In accordance with the CFR, the IRB/IEC membership must have:

IRBs must be diverse and independent to protect human subjects.

21 CFR 56.107(d):“Each IRB shall include at least one member whose primary concerns are in nonscientific areas… andat least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person affiliated with the institution.”

There is no minimum requirement of seven members (A). Nonscientists must be represented but not a majority (B). Clergy are not mandated (C). The critical safeguard is inclusion of at leastone unaffiliated member (D)to ensure independence.

Thus, the correct answer isD (At least one unaffiliated individual).