MUT- Institutional Scientific and Ethics Review Committee (ISERC)

Murang’a University of Technology Institutional Scientific and Ethical Review Committee (MUT-ISERC)

CONTACTS

Email:- mutiserc@mut.ac.ke

In line with the Belmont Report of 1979 that provides basic ethical principles and guidelines to be used in resolving ethical challenges that surround the conduct of research with human subjects, the World Health Organization (WHO) and the Council for International Organizations of Medical Sciences (CIOMS) published “Proposed International Guidelines for Biomedical Research Involving Human Subjects” in 1982.

Several revisions to these declarations have been made along the years with the aim of ensuring research bio-ethical compliance enabling the maintenance of responsible conduct and practices in research undertakings that will not impart serious harm, hurt injury directly to humans. But that is not all. Every research activity that may also indirectly pose a threat or affect humans are also considered. With this in mind, newer versions and revisions of research conductance guidelines have incorporated and accommodated practices of research that produce create and design innovative components that may pose a threat to human livelihood through potential usage risk and harm. For this reason, ethical assessment will also gauge research that evaluates innovative products, devices, application software and programs running in devices and prototype models equipment.

Review of proposed research work is examined for compliance to ethical standards for both low-risk and high-risk research practices collectively categorized into non-intrusive (those that apply mathematical modeling from archived or secondary data sources obtained on humans) and intrusive (those directly obtained from study subjects/objects both animate and inanimate). In Kenya, the mandate of ethical practice maintenance and adherence in research activity is enforced through the institutionally empowered Institutional Ethical research committee‟s (ISERC‟s). These committees are accredited, regulated and licensed by the National Bioethical Committee (NBC), an arm of the Kenya National Commission of Science Technology and Innovation (NACOSTI).

CORE MANDATE OF MUT ISERC

MUT-ISERC is committed to undertake the following and not limited to;

  1. Review and clear proposed research before its
  2. Provide independent, competent, and timely review of the ethics of proposed In its procedures and decision-making, MUT-ISERC will be independent from political, institutional, professional, and market influences.
  3. Undertake review of the ethical elements and ensure adherence of the same in the process of data collection, data processing and data dissemination.
  4. Review prospective and continuing research protocols so as to safeguard the dignity, rights, safety, and well-being of all actual or potential participants in This is in cognizance of the fact that the goals of research should never be permitted to override the health, wellbeing, and care of the research subjects/participants.
  5. Take into consideration the principle of This requires that the benefits and burdens of research be distributed fairly among all groups and classes in society, taking into account age, gender, economic status, cultural, political, religious, ideological, race and ethnic considerations.
  6. Review the adequacy of the informed consent document, particularly as to its description of the risks and benefits.
  7. Ensure that there is regular evaluation of the ethics of ongoing studies that received a positive decision.
  8. Evaluate submitted protocols/proposals for unanticipated problems, possible noncompliance, and other information and incidents that might affect approval of protocol or the subjects’ willingness to continue to participate.
  9. Act in the 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 and applicable

IMPORTANT PROCEDURES FOR ETHICAL REVIEW APPLICATION

Submission of protocols to MUT ISERC

  1. Application for ethical review can be submitted to the ISERC on any
  2. A complete research protocol submission package should be submitted by the Principal Investigator to mutiserc@mut.ac.ke.
  3. ISERC shall accept only the completed
  4. The language in which documents are to be submitted will be English. It is the responsibility of the applicant to translate the submitted document into English.

SUBMISSION OF PROPOSALS AND PROTOCOLS TO MUT ISEC

  1. Receipt of ONLINE/SOFT COPY WORD VERSION application will be acknowledged by the MUT-ISERC office and shall be communicated to the researchers.
  2. All submitted protocols will be scrutinized for completeness as guided by the protocol submission checklist.
  3. If the application is complete, a Document Receipt Acknowledgement email will be sent to the applicant.
  4. If the application is incomplete, the Secretariat notify the applicant and state clearly the items missing in the package/ request for supplementary information or changes to documents from the
  5. An ethical review processing fee is paid by the applicant as per research load category.
  6. The applicant scans the receipt and emails it to the Secretariat through the provided email address.
  7. If confirmation of payment has been done, the Secretariat will file the scanned payment receipt and continue to process the proposal for review.
  8. The Secretariat will communicate to the applicant on the duration the review will take through email, and also the decision via a physical letter.

SERVICE CHARTER

SERVICES

OFFERED

REQUIREMENTWAITING TIME
Approval of Proposal

 

·         Submit application electronically (on email or DVD) as well as ALL required hardcopies.

·         Payment of application Fee

MUT

AFFILIATED

NON – MUT

AFFILIATED

 

4-6 weeks

 

4-6 weeks

Acknowledgement of

the application

submission

N/A1 week1 week

Notification of

reviewers

N/A1 week1 week
Supplementary information or changes request

·         Payment of application Fee evidence or submission

acknowledgment

2 weeks3 weeks
Review of Amendments

·         Submit amended copy electronically

·         Highlight the amendments

2-4 weeks2-4 weeks
Renewal of expired protocol

·         Letter addressed to MUT ISERC with supporting

documents

 

3 weeks

 

4 weeks

Implementation

period

·         Study progress reports
Expedited Applications

·         Submit all required

documents electronically

2 weeks3 weeks

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