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STANDARD OPERATING PROCEDURES FOR VVU-IRB FOR HUMAN AND ANIMAL SUBJECTS

INSTITUTIONAL REVIEW BOARD BY CENTER FOR ACADEMIC RESEARCH AND ENGAGED SCHOLARSHIP (C.A.R.E.S).

 

SECTION I: FUNDAMENTALS OF HUMAN PARTICIPANT RESEARCH

 

Valley View University (VVU) upholds the utmost ethical standards in research endeavors. In projects involving human participants, the Global Campus adheres to ethical principles outlined in the Declaration of Helsinki, the Ethical Principles of the National Commission for the Protection of Human Participants in Biomedical and Behavioral Research, and the Guidelines for the Protection of Human Participants in Research as presented in this Report. Furthermore, VVU is dedicated to ensuring that all human participant research, irrespective of funding source, complies with the stipulated requirements.

The Policies and Procedures of the Institutional Review Board (IRB) apply to any research involving human and other vertebrate participants. This includes, but is not restricted to, mammals, reptiles, birds, fish, etc. These policies apply regardless of funding status, sponsorship, and whether the research is conducted on or off the VVU campus, and involves students, faculty, or staff.

 

ETHICAL PRINCIPLES STATEMENT

Valley View University is guided by the following overarching principles in formulating its policy for reviewing research involving human participants:

  • Given that human participation in research projects may pose profound ethical and civil rights concerns, The Valley View University Institutional Review Board (IRB) for the Protection of Human Participants in Research, as outlined in this document, covers all research endeavors—whether funded or unfunded, sponsored or unsponsored—conducted by Valley View students, faculty, and staff, both on and off campus.
  • All activities involving human participants must prioritize the rights, safety, health, and welfare of each participant. Special attention shall be paid to studies that may include vulnerable subjects.
  • The potential benefits to the participant and the significance of knowledge gained must outweigh any inherent risks to the individual.
  • Participation in research must be voluntary, and informed consent procedures must adhere to the IRB Policies and Procedures.
  • Consenting to be a research participant does not waive any individual rights. Participants retain the right to refuse participation or withdraw from the research at any time without facing penalties or loss of entitled benefits.
  • The principal investigator bears the primary responsibility for safeguarding information obtained about an individual during an investigation.
  • The protection of human participants is primarily the responsibility of the principal investigator, with support, approval, and monitoring by VVU-IRB, as outlined in the IRB Policies and Procedures.

 

 

 

SECTION II: OVERVIEW OF INSTITUTIONAL REVIEW BOARD

The Valley View University Institutional Review Board (IRB) is established to uphold ethical research standards among students, faculty, and staff. Any individual associated with VVU undertaking research projects must obtain approval from the IRB prior to initiating the study.

  1. Purpose of The Valley View University Institutional Review Board (VVU-IRB)

The purpose of the VVU-IRB is to ensure the protection of the rights, safety, and well-being of human subjects participating in research studies conducted on or off the VVU campus, and involving students, faculty, or staff of VVU. The VVU-IRB is the ethical oversight board that review and approve research proposals involving human participants before the research can commence. Our primary goals are as follows:

Ethical Considerations: We ensure that research projects adhere to ethical principles and guidelines, such as respect for individuals, beneficence (maximizing benefits and minimizing harm), and justice (fair distribution of benefits and burdens).

Informed Consent: We review the informed consent process to ensure that participants are provided with clear and understandable information about the research, its purpose, risks, benefits, and alternatives. We also ensure that participants voluntarily consent to participate without coercion.

Risk-Benefit Assessment: We assess the potential risks and benefits associated with a research study and evaluate whether the risks are minimized and reasonable in relation to the anticipated benefits.

Participant Privacy and Confidentiality: We review how researchers plan to protect the privacy and confidentiality of participants. This includes handling and securing sensitive information to prevent unauthorized access.

Research Design and Methods: We shall evaluate the scientific and methodological aspects of the research to ensure that the study is well-designed, feasible, and likely to contribute valuable information without undue risk to participants.

Review of Research Protocols: Researchers, including students, are required to submit detailed research protocols to the VVU-IRB for review. We shall examine these protocols to ensure that they meet ethical standards and regulatory requirements.

Continuing Oversight: Finally, we shall provide ongoing oversight throughout a research study. Researchers are typically required to report any changes to the study protocol, consent forms and adverse events, and the VVU-IRB may conduct periodic monitoring to ensure continued compliance with ethical standards.

  1. Terms of Reference
  2. The board shall review health research protocols submitted to it within a reasonable time and document its views in writing to the applicant(s), clearly identifying the study, the documents reviewed, and the dates for the following:
  • Approval for commencement of the study
  • Modifications required before its approval
  • Disapproval
  • Termination/suspension of any prior approval
  1. The board may request the investigator (s) to enlighten them on any aspect of the study but the investigator shall not participate in the deliberations of the board or the voting of the board on any issue.

 

 

  1. Compliance

The VVU-IRB shall work in compliance with but not limited to the guidelines in the following documents:

  • ICH-GCP-E6 Section 1-4
  • The Belmont Report
  • Declaration of Helsinki
  • The US Office of Human Research Protections 45 CFR 46
  • The Council for International Organization of Medical Sciences (CIOMS)

 

MEMBERSHIP

The composition of the VVU-IRB will be by the ‘45 CFR 46’ guidelines and other international guidelines. The composition of this IRB is diverse, reflecting various expertise and perspectives, which is a common practice to ensure a comprehensive review of research activities. The current IRB composition is made of Health Policy and Planning Specialist, Sociologist, Human Biologist, Legal practitioner, Social Worker, Community member/ Journalist, Veterinarian, and Bioethicist. The chair of the board shall either be a scientist from outside Valley View university or The Local Conference Executive Secretary or His representative who is scientifically inclined. The Director of VVU Research Center will be the vice chair of the Board. This current representation is statutory but subject to revision when the need arises.

The IRB members will possess the requisite qualifications, including varied experiences, expertise, and diversity in terms of race, gender, and cultural background. Sensitivity to community attitudes and a commitment to promoting respect for the IRB's guidance in protecting the rights and welfare of human participants are crucial.

Furthermore, members must demonstrate professional competence in reviewing institutional commitments, regulations, applicable laws, and standards of professional conduct and practice. IRB members can be full-time faculty or identified consultants with expertise in the field and will strive to represent diverse backgrounds, ensuring that the board does not consist solely of members from a single profession or discipline.

To meet the requirements of funded proposals, the IRB may consider adding permanent or temporary members or consultants for their review. All IRB members are required to maintain active Human Subjects and IRB Member training certificates supported by VVU.

Terms and Conditions of Appointment

  • Members would be appointed and co-opted by the Director of VVU Research Center.
  • The duration of the appointment is for 4 years, renewable thereafter.
  • Board members are required to write an acceptance letter with curriculum vitae to the administrator after nomination.
  • A member can tender a resignation from the board with proper reasons to do so, which should be acceptable to the chair and vice chair (Director of VVU Research Center).
  • A member can be replaced in the event of death or long-term assignments outside the country or for any misconduct deemed unfit for a member.
  • Reimbursement for members would be per the institutional policy.

 

 

 

 

 

RESPONSIBILITIES OF IRB CHAIR

The chair shall:

  1. Conduct VVU-IRB meetings according to standard regulations.
  2. Prepare and provide a statement of assurance when required by the regulations guiding the establishment of the VVU-IRB.
  3. Facilitate the provision of training and educational programs to VVU-IRB members, continuing VVU-IRB members, and the greater science community of the University. The training shall include programs about the basic principles of human subject protection, current literature, regulations, and guidelines affecting the VVU-IRB. 
  4. Review and accept revisions that were made per board recommendation pending protocol approval.
  5. Expected to assign expedited reviews to members of the Board to conduct, and is not excluded from taking part when necessary.
  6. Determine submissions that are exempt from review, and notify the VVU-IRB and the submitting investigator of such exemptions.
  7. Assign responsibilities and duties to the Vice-Chair and any other member of the Board in his or her absence.
  8. Appoint a secretary who will be responsible for meeting minutes and maintaining records.
  9. Supervise the Administrator and ensure he/she is performing his/her task dutifully.
  10. Arrange for subject matter experts as needed; and
  11. Ensure the timely disposition of all requests.
  12. The Chair shall sign all letters granting approval or otherwise, for protocols to be implemented. In his/her absence, the Vice-Chair shall perform this role.

RESPONSIBILITIES OF IRB VICE-CHAIR

  1. Shall perform the same duties as the chair in the absence of the chair
  2. Perform any responsibilities assigned by the chair or the IRB

RESPONSIBILITIES OF IRB MEMBER

  1. Review protocols assigned to him/her by the chair/ Vice Chair.
  2. Support the executive in the discharge of their duties when called upon.
  3. Undertake duties assigned to them by the Chair or Vice-Chair.
  4. Study the documents submitted to them before meetings.
  5. Attend meetings regularly and participate actively during deliberations.

RESPONSIBILITIES OF IRB ADMINISTRATOR

  1. The Administrator shall be responsible for the oversight of VVU-IRB documents, records, and archives.
  2. Perform a pre-review of each submission of the VVU-IRB to ensure adherence to administrative submission requirements.
  3. Undertake all administrative procedures in providing training and educational programs to new VVU-IRB members, continuing VVU-IRB members, and the greater science community of the university. The training shall include programs about the basic principles of human subject protection, current literature and regulations, and guidelines affecting the VVU-IRB and School.
  4. Support the Chair in preparing and providing a statement of assurance when required by the regulations guiding the establishment of the VVU-IRB.
  5. Design and disseminate templates for VVU-IRB submission documents, including research protocols, informed consent materials, agreements, and periodic and final reports.
  6. Design and maintain a system for collecting and filing all VVU-IRB documents, including meeting minutes, member qualifications, protocol submission versions, deviations from approval protocols, and periodic and final reports.
  7. Assist the institution in recruiting new VVU-IRB members.
  8. Prepare and submit the annual VVU-IRB operational budget and plan to the NHRC management in consultation with the Chair.
  9. Accept, verify, duplicate, and distribute all submitted items to the appropriate member for VVU-IRB review.Ensure that all required materials for submission are present and complete.
  10. Schedule meetings of the Board in consultation with the Chair.
  11. Create and distribute meeting agenda and arrange meeting logistics.
  12. Attend VVU-IRB meetings, take minutes during the meetings, and verify and distribute minutes promptly.
  13. Correspond with all submitting researchers throughout the submission and process while remaining independent of the researcher’s protocol operations. Advise submitting investigators on preparing and submitting protocols for review according to SOPs.
  14. Properly distribute and keep files of all correspondence.
  15. Assist the Chair in conducting VVU-IRB meetings. Continually study and update staff about VVU-IRB operational regulations.
  16. Be available for and attend any outside investigations or audits of the Board. Comply with requests during an investigation or audit.

 

NEW PROTOCOL REVIEW

  • New Protocol Submission

 

  1. The Principal Investigator of a protocol is responsible for following protocol submission procedures as outlined in this SOP.
  2. Whereas the Principal Investigator is an undergraduate student, the supervisor must submit on behalf of his/her students, with the graduate students, they will either submit it themselves or by the supervisor.
  3. The VVU-IRB Administrator is responsible for receiving and processing new protocol submissions, and for ensuring that all elements required for consideration are present.
  4. The submitting investigator will submit a research protocol with the following required documents:
  • Cover letter
  • Summary of the protocol
  • A full protocol
  • Application forms
  • Data Collection instruments
  • Informed Consent forms
  • Curriculum Vitas of investigators
  • Other Relevant Documents including support letters, insurance certificates where indicated, Material Transfer Agreements, Clinical Trial Agreements, Data Safety and Monitoring Board (DSMB) charter etc

 

MEETING DATES AND TIMES

  1. Except for unavoidable circumstances, the VVU-IRB shall meet once every other month, on every second Thursday of the last month at 12.30 pm prompt in the VVU-IRB Boardroom, provided materials have been submitted for review. In such a case, the VVU-IRB Chair shall provide an alternate meeting time and date. A Minimum of four meetings will be held per annum with members notified of each meeting, however, this is liable for revision depending on the workload.
  2. The agenda, previous minutes, and application forms are to be circulated to board members two weeks before the meeting.
  3. The Chair shall lead the meeting. In the absence of the Chair, the Vice-Chair shall lead the meeting.
  4. The VVU-IRB Administrator shall notify all VVU-IRB members of an upcoming meeting; the agenda, previous minutes, and application forms are to be circulated to board members two weeks before the meeting by at least one of the following means: electronic mail, courier mail, or personal delivery.
  5. In the case where the Administrator is unsuccessful in routing the materials to the VVU-IRB members, the Administrator shall at the least notify the member(s) of the occurrence of the meeting and shall arrange for alternative means of material distribution. Whenever possible, the VVU-IRB Administrator shall distribute the materials electronically.
  6. The VVU-IRB Administrator shall notify all VVU-IRB members of any changes in meeting time, date, or agenda when necessary.
  7. The VVU-IRB Administrator shall keep an archive of all copies of the meeting agenda and all other documents.

 

MEETING PROCEDURES

  1. The VVU-IRB Chair or Vice shall call the meeting to order only when a quorum of members is present. For a quorum, a majority (50% + 1 member) of VVU-IRB members must be present, including at least one member whose primary concern is in a non-scientific area.  If the protocol under review involves a target group of women, there must be a female member of the Board present to form the quorum.  If a quorum is not formed, the meeting will be rescheduled.
  2. If the meeting is to review a newly submitted protocol, the principal investigator of that protocol may be called to be present to answer questions that will be raised by the board.
  3. Investigators must submit all documents at least one month before the next meeting and the commencement of the research study.
  4. The VVU-IRB Chair is responsible for determining whether a submitted protocol qualifies for expedited review.
  5. Depending on the decision of the Chair on a particular protocol, primary reviewers would be appointed to review the protocol.

EXPEDITED REVIEW

  1. An expedited review shall be conducted by the VVU-IRB Chair or to assigned expedited members of the Board to conduct designated by the Chair from among members of the VVU-IRB in accordance with the requirements.
  2. The following categories shall be qualified for an expedited review:
    1. Research activities that present no more than minimal risk to human subjects.
    2. Minor changes in previously approved research during the period for which approval is authorized.
  3. In an expedited review, reviewers may exercise all of the authorities of the VVU-IRB except that the reviewers may not disapprove only after reviewing the non-expedited procedure.
  4. The administrator shall inform all members about the outcome of an expedited review at the next full Board meeting.
  5.  

CONTINUING REVIEW

  1.  
  2. The VVU-IRB Chair and VVU-IRB members are responsible for determining whether the research is reviewed annually, or more frequently appropriate to the degree of risk.
  3. The VVU-IRB is also responsible for determining whether an independent data and safety monitoring board is required.
  4. The Principal Investigator of the research is responsible for keeping the VVU-IRB informed of frequent reviews. The Principal Investigator is also responsible for following the continuing review procedures and deadlines as outlined in this SOP.

Determination of Frequency of Continuing Review

  1. At a research activity’s initial review, the VVU-IRB will determine:
  • How often it will re-evaluate the research project:All research will be reviewed at intervals appropriate to the degree of risk, but not less than once per year but at least once before the end of the data collection stage.
  • The factors to be considered in setting the frequency of review should include the nature of the study, the degree of risk involved, and the vulnerability of the study subject population.
  • Whether these studies need verification from sources other than the investigator that no material changes in the research have occurred.

 

  1. The Principal Investigator will utilize the continuing review form to complete the annual review report. The report will include all required elements, including the following:

 

  • The number and demographics of participants enrolled
  • Changes in principal and/or associate investigator(s)
  • A summary description of the subject experiences
  • Any serious adverse events experienced
  • Numbers of and reasons for withdrawals from the research
  • The research results obtained thus far
  • A current risk-benefit assessment based on study results
  • And any new information since the VVU-IRB’s last review.
  1. If the investigator cannot provide any of the required information, s/he will justify the delay in the report and a timetable for the provision of the information. The investigator will also submit a copy of the consent documents and procedures currently in use.
  2. The investigator will submit one hard copy of the continuing review report, with the original signature. The investigator is also encouraged to submit an electronic copy of the review report via e-mail or disc.
  3. Upon receipt of the continuing review report, the VVU-IRB Administrator will conduct a pre-committee review to ensure all the required elements are present. The VVU-IRB administrator will work with the submitting investigator to ensure all elements are present before the distribution of meeting items.  The VVU-IRB Administrator will place the continuing review report on the next meeting’s agenda.
  4. The VVU-IRB Chair may elect to invite an independent or alternate reviewer to the meeting.
  5. VVU-IRB members will consider all continuing review reports in the hands of the Chair and Vice Chair approval
  6. The VVU-IRB will review the consent process and documents to determine whether they are still accurate and complete, whether new information that may have been obtained during the study needed to be added, and whether and whether the documents being used by the clinical investigator have IRB approval.
  7. After the reassessment, the VVU-IRB may require that the research be modified or halted. The VVU-IRB may also impose special precautions or relax special requirements it had previously imposed on the research protocol. They will also determine whether any important new findings might affect the willingness of participants to continue participating in the research. If so, they will require the investigator to notify the participants of these findings.
  8. The administrator will archive continuing reports and supporting materials with the relevant meeting minutes.

Use of Data and Safety Monitoring Board (DSMB)

 

  1. In large studies or trials, the VVU-IRB may also require a DSMB to be formed to keep the VVU-IRB up-to-date on the balance between risks and benefits.
  2. The primary responsibility of DSMB is to safeguard human subjects by and analyzing accumulating data relevant to the risks and benefits regularly. Especially in long-term trials, the DSMB review data are sufficiently favorable to one treatment that the study should be discontinued. The DSMB must also decide whether adverse events are serious enough to warrant early termination of the study.

 

Evaluation Quorum 

No risk or minimal risk proposals may be evaluated by a majority of the IRB, the IRB chair, or a board member appointed by the chair. Whenever possible, the appointed board member will have competence in the research area of the proposal. When moderate or higher-risk proposals are considered, an IRB meeting will be scheduled and a majority of IRB members must evaluate the proposal before granting approval. The chair may appoint outside reviewers to evaluate a proposal as needed. Outside reviewers, except in legal matters, must have a doctorate from an accredited institution in a field related to the proposal, or be highly qualified for the specialties and submit a curriculum vitae (CV) and supporting documents to the chair. For a vote to pass, a quorum must be achieved (at least 5 IRB Board Members) and a majority ’yes’ vote must occur.

 

Order of Business

The agenda for IRB meetings shall be determined by the chair, and may include the following:

  1. Review of and action on minutes of previous meetings.
  2. Old and new business related to IRB functioning.
  3. Review and discussion of, and action, on (a) new proposals (in order of submission), (b) continuing reviews, and (c) Amendments to previously approved proposals.
  4. Other business. Actions

 

Actions 

Proposals shall be approved, approved with conditions, disapproved, or tabled until a specified future date by a majority vote of those members present.

 

Closed Meetings

To preserve the autonomy of the IRB and its decisions, IRB meetings are typically closed, as long as such closure is not in conflict with VVU or other applicable State, or local laws and regulations.

  1. Anyone may speak for or against a proposal, but remarks must be based only on the Criteria for Approval as stated for each criterion of the IRB paperwork.
  2. The chair may limit the duration of comments or the number of speakers for and against a proposal to serve the best interest of board functioning.
  3. Written comments received by the chair before the meeting will be read into the minutes or distributed and appended to the minutes, insofar as they address the Criteria for Approval.
  4. The IRB chair may invite individuals with competence in special areas to assist in the review of issues that require expertise beyond or in addition to that represented by the regular IRB members.

 

 

Voting

Only IRB members may vote.

 

Conflict of Interest

IRB members, and persons speaking or submitting written comments, must declare any potential conflict(s) of interest in advance. Members may speak for, but may not vote on their own proposals, proposals of students they are sponsoring, or any proposal in which an IRB member is or is likely to be a participant. Written comments shall explicitly address any conflict of interest or its absence (in the event of a perceived conflict of interest that could be addressed for clarity). Members who have a conflict of interest in respect of any particular protocol must declare it and recuse themselves from the Board when it is discussing that protocol and taking decisions on it.

 

Minutes 

The secretary of the IRB will keep minutes of the proceedings. The minutes must show attendance; actions taken by IRB; the vote on these actions including the number of members voting for, against, and abstaining; the basis for requiring changes in or disapproving research; and a written summary of the discussion of controversial issues and their resolution.

 

Meeting with the IRB

A meeting between the IRB and the faculty, staff, or student proposing a dissertation/Applied Doctoral project (ADP) may be required only in cases of a Full Board Review, at the discretion of the IRB. The meeting, if required, will take place via teleconference. Exempt and Expedited Reviews do not necessitate that the PI (Principal Investigator) meet with the Board. In cases of an Exempt or Expedited Review, the PI may proceed with the solicitation of participants and data collection only after receiving the formal IRB Approval Letter from the IRB Chair. Following a Full Board Review, the IRB will take one of the following actions regarding the proposal: “approved,” “approved with conditions,” “deferred,” or “disapproved.” Details regarding the possible actions are found below.

 

ACTIONS BY THE IRB 

The following are the possible actions the IRB can take following a review of an IRB proposal. 

 

Approved. The IRB will provide the principal investigator a letter indicating the start date and end date of approval. If the researcher anticipates that the research will not be completed by the expiration date, the researcher will submit a Request for Renewal form.

 

Approved with Conditions. IRB requests that are approved with conditions necessitate that revisions, clarifications, or additional documents that address the issues raised by the IRB be submitted to the IRB. The IRB will also provide a list of documents required for resubmission. The IRB Chair may act on revisions, depending on the extent of them. The investigator must wait for written notification of approval after revisions are made before proceeding with solicitation of participants and data collection.  

 

Deferred. A deferred decision is rendered when insufficient information is provided or the meeting fails to meet a quorum.

 

Disapproved. Applications are disapproved if the research does not meet the criteria for protecting participants and substantial changes would be required. No IRB request will be disapproved until it has been reviewed in accordance with the full review procedures set forth in this document. If the IRB disapproves a request for review of a research study, a written statement of the reasons for its decision will be given to the principal investigator. The principal investigator will have an opportunity to respond in person or in writing. Review of a previously disapproved protocol requires a Full IRB review.

 

Parallel IRB and Organization Permission. If approval of another IRB is required for a study to proceed, this University’s IRB will generally review the proposal first and, when satisfied with the proposal, will “approve with conditions” the study with the only condition being that the researcher secures the necessary permission(s) from the other IRB(s). Once permission from the other IRB(s) has been obtained and submitted to this University’s IRB, a full Approval Letter will be issued. The researcher can share that full approval with the other IRB if the other IRB(s) desires to have a copy it.

 

IRB RECORDS

The secretary of the IRB shall keep the following documentation of IRB activities on file for at least three years:

  1. Written procedures for the IRB.
  2. A list of IRB members including name, earned degrees, representative capacity, indications of experience such as board certifications, licenses, etc., sufficient to describe each member’s chief anticipated contributions to IRB deliberations, CITI (Collaborative Institutional Training Initiative certifications), and employment or other relationship between each member and the institution.
  3. Minutes of IRB meetings.
  4. Copies of all proposals received, scientific evaluations (if any) that accompany the proposals, copies of all internal and external correspondence related to each submitted proposal, approved sample consent documents, progress reports submitted by investigators, and reports of injuries to participants (if any).
  5. Copies of all correspondence between the IRB and the principal investigator for any study.
  6. Records of continuing review activities.
  7. Updating and maintaining the IRB repository.
  8. Statements of significant new findings provided to participants as required by the consent documents.

 

 

SECTION III:  CHARGES FOR REVIEWING A PROPOSAL BY THE REVIEW BOARD.

 All fees reflect the knowledge and time needed for a comprehensive proposal review and are appropriate to the quality of service rendered. The fee will be clear to prospective applicants who are applying for a review. Fees are reviewed and adjusted periodically in accordance with the policies of the institution; the office may consider waiving fees or charging less for specific groups, such as researchers or students from low-income areas. Payment Outline should be requested from the Administrator.

 

VVU Applicants:

 Undergraduate Student applicants from Valley View University shall pay an amount of 100 Ghana Cedis as application/administrative fee of their ethical clearances.

Master Student applicants from Valley View University shall pay an amount of 500 Ghana Cedis as application/administrative fee of their ethical clearances.

PhD student applicants from Valley View University shall pay an amount of 1000 Ghana Cedis as application/administrative fee of their ethical clearances.

Faculty and workers of VVU shall pay an amount of 400 Ghana Cedis for an application/administrative fee of their ethical clearances

 

Non VVU Applicants:

Standard Proposal Review: Fee: 1000 Ghana Cedis per proposal; this type of review covers the proposal's adherence to guidelines, clarity, and general quality.

Epidemiological/Social Science Research: 1000 Ghana Cedis per proposal, applicant shall enjoy a 10% discount if they submit five (5) or more protocols under this area at any point in time.

Clinical Trails/Biomedical Research/ Implementation Research: Clinical trials are vital for evaluating the safety and efficacy of new treatments, medical devices, and interventions, ultimately contributing to advancements in patient care and medical knowledge. Biomedical research encompasses a broad spectrum of scientific investigations aimed at understanding the underlying mechanisms of diseases, developing new therapies, and improving healthcare outcomes through interdisciplinary collaboration and innovation. implementation research focuses on bridging the gap between evidence-based interventions and real-world practice, identifying barriers and facilitators to successful implementation, and optimizing strategies to promote sustainable healthcare delivery and policy development. 5,000 Ghana cedis is the start for these services subject to changes for each depending on the time frame of the research.

Investigator-led research: Investigator-led research fosters academic freedom, allowing researchers to explore novel hypotheses and methodologies that may not align with industry priorities. Our fee structure for investigator-led research projects starts at 6,000 which includes initial consultation, protocol development, regulatory submission assistance, and ongoing support throughout the study duration.

Industry led research: Industry-led research is characterized by its focus on addressing specific commercial objectives, often involving collaboration between industry stakeholders and academic institutions to accelerate drug development or medical device innovation: Our competitive pricing for industry-led research projects starts at 10,000 Ghana cedis encompassing protocol refinement, site selection, monitoring, and quality assurance measures, tailored to meet industry standards and objectives.

Comprehensive Review: In-Depth Proposal Review: Fee: 2000 Ghana Cedis per proposal; this type of review offers a detailed analysis, including a thorough assessment of the proposal's methodology, literature review, and potential impact. It may also include suggestions for improvement.

 Specialized Expertise Review: Fee: 5000 Ghana Cedis per proposal; this type of review guarantees that the proposal is reviewed by a specialized reviewer for proposals requiring knowledge in a particular field.

 

 

 

Additional/ Expedite Services:

Feedback Session with Reviewer: Fee: 1000 Ghana cedis per hour Description: Provides the opportunity for the proposal submitted to have a discussion with the assigned reviewer to ask clarification questions or seek additional insights.

Expedited Services:

Fast-Track Review: Fee: Doubled the standard price per proposal: Speeds up the review process and provides feedback in a shorter amount of time. Perfect for time-sensitive proposals.

Protocol/consent form: Both the protocol and consent form are critical documents in ensuring the ethical conduct, scientific integrity, and regulatory compliance of clinical research studies 500 Ghana cedis is paid for such services.

 

 

 

 

Amendment and Continuing review: Amendments can vary in scope and may involve changes to study procedures, eligibility criteria, data collection methods, study population, or other aspects of the protocol. Continuing review, on the other hand, refers to the process of periodically reassessing the ongoing conduct of a research study to ensure that it continues to meet ethical standards, regulatory requirements, and participant safety throughout the duration of the study.  1000 Ghana cedis will be charged for Amendments, while 1000 Ghana Cedis will be charged at any time at any period for a Continuing review.

 

Payment and Policies:

 Payment Method:

The forms of payment accepted are credit card, bank transfer, or institutional account designated for CARES.

Discounts: Discounts are available for submitting multiple proposals, early submissions, or bulk reviews.

Refund Policy: In the case of the inability to complete the review or the existence of a documented service issue a refund may be given. The percentage of the refund will be decided by the Chair/vice Chair of the IRB i.e. the Director of C.A.R.E.S

Timelines

Submission deadlines:  Proposals must be submitted before the 15th of every month to count for the particular month.

Review duration: Reviews shall take maximum of two (2) months before reports are released. Delay in release of reports shall not exceed the period of four (2) weeks. Incomplete application may result in delays in the release of review reports.