Introduction: Why is Clinical Research Insurance the Most Critical Security Mechanism?

Clinical trials are high-risk scientific activities conducted on humans.
Therefore, ensuring that patients are protected againstis both an ethical and a legal obligation.

For clinical research in Türkiye:

➡️ Insurance is mandatory
(“Regulation on Clinical Research”, Article 23)

Insurance provisions in international sponsorship agreements:

• global insurance policy,

• local clinical research insurance,

• sponsor's responsibility,

• The CRO's responsibility is,

• hospital responsibility,

• compensation mechanisms

This is of great importance.

This article explains how clinical trial insurance is regulated in international agreements and how it is applicable in Türkiye.

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1. Why is Clinical Research Insurance Mandatory in Türkiye?

Because clinical research activities:

✔ drug side effect

✔ device defect

✔ Practices contrary to protocol

✔ AE/SAE incidents

✔ unpredictable biological reactions

✔ Researcher error

It carries a high risk.

Therefore, before obtaining research permission in Türkiye:

➡️ Insurance is mandatory for every volunteer.

This insurance:

• the death of the volunteer

• his injury,

• treatment costs,

• permanent damages

includes.

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2. Why is the insurance clause the most controversial part of international sponsorship agreements?

Because:

✔ The sponsor's global policy may not be valid in Türkiye

✔ Foreign insurance companies may not be able to provide coverage in Türkiye

✔ It may be unclear under which country's laws the compensation will be paid

✔ The sharing of responsibility between CRO and the sponsor may not be clear

✔ Insurance limits may be insufficient

Therefore, the insurance clause in the contract is regulated by a separate additional protocol specific to Turkey

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3. Minimum Coverage of Clinical Research Insurance in Türkiye

Insurance according to TİTCK:

✔ should include all volunteers

✔ It should include all risks involved in the research

✔ It must work without fault-finding

✔ Compensation payments should be expedited

✔ should not absolve the sponsor of responsibility

Insurance must fully cover the volunteer's losses.

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4. Is the Global Insurance Policy valid in Türkiye?

❗ Usually no.

Because:

• The foreign insurance company may not be licensed in Türkiye

• Compensation payments may not comply with Turkish Lira legislation

• The policy may not be compatible with Turkish law.

Therefore, TİTCK often:

➡️ Requires a valid local insurance policy in Turkey

An international policy can be supportive, but it does not replace a local policy.

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5. What is the CRO's Insurance Liability?

CRO is not required to take out insurance directly.

However:

✔ They must verify whether the sponsor has fulfilled its insurance obligations

✔ Responsible for ensuring insurance activation in AE/SAE reports

✔ The contract defines the limit of liability

Damages resulting from CRO's own fault also include:

➡️ It is protected by professional liability insurance

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6. The Hospital's Relationship with Insurance: An Indirect but Significant Responsibility

Hospitals:

✔ infrastructure responsibility

✔ responsibility for emergency response

✔ record keeping obligation

Therefore, it is included in the research process.

Although the hospital has its own professional liability insurance:

❗ Voluntary damages are covered by sponsor insurance.

The hospital will also be held liable if it is at fault.

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7. Essential Insurance Clauses in Sponsorship Agreements

It must be included in the contract:

✔ Insurance type

✔ Insurance company and policy number

✔ Coverage limit per volunteer

✔ Total coverage based on research

✔ Risks excluded from insurance coverage

✔ Compensation procedure

✔ Insurance expiration date

✔ Validity of the policy in case of litigation

✔ Validity requirement in Türkiye

If the insurance clause is insufficient, the ethics committee and the Turkish Medicines and Medical Devices Agency (TİTCK) may not grant permission.

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8. According to the Turkish Code of Private International Law, how is the applicable law determined in an insurance contract?

In the contract:

➡️ English law,
➡️ Delaware law,
➡️ Swiss law,

It may have been selected.

However, according to Articles 26 and 5 of the Private International Law Act:

✔ Turkish law applies to matters concerning Turkish public order

✔ Voluntary damages are in all cases subject to Turkish law

Well:

➡️ The choice of authority and law is limited in favor of the volunteer.

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9. What happens if insurance is missing or absent?

The Turkish Medicines and Medical Devices Agency (TİTCK) may impose the following sanctions:

❗ Research halted

❗ Permission cancelled

❗ Sponsor fined

❗ The responsibility lies directly with the sponsor

Conducting clinical research without insurance is a serious legal violation.

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10. Conclusion: Clinical Research Insurance is Both an Ethical and Legal Necessity in Türkiye – International Conventions Must Be Adapted to Local Rules

According to the 2025 plan:

• Obtaining insurance is a prerequisite for investigation

• Foreign insurance policies may not be valid in Türkiye

• Local insurance policy is often mandatory

• The sponsor cannot transfer insurance liability

• CRO and hospital take on supporting roles

• Voluntary damages are assessed under Turkish law

• The mandatory provisions of the Private International Law Act limit the insurance clauses

Revising insurance clauses in international sponsorship agreements to be specific to Turkey is the only way to reduce legal risks.