The principal investigator also did not obtain IRB approval for some changes to
study procedures before implementing the changes.
Effectively communicated with families, providers, and medical staff to efficiently
coordinate study procedures set forth the by NIH protocol.
The eligibility criteria required participants to be in their second or third year of secondary education, aged between 13 and 21 years and had the ability to
comprehend study procedures and provide informed consent / assent.
Here's how one of the study authors explained
the study procedure in The Harvard Business Review:
Yet in her view, there is still good reason to
study the procedure.
Of the 34 serious adverse events, 11 were related to the study drug and seven to
study procedures, while 16 were unrelated to a study drug or procedure, including four that occurred in participants receiving a placebo.
Overall, there were three serious adverse events for every 1,000 participants, with several occurring in subjects receiving placebos and others judged unrelated to the study drug or
a study procedure.
And half of these serious adverse events, such as Dengue fever or those affecting the volunteers taking a placebo, were not linked to the phase I experimental drugs or
study procedures.
The institutional review board at the Icahn School of Medicine at Mount Sinai approved
all study procedures, and every participant provided written, informed consent.
The links at the side relate to the history,
study procedures, and outcomes of the extensive project.
Clinical Research Assistant needed to be fluent in protocol and proper execution of
study procedures.
All study procedures were approved by the institutional review board at Tufts University School of Medicine and informed consent was documented in writing.
An overview of
the study procedures, from questionnaire development through to the reporting of survey findings, is illustrated in figure 1.
Study procedures were approved by local commissions on child protection in Bucharest, the Romanian ministry of health, and later an ethics committee including appointees from government and Bucharest University academic departments.
After a complete description of
study procedures, eligible and consenting patients completed a 20 item depression scale from the Hopkins symptom checklist.17
Written consent for
all study procedures was obtained from the mothers and children.
All participants gave written informed consent following an explanation of
the study procedures.
All study procedures involving human participants were in accordance with the ethical standards of the researchers» university Institutional Review Board and with the 1964 Helsinki declaration and its later amendments of comparable ethical standards.
Twenty - one female participants (mean age: 23.4 y, SD = 3.8) completed
the study procedures (see SI Methods for inclusion criteria).
The study was approved by the IRB at the relevant university and informed consent was obtained by all participants prior to completing
the study procedures.
All study procedures were approved by the institutional review board for human subject research.
Future research should ensure better reporting of
the study procedures and results.
We believe more research is needed and that it should ensure better reporting of
the study procedures and results.