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Items: 1 to 20 of 28

1.

Considerations in the evaluation and determination of minimal risk in pragmatic clinical trials.

Lantos JD, Wendler D, Septimus E, Wahba S, Madigan R, Bliss G.

Clin Trials. 2015 Oct;12(5):485-93. doi: 10.1177/1740774515597687. Epub 2015 Sep 15.

2.

Research misconduct identified by the US Food and Drug Administration: out of sight, out of mind, out of the peer-reviewed literature.

Seife C.

JAMA Intern Med. 2015 Apr;175(4):567-77. doi: 10.1001/jamainternmed.2014.7774.

PMID:
25664866
3.

Template protocol for clinical trials investigating vaccines--focus on safety elements.

Bonhoeffer J, Imoukhuede EB, Aldrovandi G, Bachtiar NS, Chan ES, Chang S, Chen RT, Fernandopulle R, Goldenthal KL, Heffelfinger JD, Hossain S, Jevaji I, Khamesipour A, Kochhar S, Makhene M, Malkin E, Nalin D, Prevots R, Ramasamy R, Sellers S, Vekemans J, Walker KB, Wilson P, Wong V, Zaman K, Heininger U; Brighton Collaboration Clinical Trial Protocol Working Group.

Vaccine. 2013 Nov 12;31(47):5602-20. doi: 10.1016/j.vaccine.2013.02.041. Epub 2013 Mar 13.

4.
5.

The Nuremberg Code subverts human health and safety by requiring animal modeling.

Greek R, Pippus A, Hansen LA.

BMC Med Ethics. 2012 Jul 8;13:16. doi: 10.1186/1472-6939-13-16. Review.

6.

Translating stem cell research: challenges at the research frontier.

Magnus D.

J Law Med Ethics. 2010 Summer;38(2):267-76. doi: 10.1111/j.1748-720X.2010.00487.x.

PMID:
20579250
7.

Working with the institutional review board.

Byerly WG.

Am J Health Syst Pharm. 2009 Jan 15;66(2):176-84. doi: 10.2146/ajhp070066. Review.

PMID:
19139484
8.

Cell-based interventions for neurologic conditions: ethical challenges for early human trials.

Mathews DJ, Sugarman J, Bok H, Blass DM, Coyle JT, Duggan P, Finkel J, Greely HT, Hillis A, Hoke A, Johnson R, Johnston M, Kahn J, Kerr D, Kurtzberg J, Liao SM, McDonald JW, McKhann G, Nelson KB, Rao M, Regenberg A, Siegel AW, Smith K, Solter D, Song H, Vescovi A, Young W, Gearhart JD, Faden R.

Neurology. 2008 Jul 22;71(4):288-93. doi: 10.1212/01.wnl.0000316436.13659.80. Epub 2008 May 7. Review.

PMID:
18463365
9.

How are drugs approved? Part 2: ethical foundations of clinical research.

Howland RH.

J Psychosoc Nurs Ment Health Serv. 2008 Feb;46(2):15-20. Review.

PMID:
18293779
10.

Ethical challenges in neonatal research: Summary report of the ethics group of the newborn drug development initiative.

Baer GR, Nelson RM; Ethics Group of the Newborn Drug Development Initiative.

Clin Ther. 2006 Sep;28(9):1399-407. Review.

PMID:
17062312
11.

Challenges to conducting HIV preventative vaccine trials with adolescents.

McClure CA, Gray G, Rybczyk GK, Wright PF.

J Acquir Immune Defic Syndr. 2004 Jun 1;36(2):726-33. Review.

PMID:
15167292
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14.

Informed consent and living human cells.

Maloney DM.

Hum Res Rep. 2002 Jul;17(7):3. No abstract available.

PMID:
12731490
15.

American Society of Clinical Oncology policy statement: oversight of clinical research.

American Society of Clinical Oncology.

J Clin Oncol. 2003 Jun 15;21(12):2377-86. Epub 2003 Apr 29.

PMID:
12721281
16.

Informed consent and investigational new drug abuses in the U.S. military.

Cummings ML.

Account Res. 2002 Apr-Jun;9(2):93-103.

PMID:
12625353
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19.

Protection of research subjects with emphasis on protocols involving radiation.

Classic KL, Porter BL, DiMagno EP.

Health Phys. 2001 May;80(5 Suppl):S70-6. Review.

PMID:
11316087
20.

Medical records and privacy: empirical effects of legislation.

McCarthy DB, Shatin D, Drinkard CR, Kleinman JH, Gardner JS.

Health Serv Res. 1999 Apr;34(1 Pt 2):417-25.

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