Overview

If an organization conducts research, then it should adhere to research guidelines and practices, as well as ethics, when clients are involved in research activities.

Accreditation Requirement(s)

• All organizations involved in human research activities should follow standard research protocols, guidelines, and ethics.

Implementation Tips

Some Implementation Tips provided, in part, by Robert Johnson at: www.accreditationnow.com.

• This standard does not apply to the outcomes management system in place at the organization, which is usually based on data collection and client/family/stakeholder satisfaction. The research standard is only applicable if clients are part of a research study that is part of an experimental design. For instance, to determine the efficacy of a particular medication, some clients could receive the medication; others (part of the control group) may not receive the medication.
  
  
• It is extremely important for organizations to have research policy and procedures in place that protect the rights of persons served and, in addition, protect the organization and its staff members from liability. Over the past two decades, national and international regulations concerning human research have been strengthened considerably.
  
  
• Behavioral healthcare organizations have traditionally been somewhat less stringent with regard to research regulations, as research practices have tended to be less invasive when compared to medical human research. However, with the increased focus on rights of persons served, risk management, and corporate compliance, it is recommended that all behavioral health organizations have research policies that are comprehensive and fully cover all aspects of research conducted within the organization.
  
  
• The Federal Government adopted a very comprehensive human research policy in 1991 (45 CFR 46.116), and all government agencies, with the exception of the Food and Drug Administration, adhere to the policy. That policy can be accessed at www.hhs.gov/ohrp.
  
  
• In addition, the Privacy Rule (45 CFR 160 and 164), which was created by the Health Insurance Portability and Accountability Act of 1996 (HIPAA), has specific guidelines regarding consent and authorization to conduct research with persons served. That policy can be accessed at www.aspe.hhs.gov.
  
  
• The sample policy provided follows the general outline of 45 CFR 46.116, includes guidelines from 45 CFR 160 and 164, and also includes additional components that are specific to behavioral healthcare organizations.
  
  
• Informed consent is a key component of any research project and is not merely a form. It is a process in which information must be presented in a manner that allows persons to voluntarily decide if they want to participate in research. This is an education process that should be provided in "lay language" and constructed as a teaching tool in addition to providing legal protection.
  
  
• Informed consents for research should, at a minimum, contain the following:
  
  
  1. A statement of the study involved
     
  2. An explanation of the purposes of the research
     
  3. The expected duration of the subject's participation
     
  4. A description of the procedures to be followed
     
  5. Identification of any procedures that are experimental
     
  6. A description of any reasonably foreseeable risks or discomforts to the subject
     
  7. A description of any benefits to the subject or to others
     
  8. A statement that participation is voluntary and refusal to participate will involve no loss of rights
     
  9. An explanation of whom to contact for answers to pertinent questions about the research
     
     
• Informed consent for research requires a written form to document the process of informing the research participants of the required information and documenting their acceptance through a legal signature. However, all of the elements as described above do not have to be written on the document and may be presented orally. When an oral method is used, however, there must be a witness to the process.
  
  
• It is recommended that an Institutional Review Board (IRB), as described in the policy, exist in all behavioral healthcare organizations that conduct research or allow outside researchers to access their system to conduct research. Many organizations do not conduct internal research but allow outside entities, through affiliations with universities and colleges, to conduct research within their systems. It is equally important that the organization protect itself by requiring the IRB to review and approve research conducted by an outside entity, rather than assuming that the outside organization's research approval system is meeting the organization's legal needs.
  
  
• In certain circumstances it is permissible to pay research participants with the most common form of payment to assist persons to defray the cost of participation. Be extremely careful in this area. If a token payment is being made to assist in participation, ensure that it is applied equally and that the amount or method of payment is not coercive in any manner.
  
  
• The schedule and number of meetings of your IRB should be dependant on the amount of research being conducted in your organization. For example, if your organization does not conduct internal research, your committee may want to meet on an as needed basis. Determine what your needs are and add this element to your policy.