
3 information, recruitment strategy, market strategy, or other competitively sensitive
4 information unless each affected person provides written consent or the information
5 is otherwise lawfully available to the designee.
6 I. Coordination in accordance with this Chapter shall be nonexclusive and
7 shall not require or authorize allocation of markets, patients, sponsors, trials,
8 investigators, service lines, territories, prices, reimbursement, contract terms, budget
9 terms, referral sources, or commercial opportunities among research entities or other
10 persons.
11 §3304. Speed-to-trial and capability information
12 A. The department may establish by rule or guidance categories, formats,
13 and criteria for voluntarily provided or aggregate speed-to-trial and capability
14 information useful to sponsors, contract research organizations, and site-selection
15 teams.
16 B. Rules or guidance issued pursuant to this Section may vary by project
17 type, trial phase, therapeutic area, trial complexity, research entity type, site
18 capability, institutional infrastructure, sponsor or contract research organization
19 submission completeness, or voluntary participation in department-coordinated
20 activity.
21 C. No rule or guidance issued pursuant to this Section shall require final
22 contract execution, final budget agreement, study acceptance, site activation,
23 enrollment commitment, use of the department or its designee, or disclosure of
24 information protected by law or contract.
25 D. No research entity shall be required to route sponsor or contract research
26 organization communications, feasibility information, patient or referral information,
27 contract or budget terms, recruitment strategy, trial-pipeline information,
28 patient-access strategy, referral strategy, or other confidential business information
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1 through another research entity, the department, or a designee affiliated with a
2 competing healthcare provider or research entity.
3 E. Nothing in this Chapter shall authorize the department, its designee, or
4 any research entity to require a sponsor, contract research organization, patient, or
5 referring provider to use a particular research entity, healthcare system, cancer
6 program, clinical partner, affiliate, or designee, or to route communications,
7 referrals, or confidential business information through a competing research entity,
8 except with the written consent of the affected parties and as otherwise authorized
9 by law.
10 F. Nothing in this Chapter shall prohibit voluntary collaboration,
11 consolidated feasibility responses, hub-and-spoke arrangements, decentralized trial
12 arrangements, teletrial arrangements, shared-investigator participation,
13 specialist-access planning, community-access partnerships, local follow-up support,
14 or patient-access support, where lawful, clinically appropriate, operationally feasible,
15 and consistent with patient consent, privacy law, institutional credentialing, sponsor
16 requirements, protocol requirements, and clinical judgment.
17 G. Nothing in this Chapter shall require a research entity to accept, open,
18 activate, or enroll a covered clinical project for which the research entity reasonably
19 determines that sufficient patient population, clinical expertise, investigator
20 availability, facility readiness, staffing, data capacity, credentialing, coverage
21 analysis, or operational capability is lacking.
22 §3305. External central institutional review board; local review
23 A. The requirements of this Section apply regardless of participation in
24 department-coordinated activity.
25 B. When an external central institutional review board is designated as the
26 institutional review board of record or has approved the covered clinical project, a
27 research entity shall not require separate local institutional review board approval or
28 conduct duplicate local institutional review board ethical review. Nothing in this
29 Subsection shall limit lawful local review preserved by this Section.
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1 C. For a first-in-human clinical trial, Phase I clinical trial, early-feasibility
2 device trial, or dose-escalation trial, a research entity shall rely on an external central
3 institutional review board as the institutional review board of record where permitted
4 by law and where a federally compliant reliance arrangement is available, unless
5 external central institutional review board reliance is prohibited by federal law, state
6 law, or binding federal award condition, or the sponsor or its authorized
7 representative states in writing that the research entity's institutional review board
8 serve as the institutional review board of record.
9 D. A lack of a preexisting master agreement alone shall not make an external
10 central institutional review board unavailable if a lawful study-specific reliance
11 arrangement can be executed.
12 E. If an external central institutional review board has been designated as the
13 institutional review board of record, a request pursuant to Subsection C of this
14 Section or Paragraph (F)(1) of this Section is effective only if the sponsor or its
15 authorized representative withdraws that designation or confirms in writing that the
16 external central institutional review board is unavailable. If an external central
17 institutional review board has approved the covered clinical project, local
18 institutional review board ethical review shall not occur.
19 F. For a Phase II clinical trial or Phase III clinical trial, a research entity shall
20 rely on an external central institutional review board as the institutional review board
21 of record where permitted by law and where a federally compliant reliance
22 arrangement is available, unless either of the following applies:
23 (1) The sponsor or its authorized representative requests in writing that the
24 research entity's institutional review board serve as the institutional review board of
25 record.
26 (2) The chancellor, chief executive officer, or highest-ranking executive
27 officer of the research entity or institutional operating unit with formal legal or
28 operational responsibility for the covered clinical project approves and signs a
29 written project-specific exception based on one or more of the following:
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1 (a) External central institutional review board reliance is prohibited by
2 federal law, state law, or binding federal award condition.
3 (b) Extraordinary project-specific circumstances involving project
4 feasibility, participant rights, safety, or welfare require review by the research
5 entity's own institutional review board for that covered clinical project.
6 (c) A specific federal or state legal requirement requires review by the
7 research entity's own institutional review board for that covered clinical project.
8 G.(1) Notwithstanding any provision of this Chapter to the contrary, this
9 Section shall not apply to any clinical trial, clinical investigation, or study that is a
10 Phase IV clinical trial, a Phase 4 clinical trial, or otherwise postmarketing,
11 post-approval, post-authorization, post-clearance, or post-classification, if the trial,
12 investigation, or study is conducted after approval, licensure, clearance,
13 authorization, or classification by the United States Food and Drug Administration
14 of the product for the indication or use being studied, regardless of whether the trial,
15 investigation, or study is interventional, observational, required, requested, agreed
16 to, or voluntary. No rule, guidance, pilot, cooperative endeavor agreement, written
17 agreement, or other implementation material pursuant to this Chapter shall make
18 such a trial, investigation, or study subject to this Section. Nothing in this Paragraph
19 shall prohibit the voluntary use of an external central institutional review board when
20 otherwise lawful.
21 (2) For a covered clinical project not described in Paragraph (1) of this
22 Subsection and designated by rule, pilot, cooperative endeavor agreement, or written
23 agreement of the affected parties, external central institutional review board reliance
24 standards may be established by rule, pilot, cooperative endeavor agreement, or
25 written agreement of the affected parties.
26 H. No approval required pursuant to Paragraph (F)(2) of this Section may be
27 delegated. The approving official shall be the chancellor, chief executive officer, or
28 highest-ranking executive officer of the research entity or institutional operating unit
29 with formal legal or operational responsibility for the covered clinical project. The
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1 approving official shall not be the institutional review board chair, head of the local
2 institutional review board, direct supervisor of the head of the local institutional
3 review board, principal investigator, department chair, compliance officer, legal
4 counsel, or other person primarily responsible for institutional review board
5 administration or review, unless that person is also the highest-ranking executive
6 officer of the research entity or institutional operating unit with formal legal or
7 operational responsibility for the covered clinical project.
8 I. A written exception pursuant to Paragraph (F)(2) of this Section shall state
9 the basis for the exception with reasonable specificity, shall be limited to the covered
10 clinical project, and shall not establish a standing institutional exception. The
11 research entity shall transmit the written exception, or a summary sufficient to
12 identify the statutory basis for the exception, to the sponsor, contract research
13 organization if applicable, and the department or its designee in a form that does not
14 disclose patient-identifying information, protected health information, or confidential
15 business information.
16 J. An exception pursuant to Paragraph (F)(2) of this Section shall not be
17 based solely on institutional policy or preference, administrative convenience,
18 staffing limitation, customary practice, generalized concern regarding external
19 institutional review board review, preference for duplicate ethical review,
20 disagreement with the use of external institutional review boards generally, or desire
21 to control sponsor, referral, patient-access, or contracting relationships.
22 K. A research entity that relies on its own institutional review board pursuant
23 to this Section shall maintain documentation supporting such reliance and report
24 aggregate, non-identifiable information to the department on a schedule established
25 by rule or guidance, but not more frequently than semiannually. The report shall not
26 include patient-identifying information, protected health information, confidential
27 business information, sponsor-specific nonpublic information,
28 contract-research-organization-specific nonpublic information,
29 research-entity-specific nonpublic information, investigator-specific nonpublic
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1 information, or project-specific nonpublic information. The department may set the
2 form and schedule for reports in accordance with this Subsection, but shall not
3 expand, narrow, waive, or modify the institutional review board requirements,
4 exceptions, prohibitions, or local-review protections established in this Section.
5 L. Nothing in this Chapter shall prohibit lawful local institutional review
6 relating to contracts, budgets, coverage analysis, investigator qualifications, conflicts
7 of interest, privacy, HIPAA, billing compliance, credentialing, pharmacy,
8 investigational-drug logistics, device logistics, radiation safety, radiopharmaceutical
9 handling, biosafety, cellular therapy readiness, BMT readiness, CAR-T readiness,
10 gene-therapy readiness, pediatric safeguards, facility readiness, site feasibility,
11 ancillary safety committees, local consent-language requirements, data security,
12 scientific review, disease-group review, Protocol Review and Monitoring System
13 review, Protocol Review and Monitoring Committee review, data and safety
14 monitoring, clinical protocol and data management, local context submissions, or
15 equivalent review required by law, applicable federal award conditions, accreditation
16 standards, cancer-center designation standards, reliance agreements, or written
17 objective institutional requirements directly related to local operational readiness,
18 participant safety, or institutional compliance.
19 M. Local institutional review preserved by this Section shall not be used to
20 duplicate institutional review board ethical review or delay a covered clinical project
21 based solely on institutional preference, generalized practice, administrative
22 convenience, staffing limitation, customary internal sequencing, or disagreement
23 with external central institutional review board reliance generally.
24 N. Nothing in this Chapter shall require a research entity to waive or
25 disregard legal requirements, safety obligations, federal research requirements,
26 federal award conditions, accreditation standards, cancer-center designation
27 requirements, reliance agreement responsibilities, or documented institutional
28 responsibilities.
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1 §3306. Reporting; rulemaking; funds
2 A. The department may require only aggregate, non-identifiable information
3 reasonably necessary to evaluate implementation of this Chapter and may publish
4 aggregate reports, implementation summaries, speed-to-trial information, capability
5 information, and recommendations. Information required pursuant to this Subsection
6 shall not include patient-identifying information, protected health information,
7 confidential business information, sponsor-specific nonpublic information,
8 contract-research-organization-specific nonpublic information,
9 research-entity-specific nonpublic information, investigator-specific nonpublic
10 information, or project-specific nonpublic information unless provided pursuant to
11 law or voluntary written agreement.
12 B. Public reporting in accordance with this Chapter shall be aggregated and
13 shall not include patient-identifying information, protected health information,
14 confidential business information, sponsor-specific nonpublic information,
15 contract-research-organization-specific nonpublic information,
16 research-entity-specific nonpublic information, investigator-specific nonpublic
17 information, or project-specific nonpublic information.
18 C. Nothing in this Chapter shall be construed to do any of the following:
19 (1) Create a state warranty of site performance, patient outcome, sponsor
20 selection, site selection, enrollment success, clinical outcome, federal designation,
21 regulatory approval, investment outcome, or commercial success.
22 (2) Create a private cause of action based solely on implementation of this
23 Chapter.
24 (3) Require disclosure of information prohibited from disclosure by federal
25 or state law or by enforceable contractual obligation.
26 (4) Require or authorize the department or its designee to receive, store,
27 transmit, access, control, collect, maintain, audit, or validate identifiable patient-level
28 data, source data, endpoint data, adverse-event data, protected health information,
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1 or patient-identifying information except as authorized by federal and state law,
2 contract, protocol, consent, and applicable federal requirements.
3 (5) Create immunity from federal or state antitrust law, unfair trade practice
4 law, fraud law, abuse law, conflict-of-interest law, procurement law, or ethics law.
5 (6) Require or authorize market allocation, patient allocation, sponsor
6 allocation, trial allocation, referral-source allocation, price coordination,
7 contract-term coordination, budget-term coordination, or service-line allocation
8 among competitors.
9 D. The department may adopt rules in accordance with the Administrative
10 Procedure Act to implement this Chapter and may issue guidance, templates,
11 reporting formats, capability tools, confidentiality procedures, conflict-of-interest
12 procedures, model provisions, and other nonregulatory implementation materials, but
13 only for the department's economic-development, speed-to-trial,
14 capability-presentation, marketing, aggregate-reporting, consultation,
15 voluntary-program, funding, and implementation functions pursuant to this Chapter.
16 E. Rules or guidance may establish categories of covered clinical projects,
17 standards for voluntarily provided or aggregate speed-to-trial and capability
18 information, capability criteria, aggregate reporting formats, external central
19 institutional review board reliance procedures, exception procedures, confidentiality
20 procedures, role-based collaboration categories, hub-and-spoke models, teletrial
21 models, decentralized trial models, patient-access criteria, voluntary program
22 criteria, and phased implementation by project type, institution type, therapeutic
23 area, trial phase, site, or pilot cohort. Rules or guidance shall not authorize the
24 department or its designee to regulate clinical judgment, protocol content, site
25 activation decisions, contracting decisions, patient referrals, sponsor selection,
26 substantive institutional review board determinations, or local operational
27 determinations.
28 F. The department shall consult with research entities subject to this Chapter,
29 sponsors, contract research organizations, the Louisiana Department of Health,
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1 patient-access stakeholders, privacy experts, clinical-trial operations experts, and
2 persons with relevant clinical, research, operational, contracting, regulatory,
3 academic medical center development, biomedical innovation, or
4 economic-development expertise.
5 G. Nothing in this Chapter shall be construed to require a specific
6 appropriation of funds or the creation of new positions. Subject to appropriation and
7 availability of funds, the department may seek, accept, and expend federal funds,
8 grants, gifts, donations, philanthropic contributions, private contributions,
9 cooperative endeavor funds, matching funds, and other lawful funds made available
10 for purposes of this Chapter.
11 H. Subject to appropriation, available funds, and applicable law, the
12 department may establish voluntary programs or enter into case-by-case cooperative
13 endeavor agreements or other written agreements to support this Chapter. Before
14 providing funds or other things of value, the department shall determine in writing
15 that the program or agreement serves a public purpose and reasonably advances
16 patient access, clinical-trial competitiveness, speed-to-trial, statewide capability
17 development, rural or underserved access, academic medical center development,
18 research investment, or another purpose of this Chapter. No program or agreement
19 shall confer market exclusivity, require use of or routing through the department or
20 its designee, require disclosure of information protected by law or contract, or
21 require surrender of the right to conduct, consider, refer to, contract for, or
22 participate in a covered clinical project independently.
23 Section 2. The requirements of this Act shall apply prospectively to covered clinical
24 projects for which the initial sponsor, contract research organization, site-selection, or
25 feasibility submission is received on or after the effective date of this Act. Requirements
26 established by rule, guidance, capability tool, criterion, or other implementation material
27 apply prospectively only after the effective date of that rule, guidance, tool, criterion, or
28 material.
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1 Section 3. This Act shall become effective upon signature by the governor or, if not
2 signed by the governor, upon expiration of the time for bills to become law without signature
3 by the governor, as provided by Article III, Section 18 of the Constitution of Louisiana. If
4 vetoed by the governor and subsequently approved by the legislature, this Act shall become
5 effective on the day following such approval.
DIGEST
The digest printed below was prepared by House Legislative Services. It constitutes no
part of the legislative instrument. The keyword, one-liner, abstract, and digest do not
constitute part of the law or proof or indicia of legislative intent. [R.S. 1:13(B) and
24:177(E)]
HB 1223 Reengrossed 2026 Regular Session McFarland
Abstract: Creates the La. Clinical Trial Competitiveness and Patient Access Act.
Proposed law creates the La. Clinical Trial Competitiveness and Patient Access Act.
Proposed law provides for purpose.
Proposed law defines "confidential business information", "contract research organization",
"covered clinical project", "department", "designee", "external central institutional review
board", "patient-identifying information", "protected health information", "research entity",
and "sponsor".
Proposed law allows the Louisiana Economic Development (department) to administer
proposed law and may act through a designee.
Proposed law allows the department to coordinate, verify, aggregate, and market voluntarily
provided or verified La. clinical-trial capabilities to sponsors, contract research
organizations, federal partners, site-selection teams, and other persons involved in
clinical-trial development, site selection, patient access, or economic-development activities
in a neutral, nonexclusive, and capability-based manner.
Proposed law provides that certain implementation activity outlined in proposed law is
voluntary and nonexclusive.
Proposed law allows a research entity to voluntarily provide certain information to the
department or its designee for statewide clinical-trial marketing.
Proposed law allows the department to enter into confidentiality agreements and other lawful
agreements to support implementation of proposed law.
Proposed law provides that nothing in proposed law authorizes the department to take certain
actions outlined in proposed law.
Proposed law provides that nothing in proposed law shall transfer ownership of research
programs, clinical operations, faculty governance, medical judgment, licensure standards,
credentialing authority, contracting authority, budget authority, institutional review
authority, or clinical decision-making authority from a research entity to the department or
its designee.
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Proposed law provides that a designee with certain affiliation shall not receive, collect,
access, store, transmit, or control certain information from another research entity unless
each affected person provides written consent or the information is otherwise lawfully
available to the designee.
Proposed law allows the department to establish by rule or guidance categories, formats, and
criteria for voluntarily provided or aggregate speed-to-trial and capability information useful
to sponsors, contract research organizations, and site-selection teams. Proposed law provides
that rules or guidance may vary.
Proposed law provides that no research entity shall be required to route certain information
through another research entity, the department, or a designee affiliated with a competing
healthcare provider or research entity.
Proposed law provides that nothing in proposed law shall prohibit voluntary collaboration,
consolidated feasibility responses, hub-and-spoke arrangements, decentralized trial
arrangements, teletrial arrangements, shared-investigator participation, specialist-access
planning, community-access partnerships, local follow-up support, or patient-access support,
where lawful, clinically appropriate, operationally feasible, and consistent with patient
consent, privacy law, institutional credentialing, sponsor requirements, protocol
requirements, and clinical judgment.
Proposed law provides that nothing in proposed law shall require a research entity to accept,
open, activate, or enroll a covered clinical project for which the research entity reasonably
determines that sufficient patient population, clinical expertise, investigator availability,
facility readiness, staffing, data capacity, credentialing, coverage analysis, or operational
capability is lacking.
Proposed law provides that certain requirements of proposed law shall apply regardless of
participation in department-coordinated activity.
Proposed law provides that when an external central institutional review board is designated
as the institutional review board of record or has approved the covered clinical project, a
research entity shall not require separate local institutional review board approval or conduct
duplicate local institutional review board ethical review.
Proposed law provides that for certain trials a research entity shall rely on an external central
institutional review board as the institutional review board of record where permitted by law
and where a federally compliant reliance arrangement is available, unless in certain
circumstances.
Proposed law provides that lack of a preexisting master agreement alone shall not make an
external central institutional review board unavailable if a lawful study-specific reliance
arrangement can be executed.
Proposed law provides that if an external central institutional review board has been
designated as the institutional review board of record, a request pursuant to proposed law is
effective only in certain circumstances. Proposed law further requires that if an external
central institutional review board has approved the covered clinical project, local
institutional review board ethical review shall not occur.
Proposed law provides that for a Phase II clinical trial or Phase III clinical trial, a research
entity shall rely on an external central institutional review board as the institutional review
board of record where permitted by law and where a federally compliant reliance
arrangement is available, unless either of the following applies:
(1) The sponsor or its authorized representative requests in writing that the research
entity's institutional review board serve as the institutional review board of record.
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(2) The chancellor, chief executive officer, or highest-ranking executive officer of the
research entity or institutional operating unit with formal legal or operational
responsibility for the covered clinical project approves and signs a written
project-specific exception based on certain criteria.
Proposed law provides that proposed law shall not apply to certain clinical trials, clinical
investigations, or studies.
Proposed law provides that for a covered clinical project not described in proposed law and
designated by rule, pilot, cooperative endeavor agreement, or written agreement of the
affected parties, external central institutional review board reliance standards may be
established by rule, pilot, cooperative endeavor agreement, or written agreement of the
affected parties.
Proposed law prohibits the delegation of approval required pursuant to proposed law.
Proposed law requires a written exception pursuant to proposed law to state the basis for the
exception with reasonable specificity, to be limited to the covered clinical project, and not
to establish a standing institutional exception.
Proposed law provides for what exemptions shall not be solely based on.
Proposed law provides that a research entity that relies on its own institutional review board
pursuant to proposed law shall maintain documentation supporting such reliance and report
aggregate, non-identifiable information to the department on a schedule established by rule
or guidance. Proposed law further provides what the report shall include.
Proposed law provides for what proposed law shall not inhibit.
Proposed law provides that local institutional review shall not be used to duplicate
institutional review board ethical review or delay a covered clinical project based solely on
certain circumstances.
Proposed law provides that nothing in proposed law shall require a research entity to waive
or disregard legal requirements, safety obligations, federal research requirements, federal
award conditions, accreditation standards, cancer-center designation requirements, reliance
agreement responsibilities, or documented institutional responsibilities.
Proposed law allows the department to require only aggregate, non-identifiable information
reasonably necessary to evaluate implementation of proposed law and to publish aggregate
reports, implementation summaries, speed-to-trial information, capability information, and
recommendations.
Proposed law provides relative to public reporting.
Proposed law provides that nothing in proposed law shall be construed to do any of the
following:
(1) Create a state warranty of site performance, patient outcome, sponsor selection, site
selection, enrollment success, clinical outcome, federal designation, regulatory
approval, investment outcome, or commercial success.
(2) Create a private cause of action based solely on implementation of proposed law.
(3) Require disclosure of information prohibited from disclosure by federal or state law
or by enforceable contractual obligation.
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(4) Require or authorize the department or its designee to receive, store, transmit, access,
control, collect, maintain, audit, or validate identifiable certain data or information
except as authorized by federal and state law, contract, protocol, consent, and
applicable federal requirements.
(5) Create immunity from certain law.
(6) Require or authorize certain allocation and coordination among competitors.
Proposed law allows the department to adopt rule, guidance, and other materials to
implement the provisions of proposed law.
Proposed law provides for what rules or guidance may establish.
Proposed law requires that department to consult with certain entities.
Proposed law provides relative to the appropriation of funds.
Proposed law allows the department to establish voluntary programs or other agreements to
support proposed law.
Proposed law provides that the requirements of proposed law shall apply prospectively to
covered clinical projects for which the initial sponsor, contract research organization,
site-selection, or feasibility submission is received on or after the effective date of proposed
law. Requirements established by rule, guidance, capability tool, criterion, or other
implementation material apply prospectively only after the effective date of that rule,
guidance, tool, criterion, or material.
Effective upon signature of governor or lapse of time for gubernatorial action.
(Adds R.S. 51:3301-3306)
Summary of Amendments Adopted by House
The Committee Amendments Proposed by House Committee on Commerce to the
original bill:
1. Make technical changes.
2. Add language relative to legislative findings and purpose.
3. Amend the definitions of "benchmark category" and "research entity".
4. Add the definitions of "receipt" and "repeated failure".
5. Add that nothing in proposed law shall be construed to require department
approval for certain actions or to transfer clinical decision-making authority from
a research entity to the department.
6. Amend proposed law relative to participation in the framework and relative to
entering into a participation agreement.
7. Amend proposed law relative to what shall be established in a participation
agreement.
8. Provide that a participation agreement shall not waive or reduce any duty
imposed by proposed law except as expressly authorized.
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9. Add what may be included in the registry that may be maintained by the
department or their designee.
10. Provide that compliance with proposed law shall be a condition for inclusion in
certain actions by the department. Further provide relative to cooperation with
certain department actions for certain benchmark categories.
11. Amend what a research entity shall do relative to acknowledgment of receipt, a
sponsor feasibility response or engagement determination, concurrent review,
and escalation to designated research-entity and department personnel.
12. Amend proposed law relative to the issuance of any written determination of
nonreliance.
13. Add relative to lawful local review that proposed law shall not be construed to
eliminate.
14. Provide that nothing in proposed law shall be construed to require a research
entity to accept or activate a covered clinical project in certain circumstances.
15. Remove "admitted" from admitted covered clinical projects.
16. Amend relative to the compiled information in the annual report.
17. Amend the annual report requirements.
18. Amend relative to what may happen when a research entity demonstrates
repeated failure to meet applicable benchmark expectations.
19. Add proposed law regarding benchmark categories for certain circumstances.
20. Provide that nothing in proposed law shall be construed to require the department
or its designee to collect or maintain identifiable patient information except in
certain circumstances.
The House Floor Amendments to the engrossed bill:
1. Make technical changes.
2. Remove legislative intent.
3. Remove the definitions of "benchmark categories", "complete submission",
"participation agreement", "patient-access support", "receipt", and "repeated
failure".
4. Remove certain mandatory provisions required by proposed law.
5. Remove participation agreements from proposed law.
6. Remove activation standards for covered clinical projects from proposed law.
7. Remove benchmark categories from proposed law.
8. Remove required reporting to the legislature.
9. Amend the purpose of proposed law.
10. Add the definitions of "contract research organization", "designee", "patient-
identifying information" and "protected health information".
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11. Amend the definitions of "confidential business information", "covered clinical
project", "external institutional review board", "research entity", and "sponsor".
12. Amend the department or designee's role in administering the provisions of
proposed law.
13. Amend the requirements of participation in proposed law by certain research
entities.
14. Amend the requirements of coordination outlined in proposed law.
15. Change the process by which certain information is gathered and shared by the
department or its designee.
16. Amend requirements regarding external central institutional review boards.
17. Add provisions relative to local review.
18. Amend state coordination relative to implementing proposed law.
19. Amend the exemptions to proposed law.
20. Amend confidentiality requirements of proposed law.
21. Clarify compliance requirements to certain laws.
22. Amend the requirements of the public reporting of certain information.
23. Amend the rulemaking authority to implement in proposed law.
24. Amend appropriation provisions to implement proposed law.
25. Add provisions relative to the applicability of proposed law.
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