Human Research Regulatory & Clinical Bioethics Consultants
Human Research Regulatory & Clinical Bioethics Consultants
Allegex Solutions
Allegex Solutions

Resources and References

Identifiable Information and HIPAA

http://privacyruleandresearch.nih.gov

 

OHRP HHS Code of Federal Regulations

http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html   

 

FDA Code of Federal Regulations

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm

 

FDA Guidance

http://www.fda.gov/RegulatoryInformation/Guidances/default.htm

 

World Health Organization – Research Protocol*

http://www.who.int/rpc/research_ethics/format_rp/en/

 

  *You can also purchase a research protocol template with guidance from Allegex.  It can be appropriately developed for your specific study to cover all required elements for your protocol.

 

HHS Guidance on Entities Engaged in Research

http://www.hhs.gov/ohrp/policy/engage08

 

NIH Human Subjects Protections Training

https://phrp.nihtraining.com 

 

CITI Human Subject Research Training

https://www.citiprogram.org 

 

Office of Research Integrity (ORI)

http://ori.hhs.gov

 

Research Misconduct

http://ori.hhs.gov/handling-misconduct  

 

Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP) - audit standards reference

http://aahrpp.org

 

Secretary's Advisory Committee on Human Research Protections (SACHRP)

http://www.hhs.gov/ohrp/sachrp

 

Allegex Solutions
Phone: +1 520-428-4636

E-mail: info@allegex.com

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