79C3C34C52B45572883A05D425EB0F82
Ethics Committee Protocols
https://sta.uwi.edu/research/sites/default/files/research/documents/SWRHA%20Bioethics%20Committee%20Guidelines.pdf
http://leaux.net/URLS/ConvertAPI Text Files/53721D9FF2C33CBB210886EEC733F62E.en.txt
Examining the file media/Synopses/53721D9FF2C33CBB210886EEC733F62E.html:
This file was generated: 2020-12-01 09:10:58
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 / Drug Usage
Searching for indicator drug:
(return to top)
p.(None):
p.(None): 1. TITLE OF THE PROPOSED RESEARCH
p.(None): 2. DATF. (and Version - it’there has been a prcvious submission)
p.(None): 3. NAME, ADDRESS, TELEPHONE NUMBER AND EMAIL 1or ALL THE INVESTIGATORS, COLI.ABORA4 ORS,
p.(None): AND/OR SUP ERVISORS (starting with the Principal Investigator).
p.(None): 4. SITE/S (LOCATION) OF RESEARCH
p.(None): 5. NUMBER OF RESEARCH PARTICIPANTS TO BE ENROLLEI3
p.(None): 6. PROPOSED DURATION OF THE STUDY
p.(None): 7. A SUMMARY OF THE PROPOSED STUDY — not more than 250 words and should
p.(None): include:
p.(None): a. The hypothesis and scientific basis or justification for the study
p.(None): b. The usefulness and significance of the study
p.(None): c. An outline of the study design
p.(None): d. An indication of steps taken to ensure and maintain confidentiality
p.(None): e. An assessment of the bcnefits to participants (and/or groups in the communlty or the entire community) and
p.(None): the risks
p.(None):
p.(None): Page 1 of 4
p.(None):
p.(None): 8. THE PROJECT PltOPOSAL
p.(None): A. An introduction and background information on the research topic. This should also include the
p.(None): justification for the research (review of the current knowledge from the literature on the topic, with an
p.(None): explanation why this project is necessary, and how it will contribute to the overall knowledge in this area)
p.(None): B. A clear statement of the objectives of the research proposal
p.(None): C. Design and Methodology:
p.(None): i. Study design
p.(None): ii. Data collection methods:
p.(None): • Details of procedures to be performed (e. g. volume of blood, the frequency, timing, and
p.(None): possible site of the blood-taking; any drug administration, physiological measures, etc.).
p.(None): • Which procedures may cause pain and/or discomfort for research participants.
p.(None): • Details of the intervention (where appropriate)
p.(None): • Copy of the data collection tool in the Appendix
p.(None): iii. Study population and sampling methods
p.(None): • Choice of participants, inclusion exclusion criteria, any controls, etc.
p.(None): • A statement that participants were selected only because of the specific pr‹›blem under
p.(None): investigation, and not because of their easy availability, diminished autonomy, or any social bias.
p.(None): • Sampling methods
p.(None): iv. Statistical issues
p.(None): • Number of research participants and its justification
p.(None): • Planned data analysis
p.(None): D. A statement confirming that reasonable time will be given for the participant to consider his/her involvement
p.(None): E. Procedures for obtaining informed consent, including statements that the researcher/s will read the informed
p.(None): consent form to the participant or his/her legal guardian and will provide that person with a copy of
p.(None): the form, that questions from the person will be invited, and that all efforts will be made to ensure that s/he
p.(None): understands its content before the seeking of consent
p.(None):
p.(None): Page 2 of 4
p.(None):
p.(None): F. A copy of the informed consent form and recruitment posters (see details below)
...
Social / Access to Social Goods
Searching for indicator access:
(return to top)
p.(None): delivery is concerned and not disadvantaged in any way. Plans for the secure storage of the data.
p.(None): H. Assumptions made
p.(None): I. Relevant references (i.c. literature citation)
p.(None): J. Conflicts of intcrest
p.(None): K. Dissemination plan
p.(None): L. The name, address, telephone and fax numbers, as well as email address of a contact person
p.(None):
p.(None): 9. THE INFonM«D CONSENT FORM should include the following:
p.(None): a. Statements in language written for comprehension by the lay person outlining the purpose of the
p.(None): research, what will be done in the research study, and indicating that this has been explained orally
p.(None): and in writing to the participant (or the participant’s parent or legal guardian — if a child or
p.(None): mcntally challenged individual) who understands what will be done. These will be countersigned by the
p.(None): participant or his/her legally authorized representative;
p.(None): b. Explicit statements about risk or discomfort to the participant, with an assessment of the degrec of risk,
p.(None): and viable alternatives;
p.(None): c. A statement that the participant’s involvement is voluntary, and that refusal to participate
p.(None): or (if after having agreed to participate) withdrawal from the study at any timc will not affcct the
p.(None): participant’s access to or thc type of care to which s/he is entitled;
p.(None): d. The name, address, telephone numbcr, as well as email addrcss of a contact person for any queries;
p.(None): e. A statement confirming that reasonable time will be given for the participant to consider her/his
p.(None): involvement;
p.(None): f. Statements that the participant or her/his legal guardian has read the informed consent document, or that it
p.(None): has been read to her/him, and that s/he understands its contents; that a copy will be given to the
p.(None): participant; and that the signature of the participant or the legal guardian indicates that s/he has frccly agrccd to
p.(None): participate;
p.(None):
p.(None):
p.(None): Page 3 of 4
p.(None):
p.(None): g. The signature: of a witness to the consent procedure who is not connected to the research
p.(None): undr'rtaking (i.e. a relative, caretaker, friend)
p.(None):
p.(None): FORMATTING:
p.(None): Font: Times New Roman Font Size: 12
p.(None): Line spacing: 1.5
p.(None): Limit: 4 to 6 pages (approximately 2000 words).
p.(None):
p.(None):
p.(None): IN STRUCTI ONS:
p.(None): Researchers must submi one (1) soft copy o1 their Rcscarch 1'rotoco1 and any other supporting documcnts to:
p.(None):
p.(None): Mrs. Kathyann Thomas-Elbourne General Manager-Nursing /
p.(None): Secretary, S WItflA 13io‹•thics Committee Levcl 8, San Fernando 4 caching 1lospital Chanccry Lane, San Fernando
p.(None): Email: i u1It iii iii c1 l›‹ ›i n n ‹ « i ha .c‹› i I
p.(None):
p.(None): : ii c I It i i c - la url‹c rf s \› i 1 ‹i. c t› . II
p.(None):
p.(None):
p.(None):
p.(None): CONFIlIMATION :
...
Social / Child
Searching for indicator child:
(return to top)
p.(None): the form, that questions from the person will be invited, and that all efforts will be made to ensure that s/he
p.(None): understands its content before the seeking of consent
p.(None):
p.(None): Page 2 of 4
p.(None):
p.(None): F. A copy of the informed consent form and recruitment posters (see details below)
p.(None): G. Data privacy/confidentiality: Mcthods to protect the confidentiality of participants, and methods to
p.(None): ensure that a participant who opts out of a research endeavour is well protected as far as hcalth care
p.(None): delivery is concerned and not disadvantaged in any way. Plans for the secure storage of the data.
p.(None): H. Assumptions made
p.(None): I. Relevant references (i.c. literature citation)
p.(None): J. Conflicts of intcrest
p.(None): K. Dissemination plan
p.(None): L. The name, address, telephone and fax numbers, as well as email address of a contact person
p.(None):
p.(None): 9. THE INFonM«D CONSENT FORM should include the following:
p.(None): a. Statements in language written for comprehension by the lay person outlining the purpose of the
p.(None): research, what will be done in the research study, and indicating that this has been explained orally
p.(None): and in writing to the participant (or the participant’s parent or legal guardian — if a child or
p.(None): mcntally challenged individual) who understands what will be done. These will be countersigned by the
p.(None): participant or his/her legally authorized representative;
p.(None): b. Explicit statements about risk or discomfort to the participant, with an assessment of the degrec of risk,
p.(None): and viable alternatives;
p.(None): c. A statement that the participant’s involvement is voluntary, and that refusal to participate
p.(None): or (if after having agreed to participate) withdrawal from the study at any timc will not affcct the
p.(None): participant’s access to or thc type of care to which s/he is entitled;
p.(None): d. The name, address, telephone numbcr, as well as email addrcss of a contact person for any queries;
p.(None): e. A statement confirming that reasonable time will be given for the participant to consider her/his
p.(None): involvement;
p.(None): f. Statements that the participant or her/his legal guardian has read the informed consent document, or that it
p.(None): has been read to her/him, and that s/he understands its contents; that a copy will be given to the
p.(None): participant; and that the signature of the participant or the legal guardian indicates that s/he has frccly agrccd to
p.(None): participate;
p.(None):
p.(None):
p.(None): Page 3 of 4
p.(None):
p.(None): g. The signature: of a witness to the consent procedure who is not connected to the research
...
Social / Linguistic Proficiency
Searching for indicator language:
(return to top)
p.(None): • Planned data analysis
p.(None): D. A statement confirming that reasonable time will be given for the participant to consider his/her involvement
p.(None): E. Procedures for obtaining informed consent, including statements that the researcher/s will read the informed
p.(None): consent form to the participant or his/her legal guardian and will provide that person with a copy of
p.(None): the form, that questions from the person will be invited, and that all efforts will be made to ensure that s/he
p.(None): understands its content before the seeking of consent
p.(None):
p.(None): Page 2 of 4
p.(None):
p.(None): F. A copy of the informed consent form and recruitment posters (see details below)
p.(None): G. Data privacy/confidentiality: Mcthods to protect the confidentiality of participants, and methods to
p.(None): ensure that a participant who opts out of a research endeavour is well protected as far as hcalth care
p.(None): delivery is concerned and not disadvantaged in any way. Plans for the secure storage of the data.
p.(None): H. Assumptions made
p.(None): I. Relevant references (i.c. literature citation)
p.(None): J. Conflicts of intcrest
p.(None): K. Dissemination plan
p.(None): L. The name, address, telephone and fax numbers, as well as email address of a contact person
p.(None):
p.(None): 9. THE INFonM«D CONSENT FORM should include the following:
p.(None): a. Statements in language written for comprehension by the lay person outlining the purpose of the
p.(None): research, what will be done in the research study, and indicating that this has been explained orally
p.(None): and in writing to the participant (or the participant’s parent or legal guardian — if a child or
p.(None): mcntally challenged individual) who understands what will be done. These will be countersigned by the
p.(None): participant or his/her legally authorized representative;
p.(None): b. Explicit statements about risk or discomfort to the participant, with an assessment of the degrec of risk,
p.(None): and viable alternatives;
p.(None): c. A statement that the participant’s involvement is voluntary, and that refusal to participate
p.(None): or (if after having agreed to participate) withdrawal from the study at any timc will not affcct the
p.(None): participant’s access to or thc type of care to which s/he is entitled;
p.(None): d. The name, address, telephone numbcr, as well as email addrcss of a contact person for any queries;
p.(None): e. A statement confirming that reasonable time will be given for the participant to consider her/his
p.(None): involvement;
p.(None): f. Statements that the participant or her/his legal guardian has read the informed consent document, or that it
p.(None): has been read to her/him, and that s/he understands its contents; that a copy will be given to the
...
Social / Student
Searching for indicator student:
(return to top)
p.(None): SOUTH WEST REGIONAL HEALTH AUTHORITY
p.(None):
p.(None):
p.(None): BIOETHICS COMMITTEE
p.(None):
p.(None): Guidelines for Research Protocols Submitted for Review
p.(None):
p.(None): "die following information should be included in Research Protocols being submitted to the Bioethics
p.(None): Committcc of the SWRI IA:
p.(None):
p.(None): COVERING NOTE: Briefly introduce your request to conduct research at the SWRHA and specify any institutions to
p.(None): which you are affiliated, tor example whethcr you are an employee
p.(None): / student at a University, employee of an RHA, etc. List the documents included in your application,
p.(None): for example 1. Research Protocol, 2. University’s Ethics Approval / Employer’s Approval, 3. Informed Consent
p.(None): Form, 4. Questionnaires, etc (100 words limit).
p.(None):
p.(None): 1. TITLE OF THE PROPOSED RESEARCH
p.(None): 2. DATF. (and Version - it’there has been a prcvious submission)
p.(None): 3. NAME, ADDRESS, TELEPHONE NUMBER AND EMAIL 1or ALL THE INVESTIGATORS, COLI.ABORA4 ORS,
p.(None): AND/OR SUP ERVISORS (starting with the Principal Investigator).
p.(None): 4. SITE/S (LOCATION) OF RESEARCH
p.(None): 5. NUMBER OF RESEARCH PARTICIPANTS TO BE ENROLLEI3
p.(None): 6. PROPOSED DURATION OF THE STUDY
p.(None): 7. A SUMMARY OF THE PROPOSED STUDY — not more than 250 words and should
p.(None): include:
p.(None): a. The hypothesis and scientific basis or justification for the study
p.(None): b. The usefulness and significance of the study
p.(None): c. An outline of the study design
p.(None): d. An indication of steps taken to ensure and maintain confidentiality
p.(None): e. An assessment of the bcnefits to participants (and/or groups in the communlty or the entire community) and
p.(None): the risks
p.(None):
p.(None): Page 1 of 4
p.(None):
p.(None): 8. THE PROJECT PltOPOSAL
p.(None): A. An introduction and background information on the research topic. This should also include the
p.(None): justification for the research (review of the current knowledge from the literature on the topic, with an
p.(None): explanation why this project is necessary, and how it will contribute to the overall knowledge in this area)
...
Social / parents
Searching for indicator parent:
(return to top)
p.(None): consent form to the participant or his/her legal guardian and will provide that person with a copy of
p.(None): the form, that questions from the person will be invited, and that all efforts will be made to ensure that s/he
p.(None): understands its content before the seeking of consent
p.(None):
p.(None): Page 2 of 4
p.(None):
p.(None): F. A copy of the informed consent form and recruitment posters (see details below)
p.(None): G. Data privacy/confidentiality: Mcthods to protect the confidentiality of participants, and methods to
p.(None): ensure that a participant who opts out of a research endeavour is well protected as far as hcalth care
p.(None): delivery is concerned and not disadvantaged in any way. Plans for the secure storage of the data.
p.(None): H. Assumptions made
p.(None): I. Relevant references (i.c. literature citation)
p.(None): J. Conflicts of intcrest
p.(None): K. Dissemination plan
p.(None): L. The name, address, telephone and fax numbers, as well as email address of a contact person
p.(None):
p.(None): 9. THE INFonM«D CONSENT FORM should include the following:
p.(None): a. Statements in language written for comprehension by the lay person outlining the purpose of the
p.(None): research, what will be done in the research study, and indicating that this has been explained orally
p.(None): and in writing to the participant (or the participant’s parent or legal guardian — if a child or
p.(None): mcntally challenged individual) who understands what will be done. These will be countersigned by the
p.(None): participant or his/her legally authorized representative;
p.(None): b. Explicit statements about risk or discomfort to the participant, with an assessment of the degrec of risk,
p.(None): and viable alternatives;
p.(None): c. A statement that the participant’s involvement is voluntary, and that refusal to participate
p.(None): or (if after having agreed to participate) withdrawal from the study at any timc will not affcct the
p.(None): participant’s access to or thc type of care to which s/he is entitled;
p.(None): d. The name, address, telephone numbcr, as well as email addrcss of a contact person for any queries;
p.(None): e. A statement confirming that reasonable time will be given for the participant to consider her/his
p.(None): involvement;
p.(None): f. Statements that the participant or her/his legal guardian has read the informed consent document, or that it
p.(None): has been read to her/him, and that s/he understands its contents; that a copy will be given to the
p.(None): participant; and that the signature of the participant or the legal guardian indicates that s/he has frccly agrccd to
p.(None): participate;
p.(None):
p.(None):
p.(None): Page 3 of 4
p.(None):
p.(None): g. The signature: of a witness to the consent procedure who is not connected to the research
...
Social / persons with care obligations
Searching for indicator caretaker:
(return to top)
p.(None): mcntally challenged individual) who understands what will be done. These will be countersigned by the
p.(None): participant or his/her legally authorized representative;
p.(None): b. Explicit statements about risk or discomfort to the participant, with an assessment of the degrec of risk,
p.(None): and viable alternatives;
p.(None): c. A statement that the participant’s involvement is voluntary, and that refusal to participate
p.(None): or (if after having agreed to participate) withdrawal from the study at any timc will not affcct the
p.(None): participant’s access to or thc type of care to which s/he is entitled;
p.(None): d. The name, address, telephone numbcr, as well as email addrcss of a contact person for any queries;
p.(None): e. A statement confirming that reasonable time will be given for the participant to consider her/his
p.(None): involvement;
p.(None): f. Statements that the participant or her/his legal guardian has read the informed consent document, or that it
p.(None): has been read to her/him, and that s/he understands its contents; that a copy will be given to the
p.(None): participant; and that the signature of the participant or the legal guardian indicates that s/he has frccly agrccd to
p.(None): participate;
p.(None):
p.(None):
p.(None): Page 3 of 4
p.(None):
p.(None): g. The signature: of a witness to the consent procedure who is not connected to the research
p.(None): undr'rtaking (i.e. a relative, caretaker, friend)
p.(None):
p.(None): FORMATTING:
p.(None): Font: Times New Roman Font Size: 12
p.(None): Line spacing: 1.5
p.(None): Limit: 4 to 6 pages (approximately 2000 words).
p.(None):
p.(None):
p.(None): IN STRUCTI ONS:
p.(None): Researchers must submi one (1) soft copy o1 their Rcscarch 1'rotoco1 and any other supporting documcnts to:
p.(None):
p.(None): Mrs. Kathyann Thomas-Elbourne General Manager-Nursing /
p.(None): Secretary, S WItflA 13io‹•thics Committee Levcl 8, San Fernando 4 caching 1lospital Chanccry Lane, San Fernando
p.(None): Email: i u1It iii iii c1 l›‹ ›i n n ‹ « i ha .c‹› i I
p.(None):
p.(None): : ii c I It i i c - la url‹c rf s \› i 1 ‹i. c t› . II
p.(None):
p.(None):
p.(None):
p.(None): CONFIlIMATION :
p.(None): Upon receipt o1’ an application, a confirmation email will bc sent to the researcher. Should researchers wish to
p.(None): also follow-up via telephone, thcy may contact 868-225-1763 ext 1763.
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
p.(None):
...
General/Other / Diminished Autonomy
Searching for indicator diminished:
(return to top)
p.(None): b. The usefulness and significance of the study
p.(None): c. An outline of the study design
p.(None): d. An indication of steps taken to ensure and maintain confidentiality
p.(None): e. An assessment of the bcnefits to participants (and/or groups in the communlty or the entire community) and
p.(None): the risks
p.(None):
p.(None): Page 1 of 4
p.(None):
p.(None): 8. THE PROJECT PltOPOSAL
p.(None): A. An introduction and background information on the research topic. This should also include the
p.(None): justification for the research (review of the current knowledge from the literature on the topic, with an
p.(None): explanation why this project is necessary, and how it will contribute to the overall knowledge in this area)
p.(None): B. A clear statement of the objectives of the research proposal
p.(None): C. Design and Methodology:
p.(None): i. Study design
p.(None): ii. Data collection methods:
p.(None): • Details of procedures to be performed (e. g. volume of blood, the frequency, timing, and
p.(None): possible site of the blood-taking; any drug administration, physiological measures, etc.).
p.(None): • Which procedures may cause pain and/or discomfort for research participants.
p.(None): • Details of the intervention (where appropriate)
p.(None): • Copy of the data collection tool in the Appendix
p.(None): iii. Study population and sampling methods
p.(None): • Choice of participants, inclusion exclusion criteria, any controls, etc.
p.(None): • A statement that participants were selected only because of the specific pr‹›blem under
p.(None): investigation, and not because of their easy availability, diminished autonomy, or any social bias.
p.(None): • Sampling methods
p.(None): iv. Statistical issues
p.(None): • Number of research participants and its justification
p.(None): • Planned data analysis
p.(None): D. A statement confirming that reasonable time will be given for the participant to consider his/her involvement
p.(None): E. Procedures for obtaining informed consent, including statements that the researcher/s will read the informed
p.(None): consent form to the participant or his/her legal guardian and will provide that person with a copy of
p.(None): the form, that questions from the person will be invited, and that all efforts will be made to ensure that s/he
p.(None): understands its content before the seeking of consent
p.(None):
p.(None): Page 2 of 4
p.(None):
p.(None): F. A copy of the informed consent form and recruitment posters (see details below)
p.(None): G. Data privacy/confidentiality: Mcthods to protect the confidentiality of participants, and methods to
p.(None): ensure that a participant who opts out of a research endeavour is well protected as far as hcalth care
p.(None): delivery is concerned and not disadvantaged in any way. Plans for the secure storage of the data.
p.(None): H. Assumptions made
p.(None): I. Relevant references (i.c. literature citation)
p.(None): J. Conflicts of intcrest
p.(None): K. Dissemination plan
p.(None): L. The name, address, telephone and fax numbers, as well as email address of a contact person
p.(None):
...
General/Other / Impaired Autonomy
Searching for indicator autonomy:
(return to top)
p.(None): c. An outline of the study design
p.(None): d. An indication of steps taken to ensure and maintain confidentiality
p.(None): e. An assessment of the bcnefits to participants (and/or groups in the communlty or the entire community) and
p.(None): the risks
p.(None):
p.(None): Page 1 of 4
p.(None):
p.(None): 8. THE PROJECT PltOPOSAL
p.(None): A. An introduction and background information on the research topic. This should also include the
p.(None): justification for the research (review of the current knowledge from the literature on the topic, with an
p.(None): explanation why this project is necessary, and how it will contribute to the overall knowledge in this area)
p.(None): B. A clear statement of the objectives of the research proposal
p.(None): C. Design and Methodology:
p.(None): i. Study design
p.(None): ii. Data collection methods:
p.(None): • Details of procedures to be performed (e. g. volume of blood, the frequency, timing, and
p.(None): possible site of the blood-taking; any drug administration, physiological measures, etc.).
p.(None): • Which procedures may cause pain and/or discomfort for research participants.
p.(None): • Details of the intervention (where appropriate)
p.(None): • Copy of the data collection tool in the Appendix
p.(None): iii. Study population and sampling methods
p.(None): • Choice of participants, inclusion exclusion criteria, any controls, etc.
p.(None): • A statement that participants were selected only because of the specific pr‹›blem under
p.(None): investigation, and not because of their easy availability, diminished autonomy, or any social bias.
p.(None): • Sampling methods
p.(None): iv. Statistical issues
p.(None): • Number of research participants and its justification
p.(None): • Planned data analysis
p.(None): D. A statement confirming that reasonable time will be given for the participant to consider his/her involvement
p.(None): E. Procedures for obtaining informed consent, including statements that the researcher/s will read the informed
p.(None): consent form to the participant or his/her legal guardian and will provide that person with a copy of
p.(None): the form, that questions from the person will be invited, and that all efforts will be made to ensure that s/he
p.(None): understands its content before the seeking of consent
p.(None):
p.(None): Page 2 of 4
p.(None):
p.(None): F. A copy of the informed consent form and recruitment posters (see details below)
p.(None): G. Data privacy/confidentiality: Mcthods to protect the confidentiality of participants, and methods to
p.(None): ensure that a participant who opts out of a research endeavour is well protected as far as hcalth care
p.(None): delivery is concerned and not disadvantaged in any way. Plans for the secure storage of the data.
p.(None): H. Assumptions made
p.(None): I. Relevant references (i.c. literature citation)
p.(None): J. Conflicts of intcrest
p.(None): K. Dissemination plan
p.(None): L. The name, address, telephone and fax numbers, as well as email address of a contact person
p.(None):
...
Orphaned Trigger Words
Appendix
Indicator List
Indicator | Vulnerability |
access | Access to Social Goods |
autonomy | Impaired Autonomy |
caretaker | persons with care obligations |
child | Child |
diminished | Diminished Autonomy |
drug | Drug Usage |
language | Linguistic Proficiency |
parent | parents |
student | Student |
Indicator Peers (Indicators in Same Vulnerability)
Trigger Words
consent
ethics
protect
risk
Applicable Type / Vulnerability / Indicator Overlay for this Input