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Moral EntanglementsThe Ancillary-Care Obligations of Medical Researchers$

Henry S. Richardson

Print publication date: 2012

Print ISBN-13: 9780195388930

Published to Oxford Scholarship Online: January 2013

DOI: 10.1093/acprof:oso/9780195388930.001.0001

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(p.239) Index

(p.239) Index

Source:
Moral Entanglements
Publisher:
Oxford University Press
ability to provide ancillary care. See also cost, ability and; personnel, scarcity of trained
enhanceable, and snowballing objection, 223
specialized competence, or lack thereof, as affecting, 194, 198, 215n.
accountants, professional responsibilities of, 72
AC-dependence, 130–2, 138, 143–4, 179
adverse events, reporting of, 46. See also Data Safety Monitoring Boards
as a potential source of data on ancillary care, 200–1, 226
agency, quasi-legal issue of, 181
AIDS Clinical Trial Group, 216
allocation of scarce medical resources, 19
local priorities about, 124–7
ancillary care, 2. See also medical research studies; partial-entrustment model
alternative sources of, 227. See also dependence
attitudes about, 176–7, 199–200
broad and narrow conceptions of, 69n.
cardiac, 16, 21, 56, 105
claims, 19, 42, 49–50, 54n., 124, 129, 133, 195
compared across different studies, 165–8, 225
correlative to researchers’ special ancillary-care obligations, 133
(p.240) non-participants’, 20
waivability of, chap. 5 passim. See also waiving ancillary-care claims
consensus on, emerging, 12, 217–8
counseling as, 189
data on, sorely needed, 171, 173, 177, 187, 198–201, 226
definition of, 2–3, 13, 115, 131
emergency, 16, 21, 177
for the children and other relatives of participants, 54–5
for HIV-AIDS, 6–9, 51–4, 124–6, chap. 6 passim, 199–200, 220–1
for opportunistic infections related to HIV-AIDS, 52, 150, 155
for various infections unrelated to HIV-AIDS, 51–4, 144, 156
guidance on
lacking, 1, 28–9
moving towards, 200, 219–28
in HIV-vaccine trials, xv, 6–9, 19, 43, 45, 125, 164, 166–9, 199–200
in public-health emergencies, 191–3
in public-health research, 193–6
in tertiary-care hospitals, 174–5, 177, 222
needs, 4–5
already known to the subject ex ante, 97, 145, 188–9
foreseeable, 227. See also ancillary care, planning for
non-medical, 196–8
not known to the subject ex ante, 141, 149–150, 188–9, 213
not unimportant, 4
obligations, chap. 1 passim
affirmed by consensus paper, 219, 227
generic, 69, 72, 74–5
general versus special, 15, 31, 41, 129, 218
injustice and, 48, 151, chap. 4 passim. See also non-ideal theory
limitation thereof, 39–40, 203, 217–8
not grounded in expectations, 9, 37–8, 139
polar conceptions thereof unacceptable, 10–2, 26, 214
pro tanto or defeasible (not all-things-considered), 29n., 31n.
supplementing the duty to rescue, 76, 195n. See also rescue, duty of
versus mere aspirations, 29, 30
(p.241) palliative care as, 155
paying for, 17, 29. See also cost
planning for, 30, 198, 219–22, 224–5
promises of, 11, 13
provision, meaning of, 174–7
referral for, 17, 41, 52, 155, 175, 179, 222
assisted, 41, 135, 176–7, 198, 200, 221
surgical, 18, 55, 104, 197
terminology pertaining to, 12
undue inducement not generally arising from owed, 123, 128
antidepressant medication, washout studies of, 171–2
antiretroviral medication, 19, 124, chap. 6 passim. See also ancillary care, for HIV-AIDS
Aristotle, 110n., 114n.
autonomy
in argument for limits on waivability of ancillary-care claims, 145–50
in argument for the partial-entrustment model, 61, 78–84, 91, 93, 142
specifically with regard to potential future threats thereto, 213
feminists’ criticisms of narrow conceptions of, 80, 93
glossed, 79–80
in consenting to research participation, 32
of children, parents’ role in fostering, 80–2
shielded by privacy rights, 61, 78–84, 91, 93, 142
special responsibility regarding, not principle of, at play in the argument, 208
bailment
analogy to, superseded, 39n., 215n.
claim of, waivable, 133
criticism of former reliance on, 215n.
Bangladesh, 41
Barsdorf, Nicola, 176–7, 199
Beauchamp, Tom L., 208–9, 212, 213n.
Belsky, Leah, xi, 23
Benatar, Solomon, 108–9, 118, 129, 132, 144
beneficence, obligation of, 3, 115, 206, 209. See also welfare, due concern for, obligation of
general (unspecified), 66, 168
limits to, 101n.
special, in Beauchamp & Childress, 209
specifiable, xiii, 60–2, 66, 68, 94
focus therefor provided by the duty of tactful engagement, 86–7, 92, 94–6
Benin, 18n.
Beskow, Laura M., 184
borrowing a car (example), 88–9
Brownsword, Roger, 216n.
burdening-the-helper objection, 64, 118, 217
Burke, Wylie, 184
(p.242) capabilities, basic, 131
capacity to help. See cost, ability and
Cermak, Allegra, 216n.
Chaisson, Richard, 216n.
Childress, James F., 208–9, 212, 213n.
chlamydia trachomatis (eye infection), 54–5
Cho, Mildred, 181n.
cholera, emergency treatment of, 191–2
chronic granulomatous disease, 130
claims to ancillary care. See ancillary care, claims
Clayton, Ellen Wright, 33
Cohen, G. A., 48n.
collaborative partnership with host communities, 200, 206, 219–20, 222
colonialism, legacy of, 108, 116
commensurability of strength dimensions, not presumed, 154, 165
intuitive balancing not therefore required, 165–8
compassion, no longer appealed to by the partial-entrustment model, 36n.
compensation, duty or claim of, 3, 21n., 115, 132, 133, 210, 212
contract research organizations, 216
Corr, Peter B., 217n.
corruption, 119–20
cost. See also ancillary care, paying for
ability and, 46, 197
as a strength factor on the partial-entrustment model, 42
aspects thereof, 42, 45–6, 163
gradations thereof, 163–7
moral relevance thereof, 43–5, 144n., 163
Council for International Organizations of Medical Sciences (CIOMS), 28
cryptosporidiosis. See diarrhea, cryptosporidial
Data Safety Monitoring Boards (DSMBs), 224, 226. See also adverse events, reporting of
Decew, Judith Wagner, 79
DeCherney, Stephen, 200n., 217n.
dependence. See also AC-dependence; ancillary care, alternative sources of
as a strength factor on the partial-entrustment model, 42, 138, 156
glossed, 47–8
depth (of researcher-subject engagement). See engagement
dermatology. See skin conditions
Devakumar, Delan, 191–2
diarrhea, cryptosporidial, 144, 156, 171
Dickert, Neal, 20–1, 51–7
distributive objection. See burdening-the-helper objection
Doctors Without Borders, 191, 222
duties, directed. See obligations, special, directed
Emanuel, Ezekiel J., 88n., 119, 121–2, 206–8, 215, 222
engagement
as a strength factor in the partial-entrustment model, 42, 161–3
gradations in 162, 166–7, 188–9
glossed, 48–9
no longer appealed to in the partial-entrustment model's account of scope, 36
protocol as the basis for assessing depth thereof, 162
entanglements, moral, xiii, 36n., 228
contrasted with promises, 210
neither associative nor voluntarily undertaken, 209
privacy-based, 65–106, 189–190, 204
unintended obligations, by definition, 65, 142, 209–10, 212
yet not entirely unforeseeable, 220–1
Ethiopia, 144, 216
exploitation, 2, 32, 45, 108–9, 116–9, 206, 222
Food and Drug Administration (U.S.), 178
Gates Foundation, the Bill and Melinda, 25, 201
Gelsinger, Jesse, case of, 115
Georgetown workshop on ancillary care (2006), xviii, 27, 178n., 200n., 216–23, 226–8
gingivitis. See periodontal disease
Goodin, Robert E., 14, 47n., 99–102
Grady, Christine, 27n., 124–6, 206–8, 215, 217n., 222
gratitude
a potential ground of special ancillary-care obligations, 12–3
as a strength factor on the partial-entrustment model, 42
no longer appealed to in the partial-entrustment model's account of scope, 36n.
Grimes v. the Kennedy Krieger Institute, 180–1
(p.244) guidance, practical. See also ancillary care, guidance on
four Ps of practical advice, 219–23
heart attacks, 16, 21
Helsinki, Declaration of, 27
Higgs, Elizabeth S., 217n.
HIV Prevention Trials Network, 221
HIV-related wasting, 164, 166–8, 185
HIV Vaccine Trials Network, 169
Hooper, Carwyn, 116
impartiality, commitment to
contested by special claims, 19, 73n.
departed from by special duties, 16–7, 19, 104–5, 126, 176, 179
expressed by rival accounts of ancillary-care duties, 99–106
in allocating health care, 124
incidental findings, 181–4
India, 41
Indian Council for Medical Research, 216
informed consent
process of, as forging the researcher-participant relationship, 30, 32–4, 68, 190
three functions of, 32–3
injustice. See also ancillary care, obligations, injustice and; justice
against groups, 115–6
background, 107–9, 121, 123
Institutional Review Boards (IRBs). See Research Ethics Committees (RECs)
intimacies
as canceling inhibitions on the duty to warn, 70, 76–8, 85
defined as resulting from accepting privacy waivers, 68
diverse, 71–5
helping vs. non-helping, 71
sexual, 69, 74
Joffe, Steven, 35n., 37, 183–4
journalists, professional ethics of, 73
justice, 19, chap. 4 passim. See also ancillary care, obligations, injustice and; injustice, background; non-ideal theory
as a constraint on ancillary-care obligations, 118–28
as a constraint on waiver of ancillary-care claims, 143–4, 151
basic minimum, institutional or allocative, 111, 131. See also sufficientarianism
cast by consensus paper as a potential ground of ancillary-care obligations, 218
(p.245) distributive, 110–4, 130–2
not an apt ground for the special ancillary-care obligation, 110–8, 208
potentially reinforcing ancillary-care obligations, 128–32, 204
rectificatory, 113–6, 131–2
with respect to health care, ill satisfied in the actual world, 47, 107
Kant, Immanuel, 80, 140, 207n.
Kenya, 220–1
Kumar, Nandini K., 217n.
least-cost threat avoider (LCTA) view, xvii, 14, 17, 89n., 102–5
libertarian theory, 112–4
Lie, Reidar, 217n.
lupus, 175
malaria, 1, 4, 11, 16–7, 25, 36, 41, 49–51, 64, 88n., 96, 105, 158–61, 171, 173–4, 197
Malawi, 41, 216
Mali, 54, 105
Martin, Adrienne, 76n.
McGeer, Victoria, 76n.
medical advice, unsolicited, 76–7
medical histories, taking of, covered by privacy rights, 33, 53–4
medical procedures potentially revealing ancillary-care needs
echocardiograms, 56
examination of bodily fluids, 4, 11, 16–7, 36, 49n., 50, 64, 88n., 96, 105, 174, 197
functional MRI scans, 5, 25–6, 36–7, 97, 190, 197
genetic and genomic assays, 24, 154n.
HIV tests, 6–9, 19, 43, 45, 189
interviews, 197
physical examinations, 186
tests, new vs. newly interpreted, 182n.
virtual colonoscopies, 182n.
medical research ethics
ancillary-care guidelines, lacking, 1, 27–8
requirements of, commonly asserted
ill accounting for ancillary care obligations, 205–10
independent review, 206–7. See also Research Ethics Committees
post-trial benefits, reasonable, 153. See also post-trial benefits
risk-benefit ratio, favorable 206–7
scientific validity, 206–7
social value of the scientific question (here presumed), 44–5, 206
standard of care, acceptable, for the condition under study, 64, 123, 168, 195
undue inducement, avoidance of, 109, 119–23, 217
shaped by abuses and scandals, 2, 32, 226
(p.246) medical researchers
attitudes about ancillary care, 56
duration of their interactions with participants, 49. See also engagement
identity and institutional organization of, 177–84, 223–4, 227
intensity of their interactions with participants, 49. See also engagement
not always physicians, 25, 26n.
relationship of to research subjects, 13–5
beginning thereof, 186
depth thereof. See engagement
forged via the informed-consent process, 30, 32–4, 68, 190
needing moral analysis, 20–1
roles of, 10, 11–2, 30
role obligations of,
illuminated by the partial-entrustment model, 215
sui generis and contested, 10, 27–28
“two hats” view, criticized, 24–26
teams of, 16n., 40, 47, 48, 109, 144, 177–84, 227
expandable, 197–8, 220–1, 223
medical research involving human subjects
boundaries of, 184n., 189–96
in developing countries, 1, 3, 6, 25, 28, 45, 47, 51–7, chap. 6 passim, 174, 177, 219–20, 222
regulatory definition of, 184n.
social value thereof, 44
widely varied, 172–3, 225
working definition thereof, 25–6
medical research studies
biobank-based, 33n., 176, 181–4
budgets thereof, 220, 223. See also ancillary-care, paying for; cost
confoundment of data therein, 46, 163
core aim thereof, glossed, 159
counterfactual variation in the design thereof, 158–9
drug-addiction, 172, 176, 198, 222
drug trials, 8, 18n., 24, 26, 116, 156–7, 162, 167, 171–2, 175, 200, 224
emergency, 33n.
endpoints thereof, 159, 161, 166
exclusion criteria thereof, 157, 160, 186, 188
epidemiological, 153, 180–1
genetic and genomic, 24, 172
HIV-transmission, 18, 104–5, 164–7, 197–8, 220–1
involving inpatients, 162–2, 166–7
lead-poisoning, 180–1
maternal-fetal transmission, 158–62, 164, 166–7, 171
multisite, 178–9
observational, 18, 51–7, 130, 144, 158–61, 164, 175, 220–1
(p.247) parasitological, 17, 220–1. See also diarrhea, cryptosporidial; malaria
placebo controlled, 6
protocols thereof, 6, 38, 48, 162, 181, 187, 219, 224–5
psychiatric, 171–2, 176
public-health, 26n., 180–1, 185, 190, 193–6
randomized control trials, 6, 194
safety of, 160, 195, 207
scientific aims of, general, 8–9, 11, 225. See also obligations, special, deriving from the aims of science
screening phase of, 186–9
sets of, 227
sponsors thereof, 30, 45, 116, 121, 144, 169, 177–84, 201, 222–5, 227–8
statistical significance thereof, 42. See also cost, aspects of
stratified, 53, 156–7, 159, 161
medical research subjects
borderline instances of, 185–9
family of the primary participant, 185–6, 194–6
screened-out individuals, 157, 160, 165–6, 186–9
contrasted with patients, 10
contrasted with those who are not enrolled in the study, 20
potentially benefiting from research participation, 64
recruitment of, 11, 13
by varied routes, 25
relationship of to medical researchers. See medical researchers, relationship of to research subjects
underinsured, 124, 144, 175
Mello, Michele M., 35n., 37, 183–4
mere means, moral injunction not to treat persons as, 162, 207n.
Merritt, Maria, 54n., 124–6, 178n., 193–6, 200, 217n., 225n.
Meyers, Diana Tietjens, 80
Miller, Franklin G., 35n., 37, 72n., 183–4
Molyneux, Malcolm, 30n., 217n.
moral entanglements. See entanglements, moral
moral justification, in general, 214n.
moral responsibility, forward-looking. See responsibilities, special
Mother-Offspring Malaria Study (MOMS), 51–4
Mullany, Luke C., 193–6
Murphy, Liam, 43n.
National Institutes of Health, U.S.A. (NIH), 7–8, 25, 28, 45, 129–30, 173–4, 201, 216
Nepal Newborn Washing Study (NNWS), 194–6
non-maleficence, 3, 115, 208
Nozick, Robert, 112–4
obligations, general, 15–16, 211, 218
and natural duties, 16n.
obligations, special, 211. See also ancillary care, obligations; responsibilities, special; special ancillary-care obligation, the
associative, 209
defined, 66n.
deriving from the aims of science, 11, 144n., 225
directed, xiv, 79n.
voluntary undertakings as among the grounds of, xiii, 11, 209, 211
vulnerability theory's conception of, 100
observational studies. See medical research studies, observational
Office of Human Research Protections (U.S.), 184n.
osteomyelitis (bone infection), 55–6
partial-entrustment model of medical researchers’ special ancillary-care obligations, xii, xvii, 21n., chap. 2 passim, 218
entrustment idea involved in, 35–8, 90, 146
incidental findings covered by, 182
moral justification of, chap. 3 passim, esp. 61–2, 70, 85–7, 95–6, 98, 106; 203–4. See also entanglements, moral
appeal to autonomy therein, 61, 78–84, 91, 93, 142
not intended as a basis for addressing issues of justice or exploitation, 117
paternalism worries neutralized by, 211–4
raising or lowering the bar?, 173
scope dimension of, 20, 24, 31–41, 175, 179, 187, 193, 204, 227
controversy involving, 51–7
covers what is discovered by carrying out study procedures, 50
divided into three tiers (minimal, clear, and central), 53–4, 157–61, 166–7
excludes what is obvious to the trained eye, 20, 40, 55
grounded in the nature of the researcher-participant relationship, 56
objectively determined by the study protocol, 34, 38, 179, 224
set by needed permissions, 35
reified conception of, rejected, 39
requiring a principled basis, 53, 54n., 57, 63, 72n.
(p.249) transactional, 64n., 67n., 84–96, 100, 104–6, 126, 132, 193, 209
sensitive to contextual variations, 154
stated, 2, 50
strength dimensions of, 24, 42–9, 223, 227
applicable without presuming commensurability, 154
as introducing contextual sensitivity, 97, 179
support for, initial, from existing survey studies, 199–200
two-tiered structure of, 42, 49–50
participants in medical research. See medical research subjects
participants in the Georgetown workshop. See Georgetown workshop on ancillary care (2006)
paternalism, 76, 95, 142n., 210–4
in medical research ethics, 210–1
soft, 148, 212–4
periodontal disease, 40, 175
permissions, special, 33, 38, 182n., 215. See also privacy rights, waiver of; responsibilities, special
personnel, scarcity of trained, 1, 19, 45, 127, 154, 163, 195–6. See also ability; cost, aspects of
Petros, Beyene, 217n.
pharmaceutical companies, 116, 131–2, 201, 216, 223
physicians
clinical, contrasted with medical researchers, 12
clinical, as sometimes also being researchers, 24, 26
sometimes simply acting as researchers, 26
post-trial benefits, 116, 153. See also ancillary care, for HIV-AIDS; medical research ethics, requirements of, commonly asserted
fair-benefits approach thereto, 108, 109n.
practices, moral significance thereof, 61, 67, 83, 89, 100
principles, moral
all-things-considered obligation and, 17n.
fact-independence of, necessary, denied, 48n., 61
importance of appealing to, 8–9
specification thereof, 209
prioritarianism, 130–1
privacy rights, 33, 60
anonymized samples and, 184
core function of as shielding fragile aspects of autonomy, 61, 78–84, 91, 93, 142
versus confidentiality rights, 68–9
waiver of, 33–4, 35n., 57, chap. 3 passim, 215n.
(p.250) accepted or taken up, 68
acted on in cases in which ancillary-care claims arise, 147
the accepting entity thereof, in medical research, 180–1
solicited, 68, 143–52
unilateral, 68
whose rights affected by, 186
zones of, 67–8, 78–9, 82–3
public-health interventions, 190–3
pulmonary hypertension, 54, 105
Rabinowicz, Wlodek, 176n.
Rawls, John, 111, 119, 125n.
reciprocity, 125–6
reparations. See compensation
rescue, duty of
a general obligation, 75
a potential basis of ancillary-care obligation, 13, 16, 41, 54n., 76, 168, 195n., 218
articulated (by Scanlon), 43–4
due concern for welfare, and, 219
duty to warn as a special case thereof, 60
limited to relatively easy aid, 43–4, 55, 104
not subject to waiver, 145n.
potentially conflicting with the special ancillary-care obligation, 31
researcher-participant relationship. See medical researchers, relationship of to research subjects
Research Ethics Committees (RECs), 2, 30, 32, 38, 49, 122, 165, 169, 181
as most important vehicle for providing ancillary-care guidance, 224–6
three practical questions for, 226–7
Resnick, David B., 24n., 215n.
respect for persons, precept of, not here relied upon, 207n.
responsibilities, special, 103
denied by the lawyers in Grimes, 180
deriving from special permissions, 35–6; chap. 3 passim, esp. 86–91; 136, 183–4
distinguished from special obligations, 36–7
linked to the function of waived rights, 61
reallocating, 90–1, 138, 146
return of results to research participants, 184. See also ancillary care; incidental findings
(p.251) right to refuse medical treatment, affirmed, 135
rights
alienation of, 87–8
basic, 111n., 112–3
risks, of study participation and otherwise, 123, 125
road accident sequelae, 40
Scanlon, T. M., 43
schistosomiasis, 4, 11, 16–7, 36, 49n., 50, 64, 88n., 96, 105, 174, 197, 220–1
screening of potential subjects. See medical research subjects, borderline instances of
Shiffrin, Seana, 210
Simmons, A. John, 66
Singer, Peter A., 108–9, 118, 129, 132, 144
skin conditions, 21, 76–7
South Africa, Republic of, 7, 177, 199
special ancillary-care obligation, the, 14–5, chap. 2 passim, chap. 3 passim. See also ancillary care, obligations, special; partial-entrustment model of the special ancillary-care obligation
as arising from voluntary actions, 212
hunting for ancillary-care needs not required by, 182
impartiality doubly departed from by, 16–7, 19, 104–5, 126, 176, 179
justice not an apt ground for, 110–18, 208
not essentially a professional obligation, 63, 183, 198, 214–5
principal focus of this work, 2, 14, 110, 117
supplementing general grounds for ancillary-care obligation, sometimes, 20, 31, 76, 168, 204, 218–9
sometimes not, 21
sponsors of medical research studies. See medical research studies, sponsors thereof
spousal abuse, issue of ancillary care for, 197
studies, medical research. See medical research studies
study-related care, vagueness of the notion of, 28–9
subjects of medical research. See medical research subjects
Sudan, 191–2, 222
(p.252) sufficientarianism, 130–1. See also justice, basic minimum
Sugarman, Jeremy, 217n.
Sweden, 176
tactful engagement, duty of, 61–2, 86–7, 92–4. See also beneficence, obligation of, specifiable
tactful silence, duty of
default way of fulfilling responsibility to protect fragile autonomy, 61
overridden by the duty to warn, 61–2, 86–7, 91–2
Tanzania, xvi, 51–4
Taylor, Holly, 193–6, 200
Thailand, 7
therapeutic misconception (so-called), 37
Tuskegee Syphilis Study, 32
trials (medical or drug). See medical research studies
tuberculosis, 151, 160
Uganda, xvi, 18, 104–5, 153, 164–5
United States of America, the, 47, 124, 175, 216
VanDeVeer, Donald, 213
vulnerability
a strength factor in the partial-entrustment model, 42, 156
glossed as vulnerability to another, 46–7, 99–100
rival account of ancillary-care obligations based thereon, 99–102
waiving ancillary-care claims, 215n.
ex post vs. ex ante, 137–8
limited effect of, 135–43
due partly to asymmetries of knowledge and understanding, 137
due partly to ignorance, 141–2
due partly to special responsibilities researchers have accrued, 136, 138–43
moral constraints on solicitation of, 143–52
arising from autonomy's fragility, 145–50
arising from dependence on ancillary care, 143–4
principle of restraint, 147–9, 151
moral power, in principle, to do so, 134, 138
on one's own initiative, constrained by justice, 150–2
warn, duty to, 70, 75–8, 136, 175
a special case of the duty of rescue, 60, 75
relied on by the partial-entrustment model, 61–2, 76, 85
(p.253) welfare, due concern for, obligation of, 218–9. See also rescue, duty of
Wenar, Leif, 14, 96n., 102–5, 142n., 150n.
Wendler, David, 20, 21n., 54–7, 206–8, 215, 222
Wertheimer, Alan, xiii, 36n., 64n., 134n., 143
yeast infections (vaginal candidiasis), 150
Zambian nitazoxanide trial, 156–7, 162, 167, 171