By the Division of Professional Licensure

December 2, 2004

Supercedes: May 3, 2001

The Massachusetts Board of Registration of Chiropractors (Board) has today voted to implement the following Policy Guideline. This Guideline is intended as a recommended protocol for the profession to follow. This Guideline does not carry with it the force or effect of law as would Massachusetts General Law or a Board rule or regulation. However, the Board utilizes this and other guidelines as an internal management tool in formulating decisions that relate to issues of chiropractic practice.

  1. A chiropractic procedure, service, or treatment shall be considered an "investigational intervention" if:
    1. The procedure, service, or treatment is based on existing and generally accepted chiropractic theory or methodology;
    2. The procedure, service, or treatment is not generally taught at any chiropractic college which is accredited by the Council on Chiropractic Education (CCE) or by a university accredited by the U.S. Department of Education in either the undergraduate, predoctoral, or postdoctoral programs;
    3. There is presently insufficient evidence to permit a determination about the appropriateness and/or effectiveness of the use of the procedure, service or treatment because it has not yet been subject to sufficient testing or clinical trials; and
    4. The procedure, service, or treatment warrants further clinical study because it may have sufficient potential clinical benefit for one or more specified patient populations.
  2. A chiropractor shall not perform or provide, or offer to perform or provide, any investigational intervention unless:
    1. Each patient upon whom the investigational intervention is performed has:
      1. been informed that the investigational intervention to be performed or provided is not considered part of the established curriculum of any chiropractic college accredited by the CCE;
      2. been informed that the procedure, service, or treatment is considered an investigational intervention by the Board;
      3. been informed of all of the material risks and benefits of undergoing the proposed investigational intervention; and
      4. consented, in writing, to the performance of the investigational intervention; and
    2. The chiropractor has otherwise complied with all applicable state and federal laws and regulations governing the use of human subjects in health care research activities.
  3. A chiropractor who performs, provides, or offers to perform or provide any procedure, service, or treatment which is not properly within the scope of chiropractic, as defined in M.G.L. c. 112, s. 89, or which does not qualify as an investigational intervention because it does not meet all of the above requirements, may be in violation of 233 CMR 4.06(e), 233 CMR 4.06(p) and 233 CMR 4.10(4), and may be subject to possible disciplinary action by the Board pursuant to 233 CMR 4.06.