49 Pa. Code § 49.76 - 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 §
49.71 (relating to code of ethical
practice and professional conduct), applicable 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 procedures that are experimental or relatively untried.
(iii) Describes the attendant discomforts and
risks that are most likely to occur and 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 any 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 §
49.71.
Notes
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