Research concerning all human subjects must be reviewed and approved before the human subjects are recruited or involved for any research activities. All projects must be presented on an IHEC application under New Protocol Submission.

Format for students Protocol Submission & Consent Form

IEC FORM ICMR

Researchers would be required to submit an exemption certificate for research involving human subjects, including data, cell culture, tissue derived from human, when the investigator believes the research may be exempted from ethics review and continuing IHEC oversight. The research is also NOT eligible when involving, minor, prisoners or placental tissues. If at any time point in the process of completing the exemption form, you determine that the research underway does not meet the requirements for exemption, please STOP and use the following:

• Determination of Human Subjects Research checklist, or
• Forms for initial Social and Behavioral Sciences or Biological Sciences.

Any modification involving human subjects’ research pertaining to consent/usage of drugs of biological material/ equipment etc. must receive prior IHEC approval before subjects are involved in the revised protocol. Prior to implementation, modifications must be submitted on a Research Amendment Form for revision and approval by the IHEC committee or the office.

Minor modifications to previous approved projects include those that do not overall alter the risk-benefit of the research underway. For example, changes in investigators, minor wordings or format, change in consent forms, materials, interviewing formats or questionnaires, approval of new field sites, changes to parameters which provide more extra/accurate information as a result of additional experience with the protocol etc.

Major modifications include significant protocol changes that would cause the subjects to engage in activities not previously approved; or those protocols which involve physical, emotional, or psychological well-being of participants (including the loss of confidentiality); or that involve a decreased benefit; or that otherwise result in alteration of the risk-benefit assessment for the research. Other examples include the addition of new subject population, changing the inclusion-exclusion criteria, changing the informed consent process, and changing the procedures affecting subject confidentiality. All the above constitute major modifications.

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This document is intended for use primarily by those conducting social, behavioral, or educational research. If your research involves physical procedures or devices, you may need to include sections that are contained in the biomedical template protocol.

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This document is intended for use primarily by those conducting biomedical research.

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This document is intended for obtaining consent from parents where minors are involved in research studies. WHO/ICMR regulations and Chitkara University IHEC policy have additional requirements for research involving children. One of the standard requirements with research involving children is for investigators to obtain permission from one or both parents for the child to participate in the research. However, the IHEC 's standard expectation is that investigators will use a written Parental Permission form to inform parents of the research. In most cases, Parental Permission forms do not need to be materially different from Informed Consent forms. Investigators are encouraged to use the Social-Behavioral or Biomedical Informed Consent Templates from the IHEC website.

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This document is intended for study if human subjects study involves the use of any drugs or chemical or biological agents, the study is subject to CDSCO Guidelines. Researchers planning to use these agents in human subjects’ research must complete this form and include it with an original or amended New Protocol Application Form, as applicable.

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This document is intended for use in case of serious and unexpected adverse events during research studies to human subjects. Unanticipated problems such as drug reactions, physical injury or death of human subjects during ongoing experimental research should be reported to the IHEC within 1 week of the investigator becoming aware of the event. Any other unanticipated problem should be reported to the IHEC within 2 weeks of the investigator becoming aware of the problem.

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This document is intended for use for if the human subjects study involves the use of any devices, the study is subject to FDA/CDSCO guidelines. Researchers planning to use devices in human subjects’ research must complete this form and include it with an original or amended New Protocol application, as applicable.

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This document is intended for use if researchers planning to use physical stimulation or physiological data acquisition equipment with human subjects must complete this form and append it to their original or amended New Protocol Application, as applicable.

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