The focus of this article is scientific merit and how to embed this information in a compelling but brief way into research proposals. We begin by discussing why scientific validity is an important focus of an Institutional Review Board and describe what is scientifically meritorious (good science). We end with a simple checklist and practical template that can be used to strengthen the scientific rigor of proposed research apart from its compliance with safeguards for human subjects’ rights and welfare.
KlitzmanR.How good does the science have to be in proposals submitted to IRBs? an interview study of IRB personnel. Clin Trials. 2013;10(5):761-766. doi:10.1177/1740774513500080.
2.
SelkerHPBuseJBCaliffRM. CTSA consortium consensus scientific review committee (SRC) working group report on the SRC processes. Clin Transl Sci. 2015;8(6):623-631. doi:10.1111/cts.12306.
3.
U.S. Department of Health and Human Services Office for Human Research Protections. Code of Federal Regulations: 45 CFR 46111(a)(1i) 45 CFR 46111(a)(2). http://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/. Published January15, 2009. Accessed August 22, 2016.
U.S. Department of Health and Human Services National Institutes of Health. Patient Recruitment: Ethics in Clinical Research. http://clinicalcenter.nih.gov/recruit/ethics.html. Published February25, 2016. Accessed August 22, 2016.
RosnowRLRotheram-BorusMJCeciSJBlanckPDKoocherGP.The institutional review board as a mirror of scientific and ethical standards. Am Psychol. 1993;48(7):821-826.