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Friday, November 8 • Review the flexibilities in Subpart B, including the definition of “pregnancy” as an important decision point in assessing Subpart applicability. • Consider the flexibilities in Subpart C, including the circumstances under which a subject is a “prisoner,” and a prisoner is a “subject.” Use of a DHHS Secretarial Waiver for inclusion of prisoners in epidemiology will also be discussed. • Examine the flexibilities in Subpart D, including the regulatory definition of a “child,“ and issues around assent, parental permission, and documentation of assent/permission. • Discuss best practices for forming and utilizing cooperative review agreements with partner institutions, even on a small scale, using the existing University of Pennsylvania/The Children’s Hospital of Philadelphia agreement as a case study.

Room 103

Informed Consent Realities and Possibilities in Internet Research (Research Involving the Internet & Social Networking Track)

Faculty: Elizabeth Buchanan, Donna Spruijt-Metz This session will focus on the elements of consent and internet research, with a review of the different types of internet research. In this session, faculty and attendees will: • Identify specific internet research settings and conditions for consent. • Examine how to apply the Common Rule regulatory requirements for informed consent to internet research and review regulatory flexibilities applicable to consent in such research. • Consider parental consent and child assent in internet research involving minors. • Discuss the applicability of informed consent waivers and/or waivers of documentation. • Share sample language for informed consent documents for internet research that emphasizes data security and confidentiality of research-related information. Please note this is a double session and will end at 1:45 PM. Pre-registration is required to attend. For those who pre-registered, a lunch ticket is included on your name badge. Please use this to pick up your boxed lunch, which will be located outside of the session room.

Speed it Up: Exempt… Expedite… Relax! (SBER I – Basic Track)

Room 101 Basic

Faculty: Jeffrey M. Cohen, Dean Gallant, Samantha Smith – OHRP Resource Person In this session, faculty and attendees will: • Discuss the procedural review process for social, behavioral, and educational research through a sequence of questions including: Is this activity research? Does it involve human subjects? Is my institution engaged? Is the research exempt? And may review be expedited? • Use test scenarios to explore each of the aforementioned questions. • Identify regulatory flexibilities that can be used while still assuring research is conducted ethically. Please note this is a double session and will end at 1:45 PM. Pre-registration is required to attend. For those who pre-registered, a lunch ticket is included on your name badge. Please use this to pick up your boxed lunch, which will be located outside of the session room.

B23

Scientific Merit, Generalizability, and the Risks Associated with Qualitative Research Methodologies (QRM) (SBER I – Advanced Track)

Room 301 Advanced

Faculty: Ellen Marakowitz, Julie Simpson, Karen Szala-Meneok In this session, faculty will: • Explain and illustrate QRM. • Explore the IRB review process for assessing scientific merit and risk minimization in QRM studies. • Engage the audience in a discussion of how to assess scientific merit and risk minimization in QRM studies. Please note this is a double session and will end at 1:45 PM. Pre-registration is required to attend. For those who pre-registered, a lunch ticket is included on your name badge. Please use this to pick up your boxed lunch, which will be located outside of the session room.

n ove m b e r 7- 9 , b os t on , m as s ac hu s e t t s

schedules

B21

B22

2013 AER Conference Guide  

Digital version fo the Conference Guide for the 2013 Advancing Ethical Research Conference

2013 AER Conference Guide  

Digital version fo the Conference Guide for the 2013 Advancing Ethical Research Conference

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