|Year : 2012 | Volume
| Issue : 2 | Page : 250
Department of Microbiology, Bhopal Memorial Hospital and Research Centre, Raisen Bypass Road, Karond, Bhopal - 462 038, Madhya Pradesh, India
|Date of Submission||28-Jan-2012|
|Date of Acceptance||08-Feb-2012|
|Date of Web Publication||28-May-2012|
Department of Microbiology, Bhopal Memorial Hospital and Research Centre, Raisen Bypass Road, Karond, Bhopal - 462 038, Madhya Pradesh
Source of Support: None, Conflict of Interest: None
|How to cite this article:|
Desikan P. Authors' reply. Indian J Med Microbiol 2012;30:250
Thank you for your comments on on our article on Ethics in Microbiology.  The points raised by you are of concern for every researcher. However, to answer your specific question regarding waiver of informed consent, secondary use of any sample/biological material for which originally consent was not taken ideally requires reconsent from the individuals from whom these were taken. However, this may not be always feasible for various reasons. Hence both, the ICMR guidelines and the Guidelines for Microbiologists, refer to the issue in similar way.The ICMR guidelines mention four different alternatives for the Institutional Review Board (IRB) to decide about the issue of consent in case of research on stored samples. They are:
- Reconsent is to be taken for reuse.
- Reconsent is not necessary. But the Institional Ethics Committee (IEC)/Institutional Review Board (IRB) approval to be taken for reuse.
- No objection for any use of the sample. Broad consent taken while collecting the samples.
- Reuse cannot be done. In any case, the principal investigator has to submit the research proposal to the Institional Ethics Committee (IEC)/Institutional Review Board (IRB) for reconsent or waiver or conditional consent.IECs may waive off the requirement for informed consent in the following instances (1):
- When it is impractical to conduct research since confidentiality of personally identifiable information has to be maintained throughout research as may be required by the sensitivity of the research objective, eg., study on disease burden of HIV/AIDS.
- Research on publicly available information, documents, records, works, performances, reviews, quality assurance studies, archival materials or thirdparty interviews, service programs for benefit of public having a bearing on public health programs, and consumer acceptance studies.
- Research on anonymised biological samples from deceased individuals, left over samples after clinical investigation, cell lines or cell free derivatives like viral isolates, DNA or RNA from recognised institutions or qualified investigators, samples or data from repositories or registries etc.
- In emergency situations when no surrogate consent can be taken.
| ~ References|| |
|1.||Desikan P, Chakrabarti A, Muthuswamy V. Ethical issues in microbiology. Indian J Med Microbiol 2011;29:327-30. |