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Human Research Subject Protections at University of Arizona Research Project: Mediumistic Investigation of Identity Survival and other research projects involving mediums Principal Investigator: Gary Schwartz, Ph.D. The Office for Human Research Protections (OHRP) has completed its evaluation of human subject protections in the research referenced above. Based upon its 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 found 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 found 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 found 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 V one subject was 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. The following allegations were also made: (6) Failure 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 is 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. (7) You also alleged that Dr. Schwartz violated your privacy and confidentiality as a research subject by mentioning you on several websites.  We note that the mention of you on the websites is in reference to your work as a researcher, not as a subject, or merely references the fact that you took part in his research, which was already known from his published books and your public statements.   Therefore, the HHS regulations at 45 CFR part 46 would not apply to these activities. We have determined that the corrective actions taken by the 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. The Survival of Consciousness Research Exploration This initiative is inspired by Dr. Mack’s interest in the survival of consciousness and based on anomolous experiences since his passing.  It is being carried on by Maria Talcott, with Laurie Campbell as primary research medium. Joe DuBois, DonWatson, MD and  Dr. Berney Williams act as our research advisors. Based on two months of blind data gathered after Dr. John Mack’s passing, and supported by cross correspondence that was documented immediately after Dr. Mack’s passing; we hypothesize that Dr. Mack and colleagues on the otherside, like the late Montague Keen, a prominent British parapsychologist and Dr. Elisabeth Targ are making contact. We have created a platform to allow this team of discarnates the ability for regular contact. Dr. Mack was most interested in how extraordinary experiences transform human consciousness; and how an individual integrates these anomalies in their lives in order to have a more happy and complete existence as a human being.   Our model uses mediums to communicate with the deceased (referred to as “discarnates” or “spirits”). The information received during a “reading” is taped, transcribed and evaluated.   The protocol for these readings requires a medium working alongside a person (a “sitter”) who was emotionally close to the discarnate.  For our specific project, Laurie Campbell, will be the primary medium. She will work with Maria Talcott a founding member of the John E. Mack Institute, serving as sitter, to contact discarnate scientists.  After Ms. Campbell obtains exploratory information, a separate set of mediums will be used for “confirmatory readings”. These confirmatory readings are designed to gather data that will corroborate Ms. Campbell’s information.  These other mediums have no access to information obtained by Laurie, or contact with Laurie regarding these readings. Information received will not only be used to help determine the validity of this area of consciousness research, but direction, wisdom and guidance will be sought from the eminent discarnates to assist us with advancing this research. This exploratory research phase is being conducted over the phone with Laurie Campbell in Irvine CA, and Maria Talcott in Prescott, Arizona.  All readings will be taped recorded, transcribed, and assessed for guidance and direction for what our future work will be with this research initiative. About the researchers Laurie Campbell is the former Director of the research mediums at the University of Arizona, and has been the subject of numerous research experiments at Universities. She has been featured on HBO Life Afterlife with John Edward, George Anderson and Suzane Northrup, A & E Documentary Beyond Death, Discovery Channel Canada and CBS Women to Women.  She has a new show on the Discovery channel called, Sensing Murder which will air this fall. Maria Talcott is project coordinator of the survival of consciousness exploration.  Ms. Talcott first met John Mack in 1994 during her participation in a study of people who had experienced anomalies. This contact with Dr. Mack later led to her position as Operations Manager for PEER (Dr Mack’s Program for Extraordinary Experience Research) in the Spring of 1998. At PEER she participated in the design of conferences and served as publicity and media director for Dr Mack when his book Passport to the Cosmos was released in 1999.  She is one of the core group members who initiated the founding of the John E. Mack Institute with John Mack. Her background is in business management, real estate and the environmental field; she has a business degree from Lesley College. About the project advisors Joe DuBois is a trained aerospace engineer, and research director of this initiative.  He is skilled at developing scientific protocol and has developed a number of programs using scientific methodology.  He is also married to Allison DuBois, the real life inspiration of NBC’s hit show MEDIUM,and author of the New York Times best-selling books, Don’tKiss The Good-bye and We are Their Heaven.  Joe is assistingour team at incorporating creative and alternative measuresof protocol from his years of observation of the many aspects of genuine mediumship. Don Watson, MD www.enformy.com  Dr. Berney Williams is a colleague and collaborator with DonWatson in various explorations of consciousness. In his role as a Professor with the Holos University Graduate Seminary, he has served as an advisor for more than forty doctoral research projects on Spiritual Healing and Energy Medicine. Trained as an historian of science, Berney's special interest is cross-cultural and cross-species communication. For example, one of the Holos doctoral research projects is a study of distant healing with a population of traumatized tropical birds, which achieved striking results.  Dr. Williams is also President of The Center for Environmental Energy Medicine/Studies (CEEMS).  CEEMS is now the corporate sponsor of The Council Grove Conference, one of the longest continuously running annual conferences on consciousness and  healing research. The Council Grove Conference will convene its 40th anniversary meeting in the Spring of 2008.   IN LOVING MEMORY OF DR. JOHN E. MACK   “There is perhaps no more important question to human beings than whether consciousness survives bodily death. Above all, we want to know if our individual lives continue in some form, and whether we may ever again be in contact with those we have loved.” Dr. Mack wrote these words only weeks before his own passing on September 27, 2004.

 
 

 

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