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Afternoon panel:

What is the responsibility of the researcher to the patient or subject

in cases in which human organs, tissues, cells, or body fluids (henceforth

called "human materials") are used in research that might lead to the

development of products that might have market value?

Before I respond

to this question I wish to consider briefly the point at which persons lose

their "interests" in materials that once were part of their bodies.

Ia

this discussion I shall make frequent reference to my book, Ethics and

Regulation of Clinical Research, Urban & Schwarzenberg, Baltimore, 1981.

After a person abandons human material in order to serve his or her

personal good, he or she loses all but one interest in it; that interest

is privacy.

Common ways in which this is accomplished range from urina

tion to surgical removal of a diseased organ (e.g., the gallbladder).

These materials should be seen as passing into the public domain after

the urine has been flushed or after the gallbladder has been examined by

a surgical pathologist and is destined for its usual disposition

in

cineration.

After the surgical pathologist has completed his or her

examination of the gallbladder, we permit researchers to use this organ

for their own purposes as long as the patient's privacy interests are

protected properly. Usually this is accomplished by not letting the re

searcher know whose gallbladder it was.

Thus, in the development of

something like the BeLa cell line, which, of course, has considerable

commercial value, the modern researcher usually does not know who "Helen

Lane" is.

Helen Lane is the fictitious name of the woman from whom the

original cervical cancer cells were taken to establish the Hela cell line.

We do not use informed consent in such cases.

Rather, we recognize

a "right of notice" (Levine, pp. 111-113).

The customary practices of the

hospital are made explicit on the forms used to authorize surgery or

autopsy.

The surgical permission form, for example, states that it is

customary to deliver the removed part to the surgical pathologist for

diagnostic examination and that in some cases it might be retained for

research or teaching purposes before it is destroyed.

In the event the researcher must know the name of the patient in

order to accomplish the purposes of the research, additional procedural

protections are involved.

In some cases, in order to protect privacy

interests, it is necessary to negotiate full informed consent with the

patient (Levine, pp. 112-113).

Such procedures are also used for "left

over" blood, urine, spinal fluid, and so on, collected for diagnostic

purposes.

If the researcher wishes to remove human material primarily to serve

research interests, the situation is different.

In this case, full in

formed consent is required ethically as well as by the regulations of

DHHS and FDA.

Among the elements of informed consent defined in federal regulations

00

1

an explanation of the purposes of the research..." and "A

are:

description of any benefits to the subjects or to others which may reason

ably be expected from the research."

In order to illustrate how such re

quirements are made operational in the practical arena, let us consider

the consent form we might have prepared for Dr. Hagiwara's mother (Royston, I.:

Cell Lines From Human Patients:

Who Owns Them?

A Case Report.

clinical

Research 33:442-443, 1985). In order to make this discussion less compli

cated let us disregard the fact that Dr. Hagiwara is a molecular biologist

whose father has the capacity to produce the antibody in Japan.

In passing

I wish to note that the entire incident could have been avoided by following

the Task Force recommendations I discussed this morning.

The IRB at Yale University School of Medicine would have approved a

consent form which included the following statements of purpose and

benefits:

"The purpose of this research is to learn more than we now know about

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knowledge developed in the course of this research will form the basis for

developing improved treatments for future patients with cancer of the cervix."

In general, we ask researchers to tone down their usual overly exuber

ant statements of anticipated benefit.

We do this in order to avoid creat

ing the appearance of what the Nuremberg Code refers to as "... deceit, duress, overreaching, or other ulterior form of constraint or coercion...."

Should we also go on to discuss the commercial implications of this

research?

For the sake of this discussion, let us tentatively say "yes."

The statement of benefits may be expanded to read:

"If we are successful

we may be able to develop a cure for cancer which, of course, would have

enormous market value."

If we are to make such statements, to whom should they be proferred?

As we consider answering this question it is worth keeping in mind that

most such efforts fail.

Researchers may take cells from hundreds of people

before they achieve success.

Should such statements be made to all of these

people? Are they all entitled to negotiate for a share of the proceeds?

Or, instead, is it more like a lottery in which there will be but one winner?

It is a commonplace that all scientists stand on the shoulders of their

predecessors.

They all draw on the work of those who have earlier discovered,

validated, and published.

Such is also the case for these research subjects.

Should we have discussed potential market value with all of the many men and

women who donated their cells so that researchers could learn how to make

hybridomas and monoclonal antibodies in the first place?

The number begins

to loom large.

Much is made of our current capacity to make synthetic human hormones

using recombinant techniques.

This capacity is totally contingent upon

knowing the molecular structure of the hormone.

In order to learn the

structure of ACTH, Dr. Aaron Lerner and his colleagues had to first purify

the hormone.

This required taking the pituitary glands from approximately

7,000 dead human beings.

Are their estates entitled to a share in the proceeds?

The field of drug development provides us with another example to ponder.

The average number of patients participating in phase I-III drug studies is

about 3,000. They all give their blood, their urine, and much more in order

to participate in such development.

Are they entitled to an opportunity to

negotiate for their share of the market?

If researchers have a duty to disclose their economic interests, should

we also require disclosure of what I referred to this morning as the other

traditional coins of the academic realm?

Should they disclose the relevance

of the subject's cooperation to their opportunities for promotion, recognition,

and so on?

Are the subjects entitled to a share in the Nobel Prize?

Should

Aaron Lerner offer to divide the Lita Annenberg Hazen Award with 7000 estates?

I think not.

I think that if the market value is to be disclosed, it should be at

the "stage of inevitability," the stage in applied research at which the

development of a product that could have market value becomes inevitable.

At that point, this fact could be disclosed to prospective subjects in

order to give them an opportunity to accept or reject cooperating in the

development of the product.

Thus, while some persons might be delighted

to contribute to the development of an improved oral contraceptive, some

others might not.

I agree with the intent of Congress expressed in the Organ Procure

ment and Transplantation Act in which it proscribes "...sale for valuable

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However, for various good reasons, I do not think that persons should be

encouraged to sell any parts of themselves.

It may be somewhat hypo

critical or evasive but when we give people money in exchange for "re

plenishable tissues" we usually call it a payment for services rather than

a purchase of tissue.

Moreover, the amounts of money that change hands in

such transactions tend to be rather trivial when compared with the amounts

we are considering today.

With regard to research subjects, I think we should continue the pre

vailing practice of paying them for their time and inconvenience as sugo

gested by the National Commission for the Protection of Human Subjects of

Biomedical and Behavioral Research (Levine, pp. 59-61).

If we disclose potential market value at the stage of inevitability,

no doubt some prospective subjects will wish to negotiate for a share of

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