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Ethics Policy Continuation

Word/Term

Definition

Benefit

The  acquired  right  or  privilege  through  a  contract  where  payment  of money or the giving of gifts is applied. It might also involve the impacted outcome of the research to the participants involved.

Confidentiality

The rules or promise that limits the access or places restrictions on types of information that has been received through an interaction with participants of a research.

Conflict of Interest

A conflict of interest is a variance between an individual’s professional obligations and his or her private interests. Such circumstances create a possibility that professional judgment or actions regarding a principal interest  will be overly  influenced  by a minor interest.  This may lead to actual   misconduct   when   consideration   of  personal   gain   or  financial influence may compromise an individual’s judgment and actions in the performance of his or her primary responsibilities.

Human Subjects

The  use  of  human  beings  in  a  research  process  for  investigation  of  a specific question which incorporates data collection and analysis. The process may include the use of surveys, questionnaires, interviews, focus groups or participant observation

Informed Consent

This is the voluntary choice of an individual to participate in a research based on the appreciation and understanding of the facts, implications, benefits  and  future  consequences  of  a  research  that  may  affect  their person’s decision to participate. In order to give informed consent the individual must have adequate reasoning abilities and is in possession of all the relevant facts at the time of giving consent.

Investigator

An individual  who  devotes  him/herself  to the systemic  investigation  or inquiry.

Minor

A person under the legal age of being an adult.

Research

A systemic  investigation  (i.e. the gathering  and analysis  of information)

designed to develop or contribute to knowledge.

Research Protocol

Research  protocol  is  a  detailed  plan  of  a  study;  it  should  include  the project title, project summary, project description, ethical consideration, gender issues and references.

Risk

The potential that a chosen action or activity will lead to an undesirable

outcome that may affect participants or researcher of a study.

Special Protection

Is the basic principles governing the ethical conduct of research involving

human  subjects,  these  include  the  capacity  to  consent,  freedom  from coercion and the comprehension of risk involved.

Standard Operating

Procedure (SOP)

This is the detailed written instructions that have been put in place to achieve   uniformity   of  the  performance   of  a  specific   function   by  an institution.

Vulnerable

Population/Person

A person without the capacity to make informed decision based on the mental or emotional ability.  A vulnerable person may include children depending on their age and some category of adults. They may be susceptible to exploitation or significant harm.

 

 Scope of Policy

The term ‘Investigator’ in this policy, refers to UG staff and students, and to other persons involved in collaborative research at UG.  Persons involved in collaborative research must agree  in  writing  that  this  policy  shall  apply  to  them,  whether  the  research  is  being conducted on UG’s premises or outside UG’s premises.

 Basic Ethical  Principles

The fundamental ethical principles that govern the operations of the UG Ethics Policy are the Declaration of Helsinki (1996); the International Conference on Harmonization, Good Clinical  Practice  [ICH  GCP  (E6)]  Guidelines;  Council  for  International  Organizations  of Medical Sciences (CIOMS); Belmont Report; and the Applicable Laws and Statutory Regulations of Ghana and the University.

 

 Respect for Persons

This principle seeks to ensure that human subjects have adequate information on the potential risks and benefits of the research to enable them to make an informed decision on their voluntary participation. Respect for persons encompasses two ethical principles:

i.     Respect for Autonomy

This maintains that each individual is considered as an autonomous person, capable of making rational decisions about his personal choices. Thus, individuals who take actions based on these decisions should be treated with respect for their self-determination capabilities.

 

ii.   Protection of Persons with Diminished Autonomy

This  principle  requires  that  individuals  who  are  vulnerable  or  dependent  be  offered security against harm. Though the principle of respect must be extended to the community in which the research is being undertaken, it is possible that its application may be difficult in certain instances.

 

Beneficence

It relates to the commitment to minimize the potential risks and maximize the potential benefits associated with the research. This is necessary because participating in biomedical or behavioural research expose participants to some level of risk which should be justified by the expected benefits to the subjects or the society. There are three categories of risk to which subjects could be exposed i.e., physical, psychological, social and economic risks.

i.     Physical Harm

Medical research may expose subjects  to some level of injury from medical  procedures since subjects are likely to experience possible side effects of drugs.

ii.   Psychological Harm

Participants may experience some undesirable transformations in emotions or thought- processes. Even though some of these changes may be short-lived, intermittent or long- lasting, they have the potential of causing severe psychological harm to participants.

iii.  Social or Economic Harm

Where participants participate in behavioural research that require provision of some sensitive information in relation to illegal activities, drug or use of alcohol, invasion of privacy, a breach of confidentiality could result in humiliation within one's community, loss of employment or criminal prosecution.

 

 Non-malfeasance

This  principle  ensures  that  harm  is  avoided  to  research  subjects.  It  also  requires  that subjects are given the opportunity to withdraw from a study at any time without penalty.

 Justice

It refers to the ethical obligation to treat each subject in accordance with what is morally right  and proper  and  also to give  each  person  what  is due to him  or her.  An injustice therefore happens when a person who is entitled to some benefit is denied without reasonable cause or when some burden is unduly imposed on him.

 

Institutional Authority

The  UG   Research   Ethics   Policy   establishes   and   empowers   all   three   (3)   UG   Ethics

Committees to perform the following mandates:

i.      To review all research projects involving human and non-human subjects. ii.   To respect the dignity, rights and wellbeing of all research subjects.

iii.  To maximize the public benefit of research and minimize harm.

iv. To oversee the activities in approved projects within their capacity as well as yearly scheduled continuing review and verification of compliance with approved research protocols and informed consent.

v.   Providing approval for the initiation of a new research project after successful review. vi.  To initiate periodic auditing on approved projects.

vii.  To request prompt reportage of any occurrences throughout the approved project life

cycle.

viii. To terminate or discontinue any previously approved protocol where necessary. ix.     To ensure research compliance with national and international guidelines.

 

UG Research Ethics Office

i.    The Pro-Vice Chancellor (Research, Innovation and Development) is designated as the Institutional Official (IO) in charge of the UG Research Ethics Office. He/she shall have overall oversight of all human and non-human research conducted at the University.

ii.   The UG Research Ethics Office shall be housed at the Office of Research, Innovation and Development  (ORID)  and shall coordinate  the activities  of the various  ethics committees in the University.

iii.  The Office shall have an administrator who will handle issues relating to ethics from the three (3) UG Ethics Committees.

 The UG Ethics Board

The UG Ethics Board shall comprise the Institutional Official (IO), the chairpersons and administrators from the three (3) Ethics Committees. The Board shall meet twice yearly to discuss issues relating to the activities of the three Ethics Committees.

 

 Responsibilities and Quality Assurance

 Responsibilities of the University

The University of Ghana is guided by ethical principles that aim at protecting both human and non-human subject participants as enshrined in international guidelines, and the applicable laws and statutory regulations of Ghana and the University. In view of the above, the University shall ensure that:

i. No research exposes both human and non-human subjects to any form of harm.

ii. Research subjects are protected from any form of unnecessary risk.

iii. Only qualified personnel are allowed to conduct research involving human and non- human subjects.

iv. All three (3) UG Ethics Committees are fully equipped with adequate resources and authorised to perform their duties independently without any form of interference from the University authorities.

 

 Responsibilities of the Institutional Official

The Pro Vice-Chancellor (RID), who serves as the Institutional Official (IO) shall:

i.        Have complete oversight over all research activities involving both human and non- human subjects within the University.

ii.     Chair   semi-annual   meetings   involving   Chairpersons   from   the   three   (3)   Ethics

Committees and their Administrators.

iii.       Be involved in the selection of board members for the three (3) Ethics Committees. iv.                Ensure the protection of research participants at all times.

v.     Review the qualifications and expertise of Chairs, Board Members and Administrators

periodically.

vi.      Ensure that appropriate payments of honorarium to all Chairs and Board Members are made.

 Responsibilities of Board Members

i. Ensure that research activity is carried out in compliance with the UG Research Ethics

Policy as well as national and international regulations.

ii. Ensure the protection of the rights and wellbeing of human and non-human subjects. iii. Undertake periodic audits of research work.

iv. Ensure the safety of research protocols and related materials.

 Responsibilities of the Chairpersons of Ethics  Committtees

i. The Chairperson must understand and apply the ethical principles that regulate human and non-human subject participants in research.

ii. The Chairperson must ensure equitable selection of research participants, respect the autonomy of the participants and must understand the local research context regarding the choice of participants.

iii. Have the responsibility to review, and the authority to approve, disapprove, or require modification, and suspend research activities.

iv. Ensure that informed consent forms are documented appropriately.

v. Put in place procedures to ensure participants privacy, maintenance of confidential data, and adequate protection of vulnerable participants.

   Responsibilities of the Investigator

i. The Investigator shall bear primary responsibility for the protection of human and non- human subjects in research.

ii. To adequately explain to research subjects, prior to their participation, why they are conducting   the  research,   what  procedures   research   subjects   should  follow   and  the potential risks and benefits to the research subjects and the society.

iii. The Investigator shall not coerce any individual to participate in any research unless they consent and thereby fill the informed consent forms knowing vividly the consequence of their actions.

iv. The Investigator shall at all times respect the privacy of research subjects as well as protecting confidential information of research subjects.

v.  The  Investigator  must  make  it  clear  to  research  participants  that  they  are  free  to withdraw from the research without any form of prejudice or witch-hunting.

vi. Must ensure adequate participation and cooperation with all research quality assurance reviews.

              Quality Assurance

i. There shall be monitoring of the activities of the committees to ensure full compliance to

UG Research Ethics Policy and other related policies.

ii. ORID shall ensure continuous education of all the Chairs and Members of the various UG Ethics Committees.

 

 Version Control and Change  History

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Amendment