2. Module 2 Sealy Center on Aging What kinds of scholarly products can I produce?

3. Objectives Sealy Center on Aging 1.Understand the rationale for requiring medical students to produce a scholarly product. 2.Describe the basic types of scholarly products one may undertake to produce. 3.Outline strategies for developing a project idea. 4.Suggest a potential plan for moving from idea to abstract.

4. Types of research Sealy Center on Aging 1) Biomedical research 2) Clinical research 3) Observational study 4) Case report + literature review 5) Quality improvement project 6) Education project 7) Reflective learning

5. Types of research 2 Sealy Center on Aging 1) Biomedical research 2) Clinical research 3) Observational study 4) Case report + literature review 5) Quality improvement project 6) Education project 7) Reflective learning

6. Biomedical Research Sealy Center on Aging Biomedical research is research that involves the application of the natural sciences, especially biology and physiology, to medicine. It often involves the conducting of reproducible experiments in animal models of disease, or at the cellular or molecular level.

7. Biomedical Research Sealy Center on Aging Howard Hughes Medical Institute http://www.hhmi.org/resources/labmanagement/ http://www.hhmi.org/resources/labmanagement/

8. Clinical Research Sealy Center on Aging Clinical research is research that directly involves a particular person or group of people, or that uses materials from humans, such as their behavior or samples of their tissue. A clinical trial is one type of clinical research that follows a pre- defined plan or protocol. By taking part in clinical trials, participants can not only play a more active role in their own health care, but they can also access new treatments and help others by contributing to medical research. Source: NIH (National Institutes of Health), NICHD (National Institute for Child Health and Human Development)

9. Example of UTMB clinical research Sealy Center on Aging Acute Care of the Elderly (ACE) Unit Functional Laboratory Associated with Pepper Center studies to conduct clinical trials on improving health outcomes among older hospitalized patients Focus on recovery from disease and disability through increasing patient activity resulting in reduced lengths of stay

10. Ethics in clinical research Sealy Center on Aging The ethical conduct of clinical research requires appropriate training and approval by the Institutional Review Board (IRB). All subjects (and parent / guardian for minors or those of diminished capacity) must provide written proof that they have been informed of the goals, risks and benefits of the research and consent to their participation. Sample Informed Consent Form. Not to scale.

11. Exempt Research (DHHS) Sealy Center on Aging DHHS regulations define some research as exempt from IRB review. The UTMB IRBs recognize the exempt categories, but may require submission and review by an expedited process or at a convened meeting of one of the IRBs depending on the potential risks that participants may experience. Investigators who feel their research exactly fits one of the categories for exemption may request such a determination by submitting a “Request for Exemption from IRB Review” form. Source: UTMB Research Services: http://research.utmb.edu/IRB/

12. Department Name Goes Here U.S. regulations (The Common Rule) Passed in Congress in 1974 Additional subparts added later: pregnant women/ fetuses; prisoners; children Created IRB requirement Institutions must review all federally funded human research (or all human research, depending on institutional policy) Review happens locally, at institution, not at central or national level Independent committee at investigator’s institution at participants’ institution (“performance site”) Source: Nancy E. Kass, ScD, The ethical conduct of research with human participants, Johns Hopkins [ppt]

13. Department Name Goes Here See more at NIH Clinical Center More info at: http://clinicalcenter.nih.gov/index.html

14. Module 2 Sealy Center on Aging What kinds of scholarly products can I produce?