Research eligible for expedited review
The following types of research considered having no more than minimal risk, and not involving children, foetuses, pregnant women, prisoners, mentally ill or cognitive impaired or intellectually disabled persons have been explicitly identified as eligible for expedited review:
- Review of previously approved research for changes without risk implication.
- Surveys by interview or questionnaire on non-sensitive issues.
- Collection of hair and nail clippings in a non-disfiguring manner; deciduous teeth, and permanent teeth if patient care indicates a need for extraction.
- Collection of excreta and external secretions including sweat, un-annulated saliva, and placenta removed at delivery and amniotic fluid at the time of rupture of the membrane prior to or during labour.
- Recording of data from subjects, using non-invasive procedures routinely employed in clinical practice (including use of physical sensors applied either to the surface of the body or at a distance and do not involve input of matter or significant amounts of energy into the subject or invasion of the subject's privacy; procedures such as weighing, testing sensory acuity, electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, diagnostic echocardiography, and electro-ethnography, not including exposure to electromagnetic radiation outside the visible range, such as X-rays and microwaves).
- Collection of blood samples by vein-puncture, in an amount not exceeding 450 milliliters in an eight-week period and no more than two times per week, from subjects, who are in good health and not pregnant.
- Collection of supra-gingival and sub-gingival dental plaque and calculus provided the procedure is not more invasive than routine prophylactic scaling of the teeth, and is accomplished in accordance with accepted prophylactic techniques.
- Voice recordings made for research purposes, such as investigations of speech defects.
- Moderate exercise by healthy volunteers.
- Study of existing data, documents, records, pathological specimens, or diagnostic specimens.
- Research on individual or group behavior or characteristics of individuals, such as perception, cognition, game theory, or test development, where the investigator does not manipulate subjects' behavior and the research will not involve stress to subjects.
- Research on drugs or devices for which an investigational new drug exemption or investigational device exemption is not required.
Research considered eligible for exemption from review, but subject to expedited review by CSIR- IRB
Overseas regulatory agencies recognize certain types of research as having no or negligible risk to the subjects, and considered them to be eligible for exemption from review by institutional review boards. The CSIR-IRB will not grant exemption from review for such research, but will consider processing them by expedited review.
Institutional-type applications considered by CSIR-IRB as eligible for expeditedreview
Applications and proposals lacking definite plans for involvement of human subjects, such as institutional-type centre or training grants, will be eligible for expedited review. Any study involving human subjects under the umbrella of such grants will have to be reviewed subsequently by the CSIR-IRB, prior to its initiation.
Use of test articles
Under certain circumstances, a test article may have to be administered to a human subject in a life-threatening situation, when there is no standard acceptable treatment available, or the standard treatments have failed and the subject is not enrolled, or is not eligible to enroll in a research protocol involving the test article. The following criteria apply:
- To be used in a single subject by a physician licensed to practice medicine in Ghana
- The subject is facing a life-threatening condition, for which there is no conventional treatment, or conventional treatments have failed.
- The physician has legitimate access to a test article, and believes that there is a reasonable likelihood that it may be helpful in the life-threatening condition.
- The subject to receive the test article will not be enrolled in a research study involving the test article employed.
- If subsequent use of the test article is contemplated in the same subject or in others, a new project application to the CSIR-IRB is required in advance of that use. If these criteria are met, a physician may use the test article on a subject, without prior approval of the CSIR- IRB. In this instance, the physician is required to do the followings:
i. Obtain written informed consent from the subject or subject's legal representative.
ii. Use the test article on the subject.
iii. Enter a description of the procedure in the patients’ medical record and attach a copy of the informed consent document.
iv. Within five days of using the test article, submit to the CSIR-IRB the following information in writing: Identity and address of the responsible physician, name and hospital case number of the subject, name and source of the test article; investigational new drug/device (IND) number, how much, by what route and on what date the test article was administered, information about any adverse effects observed and copy of the informed consent document used.
- The CSIR-IRB will process such notifications as an expedited review and issue an acknowledgement letter. Any subsequent use of the test article will be subject to prior full review and approval by the CSIR-IRB.
Stored tissues
- In cases where blood or tissue specimens are to be stored for future analyses, only CSIR-IRB approved analyses may be done
- Investigator must provide details of provision made to protect the privacy of the donor and maintenance of confidentiality.
- Specimen may not be shared with any third party unless approved by the IRB.
- Separate consent form for storage of residual samples and genetic testing must be obtained.
- When samples are to be exported, valid Material Transfer Agreement (MTA) should be obtained. (WHO MTA procedures recommended).
ARCHIVING/RECORD KEEPING
Meeting Records
Agendas and minutes of the IRB meetings will be kept in files .They will be maintained indefinitely.
Member Records
Member’s records should include the term and status of each member, Curriculum Vitae, appointment document and information about training received. Such information should be maintained and updated as necessary and should be retained for at least 5 years after completion of the service of active members of the IRB.
Review of Documents
The Chair of the IRB must review all IRB documents annually or whenever there is a change of IRB Chair. The documents must be reviewed and signed, where appropriate, by the Chair.
Reviewed research protocol record
The Administrator must maintain an archive of files for all research projects approved by the IRB. Such files will be retained for at least three years after completion of the research. Each project folder will include the following types of documents, as conventional hard copies:
Initial Review Application Form – FORM A, Study Protocol, Investigator's Brochure, Subject Information Sheet – English, Subject Consent Form – English, Texts of advertisements for subject recruitment - English (where appropriate), Questionnaires/Interview Guides – English (where appropriate), Investigator’s short CV, Insurance policy document, Certification documents from other agencies, as mandated by federal regulatory agencies, IRB Approval Certificate, Research Progress Report Form – FORM B, Research Final Report, Protocol Amendment Application, Statements on significant new findings and Correspondence between CSIR-IRB and investigators of the project.
Relational Database
To facilitate tracking of the steps involved in accepting, reviewing and monitoring research projects involving human subjects and evaluation of its activities statistically, the CSIR- IRB will maintain a computerized relational database on all research projects submitted for review. It will be maintained indefinitely.
Agenda
The Administrator/Secretary prepares a draft agenda for each IRB meeting for consideration and approval by the IRB. The agenda for each meeting will include:
- The date, time and venue of the meeting
- Minutes of the previous IRB meeting
- Matters arising at the previous meeting(s) that the IRB specifically asked to be considered again
- Declarations of interest relating to items on the agenda
- Applications for ethical review to be considered at the meeting, including the names of the lead reviewers
- Any other business
Minutes
The minutes of the meeting shall contain a record of the following:
- The members present and absent
- Any interests declared and the decision of the Board on the participation of the member concerned
- The submission of written comments by members
- A summary of the main ethical issues considered
- The decision of the IRB on the applications
- In the case of an approval, any special approval conditions or additional advice to be given to the applicant
- In the case of a rejection, a list of reasons for the decision
- In the case of a conditional opinion, the additional information requested by the IRB and the arrangements for considering this information and issuing the final opinion of the IRB
- When a decision is held in abeyance, the issues for further advice is required
- When an unfavorable opinion is given on a notice of amendment, the reasons for the decision and any delegation of responsibility for giving the opinion of the IRB on a modified amendment
- The outcome of any vote taken
- Any formal dissent from the decision of the IRB by a named member, with reasons
Standard Templates for Investigators
CSIR-IRB Submission Cover Letter
CSIR-IRB Informed Consent Template
CSIR-IRB Assent Form Template
CSIR-IRB Initial Submission Form Template
CSIR-IRB Serious Adverse Event Form Template
CSIR-IRB Continuing Review Form Template
CSIR-IRB Amendment Form Template
CSIR-IRB Study Closure Template
Supporting Documents for Investigators
CSIR-IRB Guidance for Preparation of Study Protocol
CSIR-IRB Guidance Notes for Preparation of Informed Consent Documents
Information for Investigators and IRB Members
CSIR-IRB Standard Operating Procedures (SOPs)
Documents for IRB Members
CSIR-IRB Review Checklist
Documents issued by IRB to Investigators
Ethical clearance
