Question

What recent initiatives have been undertaken to try and address the issue of a lack of clinical trials registration? Outline how these initiatives are designed to rectify the problem.

Answer 1

OF CLINICAL TRAIL REGISTRATION:

• The rights of the research subjects in all disciplines must be protected to the fullest possible extent.When subjects are vulnerable, the research proposal must explain how subjects rights will be protected.
• Every clinical trail being conducted on the human population must adhere to four basic principles of ethics, which are prescribed by the American Nurses Association in the year 1995, namely

1. Principle of Autonomy
2. Principle of beneficence
3. Principle of nonmalfeasance
4. Pinciple of Justice

• Every clinical trail must register with the Clinical Trail Registry of the country of the ICMER before its beginning and enrolling of the study participant and the guideliness are based on the guidelines based by the WHO and International Committee on Harmonization(ICH) provide operative guidelines designed of trail protocol.
• Proper Informed consent must be obtained from every research participant and incase an Individual who is not able to give consent of the legal guardian must be taken and it should be totally on a voluntary basis in a way to protect the clients' autonomy.
• Informed consent can be waived in the condition where research is done in an emergency situation, publicy available information, documents, records and biological samples from deceased individuals, leftover samples after clinical investigations, etc.
• At every step confidentiality of the subjects to be protected and safeguarded.
• All the research participants are also subjected to free ancillary care i.e care or treatment which a client require during the time he is undergoing the trail.So, in such a case , all the payments, reimbursements and medical services to be provided to the participants should be approved by the Institutional Ethical Committee(IEC).
• Similarly every research participant is also liable to get post trial assess and special care must be taken when trial are to be conducted on pregnant mothers, lactating mothers, children and other vulnerable population involving mentally challenged individuals and specially challenged people.
• The investigator should safeguard the confidentiality of the subjects unless a court of law demands it.
• Proper compensation impairement must be provided by the sponsor pharmaceutical company and this must be decided at the beginning of the trail.
• There is also a need to have a strong pharmacovigilance programme to monitor the adverse effects of drugs.

RECENT INITIATIVES TO OVERCOME LACK OF CLINICAL TRAIL REGISTRATION:

1. The above are the various benefits of a clinical trail registration.So its important to clarify the benefits of these to the subjects.
2. Sentence or imprisonment to the Investigator to be done if no registration of thev subject is done
3. Creating an awareness among people about the benefits of doing registeration of clinical trail and giving informed consent is important.
4. Checking of obtained informed consent is mandatory by the authorities is important
5. Education pertaining to illhaelth, sideeffects of the drug has to be done to the subjects, so as to avail future benefits of the subject.
6. Educating about the four principles are important to create awareness among the people are important.