IRB Procedures -------------- The purpose of the Institutional Review Board (IRB) is to advance the safety of scientific research by protecting human subjects, the community, and the environment. In accordance with [DHHS][1] and [FDA][2] regulations, it provides independent opinion on specific research projects with respect to the ethical principles of the community. Some of the more common ethical questions with which researchers grapple include: - *What procedures are sufficient to confirm that no one is being harmed?* - *What potential harms should be considered?* - *Who should be excluded from participation (e.g. children? women who may be pregnant?)* - *What words are sufficient to confirm that participants understand what they are doing?* - *What efforts to recruit subjects would count as coercion (e.g. advertisement? compensation?)* To place research under the authority of an IRB can build trust. The IRB has authority over any research project it approves. This authority includes rights to access the research fully as it is being conducted and to be informed about relevant developments. It also includes the abilities to suspend approval, to terminate approval, and to inform the investigator’s community, sponsors, collaborators, and publishers if the research continues without approval. To establish its own credibility, the IRB is composed of respected members of the community, transparently displays its procedures and work through the Open Science Framework (OSF), and registers with the federal [Office of Human Research Protections][3] (OHRP). Anyone aware of opportunities to improve the procedures of the IRB, or its compliance with its procedures, should please share that insight with the board members (contact information can be found on the front page of the IRB website). If the members are unresponsive to a complaint, the complaint can be [raised to the OHRP][4] and/or the general community. **Procedures:** - [Ethical Principles][5] - [How to Submit a Research Plan][6] - [How To Correct Ongoing Research][7] - [How to Use the Open Science Framework][8] - [Approval of a Research Plan][9] - [Amendment of a Research Plan][10] - [Suspension/Termination of Approval][11] - [Reporting Investigator Non-compliance][12] - [Board Meeting Procedure][13] - [Publication of IRB Opinions][18] - [Board Membership][14] - [The Chair][17] - [Appointment of Members][15] - [Termination of Membership/Voting Rights][16] - [Amendment of IRB Procedures][19] [1]: http://www.hhs.gov/ohrp/regulations-and-policy/regulations/common-rule/index.html [2]: http://www.hhs.gov/ohrp/regulations-and-policy/regulations/fda/index.html [3]: http://www.hhs.gov/ohrp/about-ohrp [4]: http://www.hhs.gov/ohrp/about-ohrp/contact-us/index.html#go-to-reporting-incidents [5]: https://osf.io/9e3gx/wiki/Ethical%20Principles/ [6]: https://osf.io/9e3gx/wiki/How%20to%20Submit%20a%20Research%20Plan/ [7]: https://osf.io/9e3gx/wiki/How%20To%20Correct%20Ongoing%20Research/ [8]: http://help.osf.io/ [9]: https://osf.io/9e3gx/wiki/Approval%20of%20a%20Research%20Plan/ [10]: https://osf.io/9e3gx/wiki/Amendment%20of%20a%20Research%20Plan/ [11]: https://osf.io/9e3gx/wiki/Suspension%20or%20Termination%20of%20Approval/ [12]: https://osf.io/9e3gx/wiki/Reporting%20Investigator%20Non-compliance/ [13]: https://osf.io/9e3gx/wiki/Board%20Meeting%20Procedure/ [14]: https://osf.io/9e3gx/wiki/Board%20Membership/ [15]: https://osf.io/9e3gx/wiki/Appointment%20of%20Members/ [16]: https://osf.io/9e3gx/wiki/Termination%20of%20Membership%20or%20Voting%20Rights/ [17]: https://osf.io/9e3gx/wiki/The%20Chair/ [18]: https://osf.io/9e3gx/wiki/Publication%20of%20IRB%20Opinions/ [19]: https://osf.io/9e3gx/wiki/Amendment%20of%20IRB%20Procedures/