California Laws on 'Human Experimentation' and 'Experimental Drugs'Author(s): Carol LevineSource: IRB: Ethics and Human Research, Vol. 1, No. 2 (Apr., 1979), pp. 9-10Published by: The Hastings CenterStable URL: http://www.jstor.org/stable/3563942 .

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April 1979

"mentally infirm.") Natalie Reatig of the Psychophar-

macology Research Branch, Division of Extramural Research Programs, NIMH, has analyzed the public re- sponses and finds that the overwhelm- ing majority expressed opposition to the proposed regulations. Only about 22 letters (5 percent) supported the proposals or urged more stringent safe- guards.

Over half of the letters were from in- dividual psychiatrists affiliated with university medical schools and depart- ments of psychiatry; another 21 per- cent of the responses were from professional personnel (also mostly psychiatrists) at hospitals, clinics, and other treatment centers. Twenty-seven letters (7 percent) were sent by various organizations, mostly mental health or professional legal associations. Sup- port for the proposed regulations came mainly from the legal organizations and from a few state departments of mental health or human resources.

In her summary Reatig notes with surprise that only twenty-five letters (6 percent) were received from IRBs or from individuals identifying them- selves as IRB members, even though the proposed regulations are addressed to IRBs and have "obvious, serious im- plications for their work." She con- cludes: "While it is likely that numbers of the responding psychiatrists also serve on review boards and chose to re- spond as researchers rather-than board members, I found this small response disappointing."

Much of the criticism in the com- ments centered around the definition of "minimal risk." Most respondents expressed concern that procedures per- formed only with the mentally dis- abled or procedures that are new or nonroutine would be precluded from the classification of "minimal risk," de- fined in the proposed regulations as "the probability and magnitude of physical or psychological harm or dis- comfort that is normally encountered in the daily lives or in the routine med- ical or psychological examination of normal individuals."

One individual writing in opposition said: "... since any psychiatric treat- ment procedure or medication is not normally encountered in the daily lives of normal individuals, [it] always in- volve[s] greater than minimal risk and, thus, the standard becomes useless for classification.... On a percentage ba- sis, the risk of an automobile accident normally encountered in the daily lives of normal individuals is greater than the risk that psychiatric patients face from treatment and/or research."

However, a supporter of the definition argued: "If these situations [the risks faced in research and the risks faced in everyday life] were comparable, there would have been no need. for these regulations."

Many respondents also protested against the proposed requirements for mandatory "consent auditors" and "patient advocates." Many argued that local IRBs ought to be given discretion- ary power to impose requirements for such protective mechanisms when, in their judgment, they are deemed neces- sary. If these roles were to be made obligatory, said a typical respondent, "who will review the consent auditors' decisions? They may be too restrictive or too lenient. They may have their own set of prejudices or develop some in the process of demonstrating that their jobs as consent auditors are worthwhile and need to be continued." Another writer complained that the consent auditor is given "no guidance as to the standards by which he/she is to evaluate the patient's capacity to ei- ther consent or assent."

Those who supported the establish- ment of consent auditors urged that they be given even wider latitude. "This appointment should be made when there is any serious question as to the individual's ability to consent or when there is more than a minimal de- gree of risk. .. ."

The Commission recommended that the need for a consent auditor should be a discretionary judgment of the IRB except in those activities in which more than minimal risk is presented by interventions that do not hold out the prospect of direct benefit for indi- vidual subjects.

Final regulations on research involv- ing those institutionalized as mentally disabled (or infirm) will probably not be issued until the revised basic set of regulations governing human subjects research (45 CFR 46, Subpart A) has been worked out by the Department.

California Laws on 'Human Experimentation' and 'Experimental Drugs'

What should be the role of a state legislature in the protection of human subjects? Legislators in California ap- parently believe it should be an active one; in addition to the bill restricting research on prisoners (Chap. 1250, AB 1592) reported on in last month's "Up- date," two other major bills have been passed and signed by Governor Brown.

AB 1752, "Human Experimenta- tion," which went into effect on Janu- ary 1, 1979, was designed mainly to bring investigators in private practice or in drug companies into a regulatory framework, particularly with regard to ensuring the informed consent of sub- jects. Even though institutions with general assurances are exempt from most of the provisions, the law still af- fects their procedures. Most signifi- cantly, any person who is being asked to participate in a "medical experi- ment" must be given-in addition to the regular consent form for the study--a copy of a statement of an "Ex- perimental Subject's Bill of Rights."

A "medical experiment" is defined as:

"(a) The severance or penetration or damaging of tissues of a human subject or the use of a drug or device, as defined in Section 26009 or 26010, electromagnetic radiation, heat or cold, or a biological substance or or- ganism, in or upon a human subject in the practice or research of medi- cine in a manner not reasonably re- lated to maintaining or improving the health of such subject or other- wise directly benefiting such subject.

"(b) The investigational use of a drug or device as provided in Sec- tions 26678 and 26679.

"(c) Withholding medical treat- ment from a human subject for any purpose other than maintenance or improvement of the health of such subject." Each institution can draw up its own

"bill of rights"; many are simply using the language of the ten points as stated in the law. The University of California, San Francisco, has drawn up a version in simpler language:

The rights below are the rights of every person who is asked to be in a research study. As an experimental subject I have the following rights:

1) To be told what the study is try- ing to find out,

2) To be told what will happen to me and whether any of the pro- cedures, drugs, or devices is dif- ferent from what would be used in standard practice,

3) To be told about the frequent and/or important risks, side effects or discomforts of the things that will happen to me for research purposes,

4) To be told if I can expect any benefit from participating and, if so, what the benefit might be,

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MO 5) To be told the other choices I

have and how they may be better or worse than being in the study,

6) To be allowed to ask any ques- tions concerning the study both before agreeing to be involved and during the course of the study,

7) To be told what sort of medical treatment is available if any complications arise,

8) To refuse to participate at all or to change my mind about par- ticipation after the study is start- ed. This decision will not affect my right to receive the care I would receive if I were not in the study.

9) To receive a copy of the signed and dated consent form,

10) To be free of pressure when con- sidering whether I wish to agree to be in the study.

Investigators who willfully fail to ob- tain "informed consent" as defined in the bill are subject to civil and criminal penalties-imprisonment in the county jail for not more than one year, or a fine not to exceed $10,000. Specifically ex- empt from the provisions of AB 1752 are terminally ill persons who have ex- ecuted a directive concerning the with- drawal or withholding of lifesaving treatment under the provisions of Cal- ifornia's Natural Death Act, which was passed in 1976.

The second major bill, "Experi- mental Drugs" (AB 3572), became law at the same time. Like the law on human experimentation, it exempts in- stitutions with general assurances from some provisions. AB 3572 applies to all uses of "experimental drugs," as defined in California law, though it probably does not include unapproved uses for approved drugs.

In situations covered by this bill the

informed consent procedure mandated in AB 1752 must be used. In addition, children aged seven and over must pro- vide their own consent. Furthermore, consent of minors shall be only for the "prescribing or administering of an ex- perimental drug which is related to maintaining or improving the health of the subject or related to obtaining in- formation about a pathological condi- tion of the subject," clearly limiting any involvement of children as con- trols. The bill also provides for filing of the "consent procedures" with the State Department of Health Services and review of all uses of experimental drugs by an IRB, either in an institu- tional setting or by a state-approved in- dependent IRB.

IRBs in other states will be watching the experience of California IRBs to see how these new laws are affecting their work.

Carol Levine

ETTERS

Was There 'Good Cause' for the 'Interim Final Regulation'?

A copy of the letter' sent by Mrs. Es- telle Fishbein to the Acting Director, Of- fice for Protection from Research Risks, was transmitted to the Administrative Conference of the United States. The Ad- ministrative Conference is an agency of the federal government that studies and makes recommendations about the pro- cedures of federal agencies; its role is ad- visory-it has no enforcement authority. Mr. Jeffrey Lubbers, Senior Staff At- torney of the Administrative Conference, responded to Mrs. Fishbein in a letter dated January 26, 1979; it is reprinted here with Mr. Lubbers' permission. This response is the opinion of Mr. Lubbers- not that of the membership of the Ad- ministrative Conference.

Chairman [Robert A.] Anthony asked me to respond to your letter of January 18 evincing your alarm over the in- creasing tendency of Federal agencies to promulgate regulations, char- acterized as "interim-final regulations" without prior public notice. You en- closed a letter of complaint to the De- partment of Health, Education and Welfare concerning the Department's interim-final regulation amending the definition of "informed consent" to in- clude advice on compensation.

I thought your letter to HEW was an extremely well-articulated statement of concern. If I were the recipient of the letter I would act promptly to find out why notice-and-comment was not pos- sible in view of the time that evidently elapsed between issuance and final publication of the amended rule.

However, as I'm sure you must real- ize, agency use of the "interim-final regulation" technique may often be salutary. The key question is whether the agency has properly invoked the "good cause" exemption of 5 U.S.C. ? 553(b)(B). Where the agency properly finds that notice-and-comment on a proposed rule (or proposed amend- ment to an existing rule) is "imprac- ticable, unnecessary, or contrary to the public interest," and incorporates that finding and a brief statement of reasons in the rule as issued, then the "interim- final" technique would be quite appro- priate. The Department did state that "good cause" existed for dispensing with notice-and-comment, though its brief statement of reasons ("The public interest would therefore be served by adding this element of informed con- sent requirements as soon as possi- ble.") might be viewed by a court as inadequate. Also the Department did seek comments on the amended defini-

tion of informed consent and stated that the amendment was "subject to possible future changes after consid- eration of public comment."

Therefore, I believe your letter is best construed as a critique of HEW's appli- cation of section 553 rather than as an argument against any agency use of the interim-final technique. Indeed, the use of interim rules might be required by law in situations where the agency has to engage in emergency regulation or fill a loophole in a regulation quickly. Of course public comments can and should still be normally sought at that point. The Administrative Conference has formally recommended such a pro- cedure when interpretive rules are is- sued without notice-and-comment (ACUS Recommendation 76-5).

In closing, I believe your vigilance as a regulated entity is well-warranted and is an intended by-product of HEW's program to implement Presi- dent Carter's Executive Order 12044. I hope you and HEW can arrive at an amicable resolution of your differences and thank you for bringing an interest- ing issue to our attention.

Jeffrey Lubbers Senior Staff Attorney

REFERENCES 'Fishbein, EA.: Objections to the "Interim Final

Regulation." IRB: A Review of Human Sub- jects Research 1 (No. 1): 9-11, March 1979.

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