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Publications

2015 Edition of the International Compilation of Human Research Standards

Abbott, Lura, and Christine Grady. “A Systematic Review of the Empirical Literature Evaluating IRBs: What We Know and What We Still Need to Learn.”Journal of Empirical Research on Human Research Ethics: An International Journal 6, no. 1 (March 2011): 3–20. doi:10.1525/jer.2011.6.1.3.

ACOG Committee Opinion. “Ethical Considerations in Research Involving Pregnant Women.” Women’s Health Issues 9, no. 4 (July 1999): 194–98. doi:10.1016/S1049-3867(99)00015-8.

Allesee, Lori, and Colleen M. Gallagher. “Pregnancy and Protection: The Ethics of Limiting a Pregnant Woman’s Participation in Clinical Trials.” Journal of Clinical Research & Bioethics 2, no. 108 (March 31, 2011). doi:10.4172/2155-9627.1000108.

Andrade, Susan E., Jerry H. Gurwitz, Robert L. Davis, K.Arnold Chan, Jonathan A. Finkelstein, Kris Fortman, Heather McPhillips, et al. “Prescription Drug Use in Pregnancy.” American Journal of Obstetrics and Gynecology 191, no. 2 (August 2004): 398–407. doi:10.1016/j.ajog.2004.04.025.

ASH. “Code of Federal Regulations.” Accessed August 30, 2014. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.102.%c2%a0.

Balen, R. “Involving Children in Health and Social Research: ‘Human Becomings’ or ‘Active Beings’?.” Childhood 13, no. 1 (February 1, 2006): 29–48. doi:10.1177/0907568206059962.

Bayer, Ronald, and Amy L. Fairchild. “Changing the Paradigm for HIV Testing—the End of Exceptionalism.” New England Journal of Medicine 355, no. 7 (2006): 647–49.

Baylis, Françoise. “Pregnant Women Deserve Better.” Nature 465, no. 7299 (June 10, 2010): 689–90. doi:10.1038/465689a.

Baylis, Francoise, and Chris Kaposky. “Wanted: Inclusive Guidelines for Research Involving Pregnant Women.” Journal of Obstetrics and Gynaecology Canada: JOGC = Journal D’obstétrique et Gynécologie Du Canada: JOGC 32, no. 5 (May 2010): 473–76.

Beigi, Richard H., Kelong Han, Raman Venkataramanan, Gary D. Hankins, Shannon Clark, Mary F. Hebert, Thomas Easterling, et al. “Pharmacokinetics of Oseltamivir among Pregnant and Nonpregnant Women.” American Journal of Obstetrics and Gynecology 204, no. 6 (June 2011): S84–88. doi:10.1016/j.ajog.2011.03.002.

Beran, Roy G. “The Ethics of Excluding Women Who Become Pregnant While Participating in Clinical Trials of Anti-Epileptic Medications.” Seizure 15, no. 8 (December 2006): 563–70. doi:10.1016/j.seizure.2006.08.008.

Binik, Ariella. “On the Minimal Risk Threshold in Research With Children.” The American Journal of Bioethics 14, no. 9 (August 15, 2014): 3–12. doi:10.1080/15265161.2014.935879.

Binik, Ariella, Charles Weijer, and Mark Sheehan. “Minimal Risk Remains an Open Question.” The American Journal of Bioethics 11, no. 6 (June 1, 2011): 25–27. doi:10.1080/15265161.2011.568579.

Blehar, Mary C., Catherine Spong, Christine Grady, Sara F. Goldkind, Leyla Sahin, and Janine A. Clayton. “Enrolling Pregnant Women: Issues in Clinical Research.” Women’s Health Issues 23, no. 1 (January 2013): e39–45. doi:10.1016/j.whi.2012.10.003.

Brandon, Anna R. “Ethical Barriers to Perinatal Mental Health Research and Evidence-Based Treatment: An Empirical Study.” AJOB Primary Research 2, no. 1 (2011): 2–12. doi:10.1080/21507716.2011.561517.

Brandon, Anna R., Geetha Shivakumar, Stephen J. Inrig, John Z. Sadler, and Simon J. Craddock Lee. “Ethical Challenges in Designing, Conducting, and Reporting Research to Improve the Mental Health of Pregnant Women: The Voices of Investigators and IRB Members.” AJOB Empirical Bioethics 5, no. 2 (2014): 25–43. doi:10.1080/23294515.2013.851128.

Brent, R. “Risks and Benefits of Immunizing Pregnant Women: The Risk of Doing Nothing☆.” Reproductive Toxicology 21, no. 4 (May 2006): 383–89. doi:10.1016/j.reprotox.2005.09.009.

Brody, Janet L., Robert D. Annett, David G. Scherer, Mandy L. Perryman, and Keely M.W. Cofrin. “Comparisons of Adolescent and Parent Willingness to Participate in Minimal and above-Minimal Risk Pediatric Asthma Research Protocols.” Journal of Adolescent Health 37, no. 3 (September 2005): 229–35. doi:10.1016/j.jadohealth.2004.09.026.

Broome, Marion, and Deborah Richards. “The Influence of Relationships on Children’s and Adolescents’ Participation in Research.” Nursing Research May/June 2003 52, no. 3 (2003): 191–97.

Broström, Linus, and Mats Johansson. “Involving Children in Non-Therapeutic Research: On the Development Argument.” Medicine, Health Care and Philosophy 17, no. 1 (February 1, 2014): 53–60. doi:10.1007/s11019-013-9486-0.

Buekers, Thomas E., and Thomas A. Lallas. “Chemotherapy in Pregnancy.” Obstetrics and Gynecology Clinics of North America 25, no. 2 (1998): 323–29.

Burns, Jeffrey P. “Research in Children.” Critical Care Medicine 31, no. Supplement (March 2003): S131–36. doi:10.1097/01.CCM.0000054905.39382.58.

Cain, Joanna, Jane Lowell, Luanne Thorndyke, and A. Russell Localio. “Contraceptive Requirements for Clinical Research.” Obstetrics & Gynecology 95, no. 6, Part 1 (2000): 861–66.

Caprio, Sonia, Ram Weiss, and William Tamborlane. “Ethics of Research Involving Vulnerable Populations.” The Lancet 362, no. 9398 (November 2003): 1857–58. doi:10.1016/S0140-6736(03)14916-1.

Casarett, David J, and Jason H.T Karlawish. “Are Special Ethical Guidelines Needed For Palliative Care Research?” Journal of Pain and Symptom Management 20, no. 2 (August 2000): 130–39. doi:10.1016/S0885-3924(00)00164-0.

Casey, Murray Joseph, Richard O’Brien, Marc Rendell, and Todd Salzman. “Ethical Dilemma of Mandated Contraception in Pharmaceutical Research at Catholic Medical Institutions.” The American Journal of Bioethics 12, no. 7 (July 2012): 34–37. doi:10.1080/15265161.2012.680532.

Chabot, Cathy, Jean A. Shoveller, Grace Spencer, and Joy L. Johnson. “Ethical and Epistemological Insights: A Case Study of Participatory Action Research with Young People.” Journal of Empirical Research on Human Research Ethics: An International Journal 7, no. 2 (April 2012): 20–33. doi:10.1525/jer.2012.7.2.20.

Chervenak, Frank A., and Laurence B. McCullough. “An Ethically Justified Framework for Clinical Investigation to Benefit Pregnant and Fetal Patients.”The American Journal of Bioethics 11, no. 5 (April 29, 2011): 39–49. doi:10.1080/15265161.2011.562595.

———. “Ethics of Maternal–fetal Surgery.” Seminars in Fetal and Neonatal Medicine 12, no. 6 (December 2007): 426–31. doi:10.1016/j.siny.2007.06.001.

———. “Ethics of Research in Perinatal Medicine.” Seminars in Perinatology 33, no. 6 (December 2009): 391–96. doi:10.1053/j.semperi.2009.07.007.

———. “Implementation of First-Trimester Risk Assessment for Trisomy 21: Ethical Considerations.” American Journal of Obstetrics and Gynecology 192, no. 6 (June 2005): 1777–81. doi:10.1016/j.ajog.2005.04.040.

Chervenak, Frank A., Laurence B. McCullough, and Stephen T. Chasen. “Clinical Implications of the Ethics of Informed Consent for First-Trimester Risk Assessment for Trisomy 21.” Seminars in Perinatology 29, no. 4 (August 2005): 277–79. doi:10.1053/j.semperi.2005.05.012.

Davidson, Andrew J., and Mike O’Brien. “Ethics and Medical Research in Children.” Pediatric Anesthesia 19, no. 10 (October 2009): 994–1004. doi:10.1111/j.1460-9592.2009.03117.x.

De Melo-Martín, Inmaculada, Dolan Sondhi, and Ronald G. Crystal. “When Ethics Constrains Clinical Research: Trial Design of Control Arms in ‘Greater Than Minimal Risk’ Pediatric Trials.” Human Gene Therapy 22, no. 9 (September 2011): 1121–27. doi:10.1089/hum.2010.230.

Dewulf, Lode. “Medicines in Pregnancy—Women and Children First? Time for a Coalition to Address a Substantial Patient Need.” Therapeutic Innovation & Regulatory Science 47, no. 5 (September 1, 2013): 528–32. doi:10.1177/2168479013497597.

Diekema, Douglas S. “Ethical Issues in Research Involving Infants.” Seminars in Perinatology 33, no. 6 (December 2009): 364–71. doi:10.1053/j.semperi.2009.07.003.

Dresser, Rebecca. “First-in-Human Trial Participants: Not a Vulnerable Population, but Vulnerable Nonetheless.” The Journal of Law, Medicine & Ethics 37, no. 1 (2009): 38–50.

Duley, Lelia, Justus Hofmeyr, Guillermo Carroli, Pisake Lumbiganon, and Edgardo Abalos. “Perinatal Research in Developing Countries – Is It Possible?”Seminars in Fetal and Neonatal Medicine 11, no. 2 (April 2006): 89–96. doi:10.1016/j.siny.2005.11.006.

Dye, Linda, Steve Hendy, Dougal Julian Hare, and Mark Burton. “Capacity to Consent to Participate in Research – a Recontextualization.” British Journal of Learning Disabilities 32, no. 3 (September 1, 2004): 144–50. doi:10.1111/j.1468-3156.2004.00262.x.

Dyson, Maynard, and Kayhan Parsi. “Characterizing the Level of Risk in Pediatric Research: An Ethical Examination of the Federal Regulations.” Journal of Clinical Ethics 21, no. 3 (2010): 212–20.

Eckenwiler, Lisa, Dafna Feinholz, Carolyn Ells, and Toby Schonfeld. “The Declaration of Helsinki Through a Feminist Lens.” International Journal of Feminist Approaches to Bioethics 1, no. 1 (Spring 2008): 161–77.

Edenborough, F. P., G. Borgo, C. Knoop, L. Lannefors, W. E. Mackenzie, S. Madge, A. M. Morton, et al. “Guidelines for the Management of Pregnancy in Women with Cystic Fibrosis.” Journal of Cystic Fibrosis, Guidelines for the management of pregnancy in women with Cystic Fibrosis, 7, Supplement 1 (January 2008): S2–32. doi:10.1016/j.jcf.2007.10.001.

Edwards, Sarah J.l., and James Wilson. “Hard Paternalism, Fairness and Clinical Research: Why Not?” Bioethics 26, no. 2 (February 1, 2012): 68–75. doi:10.1111/j.1467-8519.2010.01816.x.

Emanuel, Ezekiel J. Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary. Johns Hopkins University Press, 2003.

Eriksson, Stefan. “ON THE NEED FOR IMPROVED PROTECTIONS OF INCAPACITATED AND NON-BENEFITING RESEARCH SUBJECTS: On the Need for Improved Protections of Incapacitated.” Bioethics 26, no. 1 (January 2012): 15–21. doi:10.1111/j.1467-8519.2010.01804.x.

Faden, Ruth, and Nancy Kass. “HIV Research, Ethics, and the Developing World.” American Journal of Public Health 88, no. 4 (1998): 548–50.

Fisher, Celia B., Susan Z. Kornetsky, and Ernest D. Prentice. “Determining Risk in Pediatric Research with No Prospect of Direct Benefit: Time for a National Consensus on the Interpretation of Federal Regulations.” The American Journal of Bioethics 7, no. 3 (March 8, 2007): 5–10. doi:10.1080/15265160601171572.

Fleischman, A., and L. Collogan. “Research with Children.” In The Oxford Textbook of Clinical Research Ethics, 446–60. New York: Oxford University Press, 2008. http://books.google.com/books?hl=en&lr=&id=vKFYAtcLAxgC&oi=fnd&pg=PA446&dq=%22diseases%3B+and+the+application+of+technology+and%22+%22for+the+purpose+of+generating+new+knowledge+that+will%22+%22in+the+decision-making+process+should,+when%22+%22during+these+times+was+extremely+high+and%22+&ots=Ik-b2_bTh2&sig=sJv3OkiPok1qJxOtEqhm_sqHDqk.

Foulkes, Mary A., Christine Grady, Catherine Y. Spong, Angela Bates, and Janine A. Clayton. “Clinical Research Enrolling Pregnant Women: A Workshop Summary.” Journal of Women’s Health 20, no. 10 (October 2011): 1429–32. doi:10.1089/jwh.2011.3118.

Fullerton, Judith T., and Georgia Robins Sadler. “Ethical Considerations Related to the Inclusion of Women in Clinical Trials.” Journal of Midwifery & Women’s Health 49, no. 3 (May 2004): 194–202. doi:10.1016/j.jmwh.2003.10.014.

Gill, Denis. “Ethical Principles and Operational Guidelines for Good Clinical Practice in Paediatric Research. Recommendations of the Ethics Working Group of the Confederation of European Specialists in Paediatrics (CESP) - Springer.” Accessed August 29, 2014. doi:10.1007/s00431-003-1378-5.

Glass, Kathleen Cranley, and Ariella Binik. “Rethinking Risk in Pediatric Research.” The Journal of Law, Medicine & Ethics 36, no. 3 (September 2008): 567–76. doi:10.1111/j.1748-720X.2008.305.x.

Gong, Michelle Ng, Gary Winkel, Rosamond Rhodes, Lynne D. Richardson, and Jeffrey H. Silverstein. “Surrogate Consent for Research Involving Adults with Impaired Decision Making: Survey of Institutional Review Board Practices:” Critical Care Medicine 38, no. 11 (November 2010): 2146–54. doi:10.1097/CCM.0b013e3181f26fe6.

Gordon, Elisa J. “Trials and Tribulations of Navigating IRBs: Anthropological and Biomedical Perspectives of ‘Risk’ in Conducting Human Subjects Research.” Anthropological Quarterly 76, no. 2 (April 1, 2003): 299–320.

Grady, Christine, and Colleen Denny. “Research Involving Women.” In The Oxford Textbook of Clinical Research Ethics, 407–22. New York: Oxford University Press, 2008. 

Gupton, Annette, Maureen Heaman, and Leo Wang-Kit Cheung. “Complicated and Uncomplicated Pregnancies: Women’s Perception of Risk.” Journal of Obstetric, Gynecologic, & Neonatal Nursing 30, no. 2 (March 1, 2001): 192–201. doi:10.1111/j.1552-6909.2001.tb01535.x.

Hagger, Lynn, and Simon Woods. “Children and Research: A Risk of Double Jeopardy?” International Journal of Children’s Rights 13, no. 1/2 (January 2005): 51–72. doi:10.1163/1571818054545204.

Hall, J. K. “Research with Pregnant Women and Fetuses: Update on the Ethics and the Law.” Journal of Nursing Law 7, no. 3 (November 2000): 7–17.

Helseth, Sølvi, and Åshild Slettebø. “Research Involving Children: Some Ethical Issues.” Nursing Ethics 11, no. 3 (May 2004): 298–308. doi:10.1191/0969733004ne697oa.

Hunter, David. “Why Even Inappropriate Parental Consent Might Be Enough to Justify Minimal Risk Pediatric Research Without Clinical Benefit.” The American Journal of Bioethics 12, no. 1 (January 1, 2012): 35–36. doi:10.1080/15265161.2011.635834.

Kaposy, Chris, and Françoise Baylis. “The Common Rule, Pregnant Women, and Research: No Need to ‘Rescue’ That Which Should Be Revised.” The American Journal of Bioethics 11, no. 5 (2011): 60–62. doi:10.1080/15265161.2011.560360.

Kaposy, Chris, and Lorraine Lafferty. “Overcoming Liability Concerns in Vaccine Trials Involving Pregnant Women.” Accountability in Research 19, no. 3 (2012): 156–74. doi:10.1080/08989621.2012.678686.

Kipnis, Kenneth. “Seven Vulnerabilities in the Pediatric Research Subject.” Theoretical Medicine and Bioethics 24, no. 2 (2003): 107–20.

Koepsell, David, Robert Arp, Jennifer Fostel, and Barry Smith. “Creating A Controlled Vocabulary for the Ethics of Human Research: Towards A Biomedical Ethics Ontology.” Journal of Empirical Research on Human Research Ethics 4, no. 1 (March 2009): 43–58. doi:10.1525/jer.2009.4.1.43.

Kolch, Michael, Andrea G Ludolph, Paul L Plener, Heiner Fangerau, Benedetto Vitiello, and Joerg M Fegert. “Safeguarding Children’s Rights in Psychopharmacological Research: Ethical and Legal Issues.” Current Pharmaceutical Design 16, no. 22 (2010): 2398–2406.

Kopelman, Loretta M. “Minimal Risk as an International Ethical Standard in Research.” The Journal of Medicine and Philosophy 29, no. 3 (2004): 351–78.

———. “Moral Problems in Assessing Research Risk.” IRB: Ethics and Human Research 22, no. 5 (September 1, 2000): 3–6. doi:10.2307/3564221.

Kourtis, Athena P., Jennifer S. Read, and Denise J. Jamieson. “Pregnancy and Infection.” New England Journal of Medicine 370, no. 23 (2014): 2211–18. doi:10.1056/NEJMra1213566.

Leavitt, Frank J. “Is Any Medical Research Population Not Vulnerable?” Cambridge Quarterly of Healthcare Ethics 15, no. 01 (2006): 81–88.

Levine, Carol, Ruth Faden, Christine Grady, Dale Hammerschmidt, Lisa Eckenwiler, and Jeremy Sugarman. “The Limitations of ‘Vulnerability’ as a Protection for Human Research Participants.” The American Journal of Bioethics 4, no. 3 (2004): 44–49. doi:10.1080/15265160490497083.

Little, Margaret Olivia, Anne Drapkin Lyerly, and Ruth R. Faden. “Moving Forward With Research Involving Pregnant Women: A Critical Role for Wisdom From the Field.” AJOB Primary Research 2, no. 1 (2011): 15–17. doi:10.1080/21507716.2011.562476.

Lo B, and Barnes M. “PRotecting Research Participants While Reducing Regulatory Burdens.” JAMA 306, no. 20 (November 23, 2011): 2260–61. doi:10.1001/jama.2011.1727.

Lott, Jason P. “Module Three: Vulnerable/special Participant Populations.” Developing World Bioethics 5, no. 1 (2005): 30–54.

Lowe, Sandra A. “Diagnostic Radiography in Pregnancy: Risks and Reality.” Australian and New Zealand Journal of Obstetrics and Gynaecology 44, no. 3 (June 1, 2004): 191–96. doi:10.1111/j.1479-828X.2004.00212.x.

Lo, W. Y., and J. M. Friedman. “Teratogenicity of Recently Introduced Medications in Human Pregnancy.” Obstetrics & Gynecology September 2002 100, no. 3 (2002): 465–73.

Lupton, Martin GF, and David J. Williams. “The Ethics of Research on Pregnant Women: Is Maternal Consent Sufficient?” BJOG: An International Journal of Obstetrics & Gynaecology 111, no. 12 (2004): 1307–12.

Lyerly, Anne Drapkin, Margaret Olivia Little, and Ruth R. Faden. “Pregnancy and Clinical Research.” Hastings Center Report 38, no. 6 (2008): 53–53. doi:10.1353/hcr.0.0089.

Macklin, Ruth. “Enrolling Pregnant Women in Biomedical Research.” The Lancet 375, no. 9715 (February 2010): 632–33. doi:10.1016/S0140-6736(10)60257-7.

———. “Enrolling Pregnant Women in Biomedical Research.” Lancet 375, no. 9715 (February 20, 2010): 632–33.

Mastroianni, Anna C., and Jeffrey P. Kahn. “Risk and Responsibility: Ethics, Crimes v Kennedy Krieger, and Public Health Research Involving Children.”American Journal of Public Health 92, no. 7 (July 2002): 1073–76.

Mastroianni, Anna, and Jeffrey Kahn. “Swinging on the Pendulum: Shifting Views of Justice in Human Subjects Research.” The Hastings Center Report 31, no. 3 (May 1, 2001): 21–28. doi:10.2307/3527551.

McCullough, Laurence B., John H. Coverdale, and Frank A. Chervenak. “A Comprehensive Ethical Framework for Responsibly Designing and Conducting Pharmacologic Research That Involves Pregnant Women.” American Journal of Obstetrics and Gynecology 193, no. 3 (September 2005): 901–7. doi:10.1016/j.ajog.2005.06.020.

———. “Preventive Ethics for Including Women of Childbearing Potential in Clinical Trials.” American Journal of Obstetrics and Gynecology 194, no. 5 (May 2006): 1221–27. doi:10.1016/j.ajog.2005.10.818.

Meaux, Julie B. “Balancing Recruitment and Protection: Children as Research Subjects.” Issues in Comprehensive Pediatric Nursing 24, no. 4 (2001): 241–51.

Miller, Franklin G. “Does Research Ethics Rest on a Mistake?” American Journal of Bioethics 5, no. 1 (February 1, 2005): 34–36. doi:10.1080/15265160590927705.

Miller, Paul B., and Charles Weijer. “Moral Solutions in Assessing Research Risk.” IRB: Ethics and Human Research 22, no. 5 (September 1, 2000): 6–10. doi:10.2307/3564222.

Moodley, Keymanthri. “Microbicide Research in Developing Countries: Have We given the Ethical Concerns Due Consideration?” BMC Medical Ethics 8, no. 1 (2007): 10. doi:10.1186/1472-6939-8-10.

Morris, Marilyn C. “Pediatric Participation in Non-Therapeutic Research.” Journal of Law, Medicine & Ethics 40, no. 3 (Fall 2012): 665–72. doi:10.1111/j.1748-720X.2012.00697.x.

Morris, Marilyn C., and Robert M. Nelson. “Randomized, Controlled Trials as Minimal Risk: An Ethical Analysis*:” Critical Care Medicine 35, no. 3 (March 2007): 940–44. doi:10.1097/01.CCM.0000257333.95528.B8.

Nelson, Robert M. “A Relative Standard for Minimal Risk Is Unnecessary and Potentially Harmful to Children: Lessons from the Phambili Trial.” The American Journal of Bioethics 11, no. 6 (June 1, 2011): 14–16. doi:10.1080/15265161.2011.568588.

Nelson, Robert M., Linda L. Lewis, Kimberly Struble, and Susan F. Wood. “Ethical and Regulatory Considerations for the Inclusion of Adolescents in HIV Biomedical Prevention Research.” JAIDS Journal of Acquired Immune Deficiency Syndromes 54 (2010): S18–24.

Noah, Barbara A. “Just a Spoonful of Sugar: Drug Safety for Pediatric Populations.” Journal of Law, Medicine & Ethics 37, no. 2 (Summer 2009): 280–91. doi:10.1111/j.1748-720X.2009.00372.x.

Ott, Mary A., Joshua G. Rosenberger, and J. Dennis Fortenberry. “Parental Permission and Perceived Research Benefits in Adolescent STI Research.”Journal of Empirical Research on Human Research Ethics 5, no. 2 (June 2010): 57–64. doi:10.1525/jer.2010.5.2.57.

Participants in the Community Engagement and Consent Workshop , Kilifi, Kenya , March 2011. “Consent and Community Engagement in Diverse Research Contexts: Reviewing and Developing Research and Practice.” Journal of Empirical Research on Human Research Ethics: An International Journal 8, no. 4 (October 2013): 1–18. doi:10.1525/jer.2013.8.4.1.

Perry, Constance. “Unacceptable Risk in Pregnancy: Whose Choice and Responsibility?” The American Journal of Bioethics: AJOB 11, no. 5 (May 2011): 64–65. doi:10.1080/15265161.2011.562596.

Pritchard, Ivor A. “How Do IRB Members Make Decisions? A Review and Research Agenda.” Journal of Empirical Research on Human Research Ethics: An International Journal 6, no. 2 (June 2011): 31–46. doi:10.1525/jer.2011.6.2.31.

Racine, Eric, Emily Bell, and Constance Deslauriers. “Canadian Research Ethics Boards and Multisite Research: Experiences from Two Minimal-Risk Studies.” IRB: Ethics and Human Research (The Hasting Center) 32, no. 3 (2010): 12–18.

Rasmussen, Lisa M. “Problems with Minimal-Risk Research Oversight: A Threat to Academic Freedom?” IRB: Ethics and Human Research 31, no. 3 (May 1, 2009): 11–16.

Resnik, D B. “Eliminating the Daily Life Risks Standard from the Definition of Minimal Risk.” Journal of Medical Ethics 31, no. 1 (January 1, 2005): 35–38. doi:10.1136/jme.2004.010470.

Rossi, Wilma C., William Reynolds, and Robert M. Nelson. “Child Assent and Parental Permission in Pediatric Research.” Theoretical Medicine and Bioethics 24, no. 2 (2003): 131–48.

Ross, Lainie. “Phase I Research and the Meaning of Direct Benefit.” The Journal of Pediatrics 149, no. 1 (July 2006): S20–24. doi:10.1016/j.jpeds.2006.04.046.

Ross, Lainie Friedman. Children in Medical Research: Access Versus Protection. OUP Oxford, 2006.

Ross L, and Nelson RM. “PEdiatric Research and the Federal Minimal Risk Standard.” JAMA 295, no. 7 (February 15, 2006): 759–60. doi:10.1001/jama.295.7.759-a.

Roth-Cline, Michelle, Jason Gerson, Patricia Bright, Catherine S. Lee, and Robert M. Nelson. “Ethical Considerations in Conducting Pediatric Research.” InPediatric Clinical Pharmacology, 219–44. Springer, 2011. http://link.springer.com/10.1007/978-3-642-20195-0_11.

Schwenzer, Karen J. “Protecting Vulnerable Subjects in Clinical Research: Children, Pregnant Women, Prisoners, and Employees.” Respiratory Care 53, no. 10 (2008): 1342–49.

Shah, Seema. “The Dangers of Using a Relative Risk Standard for Minimal Risk.” The American Journal of Bioethics 11, no. 6 (June 1, 2011): 22–23. doi:10.1080/15265161.2011.572511.

Shah, Seema, Amy Whittle, Benjamin Wilfond, Gary Gensler, and David Wendler. “How Do Institutional Review Boards Apply the Federal Risk and Benefit Standards for Pediatric Research?” Jama 291, no. 4 (2004): 476–82.

Shields, KE, and AD Lyerly. “Exclusion of Pregnant Women From Industry-Sponsored Clinical Trials.” Obstetrics and Gynecology, October 2013. http://europepmc.org/abstract/MED/24104789/reload=0.

Silverman, Henry. “Protecting Vulnerable Research Subjects in Critical Care Trials: Enhancing the Informed Consent Process and Recommendations for Safeguards.” Annals of Intensive Care 1, no. 1 (December 1, 2011): 1–7. doi:10.1186/2110-5820-1-8.

Simar, M. Renee, and Virginia A. Johnson. “Pediatric Informed Consent.” Applied Clinical Trials 11, no. 7 (2002): 46–56.

Slaughter, Susan, Dixie Cole, Eileen Jennings, and Marlene A Reimer. “Consent and Assent to Participate in Research from People with Dementia.” Nursing Ethics 14, no. 1 (January 2007): 27–40. doi:10.1177/0969733007071355.

Smyth, Rebecca M.D., Ann Jacoby, and Diana Elbourne. “Deciding to Join a Perinatal Randomised Controlled Trial: Experiences and Views of Pregnant Women Enroled in the Magpie Trial.” Midwifery 28, no. 4 (August 2012): e538–45. doi:10.1016/j.midw.2011.08.006.

Snyder, Jeremy, Cari L. Miller, and Glenda Gray. “Relative Versus Absolute Standards for Everyday Risk in Adolescent HIV Prevention Trials: Expanding the Debate.” The American Journal of Bioethics 11, no. 6 (June 1, 2011): 5–13. doi:10.1080/15265161.2011.568576.

Stineman, Margaret G, and David W Musick. “Protection of Human Subjects with Disability: Guidelines for Research.” Archives of Physical Medicine and Rehabilitation 82 (December 2001): S9–14. doi:10.1053/apmr.2001.31002.

Strong, Carson. “How Should Risks and Benefits Be Balanced in Research Involving Pregnant Women and Fetuses?” IRB 33, no. 6 (2011): 1–5.

———. “Minimal Risk in Research Involving Pregnant Women and Fetuses.” The Journal of Law, Medicine & Ethics 39, no. 3 (2011): 529–38.

Sugarman, Jeremy. “Determining the Appropriateness of Including Children in Clinical Research: How Thick Is the Ice?” JAMA 291, no. 4 (2004): 494–96.

Taylor, Holly A. “Inclusion of Women, Minorities, and Children in Clinical Trials: Opinions of Research Ethics Board Administrators.” Journal of Empirical Research on Human Research Ethics 4, no. 2 (June 2009): 65–73. doi:10.1525/jer.2009.4.2.65.

Thompson, Rachel T., Eric M. Meslin, Paula K. A. Braitstein, Winstone M. Nyandiko, Samuel O. Ayaya, and Rachel C. Vreeman. “The Vulnerabilities of Orphaned Children Participating in Research: A Critical Review and Factors for Consideration for Participation in Biomedical and Behavioral Research.” Journal of Empirical Research on Human Research Ethics: JERHRE 7, no. 4 (October 2012): 56–66. doi:10.1525/jer.2012.7.4.56.

Truog, Robert D. “Will Ethical Requirements Bring Critical Care Research to a Halt?” Intensive Care Medicine 31, no. 3 (March 1, 2005): 338–44. doi:10.1007/s00134-004-2480-5.

Uebing, A. “Pregnancy and Congenital Heart Disease.” BMJ 332, no. 7538 (February 18, 2006): 401–6. doi:10.1136/bmj.38756.482882.DE.

Vallely, Andrew, Shelley Lees, Charles Shagi, Stella Kasindi, Selephina Soteli, Natujwa Kavit, Lisa Vallely, et al. “How Informed Is Consent in Vulnerable Populations? Experience Using a Continuous Consent Process during the MDP301 Vaginal Microbicide Trial in Mwanza, Tanzania.” BMC Medical Ethics 11, no. 1 (2010): 10.

Vreeman, Rachel C., Winstone M. Nyandiko, and Eric M. Meslin. “Pediatric Assent for a Study of Antiretroviral Therapy Dosing for Children in Western Kenya: A Case Study in International Research Collaboration.” Journal of Empirical Research on Human Research Ethics 4, no. 1 (March 2009): 3–16. doi:10.1525/jer.2009.4.1.3.

Webster, William S., and Jane AD Freeman. “Is This Drug Safe in Pregnancy?” Reproductive Toxicology 15, no. 6 (2001): 619–29.

Weijer, Charles. “Research Involving the Vulnerable Sick.” Accountability in Research: Policies & Quality Assurance 7, no. 1 (October 1999): 21.

———. “The Ethical Analysis of Risk.” The Journal of Law, Medicine & Ethics 28, no. 4 (2000): 344–61.

Weijer, Charles, and Paul B. Miller. “When Are Research Risks Reasonable in Relation to Anticipated Benefits?” Nature Medicine 10, no. 6 (2004): 570–73.

Wendler D. “MInimal Risk in Pediatric Research as a Function of Age.” Archives of Pediatrics & Adolescent Medicine 163, no. 2 (February 2, 2009): 115–18. doi:10.1001/archpediatrics.2008.524.

Wendler, David. “Protecting Subjects Who Cannot Give Consent: Toward a Better Standard for ‘Minimal’ Risks.” The Hastings Center Report 35, no. 5 (September 1, 2005): 37–43. doi:10.2307/3528332.

———. “Risk Standards for Pediatric Research: Rethinking the Grimes Ruling*.” Kennedy Institute of Ethics Journal 14, no. 2 (June 2004): 187–98.

Wendler, David, Leah Belsky, Kimberly M. Thompson, and Ezekiel J. Emanuel. “Quantifying the Federal Minimal Risk Standard: Implications for Pediatric Research without a Prospect of Direct Benefit.” Jama 294, no. 7 (2005): 826–32.

Wendler D, and Jenkins T. “CHildren’s and Their Parents’ Views on Facing Research Risks for the Benefit of Others.” Archives of Pediatrics & Adolescent Medicine 162, no. 1 (January 1, 2008): 9–14. doi:10.1001/archpediatrics.2007.3.

Westra, Anna E, Rám N Sukhai, Jan M Wit, Inez D de Beaufort, and Adam F Cohen. “Acceptable Risks and Burdens for Children in Research without Direct Benefit: A Systematic Analysis of the Decisions Made by the Dutch Central Committee.” Journal of Medical Ethics 36, no. 7 (July 1, 2010): 420–24.

Westra, Anna E., Jan M. Wit, Rám N. Sukhai, and Inez D. de Beaufort. “How Best to Define the Concept of Minimal Risk.” The Journal of Pediatrics 159, no. 3 (September 2011): 496–500. doi:10.1016/j.jpeds.2011.05.034.

Wild, Verina. “How Are Pregnant Women Vulnerable Research Participants?” International Journal of Feminist Approaches to Bioethics 5, no. 2 (2012): 82–104.

Last updated September 9th, 2014.