A. Each institution or agency which conducts or which proposes to conduct orauthorize human research shall establish a human research review committee.The committee shall be composed of representatives of varied backgrounds toensure the competent, complete, and professional review of human researchactivities conducted or proposed to be conducted or authorized by theinstitution or agency. No member of the committee shall be directly involvedin the proposed human research or have administrative approval authority overthe proposed human research except in connection with his responsibilities asa member of the committee.
B. No human research shall be conducted or authorized by such institution oragency unless the committee has reviewed and approved the proposed humanresearch project giving consideration to (i) the adequacy of the descriptionof the potential benefits and risks involved and the adequacy of themethodology of the research; (ii) if the research is nontherapeutic, whetherit presents more than a minimal risk to the human subjects; (iii) whether therights and welfare of the human subjects involved are adequately protected;(iv) whether the risks to the human subjects are outweighed by the potentialbenefits to them; (v) whether the risks to subjects are minimized by usingprocedures that are consistent with sound research design and that do notunnecessarily expose subjects to risk and, whenever appropriate, by usingprocedures already being performed on the subjects for diagnostic ortreatment purposes; (vi) when some or all of the subjects are likely to beincapable of making an informed decision regarding consent or are otherwisevulnerable to coercion or undue influence, such as children, prisoners,pregnant women, mentally disabled persons, or economically or educationallydisadvantaged persons, whether additional safeguards have been included inthe study to protect the rights and welfare of these subjects; (vii) whetherthe informed consent is to be obtained by methods that are adequate andappropriate and whether the written consent form is adequate and appropriatein both content and language for the particular research; (viii) whether thepersons proposing to conduct the particular human research are appropriatelycompetent and qualified; and (ix) whether the criteria for selection ofsubjects are equitable. The committee shall require periodic reports fromeach existing human research project to ensure that the project is beingcarried out in conformity with the proposal as approved.
C. The regulations of an institution or agency may authorize the committee toconduct an expedited review of a human research project which involves nomore than minimal risk to the subjects if (i) another institution's oragency's human research review committee has reviewed and approved theproject or (ii) the review involves only minor changes in previously approvedresearch and the changes occur during the approved project period.
D. Every person engaged in the conduct of human research or proposing toconduct human research shall affiliate himself with an institution or agencyhaving a research review committee, and the human research which he conductsor proposes to conduct shall be subject to review and approval by suchcommittee in the manner set forth in this section.
E. Each human research review committee of a state institution or agencyshall ensure that an overview of approved human research projects and theresults of such projects are made public on the institution's or agency'swebsite unless otherwise exempt from disclosure under the Virginia Freedom ofInformation Act (§ 2.2-3700 et seq.).
(1979, c. 38, § 37.1-236; 1986, c. 274; 1992, c. 603; 2002, c. 754; 2007, c.413.)
A. Each institution or agency which conducts or which proposes to conduct orauthorize human research shall establish a human research review committee.The committee shall be composed of representatives of varied backgrounds toensure the competent, complete, and professional review of human researchactivities conducted or proposed to be conducted or authorized by theinstitution or agency. No member of the committee shall be directly involvedin the proposed human research or have administrative approval authority overthe proposed human research except in connection with his responsibilities asa member of the committee.
B. No human research shall be conducted or authorized by such institution oragency unless the committee has reviewed and approved the proposed humanresearch project giving consideration to (i) the adequacy of the descriptionof the potential benefits and risks involved and the adequacy of themethodology of the research; (ii) if the research is nontherapeutic, whetherit presents more than a minimal risk to the human subjects; (iii) whether therights and welfare of the human subjects involved are adequately protected;(iv) whether the risks to the human subjects are outweighed by the potentialbenefits to them; (v) whether the risks to subjects are minimized by usingprocedures that are consistent with sound research design and that do notunnecessarily expose subjects to risk and, whenever appropriate, by usingprocedures already being performed on the subjects for diagnostic ortreatment purposes; (vi) when some or all of the subjects are likely to beincapable of making an informed decision regarding consent or are otherwisevulnerable to coercion or undue influence, such as children, prisoners,pregnant women, mentally disabled persons, or economically or educationallydisadvantaged persons, whether additional safeguards have been included inthe study to protect the rights and welfare of these subjects; (vii) whetherthe informed consent is to be obtained by methods that are adequate andappropriate and whether the written consent form is adequate and appropriatein both content and language for the particular research; (viii) whether thepersons proposing to conduct the particular human research are appropriatelycompetent and qualified; and (ix) whether the criteria for selection ofsubjects are equitable. The committee shall require periodic reports fromeach existing human research project to ensure that the project is beingcarried out in conformity with the proposal as approved.
C. The regulations of an institution or agency may authorize the committee toconduct an expedited review of a human research project which involves nomore than minimal risk to the subjects if (i) another institution's oragency's human research review committee has reviewed and approved theproject or (ii) the review involves only minor changes in previously approvedresearch and the changes occur during the approved project period.
D. Every person engaged in the conduct of human research or proposing toconduct human research shall affiliate himself with an institution or agencyhaving a research review committee, and the human research which he conductsor proposes to conduct shall be subject to review and approval by suchcommittee in the manner set forth in this section.
E. Each human research review committee of a state institution or agencyshall ensure that an overview of approved human research projects and theresults of such projects are made public on the institution's or agency'swebsite unless otherwise exempt from disclosure under the Virginia Freedom ofInformation Act (§ 2.2-3700 et seq.).
(1979, c. 38, § 37.1-236; 1986, c. 274; 1992, c. 603; 2002, c. 754; 2007, c.413.)
A. Each institution or agency which conducts or which proposes to conduct orauthorize human research shall establish a human research review committee.The committee shall be composed of representatives of varied backgrounds toensure the competent, complete, and professional review of human researchactivities conducted or proposed to be conducted or authorized by theinstitution or agency. No member of the committee shall be directly involvedin the proposed human research or have administrative approval authority overthe proposed human research except in connection with his responsibilities asa member of the committee.
B. No human research shall be conducted or authorized by such institution oragency unless the committee has reviewed and approved the proposed humanresearch project giving consideration to (i) the adequacy of the descriptionof the potential benefits and risks involved and the adequacy of themethodology of the research; (ii) if the research is nontherapeutic, whetherit presents more than a minimal risk to the human subjects; (iii) whether therights and welfare of the human subjects involved are adequately protected;(iv) whether the risks to the human subjects are outweighed by the potentialbenefits to them; (v) whether the risks to subjects are minimized by usingprocedures that are consistent with sound research design and that do notunnecessarily expose subjects to risk and, whenever appropriate, by usingprocedures already being performed on the subjects for diagnostic ortreatment purposes; (vi) when some or all of the subjects are likely to beincapable of making an informed decision regarding consent or are otherwisevulnerable to coercion or undue influence, such as children, prisoners,pregnant women, mentally disabled persons, or economically or educationallydisadvantaged persons, whether additional safeguards have been included inthe study to protect the rights and welfare of these subjects; (vii) whetherthe informed consent is to be obtained by methods that are adequate andappropriate and whether the written consent form is adequate and appropriatein both content and language for the particular research; (viii) whether thepersons proposing to conduct the particular human research are appropriatelycompetent and qualified; and (ix) whether the criteria for selection ofsubjects are equitable. The committee shall require periodic reports fromeach existing human research project to ensure that the project is beingcarried out in conformity with the proposal as approved.
C. The regulations of an institution or agency may authorize the committee toconduct an expedited review of a human research project which involves nomore than minimal risk to the subjects if (i) another institution's oragency's human research review committee has reviewed and approved theproject or (ii) the review involves only minor changes in previously approvedresearch and the changes occur during the approved project period.
D. Every person engaged in the conduct of human research or proposing toconduct human research shall affiliate himself with an institution or agencyhaving a research review committee, and the human research which he conductsor proposes to conduct shall be subject to review and approval by suchcommittee in the manner set forth in this section.
E. Each human research review committee of a state institution or agencyshall ensure that an overview of approved human research projects and theresults of such projects are made public on the institution's or agency'swebsite unless otherwise exempt from disclosure under the Virginia Freedom ofInformation Act (§ 2.2-3700 et seq.).
(1979, c. 38, § 37.1-236; 1986, c. 274; 1992, c. 603; 2002, c. 754; 2007, c.413.)
