E D I T O R I A L

Informed owner consent – how informed?

In this issue, Derek Flaherty raises the question as to

when informed owner consent is required for a

clinical study which compares two established

anaesthetic techniques, and highlights the problems

that anaesthetists, who do not always themselves

meet the owners, have in obtaining such consent.

We thank him for raising this important issue, so

that it can be discussed.

Few people would disagree that some form of owner

consent is needed to allow the use of data from any

patient, as otherwise there would be a breach of

patient (in this case owner) confidentiality. For

retrospective, or even non-randomized prospective

studies, where the anaesthetic technique is specifically

tailored to the individual needs of that animal,

generalized owner consent to use data usually is

acceptable, and can be incorporated into the main

consent form for treatment. However, when a pro-

spective clinical trial uses randomized treatments, the

situation changes, as the choice is no longer individ-

ually assessed on that patient’s needs.

At VAA, we have implemented the statement of

the International Association of Veterinary Editors

(IAVE), a group to which most of the major

veterinary journals belong. The author instructions

for this journal now state:

Manuscripts will be considered for publication

only if the work detailed therein:

1) Follows international, national, and/or institu-

tional guidelines for humane animal treatment;

where national or institutional guidelines do

not exist, international guidelines must be

followed, e.g., National Institutes of Health or

Euroguide;

2) Has been approved by a properly constituted

internal ethics review committee at the insti-

tution or practice at which the studies were

conducted;

3) For studies using client-owned animals (public

or private), demonstrates a high standard (best

practice) of veterinary care and, as relevant,

involves informed client/owner consent

Prior to acceptance of a manuscript, to verify

compliance with the above policies, the authors

must:

1) Attest that legal and ethical requirements have

been met with regards to the humane treat-

ment of animals described in the study;

2) Specify in Materials and methods the ethical

review committee approval process and the

international, national, and/or institutional

guidelines followed;

3) If so requested, provide evidence, such as a

signed animal use form or protocol number, of

compliance with ethical review at the institu-

tion or practice;

4) Provide evidence in Materials and methods that

the principles of reduction, refinement, and

replacement have been met.

As anaesthesiologists we have a difficult time

when it comes to doing clinical research. In the past

many of us have done things that are within the

bounds of normal clinical practice but still represent

a deviation from the usual protocol and have not

asked permission to do this. The above statements

make it clear that this is no longer acceptable and

we need owner permission if we are to collect data

from animals that involves doing something beyond

our normal practice. Since most of us do not have

direct contact with the owner this means gaining

support from the primary clinician and ensuring

that the target population of owners are consistently

asked to sign on to the protocol. We also need

‘informed’ consent, where the conversation with the

owner and the form they sign have to represent

both the expected benefits and complications that

might be associated with the research. The Office for

Human Research Protection (NIH) has a checklist

for an informed consent form that could easily be

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Veterinary Anaesthesia and Analgesia, 2012, 39, 321–323 doi:10.1111/j.1467-2995.2012.00760.x

applied to owner consent for animal research

(Table 1) (Schwenzer 2011). In the UK, the recently

published advice from the Royal College of Veteri-

nary Surgeons to support the Guide to Ethical

Conduct, emphasizes informed owner consent for

clinical research, even to the extent of obtaining this

for using blood and tissue samples for purposes

other than the reasons for which they were

obtained (RCVS 2012a,b).

Another thorny issue that we face is that of the

reward (if any) for participating in the research.

What constitutes coercion? Are we offering to pay

for the procedure so that the owner’s bill is forgiven

– this might be the only way that someone with a

low income could have the procedure done? Is this

coercion or is this providing a benefit to someone

and society (in the case of neutering operations or

vaccinations) who would not otherwise have par-

ticipated? It seems reasonable to pay for procedures

and/or drugs (and even pay expenses) that would

not otherwise have been done on the animal (e.g. a

follow-up imaging procedure) but there are obvi-

ously many grey areas in this issue (including

illegality in some countries). If the subjects are

drawn from a population of owners that have some

other intangible reward in mind this can also be a

problem. This could occur when the owners are

students, residents or staff working at the institu-

tion where the research is to be promulgated.

These owners may wish to curry favor with the

lead investigator and there may be a hope/expec-

tation that this will lead to things such as better

grades or a reward of services that might otherwise

be costly for the owner. An example of staff/

students/faculty volunteering their own animals for

a study that went horribly wrong, was provided by

Table 1 Modified from OHRP informed consent checklist.13

1. A statement that the study involves research Diffferentiates research from clinical care

2. An explanation of the purposes

of the research

3. The expected duration of the subject’s participation Permission must be obtained if you desire to contact

subject in future. This is important when banking specimens

for unknown, future genetic testing

4. A description of the procedures to be followed Limit medical jargon. Use lay terms, but don’t dummy down the

consent. Use diagrams, time lines, and tables to aid in

disclosure of complex investigational procedures

5. Identification of any procedures which are experimental Disclose which procedures are being done solely for research

6. A description of any reasonably foreseeable risks

or discomforts to the subject

Disclose probability (e.g. frequent, occasional, rarely) and

severity with forthrightness

7. A description of any benefits to the subject or to

others which may reasonably be expected from

the research

Many studies do not have the potential to directly benefit

the research subject, but may benefit future patients. This

should be stated clearly and directly

8. A disclosure of appropriate alternative procedures

or courses of treatment, if any, that might be

advantageous to the subject

In studies where there is no direct benefit, such as Phase I trials,

the alternative is simply not to participate

9. A statement describing the extent, if any, to which

confidentiality of records identifying the subject

will be maintained

Disclose what will be shared with pharmaceutical companies,

NIH, or regulatory agencies

10. For research involving more than minimal risk, an

explanation as to whether any compensation, and an

explanation as to whether any medical treatments

are available, if injury occurs and, if so, what they

consist of, or where further information may be obtained

The sponsor of the study may have more limited compensation

than your institution provides. This should be disclosed

11. An explanation of whom to contact for answers

to pertinent questions about the research and research

subjects’ rights, and whom to contact in the event of a

research-related injury to the subject

When a research subject is asked to participate in a long study,

it may be necessary to have sub-investigators who can

respond 24/7

12. A statement that participation is voluntary, refusal to

participate will involve no penalty or loss of benefits to

which the subject is otherwise entitled, and the subject

may discontinue participation at any time without penalty

or loss of benefits, to which the subject is otherwise entitled

If you are banking de-identified specimens, the limits of

withdrawal need to be disclosed

Editorial

� 2012 The Authors. Veterinary Anaesthesia and Analgesia322 � 2012 Association of Veterinary Anaesthetists and the American College of Veterinary Anesthesiologists, 39, 321–323

Francis et al. (2007) where human albumin was

administered to six otherwise healthy dogs and two

of them died! It is suggested that investigators who

are looking for such subjects from their local

community do it by posters or impersonal adver-

tisements but that they do not directly solicit the

owners so that there is less likelihood of direct

inducement (Schwenzer 2011). It is interesting

that in studies that look at attitudes to rewards for

altruistic behavior, the application of a monetary

reward to something may decrease the likelihood of

participation (Heffernan 2011).

Journal editors are put in the role of arbiters on

this subject because the rules that govern this issue

vary considerably from country to country and

what may seem to be an acceptable use of animals

in one country is abhorrent or even illegal in

another. Ethics committees in different establish-

ments, even within the same country, may interpret

the rules differently. This is an international journal

and we will try to publish articles that meet the

highest ethical principles. This means that as

authors we have to use high standards in our daily

practice and get informed owner consent if there is

any question that we are deviating from the

excellent care we all try to provide for our subjects

and patients.

To return to Mr Flaherty’s example, his study was

both legal and ethical from the point of view of the

excellent care given to the animals. His ethics

committee considered that it did not need informed

owner consent. If this had been a study using human

subjects, informed patient consent would have been

mandatory. In view of the recently published IAVE

and RCVS guidelines, his ethics committee might

come to a different conclusion today.

Peter J Pascoe & KW Clarke

E-mail: pjpascoe@ucdavis.edu;

KClarke@RVC.AC.UK

References

Francis AH, Martin LG, Halsorson GJ et al. (2007) Adverse

reactions suggestive of type III hypersensitivity in six

healthy dogs given human albumin. J Am Vet Med

Assoc 230, 873–879.

Heffernan M (2011) Wilful Blindness: Why We Ignore the

Obvious At Our Peril. Walker, New York, NY, USA.

RCVS (2012a) http://www.rcvs.org.uk/advice-and-guid

ance/code-of-professional-conduct-for-veterinary-surgeons/

supporting-guidance/use-and-re-use-of-samples-images-

post-mortems-and-disposal/ Paragraphs 12.1, 12.2, 12.8

RCVS (2012b) http://www.rcvs.org.uk/advice-and-guid

ance/code-of-professional-conduct-for-veterinary-surgeons/

supporting-guidance/recognised-veterinary-practice/

Paragraphs 25.7, 25.18, 25.19, 25.20, 25.21.

Schwenzer KJ (2011) Best practice & research in anaes-

thesiology issue on new approaches in clinical research

ethics in clinical research. Best Pract Res Clin Anaesthiol

25, 569–582.

Editorial

� 2012 The Authors. Veterinary Anaesthesia and Analgesia� 2012 Association of Veterinary Anaesthetists and the American College of Veterinary Anesthesiologists, 39, 321–323 323