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Guidelines and Guiding Resources

[updated 9 March 2017]

What the federal government established in the '70s with IRBs was a local and institutionally-based board to evaluate proposed research with human subjects.  Part of the intent was to decentralize the ethical review of such studies, leaving it to those knowledgeable at the research institution to design their own human research protections programs.  Thus, IRBs operate differently - some might say inconsistently - as they implement the same basic rules and regulations from various agencies.  Still, it's about the three basic principles of IRB:  respect for persons, beneficence, and justice.

What follows is a compilation of articles, documents, guidelines, decision trees, and more to assist both IRBs and investigators engaged in human subject research (HSR).  Do look at other web pages on the CPP IRB website for additional hints, information, forms, etc.

 

CPP specific, in addition to what is in the Policy and Procedures manual:

The University's statement of policy regarding human subject research

Collecting data in classroom situations - document on the possibility of coercion when a teacher 'studies' his/her own students

Policy on Research in International Settings - CPP document on the considerations for investigators when conducting research abroad.

Confidentiality and conflict of interest - The IRB established a guideline to address these issues for itself.  It was first approved in March 2011.  A copy can be obtained here.

Deception - This is a one page document that outlines justifications for its use, variations on informing subjects, debriefing, and dehoaxing.  It is useful to introduce concepts; the PI is encouraged to obtain more information from other sources.

Reducing the risk factor with audio and video taping - This document, from a post to the IRB Forum list-serve, describes a tool and techniques to de-identify subjects when using these techniques.

 

California state oriented:

State of California memo on personal info in research (PDF) - This PDF comes from the State administrative manual (MM-08-09) and addresses the subject of "requests for and approval to release personal information for research."  It applies to academic researchers who use personal information held in governmental databases and therefore must be protected through the state human subjects protection committee.

CSU San Bernardino's IRB Policies and Regulations website - http://irb.csusb.edu/policiesRegulations.html

 

Nationally oriented:

US - Office for Human Research Protections

Social media research oriented:

OHRP has created a series of “mini-tutorials.” These 15-20 minute videos focus on a specific aspect of human research protections, explained by OHRP staff. Go to https://www.hhs.gov/ohrp/education-and-outreach/online-education/mini-tutorials/index.html

  • Prisoner Research
  • OHRP Reporting Requirements

Oral History Association's Principles and Practices web page: www.oralhistory.org/about/principles-and-practices/

 

Internationally oriented:

Policy on Research in International Settings - CPP document on the considerations for investigators when conducting research abroad.

The Harvard Public Health Rules

"Handbook for International Management Research," edited by Betty Jane Punnett and Oded Shenkar, 2nd edition, Ann Arbor:  University of Michigan Press, 2004, 548 pp.

Additional resources for international human studies, compiled 28 Nov 2010 from the IRB list-serve:

 

Other items:

http://www.online-utility.org/english/readability_test_and_improve.jsp - A tool to evaluate the readability factor of a document; especially useful for consent forms.

The SurveyMonkey site offers blogs and perspectives for researchers. See, for example, "Should I make survey questions required?" at https://www.surveymonkey.com/blog/2016/08/29/make-survey-questions-required