Most interventional studies need approval from at least one ethics committee, either the BMRC National Research Ethics Committee or an institutional committee, and often both depending on the study and the sites. Trials of medicines or devices not yet registered for the proposed use generally need DGDA authorisation and import permissions for trial supplies. Hospitals and universities may require internal approvals before signing site agreements. The trial should also be registered in a recognised public registry before enrolment begins. We prepare an approval map at the start of each clinical trial so that nothing is missed.

Timing depends on the study's complexity, the committees involved, the completeness of the application and the number of rounds of questions. Ethics committees meet on schedules and may ask for revisions, and DGDA review of an unregistered product can take longer than ethics review. Import permissions for investigational products add a further step. We do not quote fixed timelines because the authorities do not publish guaranteed ones. Instead, we prepare full, consistent submissions, anticipate common questions and track each approval closely, which is generally the most effective way to keep a clinical trial start-up on schedule.

International practice, reflected in World Health Organization guidance and the policies of leading medical journals, is that every interventional clinical trial is registered in a public registry before the first participant is enrolled. Sponsors commonly use ClinicalTrials.gov or another primary registry recognised by the WHO International Clinical Trials Registry Platform. Ethics committees may ask for registration details, and failure to register can prevent publication of results. We advise sponsors on registration timing and content, and on keeping registry entries consistent with approved protocols, amendments and the information given to participants in consent materials.

Consent materials must explain the purpose of the study, procedures, duration, foreseeable risks and benefits, alternatives, confidentiality, compensation for injury, the voluntary nature of participation and the right to withdraw, in language participants can understand. In Bangladesh, materials should be available in Bengali and, where needed, in other languages. Special care is needed for children, people who cannot read and others who may be vulnerable. Consent should also cover data use and any transfer of samples abroad. We review clinical trial consent materials for legal accuracy and consistency with the protocol, contracts and data protection requirements.

Health information is among the most sensitive categories of personal data, and the Personal Data Protection Act 2026 affects how it is collected, used, secured and transferred. Sponsors and sites need a clear lawful basis for processing, appropriate consent, security measures and retention rules, and they should consider how coded data and samples will be shared with laboratories and regulators abroad. We advise on data processing agreements, transfer arrangements and internal procedures so that a clinical trial meets Bangladeshi requirements alongside those of the sponsor's home jurisdiction and other study countries.

Responsibility is usually allocated in the protocol, consent materials and clinical trial agreement, with sponsors generally expected to provide compensation for trial-related injury and to maintain appropriate insurance. Ethics committees review these arrangements closely. Investigators and institutions also have duties of care, and a claim may be brought in negligence or under contract. We advise sponsors and sites on clear compensation and indemnity provisions, on insurance that responds in Bangladesh, and on handling any claim fairly and promptly. Clear arrangements protect participants and reduce the risk of disputes that could damage the reputation of a study.

Payments from foreign sponsors or CROs to Bangladeshi hospitals and investigators are generally possible through banking channels, but foreign exchange rules, tax withholding and institutional policies apply. Hospitals may require payments to be made to the institution rather than to individual doctors, and government institutions often have specific procedures. Payment schedules should be linked to clearly defined milestones and supported by invoices. We advise sponsors on structuring clinical trial budgets and payment terms that local banks will process smoothly and that comply with anti-corruption expectations under the laws of the sponsor's home country.

Committees and regulators can request changes, suspend recruitment or, in serious cases, withdraw approval. Concerns often relate to safety signals, protocol deviations, consent problems or data integrity. The response should be prompt, accurate and supported by evidence of corrective action. We help sponsors and sites prepare responses, review the legal position and, if a decision appears procedurally unfair or unlawful, consider review through our dispute resolution team. In most clinical trial cases, constructive engagement resolves the issue faster than formal challenge, and protects the relationship with the reviewing body.