58 Mounce, Curci, Fortenbery Mounce, Curci, Fortenbery 59 Spotlight on Clinical Trial Sponsorship investigator can also operate as a sponsor, with all the attendant responsibilities, if they both initiate and conduct an investigation.² Id. Sponsors are primarily responsible for selecting Doug Mounce investigators, providing them with the information necessary to conduct a trial, monitoring the investigation, ensuring that it is conducted in accordance with the general investigational plan Cancer Research And Biostatistics and protocols contained in the [Investigational New Drug Application (“IND”)], maintaining an effective IND with respect to the investigations, and informing investigators or the FDA of Frank X. Curci any new risks or adverse effects associated with a drug. 21 CFR §312.50. Investigators are also Ater Wynne, LLP responsible for ensuring the investigation is conducted according to the investigational plan, but are also directly responsible for protecting the trial subjects, obtaining the informed consent of Joshua B. Fortenbery human subjects, and controlling the investigational drug. 21 CFR § 312.60. Ater Wynne, LLP Both the sponsor and the investigator are responsible parties. The Sponsor initiates the Abstract: What liability is associated with assuming the role of the “sponsor” in a clinical investigation, but the investigator actually conducts the trial. trial? This article discusses the Food and Drug Administration (FDA) regulations governing sponsorship, and how courts have interpreted those regulations in cases with a claim of injury. Sponsor and Investigator Responsibilities Subpart D of Sec. 312.50 outlines the general responsibilities of sponsors and investigators. These There is a natural concern with the responsibility implied by assuming the role of “sponsor” are shown in Table 1 below, along-with 312.20 where the responsibility for the submission of an in a clinical trial agreement. In a commercially sponsored clinical trial, for example, the INTaDbl teo 1 F DA is explained. site can reasonably require that a drug company assume most liability for subject injury Pharmaceutical companies are not the sponsor, however, for Investigator Sponsored Trials Responsibilities of Sponsors and Investigators (ISTs, sometimes called Investigator Initiated Trials IITs).¹ Between these extremes are the T able 1. Responsibilities of Sponsors and Investigators complex cases where a mix of delegated roles and responsibilities are assigned, and where the Activity/ Responsibility Sponsor – Sponsor roles and Investigator – all Sponsor “duty of care” relation between a physician and their patient may take precedence in any case. responsibilities can be responsibilities are also 21 C.F.R. §§ 312.20 and This article discusses sponsorship in terms of the FDA regulations, and reviews several cases delegated to a CRO unless responsibilities for a sponsor- Subpart D where judicial interpretation of a sponsor’s duties had an impact on liability. otherwise noted investigator Keywords: Sponsor, Investigator, Clinical Trial, Injury Claims 312.20 IND Application Responsible 312.50 General Responsible for investigator The Company as Sponsor selection, monitoring, study protocols, and adverse event The FDA regulations define “sponsor” as notification a person who takes responsibility for and initiates a clinical investigation. The sponsor may 312.52 Transfer of Obligations CRO is Responsible when be an individual or pharmaceutical company, governmental agency, academic institution, to a CRO assuming any obligation of a private organization, or other organization. The sponsor does not actually conduct the sponsor investigation unless the sponsor is a sponsor-investigator. A person other than an individual that uses one or more of its own employees to conduct an investigation that it has initiated is a sponsor, not a sponsor-investigator, and the employees are investigators. 21 CFR § 312.53 Selecting investigators Responsible, includes and monitors verifying investigator 312.3(b) (2014) qualifications, control of drug, As this definition makes clear, there is a difference between sponsoring a trial and conducting and monitor selection a trial, and this distinction can impact the sponsor’s responsibilities and liability. Further, an 2 3C1ru2c.i5al4ly ,E am ceomrgmenerccyia rl esspeoanrscohr does nRote osppeornatsei basle a f sopro mnsoonr-iintovreisntigg ator mRereeslyp boencsaiubslee tfhoery cinoitniadtue cat itnriagl and their employees conduct the trial; the druegx ccoempptiaonnys f uannddin rge tphoer ttriinalg o tnoly t ahses umeexsc ethpet iroonless forfo am s pionnfsoorrm, wehdi le its 1 An IST is a clinical trial where the sponsor is not a commercial entity. What is an IST? IST JOURNAL. Retrieved employees conducting the trial assume tFheD rAole s of an investigator. See 21 CFRc o§n 3s1e2n.3t (b) and the discussion of from http://www.istjournal.eu/for-authors Darke v. Estate of Isner, infra. 312.55 Informing Responsible for the investigators investigator brochure, and new The Journal of Research Administration, (47)1 observations 312.56 Review of ongoing Responsible for investigator investigations compliance, evaluating investigator reports, and determining discontinuation 312.57 Recordkeeping and Responsible for drug shipping retention records, financial interest related to payments, 2-year record retention, and reserve samples for testing 10 312.58 Inspection of sponsor’s Responsible for permitting records and reports FDA access 312.59 Disposition of unused Responsible for assuring Table 1 supply of investigational drug return of unused supplies Responsibilities of Sponsors and Investigators 312.60 General Responsible for conduct responsibilities of according to the signed (Form investigators 1572) investigator statement, Activity/ Responsibility Sponsor – Sponsor roles and Investigator – all Sponsor the investigational plan, responsibilities can be responsibilities are also protecting the rights, safety, 21 C.F.R. §§ 312.20 and delegated to a CRO unless responsibilities for a sponsor- and welfare of subjects, Subpart D otherwise noted investigator control of drugs, and obtaining the informed consent 312.20 IND Application Responsible 312.61 Control of the Responsible for administering 312.50 General Responsible for investigator investigational drug the drug to subjects selection, monitoring, study protocols, and adverse event 312.62 Investigator Responsible for disposition of notification recordkeeping and record the drug, case histories, and retention record retention, 312.52 Transfer of Obligations CRO is Responsible when to a CRO assuming any obligation of a 312.64 Investigator reports Responsible for progress sponsor reports, safety reports, final report, and financial reports, 60 Mounce, Curci, Fortenbery 312.66 Assurance of ReMspoounncsei,b Cleu rfcoir, FIRorBte nrebveriyew 61 312.53 Selecting investigators Responsible, includes Institutional Review Board and approval, and reporting to and monitors verifying investigator (“IRB”) review the IRB qualifications, control of drug, Table 1. Responsibilities of Sponsaonrds amnodn Iintovre ssetilgeacttioorns (continued) 312.68 Inspection of Responsible for permitting investigator's records and FDA access 312.54 Emergency research Responsible for monitoring Responsible for conducting reports exceptions and reporting to the exceptions from informed FDA consent 312.69 Handling of controlled Responsible for secure substances storage and access 312.55 Informing Responsible for the investigators investigator brochure, and new 312.70 Disqualification of a Responsible for complying Responsible for complying observations clinical investigator with FDA determinations with FDA determinations 312.56 Review of ongoing Responsible for investigator MISCELLANEOUS The consignee in the United The consignee is a qualified investigations compliance, evaluating States is the sponsor of the investigator named in the IND investigator reports, and 312.110 Import and export IND, or the consignee is the determining discontinuation requirements if a drug is domestic agent of a foreign subject to an IND that is in sponsor 312.57 Recordkeeping and Responsible for drug shipping effect, then retention records, financial interest related to payments, 2-year Subpart I—Expanded Access The responsibilities of The responsibilities of to Investigational Drugs for sponsors set forth in subpart D investigators set forth in record retention, and reserve Treatment Use of this part are applicable to subpart D of this part are samples for testing expanded acce1s1s use under applicable to expanded access 312.58 Inspection of sponsor’s Responsible for permitting this subpart use under this subpart records and reports FDA access FDA 801 Requirements Responsible for registering The PI can register the trial if 312.59 Disposition of unused Responsible for assuring trials on clinicaltrials.gov. the PI is responsible for 10 supply of investigational drug return of unused supplies Can be delegated to the PI (see conducting the trial, has qualifications) access to and control over the 312.60 General Responsible for conduct data from the clinical trial, has responsibilities of according to the signed (Form the right to publish the results investigators 1572) investigator statement, of the trial, and has the ability the investigational plan, to meet all of FDAAA's protecting the rights, safety, requirements for the and welfare of subjects, submission of clinical trial control of drugs, and obtaining information5 the informed consent 312.61 Control of the Responsible for administering In Table 1, Section 312.52 is a unique feature because sponsors can delegate roles and investigational drug the drug to subjects responsibilities to a Contract Research Organization (“CRO”), which is able to “assume, as an 312.62 Investigator Responsible for disposition of independent contractor with the sponsor, one or more of the obligations of a sponsor, e.g., design recordkeeping and record the drug, case histories, and of a protocol, selection or monitoring of investigations, evaluation of reports, and preparation of retention record retention, materials to be submitted to the Food and Drug Administration.” 312.64 Investigator reports Responsible for progress reports, safety reports, final The Role of a Contract Research Organization (CRO) report, and financial reports, A sponsor can delegate sponsor responsibilities to CROs. 21 C.F.R. § 312.52. Delegated 312.66 Assurance of Responsible for IRB review responsibilities must be detailed by the sponsor on an attachment to the New Drug Application Institutional Review Board and approval, and reporting to (“NDA”) Form 1571, 21 C.F.R. § 312.23. An investigator, by contrast, is not allowed to delegate (“IRB”) review the IRB roles and responsibilities in terms of conducting the trial. A drug manufacturer, on the other 312.68 Inspection of Responsible for permitting investigator's records and FDA access reports The Journal of Research Administration, (47)1 312.69 Handling of controlled Responsible for secure substances storage and access 312.70 Disqualification of a Responsible for complying Responsible for complying clinical investigator with FDA determinations with FDA determinations MISCELLANEOUS The consignee in the United The consignee is a qualified States is the sponsor of the investigator named in the IND 312.110 Import and export IND, or the consignee is the requirements if a drug is domestic agent of a foreign subject to an IND that is in sponsor effect, then Subpart I—Expanded Access The responsibilities of The responsibilities of 12 11 62 Mounce, Curci, Fortenbery Mounce, Curci, Fortenbery 63 hand, must assume responsibility for applying current good manufacturing practice (CGMP) to Worldwide Clinical Trials, Inc., a nationally-known contract research organization hired required under section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). by Aventis. Id. n. 3. The manufacturer’s responsibility is transferred if a CRO assumes the roles and responsibilities of The court agreed that patient supervision was part of the conduct of the trial, and not a sponsor the sponsor.³ See 21 C.F.R. § 312.52 (“A sponsor may transfer responsibility for any or all of the responsibility. Id. at 1123–24. Therefore, Aventis was only obligated to give adequate warning about obligations set forth in [21 C.F.R. Part 312] to a contract research organization.”). A manufacturer the risks to the patient’s prescribing physician. Id. at 1121. The physician then assumed investigator who desires to retain commercial rights to a drug after it has been successfully tested must only responsibility for the conduct of the trial by virtue of administering the drug. Id. at 1122. show, “substantial support”—or more than 50 percent of the cost for conducting the trial. 21 C.F.R. § 314.50(j)(4)(iii). Delegation of sponsor roles and responsibilities has been an important The claimants also argued that Aventis failed to warn patients about the risks associated with the feature in determining liability for subject injury. experimental drug, but the court held that Aventis was shielded from liability by the “learned intermediary doctrine.” Id. at 1121. In Humes v. Clinton, cited by the Kernke court, the Kansas Sponsor’s Responsibility for Conducting a Clinical Trial Supreme Court stated that the learned intermediary doctrine “allows a drug manufacturer to assume a patient places reliance on the physician’s judgment and relieves the manufacturer of a In the case of Kernke v. the Menninger Clinic (“Kernke”), for example, Aventis sponsored a trial to duty to assist the physician in communicating with patients.” 792 P.2d 1032, 1039 (1990). Thus, test their neuroleptic compound M100907, with Menninger Clinic defendants identified as the so long as a pharmaceutical company sponsor informs a prescribing physician of the dangers investigator. 173 F.Supp.2d 1117, at 1119. A patient named Joseph Kernke participated in both associated with a drug’s use, “the manufacturer’s duty to warn is satisfied.” Id. Although each state Phase I and Phase II of the trial, and he received the investigational drug in both phases. Id. at 1120. determines its own liability standards, the rule stated by the Kansas Supreme Court is currently Mr. Kernke was an outpatient who later voluntarily became an inpatient to take part in the study, the majority rule nationwide. See Terhune v. A. H. Robins Co., 577 P.2d 975, 977 (Wash. 1978) (“it has become a well-established rule that in such cases, the duty of the manufacturer to warn and he signed the consent form. Id. at 1119–20. The court noted, however, that throughout the of dangers involved in use of a product is satisfied if he gives adequate warning to the physician treatment he repeatedly told his relatives and the clinical staff that he desired to return home. who prescribes it”). Id. at 1120. After two months, when the Dose Limiting Toxicity had been established in Phase I, he became eligible to participate in Phase II of the trial, and again signed a consent form. Id. It is worth noting that a recent Texas decision casts doubt on whether the learned intermediary Three days after beginning the Phase II treatment, he left the clinic and was later found dead of doctrine applies as a matter of law in clinical trials, automatically shielding a sponsor from liability exposure. Id. regarding improper consent. In Rodriguez v. Gilead Sciences, Inc., the court stated that the learned intermediary doctrine may not apply if a physician was “incentivized to act as a drug marketer The plaintiffs alleged that Aventis, as sponsor, owed Mr. Kernke the following three duties: rather than as a treating physician.” No. 2:14-CV-324, 2015 WL 236621, at *5 (S.D. Tex. Jan. 16, (1) determining patient eligibility in terms of benefit and risk, (2) securing informed consent, and 2015). As a result, the court declined to dismiss claims against the sponsor at the pleading stage, (3) supervising patients. Id. at 1124. stating that whether the physician was adequately informed of the risks associated with a drug, or The court disagreed, and ruled for Aventis, stating: over-incentivized to enlist patients in a trial, was a question of fact that required further evidence before the learned intermediary doctrine could apply. Id. According to the FDA regulations, an investigator — in this case the Menninger defendants — is defined as “an individual who actually conducts a clinical investigation. . . .” On the As demonstrated by the above cases, the majority rule provides that a sponsor will typically have other hand, a sponsor — in this case Aventis — “does not actually conduct the investigation no duty to warn subjects of a trial’s risks so long as the sponsor provides adequate warnings to the unless the sponsor is a sponsor-investigator.” All of the duties alleged by plaintiffs in this investigator administering the trial. However, this does not mean that a sponsor is automatically case fall within the purview of the Menninger defendants as the investigator conducting the shielded from all liability, as at least in Texas, over-incentivizing an investigator might negate M100907 study; the duties do not rest with Aventis. Id. the learned intermediary doctrine, and in all cases a sponsor is still potentially liable for subject injuries if they fail to adequately warn the prescribing physician or investigator. In addition: The court notes that Aventis was not acting as a sponsor-investigator in this case. In fact, the The Sponsor’s Obligations as Employer record indicates that Aventis had delegated most of its duties as a sponsor of the drug study A treating physician’s obligation to their patient is called a “duty of care.” This is the first element 3 For complete statutory definitions and more information on the meaning of Responsible Party and sponsor, see that must be established to proceed with an action in negligence. Food and Drug Admin. (2009). Elaboration of definitions of responsible party and applicable clinical trial. Retrieved from https://prsinfo.clinicaltrials.gov/ElaborationsOnDefinitions.pdf; Food and Drug Admin. (2015). ClinicalTrials.gov In Darke v. Estate of Isner (“Darke”), the court also held that the sponsor is not responsible for protocol data element definitions. Retrieved July 13, 2015 from https://prsinfo.clinicaltrials.gov/ definitions. html#RespParty the care of the patient because, again, the sponsor does not conduct the trial unless they are a The Journal of Research Administration, (47)1 64 Mounce, Curci, Fortenbery Mounce, Curci, Fortenbery 65 sponsor-investigator. No. 022194E, 2005 WL 3729113, at *14 (Mass. Super. Nov. 22, 2005). In as the financial relationship between the two parties militated against holding that Dr. Isner was this case, the sponsor Vascular Genetics, Inc. (“VGI”) was named in a malpractice suit by the wife not acting in the furtherance of VGI’s objectives as a matter of law. Id. Therefore, the court left of Roger Darke, who died after receiving a gene therapy treatment—an injection of a substance open the critical possibility that VGI might be vicariously liable for the actions of Dr. Isner due called VEGF2 that promotes the formation of blood vessels—as part of his surgery to increase to an employer-employee relationship—which, in turn, would impute the potentially tortious vascular blood flow. Id. at *3. conduct of Dr. Isner (as the employee) to the trial sponsor (as the employer). Id VGI’s gene therapy had been approved by the FDA in 1999 to allow experimental treatment for The key takeaway from the Darke case is that while a sponsor’s control over the conduct of patients who were not candidates for bypass surgery or other standard procedures. Id. at *1. Mr. the clinical protocol does not, in and of itself, demonstrate control over the conduct of the Darke had been advised by his physician not to repeat the coronary revascularization surgery investigators, a sponsor could potentially be held liable for the tortious acts of an investigator if he had previously received, and he was referred to the hospital’s gene therapy program. Id. at *2. a court finds an “employer-employee” relationship existed between the sponsor and a particular There he consulted with Dr. Isner, who had formed VGI to develop and commercialize the gene investigator and that particular investigator committed the tortious act within the scope of that therapy. Id. Both Dr. Isner and the hospital held a twenty percent ownership interest in VGI and employment relationship. were represented on the Board of Directors. Id. at *1. Fiduciary Duties and Other Claims Mr. Darke signed a consent form for the experimental procedure, but the form did not disclose Dr. Isner’s or the hospital’s financial interest in sponsor VGI. Id. at *2. The court stated: The sponsor role has also been the basis for claims that a drug company should provide free study In its role as sponsor, VGI supplied VEGF-2 to the clinical investigators to administer to drug after the end of a clinical trial. In the case of Abney v. Amgen (“Abney”), Amgen sponsored patients participating in the trial. Furthermore, VGI, in accordance with the relevant FDA two trials to test a drug delivery method for patients suffering from Parkinson’s disease, but regulations, took on the responsibility of selecting qualified investigators, ensuring the unfortunately, both studies failed to prove that the experimental procedure was safe or effective. proper conduct of the trial, monitoring the progress of the study, and ensuring the safety and 443 F.3d 540 at 544 (2006). effectiveness of the gene therapy treatment. 21 C.F.R. § 312.50. In essence, VGI supervised This study was originally designed and initiated by physicians at the University of Kentucky the implementation of the study. Id. at 14. (UK), but the court noted that “Amgen became a sponsor of the study, meaning it had funded In other words, VGI maintained all the general supervisory responsibilities of a sponsor. However, the study and provided the study drug.” Id. at 543 n. 1. The Amgen trial at UK also used Amgen’s the court found that, as a general rule, VGI’s control—in its role as the sponsor—over the conduct protocol, and UK was only one of several sites. Id. at 543. of the clinical protocol did not demonstrate control over the conduct of the investigators and, The plaintiffs claimed that Amgen promised to continue providing the experimental treatment thus, this activity of a sponsor “is not enough by itself to inspire” liability on the sponsor. Id. to subjects after the study ended. Id. at 544. However, the plaintiffs had entered into a contract However, the court noted that its inquiry did not stop here and, thus, the court analyzed other with the investigators at UK, not with Amgen. Id. at 547. Further, because the investigators were factors and theories of law that might impose some liability on VGI. With regard to a claim independent contractors, not agents of Amgen, they had no authority to enter into a binding that VGI was directly negligent, the court held that VGI owed Mr. Darke no direct duty of care, contract on Amgen’s behalf. Id. at 548. As a result, plaintiffs could not show that Amgen had ever and thus could not be held independently negligent. Id. at *15. “Instead, such duties inhered directly promised anything to the study participants. in the responsibilities imposed upon the investigators in this case,” and the general sponsor The plaintiffs also claimed that Amgen, working through its principal investigators, owed them responsibilities enumerated under 21 C.F.R. § 312.50 were not violated. Id. Therefore, the court a fiduciary duty to treat their illness. Id. at 550. However, a fiduciary duty is only created when found in favor of VGI regarding this claim of negligence. Id. two parties agree that one will act in the interest of the other, and there was no evidence that The court next evaluated VGI’s potential “vicarious liability” in its status as an “employer” for the Amgen had undertaken sponsorship of the study primarily for the benefit of the plaintiffs. Id. actions of any of its “employees.”⁴ The court declined to state, as a matter of law, that the relation Amgen further asserted that its role as the sponsor of clinical trials would be undermined if it between VGI and Dr. Isner was not one of an employer-employee because VGI was paying Dr. could not terminate trials that were found to present a risk to study participants. Id. at 552. The Isner as a Principal Investigator (PI), and because Dr. Isner “devoted a significant portion of his court echoed the lower court’s sentiment that requiring pharmaceutical companies “to continue professional life to VGI.” Id. While VGI had argued that Dr. Isner was only an independent to produce and distribute a drug they believed to be dangerous” might deter those companies contractor and not an employee, the court said it didn’t matter what the parties called Dr. Isner, from sponsoring clinical trials. Id. at 553. This same Amgen study was also at issue in Suthers v. Amgen (“Suthers”), which arose out of a 4 ”Vicarious liability” of an employer is the legal doctrine by which an employer might be held liable for the actions controversy at another trial site, the New York University School of Medicine. 441 F.Supp.2d or omissions of its employee if it can be proven that the applicable actions/omissions occurred within the scope of employment. The Journal of Research Administration, (47)1 66 Mounce, Curci, Fortenbery Mounce, Curci, Fortenbery 67 478 (2006). In Suthers, two defendants who were part of the placebo group in Phase I were later Conclusion recruited for the Phase II expansion, at which point they “experienced marked improvement” in Liability (and the practical aspects at play with regard to potential liability) is often addressed in their condition. Id. at 481. When Amgen received news of toxicity in a primate animal study, contract negotiation of indemnification provisions prior to the study. The scope of this article was they terminated the human clinical trial and stopped supplying drug because they thought it was not intended to address indemnification provisions. In light of the court cases cited above, the effect unsafe.⁵ Id. The plaintiffs alleged that their condition worsened in the months following the end that indemnification provisions have on the actual allocation of risk is worth further investigation. of the trial and reverted to their state prior to the administration of the study drug. Id. at 481–82. In any case, claims of injury arising from clinical trial investigations may involve everyone from As in Abney, the court sided with Amgen and concluded that “there is no basis to impose a fiduciary the investigator and their institution to CROs and the drug manufacturer. The identity of the duty on the sponsor.” Id. at 488. Further, the consent form made no promise of continued drug sponsor, and their obligations in any trial, depends on the nature of the investigation and the supply, and informed subjects that the study could be terminated or cancelled by the sponsor. Id. division and delegation of responsibilities. Initiating an investigation is distinct from conducting at 483. The court also found that there was no evidence the investigator had made any promise of a clinical trial, and this distinction has important implications for one’s liability exposure. The continued drug supply—as in UK study—and that any alleged promise was contradicted by the ill-defined boundaries of responsibility and liability amongst sponsors, investigators, CROs, clear terms of the informed consent document. Id. at 484. Finally, the negligence claim was also and research sites will continue to evolve with revisions to FDA regulations and guidelines, rejected, as the plaintiffs claimed to have benefitted from administration of the drug and their and judicial interpretations of those regulations and guidelines. However, hopefully this article condition did not worsen from the pre-treatment baseline, and thus the plaintiffs could not allege provides some guidance as to what liability is currently associated with assuming the role of that Amgen had violated a duty of care or caused an injury by ceasing its gratuitous conduct. Id. “sponsor” in a clinical trial. at 489–90. The Investigator as Sponsor Doug Mounce Grants & Contracts Manager “Sponsor-Investigator” means an individual who both initiates and conducts an investigation, Cancer Research and Biostatistics (CRAB) and under whose immediate direction the investigational drug is administered or dispensed. 1730 Minor Avenue Suite 1900 The term does not include any person other than an individual. The requirements applicable Seattle, WA, 98101-1468 to a sponsor-investigator under this part include both those applicable to an investigator and Telephone: 206-839-1787 a sponsor. 21 C.F.R. § 312.3(b). Email: [email protected] All sponsor obligations under 21 C.F.R. Part 312 apply to an investigator who takes on the role of sponsor. Id. An investigator typically does this by writing a protocol for the new use of Frank X. Curci an approved drug, which it sends to the manufacturer as a proposal to support the study with Partner, Intellectual Property and Technology Attorney drugs and sometimes money. Although the pharmaceutical company is unlikely to profit from Ater Wynne, LLP such a clinical trial, it might be willing to provide this support because the trial could generate useful information or yield a humanitarian benefit if successful. The support is not considered Josh Fortenbery sponsorship under FDA regulations because the investigator writes the protocol, typically Summer Associate 2015 submits the IND, oversees the sites and other investigators, and generally assumes all other Ater Wynne, LLP sponsor responsibilities except drug manufacturing and initial shipping. An investigator-sponsor therefore takes most of the roles and responsibilities of sponsorship away from the drug company. Correspondence concerning this article should be addressed to Doug Mounce, Grants & As a result, claims of injury arising out of the above-mentioned sponsor obligations expose the Contracts Manager, Cancer Research and Biostatistics (CRAB), 1730 Minor Avenue Suite 1900 investigator to liability, instead of the drug manufacturer. Seattle, WA, 98101-1468, Telephone: 206-839-1787, Email:[email protected] 5 Interestingly, the investigator at NYU contended that the primate test subjects had received dosages at least ten times higher than what would have been given to a human and that the cause of the primates’ cerebral toxicity was the abrupt withdrawal of the study drug. 441 F.Supp.2d at 481. The Journal of Research Administration, (47)1