The Ancillary-Care Responsibilities of Researchers: Reasonable but Not Great Expectations

For an important entry into this question, see Richardson H. S. Belsky L. , “The Ancillary-Care Responsibilities of Medical Researchers: An Ethical Framework for Thinking about the Clinical Care That Researchers Owe Their Subjects,” Hastings Center Report 34, no. 1 (2004): 25–33; and Belsky L. Richardson H. S. , “Medical Researchers' Ancillary Clinical Care Responsibilities,” British Medical Journal 328, no. 7454 (2004): 1494–96. There is also a consensus paper on this topic, for which Henry Richardson has taken lead responsibility, and which has been signed by participants at the workshop entitled the Ancillary-Care Obligations of Medical Researchers Working in Developing Countries, held at Georgetown University on October 20–22, 2006 (on file with author).

Id. (Belsky and Richardson), at 1494.

For a general review of the responsibilities of researchers conducting their trials in developing countries, see Nuffield Council on Bioethics, The Ethics of Research Related to Healthcare in Developing Countries , London, 2002. The Council contends that the duty to alleviate suffering naturally extends to providing positive benefits (see para 7.13), from which it infers that, in some cases, ancillary care might be required (see para. 7.34–7.35). However, the emphasis here, as in the Council's discussion of the difficult question of the sustainability of treatment after the completion of the research (see chap. 9), is on the importance of the researchers addressing such questions before the research begins and then making their intentions clear to prospective participants. The Council returned to these issues in The Ethics of Research Related to Healthcare in Developing Countries: A Follow-Up Discussion , London, 2005 [hereinafter cited as A Follow-Up Discussion]. On the particular question of the researchers' ancillary-care responsibilities, positive obligations are again asserted albeit to be specified on a case-by-case basis (see para. 3.25–3.26).

Brownsword Compare R. , “After Investors: Interpretation, Expectation and the Implicit Dimension of the ‘New Contextualism,’” in Campbell D. Collins H. Wightman J. , eds., The Implicit Dimension of Contract (Oxford: Hart, 2003): at 103.

For these three principal ethical constituencies and the problems of pluralism to which they give rise, see Brownsword R. , Rights, Regulation, and the Technological Revolution (Oxford: Oxford University Press, 2008): At chap. 2.

See Rawls J. , A Theory of Justice (London: Oxford University Press, 1972); Dworkin R. , Taking Rights Seriously (London: Duckworth, 1978).

The jurisprudential background starts with Beyleveld D. Brownsword R. , “Law as a Moral Judgment vs. Law as the Rules of the Powerful,” American Journal of Jurisprudence 28 (1983): 79–117. However, the critical moral philosophy (which involves teasing out the implications of viewing oneself as a prospective purposive agent) is Gewirthian. See Gewirth A. , Reason and Morality (Chicago: University of Chicago Press, 1978) and Community of Rights (Chicago: University of Chicago Press, 1996).

See, further, Brownsword R. , “Making People Better and Making Better People: Bioethics and the Regulation of Stem Cell Research,” Journal of Academic Legal Studies 1, no. 1 (2005): 5–13; Brownsword R. , “Cloning, Zoning and the Harm Principle” in McLean S. A. M. , ed., First Do No Harm (Aldershot: Ashgate, 2006): 527–42, at 527.

On will and interest theories of rights, see Hart H. L. A. , “Bentham on Legal Rights,” in Simpson A. W. B. , ed., Oxford Essays in Jurisprudence, 2nd series (Oxford: Clarendon Press, 1973): At 171; MacCormick D. N. , “Rights in Legislation,” in Hacker P. M. S. Raz J. , eds., Law, Morality, and Society (Oxford: Clarendon Press, 1977): at 189.

Beyleveld Compare D. Brownsword R. , “Principle, Proceduralism and Precaution in a Community of Rights,” Ratio Juris 19, no. 2 (2006): 141–68.

See, further, Brownsword R. , “The Cult of Consent: Fixation and Fallacy,” King's College Law Journal 15, no. 2 (2004): 223–51; Beyleveld D. Brownsword R. , Consent in the Law (Oxford: Hart, 2007).

Beyleveld Compare D. Pattinson S. , “Horizontal Applicability and Direct Effect,” Law Quarterly Review 118 (2002): 623–46.

It should be emphasized that this test only takes the community as far as recognizing prima facie responsibilities. Even if A is judged to have a prima facie positive obligation in relation to B, there might yet be competing or conflicting rights-based claims to be arbitrated.

See U.K. Biobank Web site, available at <http://www.ukbiobank.ac.uk> (last visited August 22, 2007); McHale J. V. , “Regulating Genetic Databases: Some Legal and Ethical Issues,” Medical Law Review 12, no. 1 (2004): 70–96.

U.K. Biobank Ethics and Governance Framework , 2nd version, July 2006, available at <http://www.ukbiobank.ac.uk/docs/EGF_Version2_July%2006%20most%20uptodate.pdf> (last visited September 4, 2007).

Id., at 8, para. I.B.3.

Id., at 9.

Campbell A. V. , “The Ethical Challenges of Biobanks: Safe-guarding Altruism and Trust,” in McLean , supra note 8, 203–14, at 208, note 15.

Indeed, in light of the emphasis placed by the Biobank on building long-term and close relationships with its participants, it seems almost to have encouraged participants to believe that a special responsibility has been assumed.

Within a community of rights, it is arguable that agents have a positive obligation to one another to participate in projects such as the Biobank, but, for present purposes, we need not pursue that idea. See, further, Pattinson S. D. , Medical Law and Ethics (London: Sweet and Maxwell, 2006): at 345–47.

See A Follow-Up Discussion, supra note 3, at para 3.26.

Compare Gewirth, supra note 7.

Arguably, too, the researchers, by going to the other community, should treat their participants as though they were from their home community, entitled to the level of care available there. Compare the position taken by the Nuffield Council on Bioethics (in the 2002 report, supra note 3) in relation to the (high) standard of care to be given to the control group in the trial.

Compare Nuffield Council on Bioethics, The Ethics of Research Related to Healthcare in Developing Countries , London, 2002, at para. 6.25–6.32 for current thinking concerning the distinction between acceptable and unacceptable inducements. And, see, Brownsword R. , “Informed Consent: To Whom It May Concern,” Jahrbuch für Recht und Ethik (Yearbook for Law and Ethics) 15 (forthcoming 2007).

Johnston Compare C. Kaye J. , “Does the U.K. Biobank have a Legal Obligation to Feedback Individual Findings to Participants?” Medical Law Review 12, no. 3 (2004): 239–67.

See, e.g., Markesinis B. S. , “An Expanding Tort Law – The Price of a Rigid Contract Law,” Law Quarterly Review 103 (1987): 354–97; Goff Lord in White v. Jones [1995] 2 AC 207, 262–264.

“The Common Core of European Private Law Project,” initiated at the University of Trento in 1993, adopts a comparative approach that focuses on results rather than doctrinal details. See, e.g., Zimmermann R. Whittaker S. , eds., Good Faith in European Contract Law (Cambridge: Cambridge University Press, 2000); Brownsword R. “Individualism, Co-Operativism and an Ethic for European Contract Law,” Modern Law Review 64, no. 28 (2001): 628–42.

Seminally, see Kennedy D. , “Distributive and Paternalist Motives in Contract and Tort Law, with Special Reference to Compulsory Terms and Unequal Bargaining Power” Maryland Law Review 41 (1982): 563–658; generally, see, Brownsword R. , Contract Law: Themes for the Twenty-First Century, 2nd ed. (Oxford: Oxford University Press, 2006): At chap. 7.

[1932] AC 562.

Notably , Anns v. Merton London Borough Council [1978] AC 728.

Most importantly, perhaps, the courts have limited Donoghue by declaring that the overriding question is whether it would be “fair, just and reasonable” to recognize a duty in the particular circumstances. Thus, in Caparo Industries plc v. Dickman [1990] 2 AC 605, at 617–18, Lord Bridge said that, in addition to the elements of “foreseeability of damage” and a relationship of “proximity” or “neighbourhood,” it is essential “that the situation should be one in which the court considers it fair, just and reasonable that the law should impose a duty of a given scope upon one party for the benefit of the other.” (Emphasis added.)

See, e.g., Bell v. Lever Bros Ltd [1932] AC 161 (where Lord Atkin took an uncompromising line on non-disclosure); Arcos Ltd v. EA Ronaasen and Son [1933] AC 470 (where Lord Atkin was party to the unanimous House of Lords' view that sellers who failed to deliver goods corresponding precisely to the contractual description had no cause for complaint if buyers then rejected the goods purely for their own economic advantage).

See, e.g, Walford v. Miles [1992] 2 AC 128, at 138, where Lord Ackner declared that a doctrinal recognition of a duty to negotiate in good faith would be “inherently repugnant to the adversarial position of the parties.”35. U.S. Restatement 2nd Torts § 314.

[1996] 1 AC 923.

Id., at 943–44.

But, even then, compare Smith and Others v. Littlewoods Organisation Ltd [1987] AC 241, where the defendant occupiers of an empty cinema were held not liable when a fire that was started by trespassing children at the cinema spread to the claimants' adjacent premises. According to Lord Griffiths, at 251, foreseeability does not suffice, and the best that can be done is “to leave it to the good sense of the judges to apply realistic standards in conformity with generally accepted patterns of behaviour to determine whether in the particular circumstances of a given case there has been a breach of duty sounding in negligence.”39. Compare Beldam LJ in Barrett v. Ministry of Defence [1995] 3 All ER 87, at 95: The characteristic which distinguishes those [special] relationships is reliance expressed or implied in the relationship which the party to whom the duty is owed is entitled to place on the other party to make provision for his safety. I can see no reason why it should not be fair, just and reasonable for the law to leave a responsible adult to assume responsibility for his own actions in consuming alcoholic drink….To dilute self-responsibility and to blame one adult for another's lack of self-control is neither just nor reasonable and in the development of the law of negligence an increment too far.

For example, suppose that, during a trial, researchers came to realize that their study was creating an unreasonable risk of physical harm to participants. Then, researchers surely would be found to have positive responsibilities (in law) to take reasonable steps to alleviate that risk. Compare U.S. Restatement 2nd Torts § 321 and McNeilab, Inc. v. North River Ins. Co., 645 F. Supp. 525, 551.

See Canterbury v. Spence, 464 F 2d 772 (D.C. Cir. 1972); Reibl v. Hughes (1980) 114 DLR (3d) 1; and Rogers v. Whitaker (1992) 67 ALJR 47.

See, especially, Pearce v. United Bristol Healthcare NHS Trust [1999] PIQR 53 and Chester v. Afshar [2004] 4 All ER 587.

Compare Marshall v. Curry [1933] 3 DLR 260 and Murray v. McMurchy [1949] 2 DLR 442 (BCSC).

We might recall Lord Reid's enumeration of the options open to one who is asked for advice (viz., decline, accept without responsibility, accept with responsibility), in Hedley Byrne and Co. Ltd. v. Heller and Partners Ltd. [1964] AC 465, at 486.

[1992] 1 AC 294. Although cf Reid v. Rush and Tompkins Group plc [1989] 3 All ER 228 and, more recently, Crossley v. Faithful & Gould Holdings Ltd [2004] EWCA Civ 293.

See Liverpool City Council v. Irwin [1977] AC 239.

Cf Burrows J. F. “Contractual Co-operation and the Implied Term,” Modern Law Review 31, no. 4 (1968): 390–407; Collins H. “Implied Duty to Give Information During Performance of Contracts,” Modern Law Review 55, no. 4 (1992): 556–62.

Compare Baird Textile Holdings Ltd v. Marks and Spencer plc [2001] EWCA Civ 274, [2002] 1 All ER (Comm) 737.

See Brownsword R. , Contract Law: Themes for the Twenty-First Century, 2nd ed. (Oxford: Oxford University Press, 2006): At chap. 6.

I am avoiding presenting this question in the more usual terms of mandatory or optional, or default rules, because I think that these terms are apt to mislead where, as in the text, the setting is that of a community of rights.