ACCREDITATION OF ETHICS COMMITTEES BY NABH

MODULE 10

An ethics committee is a committee dedicated to the rights and well-being of research subjects, also known as an Institutional Review Board but there are some little difference between Independent Ethics Committee(IEC) and Institutional Ethics committee (IRB) like IRB direct attached with site or institution and IEC usually independent. The application process for NABH accreditation and registration with CDSCO is same. Both the processes are completely online.

Ethics Committee is a committee comprising of medical / scientific and non-medical /non-scientific members, whose responsibility is to verify the protection of the rights, safety and well-being of human subjects involved in a clinical trial and it shall be responsible for reviewing and approving the Protocol, the suitability of the investigators, facilities, methods and adequacy of information to be used for obtaining and documenting informed consent of the study subjects and adequacy of confidentiality safeguards.

There are around 1200 registered independent and institutional ethics committees. All registered ethics committees have to go through accreditation process which was introduced recently by NABH and responsibility is assigned to quality council of India (QCI) to accredit all registered ethics committees in India. On basis of NABH recommendation we have prepared a basic checklist which will be helpful for these ECs to do self-analysis for upcoming accreditation process.

The accreditation of Ethics Committee by NABH is completely online process and first step is to register as HCO (Health Care Organization) on NABH website. The detail instruction for registration process can be obtained by going through HCO manual from link : http://nabh.co/HCOManual.aspx

NABH has dedicated page on their website providing detailed information about each step of accreditation process which can be accessed through link : http://nabh.co/ClinicalTrial.aspx

NABH has provided detailed Information Brochure for Ethics Committee Accreditation Program which can be assessed from link  :http://nabh.co/Ct_Brochure.aspx

A flow chart of accreditation process can be accessed from link : http://nabh.co/Images/PDF/AccreditationProcess_ClinicalTrial.pdf

The NABH accreditation process will be performed on basis of 10 accreditation standards and 49 objective elements. Below is link of documents having standards and objective elements. http://nabh.co/CT_Standard.aspx

Procedure for Handling of Complaints and Grievances can be accessed from link below : http://nabh.co/Images/PDF/HandlingcomplaintsAppeals_Issue4.pdf

Check list for the Accreditation of Ethics Committee:

Self-Assessment Toolkit:
Organization is required to provide self-assessment report in the format ‘Self-Assessment Toolkit’ given below. All the entries are to be properly filled up. Regarding scoring following criteria would be applicable.
Compliance to the requirement: 10
Partial compliance to the requirement: 5 (if any of the sample is found to be noncomplying out of total samples selected)
Non-compliance to the requirement: 0
Not Applicable: NA
Evaluation Criteria:

  • Overall score of minimum 50% in each chapter

A. Authority for formation of Ethics Committee: Documented procedures to establish the authority for formation of Ethics Committee as per applicable rules and regulations.

Sr. No. Check-List Yes No
1. Is the Ethics Committee registered?
2. Is there any Documented Policy to ensure the Independence of the Ethics Committee’s functioning and decision making?
3. Are procedures in place to specify the authority under whom the Ethics Committee is established and administratively governed?

B.Standard Operating Procedures (SOPs): The Ethics Committee has to follows the written Procedure for its functioning as per applicable rules and regulations.

Sr. No. Check-List Yes No
1. Are procedures in place for the update of SOP?
2. Whether Ethics Committees has a SOPs for –
i. Composition (names and qualification of the members), new induction, resignation, replacement or removal of members.
ii. Declaration of conflict of interest and confidentiality agreement.
iii. Frequency of ethics committee protocol reviewing and meetings.

(i.e. Minimum time required for a single protocol, etc)

iv. Financial declaration of payments received and disbursed.
v. Policy regarding training for new and existing committee members.
vi. Policy of communication with different stake holders.
3. Whether Ethics Committees has a SOPs for –
i. Procedure for receipt of applications – original, revised, amended with supporting documents and Annexes
4 Whether Ethics Committees has a SOPs for  ethical review –
i. Review and decision making of proposals.
ii. Procedure to be followed for vulnerable population, if any.
iii. Risk-benefit analysis.
iv. Procedure for review of Informed Consent Document (subject Information Sheet and Informed Consent Form) and informed consent process.
5. Whether Ethics Committees has a SOPs for  post meeting activities including monitoring
i. Procedure for deliberations and maintaining minutes of the meeting.
ii. Procedure for reporting, analysis of SAEs and making opinion on subject compensation.
iii. Procedure for periodic review and oversight.
iv. Procedure for handling issues related to non-compliance, protocol violation, negligence, complaints by the participants and other stake holders.
v. Procedure for review of protocol amendments.
6. Whether Ethics Committees has a SOPs for  archiving
i. Procedure for control and archiving of records with confidentiality

C.Ethics Committee Composition: The Ethics Committee meets the requirement for membership as per applicable rules and regulations. Procedures are documented and followed.

Sr. No. Check-List Yes No
1. Is composition of Ethics Committees multidisciplinary and is adequate for its functioning?
2. Are subject experts and representatives of vulnerable subjects invited and consulted?
3. Whether membership, appointment, reconstitution and resignation in Ethics Committees are defined as per terms of reference?
4. Are roles and responsibilities of the members well defined?
5. Are the members trained (initial and ongoing) in applicable rules and regulations and Ethics Committee SOPs?

D.Protection of subject rights, safety and wellbeing: The Ethics Committee follows documented procedures for subject protection.

Sr. No. Check-List Yes No
Whether Ethics Committees follows documented procedures for subject protection-
1. Rights and responsibility of the subject
2. Subject’s participation and withdrawal from the trial is voluntarily.
3. Subjects are informed and comprehend (initial and ongoing) of the associated risks and benefits of the trial.
4. Confidentiality and privacy of subjects is protected.
5. Monitoring of trials is done to ensure equitable selection of subjects, with special attention to vulnerable and high risk subjects.
6. Compensation provided to subjects for participation in the trial is appropriate and as per the contract.
7. Serious adverse events are addressed, adequate medical care provided and an appropriate reporting mechanism is followed as per applicable regulations.
8. Compensation for injury to the subject is appropriate as per the regulations and monitored for noncompliance.
9. Complaints and concerns of subjects are addressed and managed appropriately.

E.Administrative support: The Ethics Committee follows documented procedures to ensure the administrative support for its activities.

Sr. No. Check-List Yes No
1. Whether Ethics Committee has Adequate financial, human resource allocation and secretariat for administrative work and record keeping?
2. Is there financial transparency of Ethics Committee activities and functioning?
3. Is there a procedure for communication between Ethics Committee, investigator/relevant site staff and institution?

F.Review Process: The Ethics Committee follows documented procedures for initial review of the trial related documents, review of amendments and periodic review.

Sr. No. Check-List Yes No
1. Review is done by the Ethics Committee in a formal meeting within a reasonable time following appropriate submission of documents by investigator as per rules and regulation. Investigator conducts only three trials at a time.
2. Initial review of proposed clinical trial evaluates the scientific validity of the protocol, risk to subjects, expected benefit and ethical standards as per applicable rules and regulations. Minimal risk is defined.
3. Informed consent document, assent form (as applicable) and translations are reviewed for appropriateness of language, accuracy and completeness of information.
4. Ethics Committee reviews the informed consent processes to ensure that subject/ their LAR are provided appropriate information, adequate time is given and impartial witness used as applicable.
5. Recruitment strategies are evaluated.
6. Proposals involving Special group (pregnant mother and children) and vulnerable population are evaluated as per regulations.
7. Contract and budget is evaluated, for indemnity, compensation, roles and responsibility as per applicable rules and regulations.
8. Review of amendments except minor ones of the originally approved protocol, consent forms, investigators brochure is done in formal meetings to evaluate the risk to trial subjects.
9. Periodic review of study is done for continuation, risk evaluation and adverse event monitoring.

G.Decision making and post meeting activities: The Ethics Committee follows documented procedures for decision making process and post meeting activities.

Sr. No. Check-List Yes No
1. Decision making process (approval/disapproval/pending) is as per applicable rules and regulations, ensuring quorum and consensus/voting requirements are fulfilled.
2. Ensure that subject is recruited into the trial only after written favorable opinion from Ethics committee and approval by regulatory authority.
3. Conflict of interest is declared prior to the review and voluntary withdrawal during decision making process is documented.
4. Decisions are based on risk assessment, scientific validity and adherence to ethical principles for the initial and periodic approvals.
5. Deliberations and decisions made during the meetings are documented, approved, signed and maintained as minutes of Meeting
6. Protocol deviations, violations and noncompliance are evaluated and appropriate actions are taken.
7. Serious adverse events are analysed and compensation amount assessed and reported to regulatory authority as per rules and regulations.
8. All decisions/opinions are notified to the investigator in writing.

H.Monitoring: The Ethics Committee follows documented procedures for monitoring and for-cause assessment.

Sr. No. Check-List Yes No
1. Subject’s rights, safety and wellbeing are monitored.
2. Adequacy and continuity of consent process is ensured.
3. For-cause assessments are conducted following non-compliance and/or complaints for the trials approved by the ethics committee.
4. Opportunities for improvement are identified and appropriate actions are initiated

I.Self-Assessment: The Ethics Committee has and follows documented procedures for self-assessment.

Sr. No. Check-List Yes No
1. Periodic self-assessments are conducted.
2. Corrective and preventive actions (as required) are implemented.

J.Record keeping and archival: The Ethics Committee follows documented procedures for record keeping and archiving.

Sr. No. Check-List Yes No
1. Security, confidentiality and integrity of all proposals and associated documents are reviewed and administrative communication is maintained as per regulatory requirement.
2. Documents and records are archived after completion /termination of trial for a minimum period of 5 years or as per the SOP. (Whichever is later)
3. Record retrieval policies and procedures are in place to ensure access to information for inspection and audit and continual protection of trial subjects post trial closure.