Research involving people carries an obligation that research on materials does not: the participants gave you something, and they are entitled to have it treated seriously.
What requires review
All research involving human participants, identifiable human data, human biological material, or animals.
This applies to research conducted by our staff, students, or collaborators; research using our patients, records, or facilities; research supervised by our people; and research submitted by external investigators who elect to use our Board.
No study within scope may begin — including recruitment, screening, consent, or data collection — before written approval is issued.
We do not grant retrospective approval. Not as a policy preference, but because it is not possible: a person cannot consent to something that has already been done to them.
The Institutional Review Board
The Institutional Review Board of Link Medical Interface (LMI-IRB) reviews all research within scope. It operates under written Terms of Reference, twelve standard operating procedures, and the Declaration of Helsinki, the CIOMS International Ethical Guidelines, ICH Good Clinical Practice for trials, and Pakistani law. Where these conflict, we apply whichever standard is most protective of the participant.
Its decisions are its own. No director, shareholder, officer, or employee of Link Medical Interface may overturn, vary, or set aside a decision of the Board. No director of this company may sit on the Board. Each is an active investigator whose protocols come before it, and none may sit on it, vote on it, or see its deliberations on their own work. The Board is chaired by a senior academic who holds no position with us.
The Board’s constitution requires, at all times, at least one member who is not a scientist, and at least one member with no employment, contract, or shareholding with this company. A meeting without both present is not quorate and cannot approve anything. Its members include practising clinicians, a statistician, a lawyer specialising in ethics, and members of the public.
The clinicians can tell whether a study is scientifically sound. They are consistently poor at noticing that a consent form is incomprehensible to an ordinary person, or that a patient would find it very hard to refuse her own physiotherapist. Somebody has to ask those questions, and our rules require that when a non-scientific member says a document cannot be understood, the Board must resolve it — not explain it away.
How review works
Full Board review is the default. Expedited review is available only for minimal-risk research; two reviewers conduct it, and they may approve or refer upward but cannot reject — refusal is a power only the full Board holds. Exempt determinations are made by the Chair, never by the investigator.
Decisions: Approved · Approved with minor modifications · Deferred · Not approved. Every decision other than approval comes with written reasons sufficient to act on. Approval lasts twelve months and lapses if continuing review is not completed. On lapse, the study stops.
After approval
Amendments require approval before implementation. Serious adverse events: 7 days. Fatal or life-threatening: 24 hours. Deviations: 7 days from discovery. A researcher who reports their own error is protecting participants, and we treat self-reported deviations more favourably than discovered ones. Continuing review: annually. Closure report: within 90 days.
Submitting
Applications go to ethics@lmi.education. You will need the application form, the full protocol, a participant information sheet, a consent form — in Urdu as well as English where any participant may not read English fluently — an assent form where children are involved, a data management plan, conflict of interest declarations, your instruments, recruitment materials, and any institutional permissions.
We accept submissions from external investigators, including those whose institutions have no constituted ethics committee. This is one of the reasons the Board exists.
Every approval carries a unique reference — LMI-IRB/YYYY/NNNN — which any journal, funder, or registry may verify with us. Records are retained a minimum of five years after study closure and are available for audit.
Correspondence with the Board is received by its Secretary. No director of this company reads it.