437 F. Supp. 2d 985 (E.D. Mo. 2006)
Washington University, a Missouri not-for-profit corporation with its principal place of business in St. Louis, filed this declaratory judgment action in the United States District Court for the Eastern District of Missouri, Eastern Division, under docket number 4:03CV1065SNL against Dr. William J. Catalona and eight research participants who intervened as defendants.1 Dr. Catalona, a urologic surgeon and researcher, was employed by Washington University from July 1, 1976, until February 23, 2003.2 He served as Chief of the Urology Division from 1984 to 1998 and helped establish the GU Biorepository for prostate cancer research materials.3
The GU Biorepository is housed in buildings owned by Washington University and administered by its employees.4 The majority of funding is supplied by the university and grants administered through it.5 The repository contains approximately 3500 prostate tissue samples in the GU Biorepository taken from patients of Dr. Catalona and other WU physicians within the Urologic Surgery Division, approximately 100,000 serum samples in the GU Biorepository, and approximately 4400 men contributed DNA samples to the GU Biorepository, with more than 30,000 research participants enrolled in prostate cancer research studies.
Research participants signed informed consent forms bearing the Washington University Medical Center logo.6 The forms used the word "donate" to characterize the delivery of the sample from the RP to the WU physician or another WU medical technician and stated that by participating, the RP "make[s] a free and generous gift of your [blood, tissue and/or DNA] to research that may benefit others."7 They stated that participation was voluntary and advised that participants could discontinue at any time.8 None of the forms addressed withdrawal of samples from the repository or transfer to another institution.9 Participants also received a Genetic Research Brochure stating that tissue would be identified and destroyed upon request to stop its use for research.10
In early 2003 Dr. Catalona left Washington University for a position at Northwestern University.11 While still a Washington University employee and after transferring his role as principal investigator on active protocols to another faculty member, he sent a February 18, 2003 letter to approximately 60,000 research participants.12 The letter informed them of his departure and enclosed a Medical Consent & Authorization form requesting release of all samples to him at Northwestern.13 Approximately 6000 recipients signed and returned the forms.14 The forms had not been approved in advance by Washington University administrators or the Human Studies Committee.15
Washington University filed suit seeking to establish its ownership of the biological materials.16 After pending summary judgment motions, the court held a permanent injunction hearing on April 9 through 11, 2005, in which all interested parties, including research participants who "donated" the subject biological materials, could coherently present their argument to the Court.17 The parties subsequently filed post-hearing briefs.18 Washington University's Intellectual Property Policy states that tangible research property belongs to the university if significant university resources were used or if obtained pursuant to externally funded research administered by the university.19 Multiple Material Transfer Agreements signed by Dr. Catalona acknowledged Washington University as the owner of the samples.20
The repository operates under federal regulations at 45 C.F.R. Part 46 requiring institutional review board oversight through Washington University's Human Studies Committee.21 No regulatory agency, including the OHRP, has taken any action against WU regarding the informed consent forms used during the relevant time-period.22 When a research participant chooses to discontinue participation, federal and state regulations govern the options WU has regarding the tissue/blood/DNA sample, and the undisputed testimony was that WU may destroy samples it no longer needs for research, store the samples indefinitely, and/or choose to "anonymize" the samples and continue to use them in certain areas of research.23
Whether Washington University owns the biological materials stored in the GU Biorepository?24
Under Missouri law, exclusive possession and control of personal property is prima facie evidence of ownership, and anyone else claiming such property bears the burden of proof by a preponderance of the evidence.25
Yes. Washington University has maintained exclusive possession of the biological materials at all times because it owns the buildings housing the GU Biorepository and employs the personnel who administer it.26 The university supplied the majority of funding for the repository and administered all external grants.27 Dr. Catalona's fundraising occurred only in his capacity as a Washington University employee.28 Washington University alone determines access to the samples through its Peer Review Panel and IRB processes.29 The university bears all legal, regulatory, and compliance risks under federal and state law.30
Multiple Material Transfer Agreements signed by Dr. Catalona expressly acknowledged Washington University as the owner.31 The university's Intellectual Property Policy states that tangible research property belongs to the university when significant university resources are used or external funding is administered by the university.32
Washington University owns the biological materials stored in the GU Biorepository.33
Whether research participants who contributed biological materials to the GU Biorepository retain ownership rights in those materials that permit them to direct the materials' use and transfer to third parties?34
Research participants who voluntarily donate biological materials for medical research part with any ownership rights once the materials are delivered.35 Federal regulations governing discontinuation of participation do not confer any right to control disposition or transfer of already-donated samples.36
No. The research participants signed informed consent forms that used the language of donation and free gift.37 The forms contained no provision allowing withdrawal or transfer of samples to another institution.38 When a participant discontinues participation, the only options available to Washington University are to destroy the sample, store it indefinitely, or anonymize it for exempt research.39 None of these options includes returning or transferring the sample.40
The federal regulations at 45 C.F.R. Part 46 do not equate the right to discontinue participation with any right to control the use or location of already-donated materials.41 No research participant ever had access to the samples after they entered the repository.42
Research participants who contributed biological materials to the GU Biorepository do not retain ownership rights that permit them to direct the materials' use and transfer to third parties.43
Whether the contributions of biological materials by research participants constitute inter vivos gifts to Washington University?44
An inter vivos gift requires present donative intent by the donor, delivery of the property to the donee, and acceptance by the donee, after which the gift cannot be revoked.45
Yes. The research participants demonstrated present donative intent by signing informed consent forms that repeatedly used the words donate and free and generous gift.46 The forms bore the Washington University Medical Center logo and the approval stamp of the university's Human Studies Committee.47 Delivery occurred when the samples were provided to Washington University physicians and technicians and placed in the GU Biorepository, which the university exclusively controls.48
Washington University accepted the materials by storing, maintaining, and using them in research under its IRB oversight.49 The participants' later regret after receiving Dr. Catalona's letter constitutes an afterthought that cannot revoke a completed gift.50
The contributions of biological materials by research participants constitute inter vivos gifts to Washington University.51
Whether Dr. Catalona's February 2003 letter and Medical Consent & Authorization forms effectively allow research participants to discontinue participation and transfer their samples to Northwestern University?52
A communication sent by a former principal investigator without prior IRB approval does not constitute valid informed consent and cannot effectuate a transfer of donated research samples.53
No. Dr. Catalona sent the letter and forms while still a Washington University employee and after he had transferred his principal investigator role to another faculty member.54 The documents were never submitted to or approved by the Human Studies Committee or any IRB at Northwestern University.55 The forms did not satisfy the elements of informed consent under 45 C.F.R. § 46.116 because they were not approved in advance.56 They were sent in a context that created undue influence over participants who had a personal connection to Dr. Catalona.57
The letter and forms therefore did not legally effectuate any discontinuation of participation or transfer of samples.58
Dr. Catalona's February 2003 letter and Medical Consent & Authorization forms do not effectively allow research participants to discontinue participation and transfer their samples to Northwestern University.59
Whether the informed consent forms used by Washington University are invalid because of exculpatory language or other deficiencies under federal regulations?60
No. The informed consent forms used by Washington University contained no language waiving legal rights or releasing any party from liability for negligence.6364 This is the only prohibition contained in 45 C.F.R. § 46.116.65 The OHRP guidance document listing examples of prohibited property-rights language is not legally binding.6667 It is not incorporated into the federal regulations.68 No regulatory agency, including the Office for Human Research Protection, has taken any action against Washington University regarding the forms.69
This confirms that they comply with all applicable requirements.70
The informed consent forms used by Washington University are not invalid because of exculpatory language or other deficiencies under federal regulations.71