Chapter 08. Stem Cell Research Commission
Regulation .01 Purpose.LinkCopy Citation
This chapter describes the policies and procedures for State-funded stem cell research in Maryland.
Regulation .02 Program Objective.LinkCopy Citation
The basic objective of the Program is to provide financial assistance to qualified applicants to advance stem cell research and its therapeutic applications.
Regulation .03 Definitions.LinkCopy Citation
A.
In this chapter, the following terms have the meanings indicated.
B.
Terms Defined.
(1)
Applicant.
(a)
“Applicant” means a person located in Maryland who applies for the financial assistance provided pursuant to this chapter.
(b)
“Applicant” includes a public or private institution of higher education and a public or private corporation.
(2)
“Commission” means the Stem Cell Research Commission created under §10-431 of the Act.
(3)
“Corporation” means the Maryland Technology Development Corporation.
(4)
“Financial assistance” means a grant or loan from the Fund.
(5)
“Fund” means the Maryland Stem Cell Research Fund created under §10-434 of the Act.
(6)
“Grantee” means an applicant who has been awarded financial assistance, whether in the form of a grant or a loan.
(7)
“Human stem cell” means a stem cell derived from human tissue.
(8)
“Institutional Review Board (IRB)” has the meaning stated in 45 CFR §46.102.
(9)
“Program” means the program for State-funded stem cell research authorized by the Act.
(10)
“Stem cell research” means basic, translational, or clinical research that:
(a)
Is conducted in Maryland; and
(b)
Uses human stem cells derived from:
(i)
Tissue obtained after the birth of a human being; or
(ii)
Unused IVF material.
(11)
“State-funded stem cell research” means, in addition to the meaning stated in §10-429(i) of the Act, stem cell research that receives financial assistance.
(12)
“Stem cell” has the meaning stated in §10-429(j) of the Act.
(13)
“Unused IVF material” means the unused material described in §§10-438 and 10-439 of the Act.
Regulation .04 Eligible Applicants.LinkCopy Citation
A.
To be eligible for financial assistance, an applicant shall certify to the Commission and the Corporation that the applicant:
(1)
Will use the financial assistance solely in accordance with the requirements of the Program;
(2)
Will conduct the stem cell research for which financial assistance is requested in Maryland;
(3)
Has the legal capacity and all necessary legal authorization to incur the obligations related to the financial assistance; and
(4)
Will comply with all applicable State and federal laws, including the requirement that stem cell research receiving financial assistance be conducted only after the approval of an Institutional Review Board.
B.
This chapter does not preclude an applicant from conducting otherwise lawful research that is ineligible for financial assistance.
Regulation .05 Financial Assistance Criteria.LinkCopy Citation
The Commission shall consider the following factors in determining whether to award financial assistance to an applicant:
A.
The scientific merit of the stem cell research described in the application, taking into account the evaluation, rankings, and recommendations of an independent scientific peer review committee pursuant to §10-435 of the Act;
B.
The ethical implications of the stem cell research described in the application;
C.
The relationship between the stem cell research described in the application and the etiology, prevention, diagnosis, or treatment of a disease;
D.
The potential impact of the stem cell research described in the application on technological innovation and the advancement of biotechnology in Maryland's academic, business, and nonprofit sectors; and
E.
The relationship between the stem cell research described in the application and other research and sources of research funding.
Regulation .06 Financial Assistance Terms.LinkCopy Citation
A.
The financial assistance may be used for the purposes stated in the application, including the cost of facilities, capital leases, and capital equipment at a place where stem cell research is conducted.
B.
The amount of indirect, unspecified, or overhead costs included in an application may not exceed the percentage of the total cost of the research identified by the Commission in a request for applications.
Regulation .07 Application.LinkCopy Citation
A.
An application for financial assistance shall be in the form and with the content identified by the Commission in a request for applications.
B.
An application shall categorize the stem cell research described in the application by reference to the categories of research identified by the Commission in a request for applications.
C.
An application shall state the intended duration of the State-funded stem cell research.
Regulation .08 Agreement Following Award of Financial Assistance.LinkCopy Citation
A.
A grantee shall execute a grant agreement or loan agreement with the Corporation, in a form prescribed by the Corporation, that:
(1)
Makes disbursement of financial assistance contingent on evidence of IRB approval of the State-funded stem cell research described in the application;
(2)
Acknowledges, as appropriate, that an award of financial assistance beyond the current fiscal year may be contingent on future appropriations to the Fund;
(3)
Establishes the scope of the State's ownership or other financial interest in the commercialization and other benefits of the results, products, inventions, and discoveries of the State-funded stem cell research described in the application;
(4)
Discusses, as appropriate, other matters related to intellectual property; and
(5)
Contains other assurances, as determined by the Corporation, related to the grantee's compliance with applicable law and the terms of the financial assistance.
B.
A grantee shall, upon request, provide information to the Commission and Corporation reasonably related to the oversight of an award of financial assistance and the progress and results of the State-funded stem cell research.
Regulation .09 Nondiscrimination.LinkCopy Citation
An applicant shall comply with all applicable federal, State, and local laws regarding discrimination and equal opportunity in employment.
Regulation .10 Drug-Free and Alcohol-Free Workplace.LinkCopy Citation
An applicant shall comply, and remain in compliance, with the State's policy concerning drug-free and alcohol-free workplaces, as set forth in Executive Order 01.01.1989.18, and shall make a good-faith effort to eliminate illegal drug use and alcohol and drug abuse from places at which work is performed that has been financed in whole or in part with financial assistance.
Regulation .11 Waiver.LinkCopy Citation
The Corporation, in consultation with the Commission, may waive or vary particular provisions of these regulations to the extent that the waiver is not inconsistent with the Act if:
A.
Conformance to the requirements of any federal, State, or local programs in connection with State-funded stem cell research necessitates waiver or variance of a regulation; or
B.
In the determination of the Corporation, the application of a regulation in a specific case or in an emergency situation would be inequitable or contrary to the purposes of the Act.
Chapter annotations
Authority: Economic Development Article, §10-409 and 10-441, Annotated Code of Maryland
History: Effective date: August 27, 2007 (34:17 Md. R. 1510)
History: Regulations .01—.11 under COMAR 14.04.01, Stem Cell Research Commission recodified to be COMAR 14.04.08, Stem Cell Research Commission effective December 30, 2019 (46:26 Md. R. 1167)
History: Regulation .03B amended effective February 22, 2021 (48:4 Md. R. 178)
History: Regulation .05A amended effective February 22, 2021 (48:4 Md. R. 178)