What are some protections for participants in a clinical research study?

The main document that states the patient rights is the informed consent form.The ICF (informed consent form) contains the side effects of the drug, the responsibilities of the patient towards the trial,responsibility of the doctors and trial coordinators towards patients,patients right to withdraw from the trial etc.
Hence it is also very important for the doctors to make sure the ICF is read thoroughly by the patient before deciding to participate in the trial, in order to maintain his rights.

i particepate work in a clinic.at first  checed all remedy that use i a batter clinicn are full or decrease. at this position we coverd the all remedy and vaceen like that  sanak biting.or dog biting etc or that ramedy that use in gernal paratice.i chected the all instrument that use in miner  sergery are that use main opprain oppration that all are sterlized condation and use for seragey if these are not sterlized. hen he is my duty at first sterlized the aal instrument for these prosses, atuclave,rays and gases. i checd the needles cutter that is cleen or batter position for cu the surange and i take pyodine solution put in syrange cutter because wen i use syrenge that cut in cutter if any becteria or virus attached with needls ofsyrange .thay urgently dead in pyodine solutin. ina clinic many duty of medicall techniction he try to safethe life of patient and himself

depend in TMF,CRA, IB,FILE

 

If the investigator and site team really concern about their study participants the first level of prevention they should take is 1. Selection of clinically significant study: When a pharmaceutical company or a Clinical Research Organization (CRO) approaching a site with a study the investigator should do stringent scrutiny of study protocol and Investigator Brochure. It is the responsibility of the principal investigator to select the study which is clinically significant furthermore, the benefit for the participants should be more than the risk.2. Acquiring voluntary consent:  Many times the participants recruited without proper consent. The participants always trust their doctor and they give consent without reading the ICF properly also it will be difficult for a normal person to read through the pages of ICF form having medical terminologies. Some EC’s suggest providing the participants with two paper ICF form which contain all the information which helps the participants to take a decision. It is also recommended to acquire consent in the presence of an investigator also the investigator should explain about the study and should make sure that the participants have no doubts about the study and the consent should be voluntary acquired.  In country like India audio video consenting is mandatory for drug trials which prevent fraudulent to an extent.3. Compliance to protocol:  When an investigator and study team adhere with protocol and other study procedures that itself can help in developing informative data also help in patient fortification. Adhering with study protocol and study procedures help in participant’s protection.4.  Proper reporting of SAEs: The investigators and site team should be properly trained to report SAE’s. Appropriate reporting of SAE does not only protect participants at your site it also help other participants from other sites as well.5. Viability for the participants: The investigators and the site team should be always available for the participants whenever necessary. The site team should share their contact also should be available for the participants24*7. It also help in tracing AE’s as well.6. Scope for free to discontinue from the study:  Participants have right to withdraw from the study at any time. Neither the investigator nor the site team should force the participants to continue with the study if they are not interested.7. Assist to get compensation: Many times it has been observed that the investigator and site stands with the pharmaceutical companies in denying compensation for the participants. If it has been found that the catastrophe happen due to the trial then the site should assist the participants in order to acquire compensation from the companies. Institutional Ethics committee also have a role in procuring reasonable compensation commensurable to the damage happened.

ICF or informed consent is the main document of protection. Incase the patient meets with a drug related SAE, the subject is liable for compensation/ insurance claim as per the trial norms. Also, please note that there is no compulsion on a subject to continue in a trial. Patients can leave out anytime and will be regarded as study dropouts.