Home > Articles > The University of Arizona's Investigation Report of Dr Gary Schwartz, psychologist

By Kristina C. Borror, Ph.D., 6th May 2007

Research Project: Mediumistic Investigation of Identity Survival and other research projects involving mediums
Principal Investigator: Dr Gary Schwartz, Ph.D.

Dear Mrs. Keen:

We have completed our evaluation of human subject protections in the research referenced above.

Based upon our evaluation, we made the following determinations relative to protections for human subjects in this research at University of Arizona (UA):

(1) Department of Health and Human Services (HHS) regulations at 45 CFR 46.103(b) and 46.109(a), require that the institutional review board (IRB) review and approve all non-exempt human subject research covered by an assurance. We determined that certain human subjects research, conducted by Dr Schwartz and published in the Journal of the Society for Psychical Research, was conducted without IRB review and approval. UA also confirmed and we found that the human subjects research described in the article entitled “Evidence of Anomalous Information Retrieval between Two Research Mediums: Telepathy, Network Memory Resonance, and Continuance of Consciousness” [Schwartz, G.E.R. and Russek, L.G.S. (2001) JSPR 65.4, 257-275] was conducted without IRB review and approval in contravention of HHS regulations at 45 CFR 46.103(b) and 46.109(a).

(2) HHS regulations at 45 CFR 46.117(a) require that informed consent be documented by the use of a written consent form approved by the IRB and that is signed by the subject, or the subject's legally authorized representative, unless the IRB waives this requirement. We determined that informed consent was not documented by a written consent form signed by the subjects for research conducted by Dr Schwartz and published in the Journal of the Society for Psychical Research and the UA IRB did not approve a waiver of the requirement to document informed consent for this research.

Corrective Actions: UA stated that the research was conducted prior to the time that Dr Schwartz was counseled that such studies require IRB approval. UA also stated that Dr Schwartz currently submits all human subjects research he conducts to the UA IRB for review and approval, and that he completed human subject protections training on September 18, 2006.

(3) HHS regulations at 45 CFR 46.111(a) require that in order to approve research covered by the HHS regulations the IRB must determine that, when appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data. HHS regulations at 45 CFR 46.103(b)(4) require that institutions follow written procedures for ensuring prompt reporting to the IRB of proposed changes in a research activity and for ensuring that such changes in approved research, during the period for which IRB approval has already been given, may not be initiated without IRB review and approval except when necessary to eliminate apparent immediate hazards to the subjects.

We determined that the principal investigator for the above-referenced research initiated changes to the research without IRB review and approval, and as a result, failed to protect the privacy of subjects and to maintain the confidentiality of data.

Corrective Actions: We note that UA recommended that,

(a) The principal investigator remove the names of subjects who have not approved the use of their names from his websites;

(b) The principal investigator no longer disclose the names of research subjects without their prior written consent;

UA also noted that the following corrective actions have been taken: the principal investigator currently submits all human subjects research he conducts to the UA institutional review board (IRB) for review and approval; the principal investigator completed human subject protections training on September 18, 2006; and the Vice President for Research, Graduate Studies, and Economic Development at UA will issue a letter of reprimand to the principal investigator, reiterating the continuing requirement to protect the privacy of subjects and the confidentiality of data, and that the PI must refrain from disclosing the names of any research subject publicly without the subject’s written consent. Copies of the letter will be sent to the principal investigator’s Department Head and Dean.

(4) We expressed concern that the principal investigator failed to provide a subject enrolled in the above-referenced research with copies of the readings in which the subject participated, as was described in the informed consent document. We noted that the informed consent document signed by the subject states:

“The content of my interviews and readings will only be available to the investigators of the VERITAS Research Program of the Human Energy Systems Laboratory in the Department of Psychology at the University of Arizona. In addition, I or the sitter may request a copy of the reading.”

Corrective Action: UA stated that the subject had participated in screening readings, not research readings and UA did not anticipate subjects requesting copies of their screening readings. UA has indicated that copies of the screening readings will also now be made available to subjects requesting such copies. We are aware that the subject has received a transcript of the screening readings in which she participated.

(5) HHS regulations at 45 CFR 46.111(b) require that in order to approve research, the IRB shall determine that when some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.

UA stated that sitters were not to be enrolled unless at least one year had passed since the death of the sitters’ loved one in order to safeguard the potential sitter from undue influence and in recognition of the potential sitter’s vulnerability after the recent passing of a loved one. UA also noted that the research protocol did not include this information and that this information was not presented to the IRB. We also note that one subject was contacted by the principal investigator to recruit for research at least as early as five months after the death of a loved one, and you were contacted to recruit for research at least as early as three months after the death of a loved one, in contravention of the policy stated above.

We determined that the protocol did not include additional safeguards for subjects who have recently lost a loved one, who may be vulnerable to coercion or undue influence.

Corrective Action: UA stated that in the event that future studies occur in which subjects have experienced a loss, it will be required that the principal investigator address the vulnerability of the subjects and that vulnerability will be considered by the IRB in its review of the research. This action adequately addresses our determination.

(6) It was also alleged that the informed consent document failed to provide a complete explanation of the purposes of the research, as required by HHS regulations at 45 CFR 46.116(a)(1). In specific, it was alleged that one of the purposes of the research was fund-raising for Dr Schwartz but this was not disclosed to subjects. UA stated that the UA investigative panel found no evidence of funding irregularities or of Dr Schwartz’s solicitation of funds from research subjects. We therefore determined that the allegation is unproven.

We have determined that the corrective actions taken by UA are appropriate under the institution's Assurance and anticipate no further OHRP involvement in this matter.

We appreciate your concern about the protection of human research subjects. Please do not hesitate to contact me should you have any questions.

Sincerely,

Kristina C. Borror, Ph.D.
Director
Division of Compliance Oversight