When research involving human participants takes place in foreign countries procedures normally followed in the foreign country to protect human participants may differ from those set forth in this policy. (An example is a foreign institution that complies with guidelines consistent with the World Medical Assembly Declaration (Declaration of Helsinki amended 1989). Researchers should consult 45CFR46.101(h) at http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.101 in developing their proposal.