Question

A research study will compare a new combined behavioral and pharmacologic treatment with the standard behavioral treatment alone for individuals with severe seasonal affected disorder (SAD). The researcher wants to include pregnant women in the study. However, the pharmacologic treatment has not been previously studied in non-pregnant women, nor have preclinical studies on pregnant animals been conducted. Is this research permitted under Subpart B

Answer 1

Such research would not be permitted by Subpart B.

We can arrive at this answer because:

• The main order issued by Subpart B for the research of pharmacologic treatment in pregnant women or fetuses is that previous clinical studies have been carried out to confirm the possible risks of the pharmacologic treatment for these organisms.

• In addition, Subpart B states that it is necessary that before testing on pregnant women, testing on pregnant animals and non-pregnant women is required.

None of these requirements were met in the research shown in the question above, for that reason we can state that the research would not be permitted by Subpart B.

More information:

https://brainly.com/question/1713839?referrer=searchResults