C661DEC5EFCA0F83910449083B33AEF8
Instruction CTNBio No. 9 of 10 October 1997
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| Indicators in focus are typically shown highlighted in yellow; |
Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; |
"Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; |
Trigger Words/Phrases are shown highlighted in gray. |
Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)
Applicable Type / Vulnerability / Indicator Overlay for this Input
Health / Health
Searching for indicator health:
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p.(None): CTNBIO NORMATIVE INSTRUCTION Nº 9, OF OCTOBER 10, 1997
p.(None):
p.(None): Provides for the rules for genetic intervention in human beings
p.(None):
p.(None): The NATIONAL BIOSAFETY TECHNICAL COMMISSION - CTNBio, in the exercise of its legal and regulatory incumbencies,
p.(None): resolves:
p.(None):
p.(None): Article 1 The Genetic Intervention in Human Beings shall follow the rules set forth in this Normative Resolution.
p.(None):
p.(None): Article 2 This Normative Resolution comes into force on the date of its publication.
p.(None):
p.(None): LUIZ ANTÔNIO BARRETO DE CASTRO
p.(None):
p.(None): Publication by the Federal Official Gazette (D.O.U.) of October 16, 1997, Section I,
p.(None): pages 23.487/23.488.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): EXHIBIT
p.(None):
p.(None): RULES ON GENETIC INTERVENTION IN HUMAN BEINGS
p.(None):
p.(None): 1. Preamble
p.(None):
p.(None): A. Every trial of genetic intervention or manipulation in human beings shall be deemed Research with Human Beings and,
p.(None): as such, qualified under Resolution No. 196/96 of the National Health Council, complying with the principles of
p.(None): autonomy, non-maleficence, beneficence and justice. Solely proposals that fulfill all requirements of
p.(None): the aforementioned Resolution No. 196/96 shall be analyzed, as detailed below.
p.(None): B. Solely proposals of genetic intervention or manipulation in human beings involving somatic cells shall be
p.(None): analyzed. Any genetic intervention or manipulation in human germination cells is forbidden, as provided for by
p.(None): article 8 of Law No. 8.974 of January 05, 1995 and Normative Resolution No. 8/97 of CTNBIO.
p.(None): C. All proposals of genetic intervention or manipulation of human beings shall be analyzed by CTNBio from
p.(None): the viewpoint of two major biosafety risks, to wit: (1) risk of horizontal transmission of the transferred nucleotide
p.(None): sequence or of the vector to other persons with which the patient has contact, and (2) risk of unintentional
p.(None): modification of germination cells, with vertical transmission of the genetic alterations to the patient’s progeny.
p.(None):
p.(None): 2. Scope
p.(None):
p.(None): As provided for by article 8 of Law No. 8.974/95, any intervention in in vivo genetic material is forbidden, except
p.(None): for treatment of genetic defects. Genetic defects mean those inherited or acquired during life that may cause problems
p.(None): to the human health.
p.(None): Genetic defects may be caused by: point mutation, chromosomal insertion, deletion, translocation,
p.(None): amplification, loss or gain, or by the presence of the genome or a part of the genome of infectious organisms.
p.(None): Somatic gene therapy or gene transfer to somatic cells are techniques of genetic intervention or
p.(None): manipulation intended for the introduction of genetic material in somatic cells by means of artificial techniques, for
p.(None): the purpose of correcting genetic defects or
p.(None):
p.(None): stimulating immune responses against the phenotypic expression of genetic defects or preventing their occurrence.
p.(None):
p.(None): 3. Requirements for Proposals for Genetic Intervention or Manipulation in Human Beings
p.(None):
p.(None): The following shall be submitted to CTNBio for evaluation:
p.(None): a. biosafety quality certificate of the laboratory or institution;
p.(None): b. description of the proposal, with answers to the topics listed;
p.(None): c. detailed experimental protocol, including the complete nucleotide sequence of the gene to be transferred
p.(None): and of the vector;
p.(None): d. documentation demonstrating approval by the Research Ethics Internal Committees as set forth by Resolution No.
p.(None): 196/96 of the National Health Council, including documents of Free Informed Consent signed by the research
p.(None): subject, pursuant to the aforementioned resolution;
p.(None): e. the resumes of the investigators, especially informing any previous experience with genetic intervention or
p.(None): manipulation in human beings.
p.(None):
p.(None): 4. Specific Topics for Proposals for Genetic Intervention or Manipulation in Human Beings
p.(None):
p.(None): 4.1. Purposes and Strategy of the Proposal
p.(None): 4.1.1. Genetic intervention for Therapeutic Purposes
p.(None): 4.1.1.1. Why is the disease selected for treatment through genetic intervention in human beings is a good candidate for
p.(None): this treatment?
p.(None): 4.1.1.2. Describe the natural course of the disease selected for treatment. Are there objective criteria to
p.(None): quantify the activity and severity of the disease? Will the knowledge of the clinical evolution of the disease enable
p.(None): an accurate evaluation of the efficiency of the genetic intervention in human beings?
p.(None): 4.1.1.3. Was the protocol prepared to prevent the disease manifestations, prevent the disease progression
p.(None): after the appearance of the early symptoms to revert the disease manifestations in seriously ill patients?
p.(None): 4.1.1.4. Are there alternative therapies? What are the advantages and disadvantages compared with the genetic
p.(None): intervention in human beings?
p.(None): 4.1.1.5. Is there any experience of genetic intervention in human beings for this disease in other countries? In
p.(None): affirmative case, present the literature in that regard.
p.(None):
p.(None): 4.1.2. Genetic intervention for Other Purposes
p.(None): 4.1.2.1. What is the purpose of the protocol of genetic intervention?
...
p.(None): Describe the treatment that will be administrated to the patients and the diagnosis methods that will be
p.(None): used to monitor the response to treatment. Describe any previous clinical trials with the same or similar methods.
p.(None): Specifically, answer:
p.(None): 4.2.3.1. Will any patient’s cells be removed for ex vivo treatment? Describe the types and number of the cells and the
p.(None): intervals at which they will be removed.
p.(None): 4.2.3.2. Will the patients be treated to eliminate or reduce the number of unmodified target cells (e.g. radiation or
p.(None): chemotherapy)?
p.(None): 4.2.3.3. What treated cells (or combinations vector/DNA) will be administrated to the patients? How will the
p.(None): administration be made? What is the volume to be used? Will the treatment be single or multiple? What is the interval
p.(None): between treatments?
p.(None): 4.2.3.4. How will the transfer and expression of the gene in the patient’s cells be determined? Will the
p.(None): expression be examined in non-target cells?
p.(None): 4.2.3.5. What studies will be conducted to evaluate the presence and effects of contaminants?
p.(None): 4.2.3.6. What are the clinical endpoints of the study? Will there be any quantitative measurements to
p.(None): evaluate the natural history of the disease? How will the clinical follow- up of the patients be made?
p.(None): 4.2.3.7. What are the expectations in relation to the major benefic or adverse effects of the gene transfer? What steps
p.(None): will be taken to prevent or revert adverse reactions, in case they occur?
p.(None): 4.2.3.8. In case that a treated patient dies, what post-mortem studies will be conducted?
p.(None): 4.2.4. Public Health Considerations
p.(None): Discuss the possible risk of gene transfer to other persons besides the patients. Especially, answer the
p.(None): following questions:
p.(None): 4.2.4.1. Is there any risk to the public health?
p.(None): 4.2.4.2. Is there any possibility that the transferred DNA will spread from the patients to other persons or to the
p.(None): environment?
p.(None): 4.2.4.3. What precautions will be taken to avoid spreading?
p.(None): 4.2.4.4. What measures will be taken to minimize the risk to the public health?
p.(None): 4.2.4.5. Given potential risks to the progeny of the patients, including vertical transmissions,
p.(None): will contraceptive measures be taken?
p.(None): 4.2.5. Qualification of the Researchers and Appropriateness of the Clinical and Laboratory
p.(None): Facilities Describe the training and experience of the team. Describe the
p.(None):
p.(None): clinical and laboratory facilities that will be used. Specifically, answer the following questions:
p.(None): 4.2.5.1. Describe the facilities where the materials to be used in the genetic intervention will be prepared, including
p.(None): environmental conditions for occasional manipulation of ex- vivo cells.
p.(None): 4.2.5.2. What professionals will be involved in the pre-clinical and clinical trials and what are their qualifications?
p.(None): Include resumes.
p.(None): 4.2.5.3. In what hospital or medical office will the genetic intervention be made? What resources are especially
p.(None): important for the study proposed? Will the patients occupy regular beds or will they be isolated? Where will
p.(None): the patients reside during the follow-up period after the genetic intervention?
p.(None):
p.(None): 4.3. Patients Selection
p.(None):
p.(None): The patients selection criteria shall comply with the rules of Resolution No. 196/96 of the National Health Council.
p.(None): Estimate the number of patients involved in the study. Describe the procedures of selection of the
p.(None): patients. Specifically, answer the following topics:
p.(None): 4.3.1. How many patients will be treated?
p.(None): 4.3.2. How many candidates to genetic intervention may be identified per year?
p.(None): 4.3.3. What is the method of patients screening?
p.(None): 4.3.4. What are the selection criteria of the potential patients?
p.(None): 4.3.5. In case that there are more candidates to the genetic intervention than vacancies, what criteria will be used to
...
Health / Physically Ill
Searching for indicator ill:
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p.(None): b. description of the proposal, with answers to the topics listed;
p.(None): c. detailed experimental protocol, including the complete nucleotide sequence of the gene to be transferred
p.(None): and of the vector;
p.(None): d. documentation demonstrating approval by the Research Ethics Internal Committees as set forth by Resolution No.
p.(None): 196/96 of the National Health Council, including documents of Free Informed Consent signed by the research
p.(None): subject, pursuant to the aforementioned resolution;
p.(None): e. the resumes of the investigators, especially informing any previous experience with genetic intervention or
p.(None): manipulation in human beings.
p.(None):
p.(None): 4. Specific Topics for Proposals for Genetic Intervention or Manipulation in Human Beings
p.(None):
p.(None): 4.1. Purposes and Strategy of the Proposal
p.(None): 4.1.1. Genetic intervention for Therapeutic Purposes
p.(None): 4.1.1.1. Why is the disease selected for treatment through genetic intervention in human beings is a good candidate for
p.(None): this treatment?
p.(None): 4.1.1.2. Describe the natural course of the disease selected for treatment. Are there objective criteria to
p.(None): quantify the activity and severity of the disease? Will the knowledge of the clinical evolution of the disease enable
p.(None): an accurate evaluation of the efficiency of the genetic intervention in human beings?
p.(None): 4.1.1.3. Was the protocol prepared to prevent the disease manifestations, prevent the disease progression
p.(None): after the appearance of the early symptoms to revert the disease manifestations in seriously ill patients?
p.(None): 4.1.1.4. Are there alternative therapies? What are the advantages and disadvantages compared with the genetic
p.(None): intervention in human beings?
p.(None): 4.1.1.5. Is there any experience of genetic intervention in human beings for this disease in other countries? In
p.(None): affirmative case, present the literature in that regard.
p.(None):
p.(None): 4.1.2. Genetic intervention for Other Purposes
p.(None): 4.1.2.1. What is the purpose of the protocol of genetic intervention?
p.(None): 4.1.2.2. Which cells will be the target of the genetic intervention? Why is the genetic intervention
p.(None): necessary?
p.(None): 4.1.2.3. Are there alternative methodologies? What are the advantages and disadvantages compared with the intervention?
p.(None):
p.(None): 4.2. Experimental Design, Expected Risks and Benefits
p.(None): 4.2.1. Structure and Characteristics of the Biological System
p.(None): Present a complete description of the methods and reactants to be used in the genetic intervention and the strategic
p.(None): reason for their use. Cover specifically the following topics:
p.(None): 4.2.1.1. In case of gene transfer, what is the structure of the cloned DNA to be used?
p.(None): 4.2.1.1.1. Describe the origin of the gene (genomic or DNA), the vehicle and form of the evidence that the material to
p.(None): be transferred corresponds to the intended gene transfer. Provide the complete nucleotide sequence, a detailed
p.(None): map of the construction and (incomplete)
p.(None): 4.2.1.1.2. What regulating elements are present in the construction (e.g. promoters, enhancers,
p.(None): polyadenylation sites, replication origins, etc.). What is the source of those
p.(None):
p.(None): elements? Summarize what is known about the regulating character of each element. Is the gene to be transferred
...
Social / Marital Status
Searching for indicator single:
(return to top)
p.(None): necessary?
p.(None): 4.1.2.3. Are there alternative methodologies? What are the advantages and disadvantages compared with the intervention?
p.(None):
p.(None): 4.2. Experimental Design, Expected Risks and Benefits
p.(None): 4.2.1. Structure and Characteristics of the Biological System
p.(None): Present a complete description of the methods and reactants to be used in the genetic intervention and the strategic
p.(None): reason for their use. Cover specifically the following topics:
p.(None): 4.2.1.1. In case of gene transfer, what is the structure of the cloned DNA to be used?
p.(None): 4.2.1.1.1. Describe the origin of the gene (genomic or DNA), the vehicle and form of the evidence that the material to
p.(None): be transferred corresponds to the intended gene transfer. Provide the complete nucleotide sequence, a detailed
p.(None): map of the construction and (incomplete)
p.(None): 4.2.1.1.2. What regulating elements are present in the construction (e.g. promoters, enhancers,
p.(None): polyadenylation sites, replication origins, etc.). What is the source of those
p.(None):
p.(None): elements? Summarize what is known about the regulating character of each element. Is the gene to be transferred
p.(None): potentially oncogenic? In affirmative case, what are the risks involved and what measures may be taken to reduce those
p.(None): risks?
p.(None): 4.2.1.1.3. Summarize the steps of the process to obtain the construction.
p.(None): 4.2.1.2. What is the structure of the material that will be administrated to the patient and how will it be
p.(None): administrated?
p.(None): 4.2.1.2.1. Describe the preparation, structure and composition of the materials that will be administrated to the
p.(None): patient or used to treat the patient’s cells:
p.(None): 4.2.1.2.1.1. In case of DNA, what is the pureness (both in terms of being a single molecular species and in terms of
p.(None): contamination with proteins, carbohydrates, lipids, etc.). What are the tests used to stimulate said pureness and what
p.(None): is its sensitivity?
p.(None): 4.2.1.2.1.2. In case of a virus, how was it prepared from the DNA construction? In what cells were the viruses grown?
p.(None): What medium and serum were used? How was the virus purification made? What is its pureness structure and level? What
p.(None): measures were taken (and how efficient are they) to detect the presence of contamination by other viruses, DNAs, RNAs
p.(None): and/or proteins?
p.(None): 4.2.1.2.1.3. In case that co-cultivation was used, what cells were used? What measures were taken (and how efficient
p.(None): are they) to detect the presence of any contamination?
p.(None): 4.2.1.2.2. Describe any other material that will be used in the preparation of the inoculum. For example,
p.(None): if a viral vector is being used, what is the nature of the helper virus? If other carrier particles are used, what is
p.(None): their nature?
p.(None): 4.2.2. Pre-Clinical Studies, Including Risk Survey Studies
p.(None): Describe results of trials in cell cultures or experimental animals demonstrating the safety, efficiency
p.(None): and feasibility of the proposed procedures. Explain why the experimental model chosen is the most
p.(None): appropriate one.
p.(None): 4.2.2.1. Gene transfer system
p.(None): 4.2.2.1.1. What are the target cells for the gene transfer? What cells will be treated ex vivo and reinserted in the
p.(None): patient? How will the selection of the target cells that will receive the transferred DNA will be made? How will the
p.(None): characterization of the cells will be made before and after treatment? What are the theoretical and practical data that
...
p.(None): germination cells? What is the sensitivity of those analyses?
p.(None): 4.2.2.3.5. Was the gene transfer protocol for human beings tested in non-human primates or other
p.(None): laboratory animals? Specifically, is there any evidence of recombination of the retroviral vector
p.(None): with endogenous retroviruses or other viral sequences present in those animals?
p.(None): 4.2.2.4. Non-Retroviral Gene Transfer Systems
p.(None): 4.2.2.4.1. What animal trials were conducted to determine if there is any risk of undesirable or harmful
p.(None): consequences of the gene therapy protocol (including insertion of DNA in non-target cells, especially germination
p.(None): cells)? For how long were the animals studied after the treatment? What other biosafety trials were conducted?
p.(None): 4.2.3. Clinical Procedures, Including Patients Monitoring
p.(None): Describe the treatment that will be administrated to the patients and the diagnosis methods that will be
p.(None): used to monitor the response to treatment. Describe any previous clinical trials with the same or similar methods.
p.(None): Specifically, answer:
p.(None): 4.2.3.1. Will any patient’s cells be removed for ex vivo treatment? Describe the types and number of the cells and the
p.(None): intervals at which they will be removed.
p.(None): 4.2.3.2. Will the patients be treated to eliminate or reduce the number of unmodified target cells (e.g. radiation or
p.(None): chemotherapy)?
p.(None): 4.2.3.3. What treated cells (or combinations vector/DNA) will be administrated to the patients? How will the
p.(None): administration be made? What is the volume to be used? Will the treatment be single or multiple? What is the interval
p.(None): between treatments?
p.(None): 4.2.3.4. How will the transfer and expression of the gene in the patient’s cells be determined? Will the
p.(None): expression be examined in non-target cells?
p.(None): 4.2.3.5. What studies will be conducted to evaluate the presence and effects of contaminants?
p.(None): 4.2.3.6. What are the clinical endpoints of the study? Will there be any quantitative measurements to
p.(None): evaluate the natural history of the disease? How will the clinical follow- up of the patients be made?
p.(None): 4.2.3.7. What are the expectations in relation to the major benefic or adverse effects of the gene transfer? What steps
p.(None): will be taken to prevent or revert adverse reactions, in case they occur?
p.(None): 4.2.3.8. In case that a treated patient dies, what post-mortem studies will be conducted?
p.(None): 4.2.4. Public Health Considerations
p.(None): Discuss the possible risk of gene transfer to other persons besides the patients. Especially, answer the
p.(None): following questions:
p.(None): 4.2.4.1. Is there any risk to the public health?
p.(None): 4.2.4.2. Is there any possibility that the transferred DNA will spread from the patients to other persons or to the
p.(None): environment?
p.(None): 4.2.4.3. What precautions will be taken to avoid spreading?
p.(None): 4.2.4.4. What measures will be taken to minimize the risk to the public health?
...
General/Other / Impaired Autonomy
Searching for indicator autonomy:
(return to top)
p.(None): CTNBIO NORMATIVE INSTRUCTION Nº 9, OF OCTOBER 10, 1997
p.(None):
p.(None): Provides for the rules for genetic intervention in human beings
p.(None):
p.(None): The NATIONAL BIOSAFETY TECHNICAL COMMISSION - CTNBio, in the exercise of its legal and regulatory incumbencies,
p.(None): resolves:
p.(None):
p.(None): Article 1 The Genetic Intervention in Human Beings shall follow the rules set forth in this Normative Resolution.
p.(None):
p.(None): Article 2 This Normative Resolution comes into force on the date of its publication.
p.(None):
p.(None): LUIZ ANTÔNIO BARRETO DE CASTRO
p.(None):
p.(None): Publication by the Federal Official Gazette (D.O.U.) of October 16, 1997, Section I,
p.(None): pages 23.487/23.488.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None): EXHIBIT
p.(None):
p.(None): RULES ON GENETIC INTERVENTION IN HUMAN BEINGS
p.(None):
p.(None): 1. Preamble
p.(None):
p.(None): A. Every trial of genetic intervention or manipulation in human beings shall be deemed Research with Human Beings and,
p.(None): as such, qualified under Resolution No. 196/96 of the National Health Council, complying with the principles of
p.(None): autonomy, non-maleficence, beneficence and justice. Solely proposals that fulfill all requirements of
p.(None): the aforementioned Resolution No. 196/96 shall be analyzed, as detailed below.
p.(None): B. Solely proposals of genetic intervention or manipulation in human beings involving somatic cells shall be
p.(None): analyzed. Any genetic intervention or manipulation in human germination cells is forbidden, as provided for by
p.(None): article 8 of Law No. 8.974 of January 05, 1995 and Normative Resolution No. 8/97 of CTNBIO.
p.(None): C. All proposals of genetic intervention or manipulation of human beings shall be analyzed by CTNBio from
p.(None): the viewpoint of two major biosafety risks, to wit: (1) risk of horizontal transmission of the transferred nucleotide
p.(None): sequence or of the vector to other persons with which the patient has contact, and (2) risk of unintentional
p.(None): modification of germination cells, with vertical transmission of the genetic alterations to the patient’s progeny.
p.(None):
p.(None): 2. Scope
p.(None):
p.(None): As provided for by article 8 of Law No. 8.974/95, any intervention in in vivo genetic material is forbidden, except
p.(None): for treatment of genetic defects. Genetic defects mean those inherited or acquired during life that may cause problems
p.(None): to the human health.
p.(None): Genetic defects may be caused by: point mutation, chromosomal insertion, deletion, translocation,
p.(None): amplification, loss or gain, or by the presence of the genome or a part of the genome of infectious organisms.
...
Orphaned Trigger Words
p.(None): 4.2.2.1.4. How many copies of the transferred DNA are expected to be present per cell? What is the stability of the
p.(None): transferred DNA?
p.(None): 4.2.2.2. Gene Transfer and Expression in Terms of Persistence and Structure Stability
p.(None): 4.2.2.2.1. What models of tissue culture and experimental animals were used in laboratory studies to
p.(None): evaluate the in vitro and in vivo efficiency of the gene transfer system? What are the similarities and
p.(None): differences of those models compared with the proposed gene transfer to human beings?
p.(None): 4.2.2.2.2. What is the estimated minimum level of gene transfer and/or expression required for successful
p.(None): gene transfer? How was that level determined?
p.(None): 4.2.2.2.3. Explain in details the pre-clinical trials that demonstrate the efficiency of the transfer system in terms
p.(None): of minimum levels required for the gene transfer.
p.(None): 4.2.2.2.4. Does the integrated DNA modify the expression of other genes? How was that determined?
p.(None): 4.2.2.2.5. In what percentage of the cells that received the transferred DNA does gene expression occur? Is the
p.(None): product of the transferred gene biologically active? What proportion of normal activity is derived from
p.(None): the transferred gene? How was that determined?
p.(None): 4.2.2.2.6. Is the transferred gene expressed in any cells other than the target cells? How was that determined?
p.(None): 4.2.2.3. Retroviruses-Based Transfer Systems
p.(None):
p.(None): 4.2.2.3.1. What cellular types will be infected by the retroviral vector? Is the production of viral particles expected
p.(None): to occur?
p.(None): 4.2.2.3.2. How stable are the retroviral vector and the resulting provirus in terms of deletion,
p.(None): rearrangements, recombination and mutation? What information is available about the risk of recombination with
p.(None): endogenous retroviruses or other viruses that may be present in the patient’s cells?
p.(None): 4.2.2.3.3. Is there any evidence that the gene transfer may have any adverse effects (e.g. development of neoplasias,
p.(None): harmful mutations, regeneration of infectious particles, immune responses, etc.)? What precautions will be taken
p.(None): to minimize the pathogenicity of the retroviral vector? What pre-clinical trials were conducted to estimate
p.(None): said pathogenicity?
p.(None): 4.2.2.3.4. Is there any trial evidence that the vector may penetrate untreated cells, especially
p.(None): germination cells? What is the sensitivity of those analyses?
p.(None): 4.2.2.3.5. Was the gene transfer protocol for human beings tested in non-human primates or other
p.(None): laboratory animals? Specifically, is there any evidence of recombination of the retroviral vector
p.(None): with endogenous retroviruses or other viral sequences present in those animals?
p.(None): 4.2.2.4. Non-Retroviral Gene Transfer Systems
p.(None): 4.2.2.4.1. What animal trials were conducted to determine if there is any risk of undesirable or harmful
p.(None): consequences of the gene therapy protocol (including insertion of DNA in non-target cells, especially germination
p.(None): cells)? For how long were the animals studied after the treatment? What other biosafety trials were conducted?
p.(None): 4.2.3. Clinical Procedures, Including Patients Monitoring
p.(None): Describe the treatment that will be administrated to the patients and the diagnosis methods that will be
p.(None): used to monitor the response to treatment. Describe any previous clinical trials with the same or similar methods.
p.(None): Specifically, answer:
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| autonomy | Impaired Autonomy |
| health | Health |
| ill | Physically Ill |
| single | Marital Status |
Indicator Peers (Indicators in Same Vulnerability)
Trigger Words
consent
ethics
justice
risk
Applicable Type / Vulnerability / Indicator Overlay for this Input