Prior to initiating a study/clinical trial, researchers must obtain approval from national regulatory authorities (NRAs) and ethics committees to conduct clinical trials. The ethics committees review the integrity of the protocol, because poorly designed studies that are either not needed or cannot answer the question are unethical.    

Topics:

Regulatory  |  Committees

Regulatory

When starting your research, researchers should familiarise themselves with the national framework in place for conducting studies/trials. The researcher must ensure that their piece of research complies with the appropriate national and international standards and guidance, regulations and legislation.

Useful links:

Single module courses (TGHN e-Learning):

Modular courses (TGHN e-Learning):

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Committees

There are various committees, which can be involved in your research. The templates here are associated with those of an Ethics Committee. An Ethics Committee is the authorised body to review documents for research taking place in the insitution.

Downloads:

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The Ethics Working Group on ZIKV Research & Pregnancy, an interdisciplinary group of international experts in vaccinology, maternal and child health, public health, and ethics, has developed ethics guidance for including the interests of pregnant women and their offspring in the ZIKV vaccine research agenda: “Pregnant Women & the Zika Virus Vaccine Research Agenda: Ethics Guidance on Priorities, Inclusion, and Evidence Generation.”

This guidance provides concrete recommendations for how various actors involved in ZIKV research and development efforts can help ensure that the needs of pregnant women and their offspring are adequately included and addressed in the race toward an efficacious vaccine against ZIKV. Key audiences for the document include: global, regional and national public health agencies; ZIKV researchers and vaccine manufacturers; funders for ZIKV vaccine R&D; regulatory authorities and oversight bodies for human subjects research; and research ethics committees. 

You can find more information about the project as well as the full document and executive summary on the project website: www.zikapregnancyethics.org.

If you have any questions about this guidance, please contact Carleigh Krubiner (ckrubiner@jhu.edu) or Elana Jaffe (elana_jaffe@med.unc.edu). Follow the project on Twitter @pregnancyethics