Human+Research+Pd.+5

BIBLIOGRAPHY: WEBSITES: [|www.nih.gov] [|www.hhs.gov] WEB EVALUATION: JEN CASTOR 1. This website was written by Michael Kalichman, Ph.D. and Dena Plemmons, Ph.D in 2008. 2. This is a site for education and the organization Resources of Research Ethics Education. 3. This article is research based and not persuasive. 4. It was very good for me to use becuase it was easy to understand and had a lot of information. I would recommend it. •  http://www.research-ethics.net/index/topics/human_subjects /  1.

WEB EVALUATION: MICHELLE CASTOR history.nih.gov/01docs/historical/2020b.htm
 * 1) This website was written by Robert Martensen. NIH stands for National Institute of health
 * 2) This website is a .gov website from the government. It was on a web site that was recommended.
 * 3) This website shows a timelinw of laws, guidelines, and polices that have happened concerning human research.
 * 4) This website is very good because it showed all the laws on human research and what they basically do. All the websites I found were really complicated.

This is our human research page. Group members: JUST DO YOUR TOPIC AND THEN PUT IT ON THE PAGE!!!!!!!!!!!!!!!! DO NOT USE WIKIPEDIA LIKE YOU ARE DOING NOW!!!!!!!  Question: Should humans be used for medical and psychological studies? If so, what guidelines should be instated to protect subjects?
 * Winston**- Educator
 * Michelle**- Lawyer
 * Riya**- Sociologist
 * Jen**- Scientist

Links: http://bioethics.com/?p=4723 - Lawyer http://bioethics.od.nih.gov/IRB.html REALLY GOOD = This could include cloning, using medicines on humans, and stem cell research.

Regulations for Human research: DHHS (Department of Health and Human Services)- reg. governing human research- Title 45, Part 46of the Code of Federal Regulations Guidance Doc on human research: Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject protection: May 12th Secretary of DHHS Policies on Human Research: Office of Human research Protection (OHRP): provides leadership OHRP site contains Federal Regulations for the Protection of Human Subjects Human Subject Regulations Decision Charts

Policy documents:


 * **[|Inclusion of Children Policy Implementation Page]**
 * [|NIH Grants Policy Statement (12/03)]
 * [|Inclusion of Women and Minorities as Participants in Research Involving Human Subjects Policy Implementation Page]
 * [|NIH Policies and IC Guidance for Data and Safety Monitoring of Clinical Trials]
 * [|Required Education in the Protection of Human Research Participants Policy]
 * [|Frequently Asked Questions for the Requirement for Education on the Protection of Human Subjects]
 * [|Revised Policy For IRB Review of Human Subjects Protocols in Grant Applications]

Guidance documents:

 [|The Department of Energy (DOE) Protecting Human Subjects]: Regulations Protection
 * **[|Certificates of Confidentiality Kiosk]**
 * [|National Advisory Council on Drug Abuse Guidelines for Administration of Drugs to Human Subjects]
 * <span style="FONT-FAMILY: Arial,Helvetica,sans-serif">[|NIAAA Recommended Council Guidelines on Ethyl Alcohol Administration in Human Experimentation]
 * <span style="FONT-FAMILY: Arial,Helvetica,sans-serif">[|NIH Guidance on Informed Consent for Gene Transfer Research]
 * <span style="FONT-FAMILY: Arial,Helvetica,sans-serif">[|NIH HIPAA Privacy Rule Information for Researchers]
 * <span style="FONT-FAMILY: Arial,Helvetica,sans-serif">[|NIMH Issues to Consider in Intervention Research with Persons at High Risk for Suicidality]
 * <span style="FONT-FAMILY: Arial,Helvetica,sans-serif">[|Research Involving Individuals with Questionable Capacity to Consent: Points to Consider]
 * <span style="FONT-FAMILY: Arial,Helvetica,sans-serif">[|Research Involving Private Information or Biological Specimens (PDF]

[|Centers for Disease Control and Prevention Human Subjects Research]

[|FDA Regulations for Protection of Human Subjects]:

//General Reference Center Gold-// research ethics Stem cell research Cloning <span style="COLOR: rgb(255,0,251); FONT-FAMILY: Arial,Helvetica,sans-serif">Payment for research samples Placebos Using medicine on humans
 * __Research topics include:__**

http://www.hhs.gov/ohrp/policy/index.html LAWS

//Website:// http://find.galegroup.com/ovrc/retrieve.do?subjectParam=Locale%252528en%25252C%25252C%252529%25253AFQE%25253D%252528su%25252CNone%25252C22%252529human%252Bmedical%252Bresearch%252524%257E%25291&contentSet=GSRC&sort=Relevance&tabID=T010&sgCurrentPosition=0&subjectAction=SEE_REFERENCE&prodId=OVRC&searchId=R4&currentPosition=5&userGroupName=berw2747&resultListType=RESULT_LIST&sgHitCountType=None&qrySerId=Locale%28en%2C%2C%29%3AFQE%3D%28SU%2CNone%2C31%29%22Human+Medical+Experimentation%22%24&inPS=true&searchType=BasicSearchForm&displaySubject=&docId=EJ3010089231&docType=GSRC#contentcontainer
 * Riya's Web Evaluation:**
 * 1) This website was written by Ed. Terry O'Neill in 1999.
 * 2) It is a .com website, but it is from the Opposing Viewpoints Resource Center, which is linked from the CHS research guide.
 * 3) This article appears to be biased. It is FOR human research, and shows a lot of the pros of human research. It presents factual information, however, there seems to be little to no information about the cons of human research.
 * 4) This website was very effective because it was the only one I found that supported human research. I would recommend it to any student wishing to discover the pros about human research, as opposed to just the cons.

> Both the spirit of the regulations and good science require that individuals give thoughtful consideration to the decision to conduct research with human subjects. > No research study of human subjects should be carried out that is not explicitly part of an approved protocol. > The decision to participate in research should be based on truly informed consent. This means that researchers have an ongoing obligation to ensure that subjects understand the risks and benefits of participation, which should continue only if the subjects (or their surrogates) freely agree to remain in the study. > If you are responsible for training others or if you observe indifference to considerations for human subjects in research studies, you should make attempts to initiate discussion, to identify relevant regulations, and to promote responsibility. If violations of regulations are observed, then those observations should be reported to the appropriate people in the institution. ||
 * Summary ||
 * * **//Critically evaluate the decision to conduct research with human subjects//**
 * **//Comply with regulations//**
 * **//Protect individual rights to self-determination//**
 * **//Promote responsible use of human subjects//**