In a long term study, the patients are followed by telephone. There is a need to take re-consent with a new version of the ICF approved by EC. As the follow-up visits are not planned in near future, can one take telephonic re-consent of these patients?
Dr Parimal Gandhi
In Indian regulations, there is no provision for alternative to face-to-face consent.
The US FDA in 2014 Guidance on Informed Consent Information Sheet describes the process of conducting telephonic consent. The FDA mandates that when written informed consent is required, informed consent cannot be obtained solely by telephone.
As per the US FDA, in certain situations an alternative to a face-to-face consent interview may be appropriate e.g. when the subject or the subject’s legally authorized representative (LAR) is unable to visit the investigational site to sign the informed consent form (ICF), or if the screening procedures for the clinical investigation require prior activity, such as fasting, that requires consent but does not require a visit to the investigational site. However, in situations when telephonic consent is appropriate, the IRB should consider whether the procedures will provide effective communication and accomplish the goals of the informed consent process. Alternative procedures may be of special concern when the clinical investigation involves complex procedures or when risks may be difficult to comprehend.
In case telephonic consent is approved by IRB, the ICF form can be sent to the subject or the subject’s LAR by fax or e-mail, and the consent interview may then be conducted by telephone when the subject or subject’s LAR can read the ICF during the discussion. After the consent discussion, the subject or the subject’s legally authorized representative can sign and date the consent form and return the document to the clinical investigator by fax, scanning the ICF and returning it through a secure e-mail account, or by posting it to a secure internet address. Alternatively, the subject may bring the signed and dated ICF during his/her next visit to the clinical site or mail it to the clinical investigator.
Can we contact subjects via email to remind them of upcoming follow appoints? Does this require EC approval?
Dr Indra Kapadia
The EC has to decide which written communications with already recruited subjects require EC review and approval prior to use. The EC has to consider whether such communications e.g. email would impact on the rights and welfare of the subject. If any written communication has no effect on the conduct of the trail, the science or methodology, associated risks and benefits, or the potential willingness of subjects to continue participation, then it would not require prior review and approval by the EC.
EC review and approval would not be necessary for a written communication that simply reminds a subject of his/her next appointment, including communications that provide reminders that are consistent with the written informed consent and protocol, such as the need to fast prior to the appointment.
What is regulatory definition of Corrective Action and Preventive Action?
Corrective and preventive action programmes are not specifically addressed in clinical trial regulations. However, the US FDA has discussed this in the quality system regulation for medical devices.
The definitions referenced in regulatory discussions from ISO 9000:2005 are as follows:
Corrective Action: Action to eliminate the cause of a detected nonconformity or other undesirable situation in order to prevent recurrence. There can be more than one cause of a nonconformity.
Preventive Action: Action to eliminate the cause of a potential nonconformity or other undesirable potential situation in order to prevent occurrence. There can be more than one cause for a potential nonconformity.
A subject has not returned for follow-up? How many attempts the investigator should make to contact the subject?
Dr Mohmed Khan
Generally, the sponsor would provide direction in the protocol or the general investigational plan regarding how and how often/long to pursue a subject who fails to return for follow-up visits. This is desirable for consistency across the study. A large number of subjects lost to follow-up could indicate that potential study subjects were not adequately informed of study expectations and the need to commit to appropriate follow-up prior to their inclusion in the study. Hence, it is desirable that the site should make several attempts to contact these subjects, including use of a registered/couriered letter. Log documentation of telephone calls as well as copies of all correspondence should be maintained in the subject's study file. During inspection, the FDA inspectors would expect to find such documentation at the site.
Dr Arun Bhatt is a Consultant - Clinical Research & Development,
Mumbai. Readers can send their queries at:firstname.lastname@example.org