Section 47.76. Research and publication

(a) Protection of human subjects.

(1) A licensee shall plan, design, conduct and report research in a manner consistent with this chapter, the codes of ethics in § 47.71 (relating to codes of ethical practice and professional conduct), Federal and State laws, host institutional rules and scientific standards governing research with human subjects.

(2) A licensee shall obtain informed consent from participants by using language that the licensee believes would be understandable to the research participants and that:

(i) Accurately explains the purpose and procedures to be followed.

(ii) Identifies any procedures that are experimental or relatively untried.

(iii) Describes the attendant discomforts and risks that are most likely to occur, which are known to the licensee.

(iv) Describes the benefits or changes in individuals or organizations that might be reasonably expected.

(v) Discloses appropriate alternative procedures that may be advantageous for the subject.

(vi) Offers to answer inquiries concerning the procedures.

(vii) Instructs that subjects are free to withdraw their consent and discontinue participation in the research project at any time.

(3) When a participant is not capable of giving informed consent, licensees shall provide an appropriate explanation, obtain agreement for participation and obtain informed consent from a participant’s parent, guardian, court-appointed representative or the holder of the participant’s power of attorney.

(4) Information obtained about research participants during the course of the research is confidential. The licensee shall explain to the participant whether the possibility exists that others may obtain access to the information, and also explain the plans for protecting the participant’s confidentiality as part of the procedure for obtaining informed consent.

(b) Reporting and publication of results.

(1) Licensees may not engage in fraudulent research, distort data, misrepresent data or deliberately bias their results.

(2) Licensees shall plan, conduct, report and publish accurately and in a manner that minimizes the possibility that results will be misleading.

(c) Other ethical obligations. In addition to the provisions of this section, a licensee’s ethical obligations with regard to research and publication are governed by this chapter and those codes of ethics and standards of practice to which the Board subscribes in § 47.71.

The provisions of this § 47.76 adopted September 17, 2010, effective September 18, 2010, 40 Pa.B. 5320.