TERMS OF REFERENCE AND OPERATIONAL GUIDELINES FOR THE ETHICAL REVIEW COMMITTEE OF THE GHANA HEALTH SERVICE, GHANA

1. Objective
The objective of these Guidelines is to contribute to the development of quality and consistency in the ethical review of research carried out in the Ghana Health Service. These guidelines are intended to complement existing laws, regulations and practices and to serve as a basis upon which research can be reviewed and approved within the Ghana Health Service. It is largely an adaptation of the Operational Guidelines for Ethics Committees that review Biomedical Research document (WHO Geneva 2000).

The main function of the Ethical review Committee is to provide independent, competent and timely review of the ethics of proposed studies. It shall be a multi-disciplinary group with a maximum number of 11 people. The records of activities of the ERC shall be retained for at least three years after completion of the research. All records shall be accessible for inspection and copying by authorized persons of the GHS at reasonable times and in a reasonable manner.

2. The Role of the ERC

The purpose of the ERC in reviewing bio-medical and applied research is to contribute to safeguarding the dignity, rights, safety and well being of all actual or potential research participants. A cardinal principle that is to guide this committee is that research involving human participants gives respect for the dignity of persons and the goals of research should never be permitted to override the health well being and care of research participants. The ERC should take into consideration the principle of justice.

Justice requests that the benefits and burdens of research be distributed fairly among all groups, and classes in society, taking into account age, sex, economic status, culture and ethnic considerations. The ERC should provide independent, competent and timely review of the ethics of proposed studies.

i. Its composition, procedures and decision-making should be independent from political, institutional, and professional and market influences.

ii. The ERC should be efficient and competent in its work

iii. The ERC is responsible for carrying out the review of the protocol for the proposed research studies before the commencement of the studies

iv. It is also to ensure that there is regular evaluation of the ethics of ongoing-studies that received a positive decision.

v. The ERC is responsible for acting in the full interest of potential research participants and concerned communities taking into account the interests and needs of the researchers and having due regard for the requirements of relevant regulatory agencies where applicable

Functions

i. To evaluate or review and approve, recommend modification in or disapprove all research proposals in the research proposal submitted to the Ghana Health Service.
ii. To ensure that all ethical issues are considered within the proposals submitted for review and approval.

iii. To monitor the progress of a research study approved by the committee and to continue the review of research activities at interval appropriate to the degree of risk but not less than once a year.

iv. To serve as a link between the Ghana Health Service and other Ethical Review Committees and research institutions in the country.

v. To ensure that whatever necessary, adequate information is presented to participants before commencements of research activities and that there is no coercion or influence and that rights and welfare of subject are protected.

vi. To continue review of research at intervals appropriate to the degree of risk but no less than once a year.

vii. To observe or authorize a third part to observe the consent process and research activities.

viii. To ensure that researchers are well informed of the procedures for protocol writing and consent of subjects.

ix. To maintain adequate documentation of ERC activities, i.e.

1. Copies of all research proposals reviewed.
2. Copies of scientific evaluations.
3. Approved sample consent documents.
4. Progress reports submitted by investigator.
5. Reports of injuries to subjects.
6. Detailed minutes
7. Records of continuities review activities.
8. Copies of all correspondence with investigators
9. A list of all ERC Members as per attached form
10. Written procedure for the review process

 

The Composition of the ERC

The aim is to constitute a committee competent enough to review and evaluate all of the ethical aspects of the research projects it shall receive. Therefore it should be multi-disciplinary and multi-sectoral in composition including relevant scientific expertise, balanced age and sex distribution and laypersons representing the interests and the concerns of the community to promote complete and adequate review of research activities. It shall thus be sufficiently qualified through the experience and expertise of its members. It should be established in accordance with the applicable laws and regulations of the country and in accordance with the values and principles of the communities of Ghana Health Service and later shall be responsible for appointing members of the committee.

The maximum number of should be 11 but minimum number of members required to compose a quorum is 5. The professional qualification requirements should include:

1. Lawyer
2. Epidemiologist
3. Social Scientist
4. Physician
5. Layperson/Teacher
6. Journalist
7. Minister/Pastor

2.1. Criteria for selection

i. They should be senior members with expertise in research especially biomedical and or operational/applied research.
ii. They should have areas of expertise or interest relevant to health and or policy
iii. They should be deemed capable by both their institution and the Director-General of the Ghana.

iv. Conflicts of interests shall be avoided when making appointments, but where unavoidable, the mode of appointment shall be transparent with regard to such interests.

2.1.1 Terms of Appointment

i. The members shall be appointed by direct appointment.
ii. Conflict of interest shall be avoided when making appointments, but where unavoidable, the mode of appointment shall be transparent with regard to such interest.
iii. Each member shall be appointed for two years.
v. The Director-General of the Ghana Health Service shall renew the appointment.

vi. A member should be willing to publicize his/her full name, profession.

vii. All reimbursement for work and expenses if any, within or related to an ERC should be recorded.

viii. Members shall sign a confidentiality agreement regarding meting deliberations, application, information on research participants and related matters including all ERC administration staff.

ix. A member can resign from the committee but should give a written notice.

2.1.2 Independent Consultants

The ERC may call upon or establish a standing list of independent consultants who may provide expertise to the ERC on proposed research protocols. These consultants may be specialist on ethical or legal aspects specific diseases or methodologies or they may be representatives of communities, patients or special interest groups.

2.1.3 Education for ERC members
All ERC members should have initial and continued regarding the ethics and science of both biomedical applied research.

2.2. Meetings
The committee shall meet quarterly i.e. four times in the year. At least five members shall form a quorum and no quorum shall consist entirely of members of only one profession. A quorum shall include at least one member who is independent of the Ghana Health Service.

2.2.1 Meeting Requirements
ERC should meet regularly on scheduled dates that are announced in advance. The meeting requirements should include the following:

i. Meeting should be planned in accordance with the needs of the workload
ii. ERC members should be given enough time in advance of the meeting to review the relevant documents;
iii. Minutes of meetings should be recorded; there should be an approval procedure for the minutes.
iv. The applicant, sponsor, and or investigator may be invited to present the proposal or elaborate on specific issue;

v. Independent consultants may be invited to the meeting or to provide written comments, subject to applicable confidentiality agreements.

2.3 Mechanism for ethical review

i. A format for reviewing proposals shall be prepared by the Health Research Unit and presented at the first meeting of the committee for review. It shall thereafter be used to review all proposals submitted to the said committee.

ii. The Health Research Unit shall act as the secretariat and receive, compile and send out copies of all proposals to various members of the committee depending on their expertise and areas of interest.

iii. Any proposal deemed to be outside the scope of any of the members would be sent to a know expert in that field. A list of available experts in the country shall be compiled and updated periodically by the Health Research Unit of the Ghana Health Service.

iv. Members of the committee should receive the proposals not later than two weeks before the review meeting date.

v. Criteria for approval shall be prepared and presented to the committee for approval by the Health Research Unit. They shall include broadly scientific relevance, relevance to the Ministry’s policy, issues of consent and ethical issues.

2.4 Submission of Application for Review and Clearance
All applications should be submitted to the Health Research Unit of the Ministry of Health

2.4.1. Application
A researcher or the principal investigator should submit an application for review to the Ethics Committee.

2.4.2 Documentation

The applicant should submit all documents required for a thorough and complete review of the ethics of the proposed research. These may include but is not limited to:

i. A signed and dated application form;
ii. The protocol of the proposed research (clearly identified and dated) together with supporting documents and annexes;
iii. A summary (as far as possible in non-technical language) synopsis, or diagrammatic representation (flow chart) of the protocol;
iv. A description (usually included in the protocol) of the ethical consideration involved in the research;
v. Case report forms, diary cards, other questionnaires intended for the research participants.
vi. When the research involves a study product (such as a pharmaceutical or device under investigation), and adequate summary of all safety, pharmacological pharmaceutical, and toxicological data available on the study product, together with a summary of clinical experience with the study product to date (e.g., recent investigators’ brochure, published data, a summary of the product’s characteristics);
vii. Curriculum vitae of investigator (s) (updated, signed and dated);
viii. Material to be used (including advertisements) for the recruitment of potential research participants;
ix. A description of the process used to obtain and document consent;
x. Written and other forms of information for potential research participants (clearly identified and dated) in the language(s) understood by the potential participants and, when required in other languages.
xi. A statement describing any compensation for study participation (including expenses and access to medical care) to be given to research participants;
xii. A description of the arrangements for indemnity, if applicable;
xiii. A description of the arrangements of insurance coverage for research participants, if applicable.
xiv. A statement of agreement to comply with ethical principles set out in relevant guidelines;
xv. All significant previous decisions (e.g. those leading to a negative decision or modified protocol) by other ERCs or regulatory authorities of the proposal study (whether in the same location or elsewhere) and in indication of modification) to the protocol made on that account. The reasons for previous negative decisions should be provided.

Review
All properly submitted application should be reviewed in a timely fashion and according to an established review procedure.

Element of the Review
The primary task of an ERC lies in the review of research proposal and their supporting documentation, with special attention given to the informed consent process documentation, and the suitability and feasibility of the protocol. ERCs need to take at into prior scientific review, if any, and the requirements of application laws and regulations. The following should be considered, as applicable.

2.6.1 Scientific Design and Conduct of the Study.

i. The appropriateness of the study design in relation to the objective of the study. The statistical methodology (including sample size calculation) and the potential for reaching sound conclusions with the smallest number of research participants;
ii. The justification of predictable risks and inconveniences weighed against the anticipated benefits for the research participants and the concerned communities;
iii. The justification for the use of control arms;
iv. Criteria for suspending or terminating the research as a whole;
v. The adequacy of provision of made for monitoring and auditing and conduct of the research, including the constitution of a data safety monitoring board (DSMB):
vi. The adequacy of the site, including the supporting staff, available facilities, and emergency procedures.
vii. The manner in which the result of the research will be reported and published.

2.6.2 Recruitment of Research Participants

i. The characteristics of the population from which the research participants will be drawn (including sex, age, literacy, culture, economics status, and ethnicity):
ii. The means by which initial contact and recruitment is to be conducted:
iii. This means by full information is to be conveyed to potential research participants or their representative;
iv. Inclusion criteria for research participants
v. Exclusion criteria for research participants
vi. Care and Protection of Research Participants
vii. Any plans to withdraw or with standard therapies for the purpose of the research, and the justification for such action;
viii. The medical care to be provided to research participants during and after the course of the research;
ix. The adequacy of medical supervision and psycho-social support for the research participants;
x. Steps to be taken if research participants voluntarily withdraw during the course of the research;
xi. The criteria for extended access to, the emergency use of, and/or the compassionate use of study products;
xii. The arrangements, if appropriate, for informing the research participant’s general practitioner (family doctor), including procedures for seeking the participant’s consent to do so;
xiii. A description of any plans to make the study product available to the research participants following the research;
xiv. A description of any financial costs to research participants;
xv. The rewards and compensation for research participants (including money, services, and /or gifts);
xvi. The provisions for compensation/treatment in the case of the injury/disability/death of a research participant attributable to participation in the research;
xvii. The insurance and indemnity arrangements.

2.6.3 Protection of Research Participant Confidentiality
i. A description of the process who will have access to personal data of the research participants, including medical records and biological samples;
ii. The measures taken to ensure the confidentiality and security of personal information concerning research participants.

2.6.4 Informed Consent Process
i. A full description of the process for obtaining informed consent, including the identification of those responsible for obtaining consent;
ii. The adequacy, completeness, and understandability of written and oral information to be given to the research participants, and where appropriate, their legally acceptable representative(s);
iii. Clear justification for the intention to include in the research individuals who cannot consent, and a full account of the arrangements for obtaining consent or authorization for the participation of such individuals;
iv. Assurance that research participants will receive information that becomes available during the course of the research relevant to their participation (including their rights, safety, and well-being);
v. The provision made for receiving and responding to queries and complaints from research participants or their representatives during the course of a research project.

2.7 Elements of Informed Consent
In seeking informed consent, the following information shall be provided to each subject:

i. A statement that the study involves research, and explanation of the purposes of the research, and the expected duration of the subject’s participation.
ii. A description of the procedures to be followed and identification of any procedures which are experimental;
iii. A description of any reasonably foreseeable risks or discomforts to the subject;
iv. A description of any benefits to the subject or to others which may reasonably be expected from the research;
v. A disclosure of appropriate alternative procedures or courses or treatment, if any, that might be advantageous to the subject;
vi. A statement describing the extent, if any to which confidentially of records identifying the subject will be maintained;
vii. For research involving more than minimal risk, in explanation as to whether by compensation, and explanation as to whether any medical treatments are available, if injury occurs and, if so, what they consist of a or where further information may be obtained;
viii. An explanation of whom to contact in the event of research-related injury to the subject and;
ix. A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefit, to which the subject is other entitled.

Additional elements of Informed Consent
When appropriate one or more of the following elements of information shall also be provided to each subject:

i. A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable;
ii. Anticipated circumstances under which the subject’s participation may be terminated by the investigator without regard to the subject’s consent;
iii. Any additional costs to subject that may result from participation in the research;
iv. The consequences of a subject’s decision to withdraw from the research, and the procedure for orderly termination of participation by the subjects;
v. A statement that significant new finding developed during the course of research, which may related to the subject’s willingness to continue participation, will be provided to the subject;
vi. The approximate number of subjects involved in the study.

2.7.1 Community Considerations
i. The impact and relevance of the research on the local community and on the concerned communities from which the research participants are drawn;
ii. The steps taken to consult with the concerned communities during the course of designing the research;
iii. The influence of the community on the consent of individuals;
iv. Proposed community consultation during the course of the research;
v. The extent to which the research contributes to capacity building, such as the enhancement of local healthcare, research and the ability to respond to public health needs;
vi. A description of the availability and affordability of any successful study product to the concerned communities following the research;
vii. The manner in which the results of the research will be made available to the research participants and the concerned community.

2.7.2 Expedited Review
ERCs shall establish procedures for the expedited review of research proposals. These procedures should specify the following:

i. The nature of the applications, amendments, and other considerations that will be eligible for expedite review;
ii. The quorum requirement(s) for expedited review;
iii. The status of decision (e.g., subject to confirmation by the full ERC or not)

2.7.3 Decision-making
In making decisions on applications for the ethical review of biomedical research, an ERC should take the following into consideration:

i. A member should withdraw from the meeting for the decision procedure concerning an application where there arises a conflict of interest; the conflict of interest should be indicated to the chairperson prior to the review of the application and recorded in the minutes;
ii. A decision may only be taken when sufficient time has been allowed for review and discussion of an application in the absence of the non-members (e.g., the investigator, representatives of the sponsor, independent consultants) from the meeting, with the exception of ERC staff;
iii. Decisions should only be made meeting where a quorum (as stipulated in the ERC’s written operating procedures in present;
iv. The documents required for a full review of the application should be complete and the relevant elements mentioned above should be considered before a decision is made;
v. There should be a predefined method for arriving a decision (e.g., by consensus, by vote); it is recommended that decisions be arrived at through consensus, where possible, when a consensus appears unlikely, it is recommended that the ERC vote;
vi. Advice that that non-binding may be appended to the decision;
vii. In cases of conditional decisions, clear suggestions for revision and the procedure for having the application re-reviewed should be specified;
viii. A negative decision on an application should be supported by clearly stated reasons.

2.7.4 Communicating A Decision

A decision should be communicated in writing to the applicant according to ERC procedure, preferably within two weeks of the meeting at which the decision was made. The communication of the decision should include, but is not limited to, the following:

i. The exact title of the research proposal reviewed;
ii. The clear identification of the protocol of the proposed research or amendment, date and version number (if applicable), on which the decision is based;
iii. The means and (where possible) specific identification numbers (version numbers/dates) of the documents reviewed, including the potential research participant information sheet/material and informed consent form;
iv. The name and title of the applicant;
v. The name of the site(s);
vi. The date and place of the decision;
vii. A clear statement of the decision reached;
viii. Any advice by the ERC;
ix. Any requirements by the ERC including suggestions for revision and the procedure for having the application re-reviewing in the case of a conditional decision;
x. A statement of the responsibilities of the applicant; for example, confirmation of the acceptance of any requirements imposed by the ERC in the case of a positive decision, submission of progress report(s); the need to notify the ERC in case of protocol amendments (other than amendments involving only logistical or administrative aspects, amendments to the recruitment material, the potential reform; the report unforeseen circumstance, the termination of the study, or significant decision by other ERCs; the information the ERC expects to receive in order to perform ongoing review; the final summary or final report;
xi. The schedule/plan of ongoing review by the ERC;
xii. Clearly stated reason(s) for the negative decision in the case of a negative decision;
xiii. Signature (dated) of the chairperson (or other authorized person) of the ERC

2.8 Follow-Up

ERCs should establish a follow-up procedure for following the progress of all studies for which a positive decision has been reached, from the time the decision was taken until the termination of the research. The ongoing lines of communication between the ERC and the applicant should be clearly specified. The follow-up procedure should take the following into consideration:

i. The quorum requirements, the review procedure, and the communication procedures for follow-up reviews, which may vary from the requirements and procedures for the initial decision on an application;
ii. The follow-up review intervals should be determined by the nature and the events of research projects, though each protocol should undergo a follow-up review at least once a year;

The following instances or events require the follow-up review at least once a year;

i. Any protocol amendment likely to affect the rights, safety and or well-being of the research participants or the conduct of the study;
ii. Serious and unexpected adverse events related to the conduct of the study or study product, and the response taken by investigators, sponsors, and regulatory agencies:
iii. Any event or new information that my affect the benefit/risk ratio of the study;

Further action should be taken as follows:
i. A decision of a follow-up review should be issued and communicated to the applicant, indicating a modification, suspension, or termination of the ERC’s original decision or confirmation that the decision is still valid;
ii. Premature suspension/termination should be communicated to the ERC;
iii. The ERC should receive notification from the applicant at the time of the completion;
iv. The ERC should receive a copy of the final summary or final report of a study.

Documentation and Archiving
All documentation and communication of the ERC should be dated, filed and archived according to written procedures. A statement is required defining the access and retrieval procedure (including authorized persons) for the various documents, files, and archives.
It is recommended that documents be archived for a minimum period of 3 years following the completions of a study.

Documents that should be filed and archived include, but are not limited to:

i. The constitution, written standard operating procedures of the ERC, and regular (annual) report;
ii. The curriculum vitae of all ERC members
iii. A record of all income and expenses of the ERC including allowance and reimbursements made to the secretariat and ERC members;
iv. The published guidelines for submission established by the ERC
v. The agenda \of the ERC meeting;
vi. One copy of all materials submitted by an applicant;
vii. The correspondence by ERC members with applicants or concerned parties regarding application, decision, and follow-up;
viii. A copy of the decision and any advice or requirements sent to an applicant;
ix. All written documentation received during the follow-up;
x. The notification of the completion, premature suspension, or premature termination of a study;
xi. The final summary or final report of the study.