ICMR DRAFT GUIDELINES FOR ASSISTED REPRODUCTIVE TECHNOLOGIES

ICMR DRAFT GUIDELINES FOR ASSISTED REPRODUCTIVE TECHNOLOGIES

A CRITIQUE AND SOME RECOMMENDATIONS

When Indian Council of Medical Research put out Draft guidelines for regulating Assisted Reproductive Technologies, we submitted a detailed reply suggesting amendments.

General Comments

The document released by ICMR ‘Ethical guidelines for the Biomedical Research on Human Subjects’ in 2000 contained a chapter suggesting guidelines for the practice of Assisted Reproductive Technologies [ART]. The current draft guidelines appear to be an effort to broaden the scope of the earlier guidelines. We had submitted, on 6th September 1999, our suggestions to improve the earlier draft. Here we reiterate some of the points which were not incorporated in the ICMR Code, in addition to the detailed critique of the ART-specific new draft guidelines.

Although the new guidelines attempt to incorporate some issues related to gender inequality, they still fall short on many fronts as detailed later. The ethical guidelines should go beyond technicalities and build effective safeguards so that the unequal power relationship between the providers of new technology and users is minimised. The guidelines should also keep in mind the unequal gender balance, and ensure that the rights of women users of these technologies are not compromised in any manner.

For instance, ethical guidelines should not accept social stigma attached to infertility as a norm. Societies have evolved social ways for childless couples to deal with infertility, for instance, adoption, foster-parenthood, etc. The guidelines should ideally encourage adoption and foster parenthood, and certainly not make loaded statements such as ‘Infertility is a tragic condition. The agony and trauma of subfertility is best felt and described by infertile couple themselves’ [in ‘Introduction’]. We also take this opportunity to stress the need for prevention of infertility as a public health measure, since the country can ill-afford costly techniques of ART.

Scientific developments such as stem cell research have a direct impact on ART. The ethical dilemmas involved in commercial transfer of embryonic material, stem cells etc are deep, and have yet to be played out in the arena of individual lives, the medical establishment and the market. It is still too early to visualise all the knotty and complex situations that could emerge. However, ethical guidelines for ART need to be broad and flexible in order to accommodate these future scenarios, but stringent enough to prevent violation of individual rights. The present draft guidelines have rather detailed descriptions of technical procedures and lists of indications for the same, so also discussion on the diagnosis of infertility and complications associated with the procedures, all of which are redundant.

The discussion on technical procedures is relevant only in so far as it poses ethical dilemmas that can be foreseen. Moreover, the guidelines have not been drafted keeping in mind a long-term perspective. Scope should be left in the guidelines to consider introduction of new technologies and the debates ensuing from their potential use. This is also true for anticipating future modifications and advances in diagnostic techniques. For example, laboratory tests which should be carried out for ensuring sperms are from a healthy, uninfected donor should include ruling out HIV, HBV, HCV, syphilis and other known sexually transmitted diseases, but not restrict itself only to these infections. A basic minimum should be mentioned in the clause relating to such cases, leaving scope to add more in the future.

The field of Assisted Reproduction is a rapidly developing one. Newer techniques, modifications of existing ones and new approaches characterise this specialisation. In this context, particular care needs to be taken to ensure that the rights of women subjects of research as well as consumers of these techniques are articulated. For instance, infertile women, due to their intense desire to conceive are particularly vulnerable to commercial interests. Guidelines for ART must safeguard their interests.

It is unclear whether the Guidelines for Assisted Reproductive Technologies is proposed to be a part of the ‘Ethical guidelines for the Biomedical Research on Human Subjects’ or the ICMR Code or a stand-alone document. If the former is the case, guidelines covering research-specific issues (for instance clinical trials) have been dealt with in the ICMR Code. However, if the current ART Guidelines are to stand on their own, there is a need to reiterate some safeguards for research subjects. This is particularly necessary in the commercial context where the manufacturer-researchers themselves stand to gain from the results of the trials. It is then incumbent upon neutral bodies to ensure that ethical guidelines are adhered to and also bring to light any violations. For this, well-formulated guidelines drafted with foresight and a long-term vision are a must.

Specific Comments

We would like to divide our comments in two sections :

A. Comments on three issues which need more attention throughout the document and should get a priority treatment, namely - informed consent, access of ARTs to any consenting adult and prevention of sex selection during ART practice.

B. Specific comments on each of the section of draft guidelines.

A.1. Informed Consent

Though the sample consent forms have been included in the guidelines, there is no direct mention of the issue of ‘informed consent’ [except a small section 3.2.5]. The general guidelines published in 2000 do have a section, however, the relevant portions and expanded scope related to the specific field needs a special mention in these guidelines.

1. While conducting clinical trials or offering newer technologies, it should be ensured that the person is provided adequate information in easily understandable language. Information about the potential risks and benefits should be provided verbally as well as in the written form in a simple, easily understandable language with minimum use of technical jargon. Written information should be provided in vernacular language whenever necessary, even for newer potentially complicated procedures.

2. As a general rule, signing the proforma as an evidence of informed consent (written informed consent) should be witnessed by a person not related with the trial.

3. In matters of Informed Consent, research in genetics, assisted reproductive technologies, etc. should not be treated as different from other types of research. Counselling followed by written informed consent has to be mandatory.

4. Even when the research design involves no more than minimal risk (for example, where the research involves only collecting data from subjects’ records) the ethical review committee should make a case-by-case judgement about waiving some or all elements of informed consent.

5. Participants in the clinical trials should be offered life insurance for potential danger. Such compensation should be provided to every participant who has actively participated in the trial, regardless of whether he/she continues to participate until the end of the trial. A minimum period of participation in the trial should make the person eligible for the insurance cover. At the time of signing the consent form, the participant should be made fully aware of the health insurance provided. The package should form part of the written consent form.

6. Confidentiality of the data. At the time of signing the consent form, the participant should be consulted and permission obtained to use the data for further analysis, provided the identity of the participant is not disclosed. The co-ordinator of the study should not be allowed to disclose the identity of the participants to individuals or institutions not associated with the trial, without seeking permission from the ethical committee involved in the approval of the protocols of the trial.

7. The exchange of faith [between the co-ordinator and the participants of the trial] should be mutual - both sides should be in possession of records/copies of the papers signed by both parties as part of a moral agreement.

8. The scope of the information provided to the prospective research subjects needs to be widened. Hence it is our recommendation that the following information be mandatory:

    • The experimental nature of the drug/ procedure/technique.

    • The goals of the study.

    • The nature of the drug/procedure/technique used, including its significance in physiological and/or pathological processes.

    • The likely mode of action of the preparation/procedure/technique under trial.

    • The results of prior studies of similar nature using the similar preparation, including adverse reactions.

    • Theoretical risks including adverse reactions not seen in previous studies.

    • Options of treatment for problems arising out of the testing of the drug/ procedure/technique.

    • Compensation available for subjects who experience adverse reactions. This information may include the source of compensation and the spectrum of coverage (e.g. medical treatment, lost income, pain and suffering).

    • Real and theoretical benefits from participation in the study.

    • Study design, including: eligibility criteria for participation; number of participants and centres; duration of study; mode of administration of a formulation and route of administration; number and nature of visits: in particular, procedures potentially considered invasive should be outlined (e.g. blood drawing, HIV testing, physical examination, injections, skin tests).

    • The need to be re-contacted in the course of follow-up studies.

    • Provisions for confidentiality of patient records. (In general, patient information is restricted to study personnel, within the limits of the law. Data should be published in such a way that the identity of individual patients is protected.)

    • The name and telephone number of a person who may be contacted for further information pertaining to the trial or for reporting of adverse reactions.

A.2. In general, ARTs should be made available to any consenting adults who desire to have a child using these technological innovations. The marital status of the persons - married, unmarried, single, divorced - as well as their sexual orientation -- heterosexual, homosexual or bisexual -- should not be used as decision-making criteria. Changing social trends the world over should be kept in mind while setting up ethical guidelines and accordingly the words ‘husband’ and ‘wife’ must also be substituted by ‘male partner’ and ‘female partner’.

A.3. Prevention of sex selection during ART

The Government of India has passed an act to prevent sex determination, namely the PNDT Act 1994. There is a further move to widen the scope of this Act and prevent sex selection using any one of the existing or newly developing techniques that might come into use in India. In the same spirit, ART guidelines should be explicit about not selecting sperm or choosing a methodology which will preferentially select sex for non-medical reasons.

B. Specific Sectionwise Comments.

Chapter 1

The elaborate ‘Introduction’ and ‘Brief history’ sections appear unnecessary as a part of document specifying ethical guidelines. [1 & 1.1]

Portraying ART as an adjunct to birth control is a euphemism and such a comparison need not be made. [1.1.1]

The section on definitions needs to be trimmed [1.2], however, a scope for inclusion of future technologies which may become the mainstay of ART practice needs to be acknowledged and is lacking in the current definition of ART.

The section on physical requirements for an ART clinic is currently too rambling and needs to be tightened. [1.3] A general purpose laboratory may or may not be a part of the clinic itself, provided it is available in close proximity. [1.3.1.3] Additionally, the laboratory facilities should be such to include diganosis of HIV, HBV, HCV, syphilis, gonorrhoea, chlamydia etc. but should not be restricted only to these. It should be possible to rule out any new, relevant infection. Similarly estimation of various hormones should be done at least with assays as sensitive and specific as immunoassays, not restricting the technology to immunoassays permanently [1.3.3.1]. These details may be left to the discretion of a Committee, perhaps under the National Accreditation Committee (NAC), and rules for the same formulated.

ART involves many complex issues and some of the ethical and legal dilemmas posed while using ART are different. A counsellor should be well versed with such issues and as far as possible should not be influencing the decisions of the potential users of ART without explaining the positive and negative aspects of the issue. [1.5.4]

The indications and contra-indications of various procedures need not be a part of the ethical guidelines [1.6] ICSI using sperm directly from epididymis or testis as a procedure is currently associated with [and likely to remain so until radical technological developments to identify defective sperm is developed] much higher rate of ‘abnormal’ offspring born after its use. Any attempt to ‘mature’ sperm in vitro or use sperm directly from epididymis or testis should not be permitted as a legal ART, until adequate safety data about the use of such sperm becomes available. [1.6.6, 1.6.11.2]

Chapter 2.

General guidelines for selection of patients for ART should be given, according to a broad principle. Details as mentioned in this chapter appear unnecessary, and can be left to the Committee (mentioned above) to details, with time-to-time updating.

Chapter 3.

What kind of research can be done, what can/should be the maximum age [in days] of embryos are contentious issues the world over. However, the ethical guidelines need not set out priorities for research in this document, but if anyone wishes to use the spent embryos for research the name of the accreditation authority should be mentioned [3.2.9] and principles of ‘informed consent’ mentioned above followed meticulously. Infertility clinics, if doing research, should have a properly constituted institutional ethics committee to approve protocols etc. based on ICMR guidelines. [3.2.9]. The provisions of ‘informed consent’ and other ethical guidelines for providing conselling, health insurance etc. should also apply to any newer techniques or modifications in techniques even if these are not part of a formal trials. In this chapter, as in everywhere else, the guidelines reveal biases which could work against the interests of certain sections who are not within the narrowly defined confines of the family e.g. single parents, non-heterosexuals etc. Hence ‘husband’ should be uniformly replaced by ‘male partner’ and ‘wife’ with ‘female partner’. [3.5.8]

Based on the law already in existence, a clear emphasis should be made to ban sex selection by any procedure including PGD [3.5.10]

The guidelines reinforce conservative attitudes by recommending matching of religious and ethnic background for donor insemination. Issues like religion, caste and educational level have no bearing on genetic inheritance and should not be considerations during donor selection. [3.5.14]

Descriptions in sections 3.6.1, 3.7.1 and 3.9.1.6 should be futuristic in attitude i.e. should leave scope for inclusion/exclusion of more/different diseases and infections.

The reasons for permitting law firms to run semen banks are not clear [3.9.1.1].

The ART centre should not only be not involved in the negotiations of ‘surrogacy’ deals but should also not get monetary benefits from the deal. [3.10.3]

Ethical guidelines for practice of ART need not include positive or negative intent statements on what research should or should not be done and/or encouraged [3.14.11, 3.14.12] instead it should restrict itself to stating what is banned.

Responsibilities of the accreditation authority [3.15] need to be properly defined as this becomes not only the accreditation authority but also the supervisory/regulatory authority in due course of time. More specific details about this are mentioned below in the context of Chapter 9.

In today’s world, statements such as ‘However, it is universally recommended that AID should be performed only on married women and that too, with the written consent of her husband’ [3.16.4] are objectionable. There should not be an attempt to leave single women [widows, unmarried, separated] out of these facilities if they wish to make use of it. Similarly if gay couples wish to have a child using AID, they should also not be prohibited from seeking help. Reinforcement of husband-wife-in-laws etc. kind of family structure as the only family structure acceptable to the society is not a message that these ethical guidelines should convey. Rights of [sexual] minorities in the society need to be accepted. This has already been stated under 3.16.6 in the same document and the rest of the guidelines should follow it.

Chapter 4.

A general comment on consent forms is about inclusion of a statement declaring prohibition of sex selection. For example, in forms 4.2, 4.3 and 4.6 the following sentence can be added :

‘We are aware that a child of desired sex cannot be asked for during this process, as it is against the law.’ Another statement delineating the doctor’s legal responsibility should also be added in the document providing information about the technique: “This clinic does not provide services for sex selection, as it is illegal.”

Certain forms of ICSI, especially using PESA and TESA, are too frequently associated with malformed babies and hence their use should not be permitted at this juncture. Hence consent form 4.5 should be withdrawn and a clause in form 4.4 regarding use of ICSI should be appropriately modified.

Since uncertainty over undetectable HIV looms large on ART in general, especially so for the surrogate mother, it is recommended that a health insurance package for 10 years in specific HIV context should be included as a part and parcel of surrogacy contract [4.7].

The dos and don’ts for the surrogate mother appear to be unnecessarily stringent and an encroachment of her rights. Care must be taken, without moral overtones, to reach a balance between the rights of all the persons involved in the process – the genetic parents, the surrogate mother, her partner, and the child-to-be. [4.7/4.8]

On page 13 of chapter 4, under 4.8, para 8 from above- the word ‘biological’ parents should be replaced by ‘prospective’ parents - as here the surrogate mother is one biological parent.

Chapter 5.

Appears unnecessary. A mention about using ‘trained’ people should be made somewhere but such details as are mentioned here are not required. A separate manual may be prepared by the Accreditation Authority and revised frequently to give such dos and don’ts about the procedures and the clinic.

Chapter 6.

Guidelines for the practice of ART is not a place to recommend what research should be done in the context of ART and embryos. This kind of advocacy should not be a part of this document.

CHAPTER 7 - CHECK

Chapter 8.

In our opinion, deciding research priorities and/or setting up a national data base is outside the purview of this document.

Chapter 9.

There are many issues which need to be detailed about the National Accreditation Committee [NAC]. Some of them are: what is the scope of the NAC - is it only responsible for issuing and revoking licenses? Or does it recommend revoking of license to some other authority? What should be the qualifications of various members to be appointed on it? Should there be state level ACs for efficient implementation? Is it a governmental committee with an IAS officer as member secretary or a non-government type with all ad hoc appointed members? What executive power does it have? If it has executive powers for inspection of ART clinics etc. what should be the modus operandi? There should be a balance between autonomy of functioning and unbridled powers,

Additional Points

We had listed the following points, which were not incorporated in the existing guidelines for ART. We reiterate them here as we feel they are of relevance:

1. General Ethical and Legal Aspects

In case of serious/life threatening illness which needs the biological parents’ or siblings e.g.. bone-marrow transplant, kidney transplant etc., should the identity of a sperm or egg donor be revealed? What are the legal aspects of these situations, relating to inheritance, custody etc.?

2. Selection of Donor

We would also like to point out that, Rh blood grouping which is relevant to the selection procedure has currently been omitted, and should be included in the criteria.

In order to avoid transmission of HIV, we would like to point out that the stipulation of “It is preferable that donated sperm is cryo-preserved...” needs to be altered to “It is essential that donated sperm be cryo-preserved...”.

Since donation of oocytes is a more invasive procedure than donation of sperm, and hence more risky for the woman, potential injury to the donor woman needs to be taken into consideration, and the providing of health insurance needs to be considered, in case of a problem arising out of such a procedure. Offer of a health cover should be a part of the undertaking from the potential recipient of the oocyte, without disclosing the identity of the donor.

Leave from the workplace for IVF (for repeated egg-harvesting) should come under Maternity Benefits Act.