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State and Other Policies, including International Policies

Other policies regarding human subject protection can also apply to research with human subjects.

The Commonwealth of Virginia, for example, has specific laws relating to the protection of human subjects.  The Code of Virginia § 32.1-162.20 expresses the applicability of federal regulations to human research conducted in Virginia.  Generally, state law conforms to federal law, as specified in excerpt from the Code of Virginia below.

Code of Virginia § 32.1-162.20. Applicability of federal policies.  Human research which is subject to policies and regulations for the protection of human subjects promulgated by any agency of the federal government shall be exempt from the provisions of this chapter.  In lieu of promulgating regulations pursuant to the requirements of this chapter, an institution or agency may comply with this chapter by promulgating regulations under the provisions of the Administrative Process Act (§ 2.2-4000 et seq.) governing human research projects which incorporate, explicitly or by reference, federal policies and regulations for the protection of human subjects. However, in the case of projects which are not required, by reason of their nature, the source of their funding, or the lack thereof, to comply with federal policies and regulations, the institution or agency may enforce compliance by filing a petition for an injunction in the appropriate circuit court. This section shall not preclude any other enforcement action available to the institution or agency.(1979, c. 38, § 37.1-237; 1992, c. 603.)

State law also provides useful detail on the issue who can be a legally authorized representative of minors in research for the purposes of informed consent.  Under state law, minors are persons under the age of 18. See § 32.1-162.18. Informed consent of the Code of Virginia for details on this issue.

Local Policies

Some Virginia localities have detailed procedures for the review and approval of research conducted in their schools or offices.  For example, Richmond Public Schools study requirements dictate that an external study demonstrate "Alignment with the goals and objectives of the Richmond Public Schools, with the requirements of the Family Educational Rights and Privacy Act (FERPA), and with the policy for conducting research in the division..."  Researchers interested in performing research in Richmond Public Schools must be prepared for an extensive review process both by the University of Richmond IRB and the by the Richmond Public Schools Office of Research and Evaluation.  Richmond is not alone is requiring prior review of research proposals.  Chesterfield County Public Schools also have a process for reviewing external studies involving schools.  Researchers planning to conduct research with local government agencies or schools should determine in advance what the locality will require in terms of its review of research proposals and factor local review into their research schedule.

Other Policies

Federal and private grantors often have grant-specific policies that researchers must adhere to.  For example, NIH grants require the completion of training prepared by NIH.  It is the responsibility of the researcher to determine what grant-specific policies will affect their research.  Such policies should be referenced in the research proposal submitted to the University of Richmond IRB.

A frequent question asked of the IRB is when does the University of Richmond become "engaged" in research.  Research "engagement" requires IRB review.  However, the UR IRB has determined that simply forwarding a survey (without recruiting or consenting subjects or other actions) does not necessarily constitute research engagement by the University of Richmond.  OHRP guidance on research engagement is useful, but researchers with questions on research engagement should contact the IRB Chair with specific questions.

International Policies

Almost all studies abroad will require review by both a local IRB and the UR IRB.  SIT study abroad programs have human subject protections that are specific to the country in which the research is done.  SIT offices generally have an IRB which will provide concurrent review with the UR IRB.  SIT policies on human subjects' research can be downloaded HERE.  Local SIT policies may vary.  Students conducting research abroad through an SIT program should contact both the UR IRB Chair and the local SIT program manager for details on IRB review.

The International Compilation of Human Research Standards is a listing of over 1,000 laws, regulations, and guidelines on human subjects protections in 107 countries and from several international organizations. The Compilation is designed for use by IRBs, researchers, sponsors, and others. Many of the listings embed hyperlinks to the source document.

The 2014 edition is now available, and can be accessed through the OHRP website in both Word and PDF formats: http://www.hhs.gov/ohrp/international/index.html  Three new countries are spotlighted in the 2014 edition: Cameroon, Mozambique, and Zambia.  The 2014 edition also includes hundreds of updates from the 2013 edition.

As in the past, the new edition updates the human research standards based on information provided by in-country experts.

Community-engaged Research

While the University of Richmond does not have university-specific policies related to community-engaged research, Virginia Commonwealth University has extensive information about this type of research activity.  The guidelines in VCU's policy are a good starting point for researchers at the University of Richmond who are interested in community-engaged research.  However, the University of Richmond IRB is not bound by any of the policies on the VCU site.  The board will evaluate all community-engaged research on a case-by-case basis.