79C3C34C52B45572883A05D425EB0F82
Ethics Committee Guidelines: Procedures for Researchers
https://clinregs.niaid.nih.gov/sites/default/files/documents/liberia/G-LIBR-NHSREC.pdf
http://leaux.net/URLS/ConvertAPI Text Files/54971936AB4390C1C8644736146236C5.en.txt
Examining the file media/Synopses/54971936AB4390C1C8644736146236C5.html:
This file was generated: 2020-12-01 09:17:03
| 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
| Vulnerability Type | Vulnerability | Indicator | # Matches |
|---|
| Health | Drug Usage | influence | 3 |
| Social | Student | student | 3 |
Health / Drug Usage
Searching for indicator influence:
(return to top)
p.(None): accordance with the ‘research misconduct’ processes specified in the LIBR/NHSREC STANDARD OPERATING PROCEDURES. Where
p.(None): a complaint about a researcher alleges serious misconduct that falls outside the range of ‘research misconduct’ as
p.(None): described in the LIBR/NHSREC STANDARD OPERATING PROCEDURES, the matter will be dealt with under governmental processes
p.(None): for dealing with other forms of misconduct.
p.(None):
p.(None): 1.13. Confidentiality of Protocols
p.(None):
p.(None): LIBR/NHSREC documents and protocols are to be maintained in a secure environment. All documents distributed to
p.(None): Committee members must be securely stored. Committee files are to be kept in locked cabinets and accessed only by
p.(None): authorized individuals
p.(None):
p.(None):
p.(None): 2. Researchers
p.(None):
p.(None):
p.(None): 2.1. Researchers’ Responsibilities
p.(None):
p.(None): Researchers are expected to be aware of the values and principles of ethical and responsible conduct of human research,
p.(None): including appropriate consideration of:
p.(None):
p.(None): 1. research merit and integrity;
p.(None): 2. justice;
p.(None): 3. beneficence; and
p.(None): 4. respect.
p.(None):
p.(None):
p.(None): This should be reflected in any proposal put to the LIBR/NHSREC for consideration.
p.(None):
p.(None): 2.2. Conflict of Interest
p.(None):
p.(None): Researchers should establish transparent processes to identify and manage actual and potential conflicts of interest.
p.(None):
p.(None): A conflict of interest in the context of research exists where:
p.(None):
p.(None): • a person’s individual interests or responsibilities have the potential to influence the carrying out of his or her
p.(None): institutional role or professional obligations in research; or
p.(None):
p.(None): • an institution’s interests or responsibilities have the potential to influence the carrying out of its research
p.(None): obligations.
p.(None):
p.(None): the institution or researcher’s influence/association has possible propensity to compromise the objectivity and outcome
p.(None): of the research.
p.(None):
p.(None): While a conflict may relate to financial interests, it can also relate to other private, professional or institutional
p.(None): benefits or advantages that depend significantly on the research outcomes.
p.(None): A researcher with a conflict of interest bearing on research should immediately inform the LIBR/NHSREC about the
p.(None): conflict.
p.(None):
p.(None):
p.(None): 2.3. Submission Types
p.(None):
p.(None): New Submission – a research proposal NOT considered by LIBR/NHSREC previously;
p.(None):
p.(None): Re-Submission – a submission on an unapproved research proposal that has been considered by LIBR/NHSREC previously. The
p.(None): submission could be a revised proposal, provision of further information or a response to specified matters of
p.(None): conditional approval;
p.(None):
p.(None): Protocol Change – only on previously approved research proposals where there is a change in protocol relating to
p.(None): methodology. A change in rationale need not require LIBR/NHSREC approval but should be assessed before reaching that
p.(None): decision.
p.(None):
p.(None):
p.(None): 2.4. New Submissions
p.(None):
p.(None): All submissions must be typed, dated, signed and presented to the LIBR/NHSREC electronically or by hard copies.
p.(None):
p.(None): New submissions must also include all documents and material used to inform the potential participants including
p.(None): information sheets, consent forms, questionnaires, letters of invitation and internet content.
p.(None): All participant information sheets should include a signature block. Researchers should also include the name of the
p.(None): principal investigator, sponsor or sponsors, and contact information.
p.(None):
...
Social / Student
Searching for indicator student:
(return to top)
p.(None): principal investigator, sponsor or sponsors, and contact information.
p.(None):
p.(None): All submissions must be received by the LIBR/NHSREC by no later than the close off for submissions, usually 6 weeks
p.(None): prior to each meeting.
p.(None):
p.(None): The Principal Researcher or his/her representative should be available for comments and clarifications at anytime the
p.(None): Committee request such presence.
p.(None):
p.(None):
p.(None): 2.5. Declaration of Funding Sources
p.(None):
p.(None): A researcher is required to disclose the amounts, sources or potential sources of funding in any research proposal and,
p.(None): following approval of the proposal, any subsequent funding sources.
p.(None):
p.(None): 2.6. Payments for Participants
p.(None):
p.(None): It is generally unacceptable to LIBR/NHSREC to pay participants for their involvement in research. A payment, gift,
p.(None): reward or any other inducement that is likely to encourage participants to take risks is ethically unacceptable.
p.(None):
p.(None): Reimbursement of direct costs to participants taking part in research, including costs such as travel, accommodation
p.(None): and parking shall be permitted.
p.(None):
p.(None):
p.(None): 2.7. Complaints/Adverse Occurrences
p.(None):
p.(None): Participants shall be advised of the first point of contact for complaints. The consent form signed by participants
p.(None): shall include the name and telephone number of this contact.
p.(None):
p.(None): The first instance of a complaint shall be directed to the LIBR/NHSREC ethics committee VIA THE ADDRESS BELOW:
p.(None): LIBR/NHSREC
p.(None): Charlesville, Margibi County Email: director.libr@gmail.com
p.(None):
p.(None):
p.(None): 2.8. Student Research
p.(None):
p.(None): In considering approval of PhD or other student research, the LIBR/NHSREC shall consider the merit and integrity of the
p.(None): proposed study, including whether:
p.(None):
p.(None): • the potential benefit of the research will outweigh any possible harm to participants;
p.(None): • the results of the research will create new knowledge or be a slight revision of other research;
p.(None): • the design and methodology of the research is appropriate to achieving desired aims;
p.(None): • the research will be closely supervised by a person or team with experience, qualifications and competence
p.(None): appropriate to the research;
p.(None):
p.(None): • the research will be conducted using facilities and resources appropriate to the research;
p.(None): • the research will be carried out using the recognized principles of research conduct.
p.(None):
p.(None): All correspondence from the (student) researcher - especially to participants - should be on university stationery,
p.(None): clearly identifying the status of the Researcher within the University. Information to Participants shall also identify
p.(None): the Supervisor in such a way that indicates their professional oversight of, and responsibility for, the research
p.(None): activity.
p.(None): Students must ensure secure storage and, where necessary, destruction of data. Research files are to
p.(None): be kept in locked cabinets at the university responsible for the research, and accessed only by authorized individuals.
p.(None):
p.(None): 2.9. Presentation of Research Protocols
p.(None):
p.(None): The LIBR/NHSREC encourages researchers to make themselves available for contact, including attendance, at the meeting
p.(None): when their project is being considered in order to answer any questions that may arise. It may be reasonable in some
p.(None): instances for the Sponsor to attend on behalf of the Researcher.
p.(None):
p.(None): When facilities are available during LIBR/NHSREC meetings for conference call, connection with researchers shall
p.(None): normally be sufficient. The LIBR/NHSREC Secretariat will contact researchers prior to the meeting to make appropriate
p.(None): arrangements.
p.(None):
p.(None):
p.(None): 2.10. Change to Protocol
p.(None):
p.(None): Principal researchers are required to advise the LIBR/NHSREC in writing if their research protocol, as approved by
p.(None): LIBR/NHSREC, changes before the study commences or at any time during the study. The LIBR/NHSREC will then reassess the
p.(None): proposal and reach a decision based on the revised protocol. It is preferable that significant protocol changes on
p.(None): studies which have not yet commenced be shown as changes on the original approved proposal
p.(None):
p.(None):
p.(None): 2.11. Reporting Requirements
p.(None):
...
Orphaned Trigger Words
p.(None):
p.(None):
p.(None): 1.11. Monitoring
p.(None):
p.(None): The LIBR/NHSREC shall, as a condition of approval of each protocol, require researchers to report on a Three –monthly
p.(None): basis from the date of approval. Researchers are to immediately report anything that may warrant a review of the
p.(None): protocol including:
p.(None):
p.(None): 1. serious and unexpected adverse effects on participants;
p.(None): 2. proposed changes to the protocol; and
p.(None): 3. Unforeseen events that might affect continued ethical acceptability of the project.
p.(None):
p.(None):
p.(None): 1.12. Complaints Procedure
p.(None):
p.(None): Whenever a complaint about a researcher raises the possibility of ‘research misconduct’ the matter will be handled in
p.(None): accordance with the ‘research misconduct’ processes specified in the LIBR/NHSREC STANDARD OPERATING PROCEDURES. Where
p.(None): a complaint about a researcher alleges serious misconduct that falls outside the range of ‘research misconduct’ as
p.(None): described in the LIBR/NHSREC STANDARD OPERATING PROCEDURES, the matter will be dealt with under governmental processes
p.(None): for dealing with other forms of misconduct.
p.(None):
p.(None): 1.13. Confidentiality of Protocols
p.(None):
p.(None): LIBR/NHSREC documents and protocols are to be maintained in a secure environment. All documents distributed to
p.(None): Committee members must be securely stored. Committee files are to be kept in locked cabinets and accessed only by
p.(None): authorized individuals
p.(None):
p.(None):
p.(None): 2. Researchers
p.(None):
p.(None):
p.(None): 2.1. Researchers’ Responsibilities
p.(None):
p.(None): Researchers are expected to be aware of the values and principles of ethical and responsible conduct of human research,
p.(None): including appropriate consideration of:
p.(None):
p.(None): 1. research merit and integrity;
p.(None): 2. justice;
p.(None): 3. beneficence; and
p.(None): 4. respect.
p.(None):
p.(None):
p.(None): This should be reflected in any proposal put to the LIBR/NHSREC for consideration.
p.(None):
p.(None): 2.2. Conflict of Interest
p.(None):
p.(None): Researchers should establish transparent processes to identify and manage actual and potential conflicts of interest.
p.(None):
p.(None): A conflict of interest in the context of research exists where:
p.(None):
p.(None): • a person’s individual interests or responsibilities have the potential to influence the carrying out of his or her
p.(None): institutional role or professional obligations in research; or
p.(None):
p.(None): • an institution’s interests or responsibilities have the potential to influence the carrying out of its research
p.(None): obligations.
p.(None):
p.(None): the institution or researcher’s influence/association has possible propensity to compromise the objectivity and outcome
p.(None): of the research.
p.(None):
p.(None): While a conflict may relate to financial interests, it can also relate to other private, professional or institutional
p.(None): benefits or advantages that depend significantly on the research outcomes.
p.(None): A researcher with a conflict of interest bearing on research should immediately inform the LIBR/NHSREC about the
p.(None): conflict.
p.(None):
p.(None):
p.(None): 2.3. Submission Types
p.(None):
p.(None): New Submission – a research proposal NOT considered by LIBR/NHSREC previously;
p.(None):
p.(None): Re-Submission – a submission on an unapproved research proposal that has been considered by LIBR/NHSREC previously. The
p.(None): submission could be a revised proposal, provision of further information or a response to specified matters of
p.(None): conditional approval;
p.(None):
p.(None): Protocol Change – only on previously approved research proposals where there is a change in protocol relating to
p.(None): methodology. A change in rationale need not require LIBR/NHSREC approval but should be assessed before reaching that
p.(None): decision.
p.(None):
p.(None):
p.(None): 2.4. New Submissions
p.(None):
p.(None): All submissions must be typed, dated, signed and presented to the LIBR/NHSREC electronically or by hard copies.
p.(None):
p.(None): New submissions must also include all documents and material used to inform the potential participants including
p.(None): information sheets, consent forms, questionnaires, letters of invitation and internet content.
p.(None): All participant information sheets should include a signature block. Researchers should also include the name of the
p.(None): principal investigator, sponsor or sponsors, and contact information.
p.(None):
p.(None): All submissions must be received by the LIBR/NHSREC by no later than the close off for submissions, usually 6 weeks
p.(None): prior to each meeting.
p.(None):
p.(None): The Principal Researcher or his/her representative should be available for comments and clarifications at anytime the
p.(None): Committee request such presence.
p.(None):
p.(None):
p.(None): 2.5. Declaration of Funding Sources
p.(None):
p.(None): A researcher is required to disclose the amounts, sources or potential sources of funding in any research proposal and,
p.(None): following approval of the proposal, any subsequent funding sources.
p.(None):
p.(None): 2.6. Payments for Participants
p.(None):
p.(None): It is generally unacceptable to LIBR/NHSREC to pay participants for their involvement in research. A payment, gift,
p.(None): reward or any other inducement that is likely to encourage participants to take risks is ethically unacceptable.
p.(None):
p.(None): Reimbursement of direct costs to participants taking part in research, including costs such as travel, accommodation
p.(None): and parking shall be permitted.
p.(None):
p.(None):
p.(None): 2.7. Complaints/Adverse Occurrences
p.(None):
p.(None): Participants shall be advised of the first point of contact for complaints. The consent form signed by participants
p.(None): shall include the name and telephone number of this contact.
p.(None):
p.(None): The first instance of a complaint shall be directed to the LIBR/NHSREC ethics committee VIA THE ADDRESS BELOW:
p.(None): LIBR/NHSREC
p.(None): Charlesville, Margibi County Email: director.libr@gmail.com
p.(None):
p.(None):
p.(None): 2.8. Student Research
p.(None):
p.(None): In considering approval of PhD or other student research, the LIBR/NHSREC shall consider the merit and integrity of the
p.(None): proposed study, including whether:
p.(None):
p.(None): • the potential benefit of the research will outweigh any possible harm to participants;
p.(None): • the results of the research will create new knowledge or be a slight revision of other research;
p.(None): • the design and methodology of the research is appropriate to achieving desired aims;
p.(None): • the research will be closely supervised by a person or team with experience, qualifications and competence
p.(None): appropriate to the research;
p.(None):
p.(None): • the research will be conducted using facilities and resources appropriate to the research;
p.(None): • the research will be carried out using the recognized principles of research conduct.
p.(None):
p.(None): All correspondence from the (student) researcher - especially to participants - should be on university stationery,
p.(None): clearly identifying the status of the Researcher within the University. Information to Participants shall also identify
p.(None): the Supervisor in such a way that indicates their professional oversight of, and responsibility for, the research
p.(None): activity.
p.(None): Students must ensure secure storage and, where necessary, destruction of data. Research files are to
p.(None): be kept in locked cabinets at the university responsible for the research, and accessed only by authorized individuals.
p.(None):
p.(None): 2.9. Presentation of Research Protocols
p.(None):
p.(None): The LIBR/NHSREC encourages researchers to make themselves available for contact, including attendance, at the meeting
p.(None): when their project is being considered in order to answer any questions that may arise. It may be reasonable in some
p.(None): instances for the Sponsor to attend on behalf of the Researcher.
p.(None):
p.(None): When facilities are available during LIBR/NHSREC meetings for conference call, connection with researchers shall
p.(None): normally be sufficient. The LIBR/NHSREC Secretariat will contact researchers prior to the meeting to make appropriate
p.(None): arrangements.
p.(None):
p.(None):
p.(None): 2.10. Change to Protocol
p.(None):
p.(None): Principal researchers are required to advise the LIBR/NHSREC in writing if their research protocol, as approved by
...
Appendix
Indicator List
| Indicator | Vulnerability |
|---|
| influence | Drug Usage |
| student | Student |
Indicator Peers (Indicators in Same Vulnerability)
Trigger Words
consent
ethics
harm
justice
risk
welfare
Applicable Type / Vulnerability / Indicator Overlay for this Input
| Vulnerability Type | Vulnerability | Indicator | # Matches |
|---|
| Health | Drug Usage | influence | 3 |
| Social | Student | student | 3 |