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Response to Questions of MIOCR Project Evaluation

RESPONSE TO QUESTIONS REGARDING
DEVELOPMENT OF A MIOCR PROJECT EVALUATION

The law structures the Mentally Ill Offender Crime Reduction Grant program (MIOCR) within a local framework that applies to all aspects of the project, including planning, implementation, and evaluation. (Penal Code Section 6045 et. seq.). This framework is explicit in the mandate that counties competing for a grant establish a Strategy Committee comprised of key local policy and decision-makers and requires that this committee develop a local plan upon which the demonstration grant proposal is based. The required minimum composition of the Strategy Committee (sheriff or director of corrections, superior court judge, law enforcement agency representative, mental health director, and mental health facility client, representatives from organizations that can provide, or have provided, treatment or stability, including income, housing, and caretaking, for persons with mental illnesses) is designed to ensure that community needs and community norms are reflected in the local plan.

The Board of Corrections (BOC) is committed to upholding this local structure in administering the MIOCR. Toward this end, the Request for Proposals (RFP) for demonstration grants stipulates that counties must determine how they will approach their proposed project. The BOC does not purport to know the community needs or norms that will impact the selection of an appropriate project plan or evaluation design for a particular county.

In response to questions and issues raised about the BOC’s preferred evaluation design (random selection of subjects from the county's targeted population, or eligible pool), we have created this summary to clarify our understanding of, and approach to, the evaluation component of this grant program.

The MIOCR legislation did not anticipate that the MIOCR demonstration projects would involve a denial of treatment to anyone, but rather would compare the effectiveness (and cost-effectiveness) of two configurations of accepted treatments. The purpose of the county’s program evaluation strategy will be to determine whether the modified or enhanced treatment produces better results than the treatment currently in place.

Several governmental, educational, and professional organizations, including the National Institutes of Health, the University of California, and the American Psychological Association, have adopted principles and guidelines regarding the use of human subjects in research studies. The most authoritative source of information for guidance on that issue is Title 45 of the Code of Federal Regulations, Section 46 (45 CFR § 46), "Protection of Human Subjects." Generally, there is agreement among all sources that research involving people as subjects should 1) respect persons, 2) maximize benefits and minimize possible harm to participants, and 3) result in benefits that can be fairly distributed (Belmont Report, 1979).

The question is, how should these principles and regulations affect the selection of an evaluation approach to an MIOCR demonstration grant proposal? First, guidelines for identifying and resolving human subjects issues can be readily accessed and used to review any proposed project and its evaluation plan. Second, familiarity with county standards, procedures, regulations and guidelines can alert a Strategy Committee to potential issues specific to their locale. The BOC encourages each bidder to a) design their evaluation according to the highest ethical standards; and b) comply fully with the procedures and regulations that the county determines applies specifically to them.

The BOC anticipates that MIOCR demonstration projects will not contain the types of procedures that trigger human subjects concerns (Title 45 CFR § 45) because they will:

  • involve program evaluation of demonstration projects;
  • compare the effectiveness of an existing program/treatment with the effectiveness of a modified program/treatment;
  • represent existing, recognized approaches to the issue at hand;
  • not include interventions that are experimental; and
  • not put human subjects in harms way.

In the final analysis, however, counties must determine, at the local level, what regulations, guidelines, community standards and current practices regarding the use of human subjects may apply to the demonstration project being proposed – and comply with whatever those standards are. If the proposed project involves an experimental intervention/treatment or presents a risk to participants, counties should take special care to review pertinent regulations to protect the rights of human subjects.

Additional information about human subjects issues can be found in: