Fwd: Clinical Trials Draft Rules: DEADLINE 15th MARCH
Vaishnavi Jayakumar
From: Amba Salelkar <am...@equalscpsj.org>
Date: Thu, Mar 15, 2018 at 12:56 PM
Subject: Re: Clinical Trials Draft Rules: DEADLINE 15th MARCH
To: Vaishnavi Jayakumar <jayakumar...@gmail.com>, SMRC <smrcbb...@gmail.com>, Dlu South <dlu....@gmail.com>, Poonam Natarajan <poonat...@gmail.com>, Rajul Padmanabhan <rajulpad...@hotmail.com>, Porkodi Palaniappan <porkodi....@gmail.com>, Sarbani Dasroy <sarb...@gmail.com>, Amita Dhanda <amita...@gmail.com>, Pavan Muntha <pavan...@gmail.com>, Radhika Alkazi <radhika....@gmail.com>, Rajive Raturi <rajive...@gmail.com>, Mahesh Chandrasekar <mahesh.ch...@gmail.com>, Bishakha Datta <bish...@pointofview.org>, nidhi goyal <nidhig...@gmail.com>, Aiswarya Rao <aiswar...@gmail.com>, Kriti Sharma <sha...@hrw.org>, Jeeja Ghosh <jeeja...@gmail.com>, Beena Prithiveeraj <beena_pri...@hotmail.com>, Deepak Thanumalaya meenakshi nathan <deepak...@gmail.com>, deafenabled <deafe...@gmail.com>, Vandana Gopikumar <vandana....@thebanyan.org>, "she...@gmail.com" <she...@gmail.com>, Louis Lobithas <lobi...@gmail.com>, kragu ram <raghur...@gmail.com>, Paul Ramanathan <paulram...@gmail.com>, Narasimha Rao <bnrn...@yahoo.com>, Dhana Sekar <pardev...@gmail.com>, EKTHA DPO <ektha....@gmail.com>, bhumik...@unwomen.org, Shruthi Chandrasekaran <shruthi.cha...@gmail.com>, sssang...@yahoo.co.in, Women's Forum <sfr...@gmail.com>, Titus Ircds <ircd...@gmail.com>, Chidambaranathan <tnhandica...@yahoo.co.in>, Sultan Ismail <sultan...@gmail.com>, Ranjitha Gunasekaran <ranjitha.g...@gmail.com>, People welfare Development Trust <pwdtru...@gmail.com>, viakalathur sunder <sun...@imsc.res.in>, BHARGAV SUNDARAM <bharg...@gmail.com>, "shanti ." <sha...@enable-india.org>, Nilesh Singit <nilesh...@hotmail.com>, SC Vashishth <subhashv...@gmail.com>, P Rajasekharan <ra...@v-shesh.com>, Pooja Parvati <pooja....@gmail.com>, Vidushi Kothari <vid...@ommetals.com>, Trinayani Ritika Sahni <trinayan...@gmail.com>, Radha Srinivasan <radha.ja...@gmail.com>, Kalpana Kannabiran <kalpana.k...@gmail.com>, Gautam Chaudhury <gautamc...@hotmail.com>, Nirmita Narasimhan <nir...@cis-india.org>, Vasanthi Nimushakavi <vasanthi.n...@gmail.com>, "Kothari, Jayna" <jayna....@clpr.org.in>, madhumitha venkataraman <madhumitha....@gmail.com>, Aparna Mittal <Aparna...@patientsengage.com>, Def Chennai <deafenabl...@gmail.com>, Ramya Miryala <ramyam...@gmail.com>, "V.S.Ramana" <vsra...@lntecc.com>, "Simmachandran P Chandran." <sps...@gmail.com>, "j.rave...@abilityfoundation.org" <j.rave...@abilityfoundation.org>, sankara raman srinivasan <sankar...@gmail.com>, Janaki Ramanathan <janakiram.mu...@gmail.com>, Meenu Bhambhani <bhambha...@gmail.com>, Arman Ali <alya...@gmail.com>, "alya...@gmail.com Ketan Kothari" <kkot...@sightsavers.org>, sudha kaul <sudha...@gmail.com>, Action for Autism <actionf...@gmail.com>, National Platform For The Rights of the Disabled <npr...@gmail.com>, Ratnaboli Ray <rayrat...@gmail.com>, R Mallik <rma...@creaworld.org>, Reshma Val <sat.yug...@gmail.com>, Bapu Crpd <bapu.crp...@gmail.com>, Renu Addlakha <addl...@gmail.com>, Dipendra Manocha <d...@saksham.org>, harish <har...@accessindia.org.in>, Bhushan Punani <bhusha...@gmail.com>, Syamala G <syam...@gmail.com>, Uma Tuli <naai...@abilympicsindia.org>, Society for Disability Rehabilitation Studies <sdr...@gmail.com>, Govindarao Langoju <drgovi...@gmail.com>, Akhil Paul <akhil...@gmail.com>, Rajiv Rajan <rajiv....@gmail.com>, K Ramkrishna <contact.r...@gmail.com>, Poonam Natarajan <poon...@yahoo.com>, Srikala Bharath <srikala...@gmail.com>, ian cardozo <ian_c...@yahoo.com>, vkgautam <mailme.v...@rediffmail.com>, Ajin Sen <aji...@gmail.com>, philipmsimon <philip...@rediffmail.com>, Philip Simon <philipms...@gmail.com>, Anil Joshi <anilu...@gmail.com>, Shrirang Bijur <sn_b...@rediffmail.com>, Dholakia <drhtdh...@rediffmail.com>, prasannapincha <prasann...@gmail.com>, sara.va...@cbmsaro.org, Jayashree ramesh <in...@ashaforautism.com>, Basavaraju <basa...@apd-india.org>, Srinivasa Murthy <smurt...@gmail.com>, Shanti Auluck <shanti...@gmail.com>, krvsush <krv...@gmail.com>, umesh....@cbmsaro.org, Iona Kundu <menta...@gmail.com>, sudeepgo <sude...@rediffmail.com>, Vishal Gagan <vishal...@gmail.com>, avinash shahi <shahi88...@gmail.com>, Suranjana Ghosh <ghosh.s...@gmail.com>, Antara Telang <anta...@gmail.com>, "smiti_...@hotmail.com" <smiti_...@hotmail.com>, Rajesh Bhatia <bhatia....@gmail.com>, Colin Gonsalves <colin.g...@hrln.org>, rijulkochhar <rijulk...@gmail.com>, Amar Jain <amarja...@gmail.com>, Deepa Sonpal <deepa...@gmail.com>, Aishwarya Lakshman <aishwarya...@abilityfoundation.org>, sneha mishra <aai...@gmail.com>, Rajan Mani <raja...@gmail.com>, Zulekha Islam <zulekh...@gmail.com>, Chethana Venkataraghavan <chethanaven...@gmail.com>, Alagammai Chenthilnathan <alag...@gmail.com>
Cc: "Meenakshi B." <meen...@equalscpsj.org>, Sudha Ramamoorthy <su...@equalscpsj.org>
To,
The Under Secretary (Drugs),
Ministry of Health and Family Welfare, Government of India,
Room No. 414 A, ‘D’ Wing,
Nirman Bhawan, New Delhi –110011
Subject: New Drugs and Clinical trials Rules, 2018.
15th March 2018
Sir,
We the undersigned are tendering our views on the proposed rules from the perspective of persons with disabilities, to ensure that persons with disabilities can participate in clinical trials with the same safeguards as accorded to other persons.
The WHO estimates that 10 to 15% of the population of any Country experiences disability, thus making this a large constituency of persons to include in any policy and programme planning. In addition, obligations under the Convention on the Rights of Persons with Disabilities also mandate that persons with disabilities be given the support that they need to make informed decisions regarding their healthcare (Article 25) and that no one shall be subjected without his or her free consent to medical or scientific experimentation (Article 15). This has been acknowledged in the recently passed Rights of Persons with Disabilities Act, 2016 and which provides that:
Section 6 (2) No person with disability shall be a subject of any research without,—
(i) his or her free and informed consent obtained through accessible modes, means and formats of communication; and
(ii) prior permission of a Committee for Research on Disability constituted in the prescribed manner for the purpose by the appropriate Government in which not less than half of the Members shall themselves be either persons with disabilities or Members of the registered organisation as defined under clause (z) of section 2.
The Rights of Persons with Disabilities Rules, 2017 further states that:
Rule 4: The Committee for Research on Disability will be chaired by an eminent person with experience in science or medicine.
Other members will include, from the Government:
A nominee of the Director General of Health Services, and the Director, Department of Empowerment of Persons with Disabilities, New Delhi shall be the Member Secretary;
Four persons drawn from National Institutes representing physical, visual, hearing and intellectual disabilities;
Five persons as representatives of the registered organizations, from each of the five groups of specified disabilities in the Schedule to the Act, to be nominated by the Central Government –Members;
Provided that at least one representative of the registered organizations is a woman.
Rule 5: No person with disability shall be a subject of research except when the research involves physical impact on his body.
Our submissions seek to bring the proposed rules in harmonization with the rights paradigm for persons with disabilities under the CRPD and the abovementioned Act and Rules, and to ensure that persons with disabilities can participate in clinical trials on an equal basis with others.
In addition to the suggestions below, we strongly urge the
Central Drugs Standard Control Organization to make their website, along with all documentation hosted on the website, to be made accessible in line with the latest Web Content Accessibility Guidelines.
We are ready and willing to appear before the Committee to further elaborate our submissions, if required.
Sincerely yours,
Amba Salelkar
For the Equals Centre for Promotion of Social Justice
Detailed Comments on the Rules
Rule 2 (To be added):
“Accessible formats” include includes different languages (including sign and signed languages), display of text, Braille, tactile communication, large print, accessible multimedia as well as written, audio, plain-language, human-reader and augmentative and alternative modes, means and formats of communication, including accessible information and communication technology
“Informed Consent” means consent given with the knowledge of the purpose and nature, the consequences, and the risks of the clinical trial or related procedure supplied in plain language and other accessible formats.
“Person with disability” is as per Section 2 (s) of the the Rights of Persons with Disabilities Act, 2016.
Rule 12: Proceedings of Ethics Committee
Within the list of members, to be included:
“Representative of an organization who has worked on the rights of persons with disabilities and is familiar with accessible formats for persons with disabilities.”
Rule 13: Maintenance of records by Ethics Committee
“The Ethics Committee shall maintain data, record, registers and other documents related to the functioning and review of clinical trial or bioavailability study or bioequivalence study in accessible formats”
Rule 25: Conditions of permission for conduct of clinical trial.
To be included:
The Central Licensing Authority must be satisfied that:
(i) The information required for according informed consent from trial participants is available in accessible formats.
(ii) That the applicant has empanelled certified sign language interpreters, special educators and communication facilitators.
(iii) the laboratory owned by any person or a company or any other legal entity and utilised by that person to whom permission for clinical trial has been granted is an accessible premises in accordance with the Guidelines framed under Section 40 of the Persons with Disabilities Act, 2016.
Chapter VI and Seventh Schedule
In case of disability (permanent or otherwise) attention must be paid to enabling the removal of barriers that the participant experiences on account of the impairment that is caused on account of the clinical trial. It is requested that the Committee kindly reevaluate the method of determination of compensation in light of the evolved rights discourse of persons of disabilities.
Consent of Patients
The use of the term “legal heirs” under Rule 91, 92 should be revised as below:
Second Schedule
(2) (B) (ii) (b) should be reworded to ensure all possible efforts to attain informed consent from the patient are made, and if the same are not possible because of their state of coma/unconsciousness, it should be done in line with their will and preference as can be ascertained.
Third Schedule
2. Informed Consent
(a) In
all trials, a freely given, informed, written consent is required to be
obtained from each study subject in an
accessible format as per the subject’s preference. The Investigator must
provide information about the study verbally as in
accessible formats as well as using a patient information sheet, in a
language that is non- technical and understandable by the study subject.
(b) The subject’s consent must be obtained in writing or in an accessible format using an ‘Informed Consent Form’. Both the patient information sheet as well as the informed consent form should have been approved by the ethics committee and furnished to the Central Licensing Authority. Any changes in the informed consent documents should be approved by the ethics committee and submitted to the Central Licensing Authority before such changes are implemented.
(c) Informed consent must be obtained from all subjects of a clinical trial who are conscious. Persons with disabilities must be given information in accessible formats and given access to supported decision making accommodations as per their choice. In the event of the subject being unconscious, the consent for the clinical trial will be given by their nominated representative or next of kin, in accordance with their will and preference, as can be ascertained.
(g) An audio-video recording of the informed consent process in case of vulnerable subjects or in case accessible formats have been used in clinical trials of New Chemical Entity or New Molecular Entity including procedure of providing information to the subject and his understanding on such consent, shall be maintained by the investigator for record:
Provided that in case of clinical trial of anti-HIV and anti-leprosy drugs, only audio recording of the informed consent process of individual subject including the procedure of providing information to the subject and his understanding on such consent shall be maintained by the investigator for record.
5. Ethics Committee
(ii) The ethics committee should exercise particular care to protect the rights, safety and well-being of all vulnerable subjects participating in the study, e.g., members of a group with hierarchical structure (e.g. prisoners armed forces personnel, staff and students of medical, nursing and pharmacy academic institutions), patients with incurable diseases, unemployed or impoverished persons, patients in emergency situation, ethnic minority groups, homeless persons, nomads, refugees, minors, persons with disabilities and persons who are not conscious at the time of the trial. The Committee will also ensure that persons with disabilities are given access to communicate and receive communication using accessible formats throughout the trial.
TABLE 3
INFORMED CONSENT
1. Checklist of informed consent documents for clinical trial subject –
1.1 Essential elements, all to be recorded in a simple language and in an audio visual format, and be made available in other accessible formats if required by the subject:
(list)
1.2 Additional elements, which may be required:
(a) Statement of foreseeable circumstances under which the participation of the subject may be terminated by the Investigator without his/her consent.
(b) Additional costs to the subject that may result from participation in the study.
(c) The consequences of a Subject’s decision to withdraw from the research and procedures for orderly termination of participation by Subject.
(d) Statement that the Subject or Subject's representative will be notified in a timely manner if significant new findings develop during the course of the research which may affect the Subject's willingness to continue participation will be provided.
(e). A statement that the particular treatment or procedure may involve risks to the Subject (or to the embryo or foetus, if the Subject is or may become pregnant), which are currently unforeseeable.
(f) Approximate number of Subjects enrolled in the study.
(g) Acknowledgement of reasonable accommodation needs of the Clinical Trial Subject if the person has a disability.
(h) Information in relation to sign language interpreters, communication facilitators, special educators, other support personnel etc. to enable the participation of the persons with disability in the trial.
2. Format of informed consent form for Subjects participating in a clinical trial – Informed Consent form to participate in a clinical trial
Should also include data on whether the clinical trial subject has a disability, and the nature of the impairment.
The Rules are attached here (PDF). We have prepared a short explainer to the law and how it is connected tp the 2016 Disability Act and Rules hereHi everyone,The Clinical Trials Draft Rules are out for comment, deadline being the 15th of March.
https://youtu.be/uvPZhGPCWQA
The video is audio described and has closed captions. It is in english.
We are compiling responses from the sector, do write to us or whatsapp/text your views on 9884045265.
You can also submit directly to Under Secretary (Drugs),
Ministry of Health and Family Welfare, Government of India, Room No. 414 A, ‘D’ Wing,
Nirman Bhawan, New Delhi –110011 or sent on email
drugsdi...@nic.in.Warm regards,Amba
Equals Centre for Promotion of Social Justice, INDIA
Find us online (opens hyperlinks)