Chitkara University Institutional Ethics Review Board (CU-IHEC) fulfill the goals to protect human subjects and support the design and conduct of sound research by reviewing for approval CU-IHEC submissions: new applications, amendments to approved studies, and continuing reviews.

The IHEC ensures that appropriate safeguards exist to protect the rights and welfare of research subjects. In fulfilling these responsibilities, the IHEC reviews all the research documents and activities that bear directly on the rights and welfare of the subjects of proposed research. The application or protocol, the consent/assent document(s), research equipment form, tests, surveys, questionnaires and similar measures, and recruitment documents are examples of documents that the IHEC reviews.

Before any human subject is involved in research in relationship to this institution, the IHEC will give proper consideration to:

• The risks to the subjects;
• The anticipated benefits to the subjects and others;
• The importance of the knowledge that may reasonably be expected to result; and
• The informed consent process to be employed.

The IHEC has the authority to approve, require modifications to secure approval, and disapprove all research activities overseen and conducted by the organizations. The IHEC has the authority to suspend, place restrictions, or terminate approval of research activities that fall within its jurisdiction that are not being conducted in accordance with IHEC requirements or that have been associated with serious harm to subjects. The IHEC has the authority to observe or have a third party observe the consent process and/or the research if the IHEC determines it to be indicated.

Research involving all human subjects carried in the institution by graduates, post-graduates, faculty or staff in Chitkara University must receive approval from the Chitkara University IHEC. The research under study should meet the definitions and requirements of both research and human subjects. The researcher should complete the IHEC process.

All Principal Investigators (PI) are to submit their protocols to IHEC for review by filling the application form(s) as applicable. Graduates, post-graduates and research scholars (PhD or Trainees) must submit the completed forms and get their protocols certified by a faculty PI. Protocols will first be reviewed for exemption or expedited reviews. Periodic meetings generally will be held once every two-four month. Completed Protocols received after the deadline will be reviewed in the following IHEC meeting.

All applications for review should be submitted to ihec.ccp@chitkara.edu.in. Incomplete forms will not be processed. It is the sole responsibility of the PI to ensure that the forms are duly filled and submitted.

Proposals which present less than minimal risk fall under this category as may be seen in following situations :

Research on educational practices such as instructional strategies or effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

Exceptions:

• When research on use of educational tests, survey or interview procedures, or observation of public behavior can identify the human participant directly or through identifiers, and the disclosure of information outside research could subject the participant to the risk of civil or criminal or financial liability or Ethical Review Procedures 12 INDIAN COUNCIL OF MEDICAL RESEARCH psychosocial harm.
• When interviews involve direct approach or access to private papers.

The proposals presenting no more than minimal risk to research participants may be subjected to expedited review. The Member- Secretary and the Chairperson of the IEC or designated member of the Committee or Subcommittee of the IHEC may do expedited review only if the protocols involve-

• Minor deviations from originally approved research during the period of approval (usually of one year duration).
• Revised proposal previously approved through full review by the IHEC or continuing review of approved proposals where there is no additional risk or activity is limited to data analysis.
• Research activities that involve only procedures listed in one or more of the following categories: Clinical studies of drugs and medical devices only when i. research is on already approved drugs except when studying drug interaction or conducting trial on vulnerable population or ii. Adverse Event (AE) or unexpected Adverse Drug Reaction (ADR) of minor nature is reported.
• Research involving clinical materials (data, documents, records, or specimens) that have been collected for non-research (clinical) purposes.
• When in emergency situations like serious outbreaks or disasters a full review of the research is not possible, prior written permission of IHEC may be taken before use of the test intervention. Such research can only be approved for pilot study or preliminary work to study the safety and efficacy of the intervention and the same participants should not be included in the clinical trial that may be initiated later based on the findings of the pilot study.

• Research on interventions in an emergency situation: When proven prophylactic, diagnostic, and therapeutic methods do not exist or have been ineffective, physicians may use new intervention as an investigational drug (IND) / devices/ vaccine to provide emergency medical care to their patients in life-threatening conditions. Research in such instance of medical care could be allowed in patients - Ethical Review Procedures INDIAN COUNCIL OF MEDICAL RESEARCH (ICMR)
  • when consent of person/ patient/ responsible relative or custodian/ team of designated doctors for such an event is not possible. However, information about the intervention should be given to the relative/ legal guardian when available later;
  • when the intervention has undergone testing for safety prior to its use in emergency situations and sponsor has obtained prior approval of DCGI;
  • only if the local IEC reviews the protocol since institutional responsibility is of paramount importance in such instances.
  • if Data Safety Monitoring Board (DSMB) is constituted to review the data;
• Research on disaster management: A disaster is the sudden occurrence of a calamitous event at any time resulting in substantial material damage, affecting persons, society, community or state(s). It may be periodic, caused by both nature and humans and creates an imbalance between the capacity and resources of the society and the needs of the survivors or the people whose lives are threatened, over a given period of time. It may also be unethical sometimes not to do research in such circumstances. Disasters create vulnerable persons and groups in society, particularly so in disadvantaged communities, and therefore, the following points need to be considered when reviewing such research:
  • Research planned tobe conducted after a disaster should be essential culturally sensitive and specific in nature with possible application in future disaster situations.
  • Disaster-affected community participation before and during the research is essential and its representative or advocate must be identified.
  • Extra care must be taken to protect the privacy and confidentiality of participants and communities.
  • Protection must be ensured so that only minimal additional risk is imposed.
  • The research undertaken should provide direct or indirect benefits to the participants, the disaster-affected community or future disaster-affected population and a priori agreement should be reached on this, whenever possible, between the community and the researcher.
  • All international collaborative research in the disaster-affected area should be done with a local partner on equal partnership basis.
  • Transfer of biological material, if any, should be as per overnment rules taking care of intellectual property rights issues.

    [Source: ICMR Guidelines]

All participants themselves are responsible to go through the review process and decision tree information available on the site and ensure which category their research qualifies for whether new protocol, exemption or expedited review. To submit the form, PI/Supervisor and researcher are responsible to check the submission dates which will be updated on IHEC home page and submit the form timely. No personal requests shall be entertained.