R495-820-6. Research Involving Placebos

  (1) When the use of placebos is proposed, the Department imposes the following restrictions to protect participants from studies that would withhold active treatment:

  (a) The DHS IRB shall not approve placebo studies that target individuals having:

  (i) Any pending criminal case;

  (ii) Who are incarcerated or in detention; or

  (iii) Who have a pending competency evaluation or commitment procedure.

  (iv) No minor or vulnerable adult under the guardianship or custody of any division of the Department may be recruited, enrolled, or participate in any research study that involves the use of a placebo.

  (v) A serious medical or mental illness.

  (b) If an individual has entered a study prior to involvement with civil or criminal legal proceedings, and subsequently becomes involved in any such action, the researcher shall report the event to:

  (i) The DHS IRB;

  (ii) The agency or entity that has assumed guardianship or responsibility for that person, if any.

  (ii) If a minor or vulnerable adult has entered a study involving placebos prior to entrance into state guardianship or legal custody, then a referral will be made to the division gatekeeper or entity that has guardianship or custody, to determine whether the minor's or vulnerable adult's continued participation in the study is appropriate. That determination shall consider:

  (A) The opinions of medical or psychological experts who have provided care for the minor or vulnerable adult prior to and during the study;

  (B) If the placebo research involves a minor in the custody of the Division of Child and Family Services, the minor's Guardian ad Litem, if one has been appointed, shall be notified and that notification shall be documented in Department records and sent to the DHS IRB.

  (C) If the minor's parent(s), prior to the minor's entrance into state custody or guardianship, had agreed to and signed an informed consent form prior to the minor's participation in the study.

  (D) If the placebo research involves a vulnerable adult who is a ward of the Office of Public Guardian, the Office of Public Guardian shall be notified and that notification shall be documented in Department records and sent to the DHS IRB.

  (c) Placebos may only be used in studies where no proven or known effective standard of care, prophylactic, diagnostic, or therapeutic method exists. If a proven or known effective standard of care or treatment exists, whether or not the standard of care has been subjected to empirical testing, that treatment shall not be withheld unless the participant is also receiving another known effective standard of care or treatment during the duration of his/her study participation. The IRB may consider for review placebo studies as long as participants continue to receive a known pharmaceutical and/or psychotherapeutic standard of care.

  (d) Recruitment for the placebo study shall not be limited exclusively to subjects who are receiving services that are either partially or fully funded by monies allocated through the Department.

  (e) If the minor or adult has a current diagnosis of serious mental illness at the beginning of a proposed study, the individual will be excluded from participation in placebo studies, unless the participant is also receiving, and continues to receive during the study participation, another active known effective standard of pharmaceutical or non-pharmaceutical care or treatment intervention.

  (f) Frequent and close clinical monitoring, as dictated by the medical need of each client, is required in order to assure the ongoing safety and well-being of each human subject. Monitoring shall be documented by the researchers and medical personnel in each client's clinical record.

  (g) Any individual with active homicidal or suicidal ideations, or who poses a foreseeable threat to themselves or others, is prohibited from participation in any study that involves the use of a placebo.