Research Basics
Tools for Developing a Research Protocol:
Every clinical investigation begins with the development of a clinical protocol. The protocol is a document that describes how a clinical trial will be conducted (the objective(s), design, methodology, statistical considerations and organization of a clinical trial,) and ensures the safety of the trial subjects and integrity of the data collected.
Tools for Developing and Informed Consent Form:
The documents and process provided here is meant as guidance not as a formula. Informed consent needs to be tailored to specific study needs. However working with these forms can give you a basic understanding of the elements needed in an informed consent form. The need to inform research participants about a study is not satisfied with the signature on a page, it requires engaged communication with the research participant.
Overview of IRB Process:
Institutional Review Board or Human Participants Committee (IRB/HPC) Is a mandatory process for research conducted with human subjects involvement. Researchers must develop a clear and organized protocol and submit that protocol for evaluation by an Institutional Review Board (IRB) to assess if the the protocol meets current ethical standards for research. Many institutions have IRBs to support their staff: colleges, universities, hospitals and even some community agencies have review boards established. In recent years many private Institutional Review Boards have developed to meet the high demand for research outside of large institutions. Private review boards will review a research protocol and offer edits and additions to a principal investigator for a fee. Typically this fee is between $1,500 and $10,000 depending on the scope of the project.
In order for a study to be published a researcher must complete training in ethical research. If you have not completed this type of training or even if you have getting a certificate from CITI can help make sure your project is a success. Here is a link to the CITI ethical human participants training: https://www.citiprogram.org/index.cfm?pageID=88
Links to Info About IRB Process:
Private IRBs
Every clinical investigation begins with the development of a clinical protocol. The protocol is a document that describes how a clinical trial will be conducted (the objective(s), design, methodology, statistical considerations and organization of a clinical trial,) and ensures the safety of the trial subjects and integrity of the data collected.
- Link to UCSF Research Hub: http://hub.ucsf.edu/protocol-development
- Link to World Health Organization Protocol
Development Page: http://www.who.int/rpc/research_ethics/format_rp/en/ - Link to North Westerns IRB Forms Page: http://irb.northwestern.edu/templates-forms
Tools for Developing and Informed Consent Form:
The documents and process provided here is meant as guidance not as a formula. Informed consent needs to be tailored to specific study needs. However working with these forms can give you a basic understanding of the elements needed in an informed consent form. The need to inform research participants about a study is not satisfied with the signature on a page, it requires engaged communication with the research participant.
- Link to Rochester Institute of Tech: http://www.rit.edu/research/hsro/informed_consent_document_sample_tips
- Link to Stanford IRB/Informed Consent Page: http://humansubjects.stanford.edu/new/resources/consent/
- Link to Sample Informed consent: http://www.docstoc.com/docs/44389062/Sample-Informed-Consent-Form---PDF
Overview of IRB Process:
Institutional Review Board or Human Participants Committee (IRB/HPC) Is a mandatory process for research conducted with human subjects involvement. Researchers must develop a clear and organized protocol and submit that protocol for evaluation by an Institutional Review Board (IRB) to assess if the the protocol meets current ethical standards for research. Many institutions have IRBs to support their staff: colleges, universities, hospitals and even some community agencies have review boards established. In recent years many private Institutional Review Boards have developed to meet the high demand for research outside of large institutions. Private review boards will review a research protocol and offer edits and additions to a principal investigator for a fee. Typically this fee is between $1,500 and $10,000 depending on the scope of the project.
In order for a study to be published a researcher must complete training in ethical research. If you have not completed this type of training or even if you have getting a certificate from CITI can help make sure your project is a success. Here is a link to the CITI ethical human participants training: https://www.citiprogram.org/index.cfm?pageID=88
Links to Info About IRB Process:
- Link About IRB Process: http://www.scis.nova.edu/~cannady/IRB_Info.htm
- Wikipedia on IRB: http://en.wikipedia.org/wiki/Institutional_review_board
- Link About IRB FAQ from Tufs University: http://www.tufts.edu/central/research/ResearchNews/Administrations/MIRBIssue4.htm
- Link About IRB FAQ Cornell University: http://www.irb.cornell.edu/faq/
Private IRBs
- Link to Private IRB: http://www.heartlandirb.org/
- Link to Private IRB: http://www.circare.org/info/commercialirb.htm
- Link to Private IRB: http://www.wirb.com/Pages/IRBServices.aspx
- Link to Private IRB: http://www.solutionsirb.com
- Link to Private IRB: https://www.salusirb.com
