Review IRB Checklist. Gather information on Stanley Milgram’s study on obedience and authority. Using the IRB checklist as a guideline, what were some major concerns you had regarding the Milgram study? How would you redesign Milgram’s study to have it pass IRB standards?
Applicant Name / IRB Protocol Number ___________________________________________
0 Selected appropriate level of review (exempt = archival; expedited = minimal risk w/ general population; full = at risk population or more than minimal risk)
0 Included principal Investigator and Faculty Research Supervisor’s names and contact information
0 Provided a proposed start date for the project
0 Explained purpose of the study & purpose seems reasonable
0 Offered a brief but detailed summary of the project, including methodology
0 Proposed protocol’s time required, compensation provided and activities seem appropriate
0 Described participant demographics (Anticipated sample size & if members of special groups –institutionalized, protected, age, health status, etc.)
0 Indicated that deception will or will not be used in the study
0 Indicated that audio or videotapes will or will not be used in the study
0 Described the precautions that will be taken to insure the confidentiality, privacy or anonymity (cannot be both confidential and anonymous at the same time) of the participants
0 Described procedures where confidentiality may be broken by law (e.g., child abuse, suicidal intent).
0 Described where the research will take place
0 Provided a full example of the proposed Informed Consent and Assent (Attach copies of all relevant forms) or describes alternative methods where consent is not appropriate
0 Described any possible physical, psychological, social, legal, economic or other risks to participants
0 Described procedures implemented for correcting harm potentially caused by participating in the study
0 Explained the potential benefits of the study (to participant and to professional audience)
0 Noted any areas that may provide a conflict of interest or promote a coercive atmosphere
The Consent Form (information provided must match the claims in the application)
0 Consent is written at an appropriate level for the proposed participant pool (generally 8th grade level)
0 If non-English speakers are part of the participant pool, consent is in their native language
0 Participant is told clearly why he or she was selected
0 Participant is given a clear estimate of the number of expected participants
0 Participant is given a clear explanation of why the research is being done
0 The principal investigator clearly notes that the study is being done for doctoral studies or other applicable
0 The principal investigator clearly explains if (or what) compensation will be provided (what does the participant gain by participating in this study – if monetary or other concrete benefit, how and when will it be distributed)
0 Participant is given a clear explanation of exactly what participation will involve (time required, type of activities expected, type of questions asked, etc.)
0 Participant is told that he or she has the right to choose not to participate, and can withdraw at any time without harm
0 Where applicable, participant is told that if child or dependent adult abuse is detected, abuse will have to be reported
0 Participant is given a clear explanation of potential risks or discomforts and an estimate of likelihood of same
0 As applicable, participants are told how to request results or how they will receive results, and these processes are appropriate and not unduly onerous
0 Participant is told exactly how privacy/confidentiality/anonymity will be maintained, including who will see the data
0 Participant is told if taping is possible or required and, if so, how those tapes will be kept safe (including who transcribes the materials – for example: principal investigator or a transcription service).
0 Participant is told that his or her decision to participate will not affect any relationship that seems relevant
0 Participant is given full contact information for principal investigator and faculty research supervisor
0 Participant is given IRB contact information including reason why one might use same
0 Attached an Institutional Permission Letter (where research is taking place if appropriate) or an Assurance of Adherence to Governmental Regulations concerning Human Subjects/Participants (if research project is conducted outside the US)
0 Attached a Letter of Informed Consent and (where necessary) Parent/guardian Permission Letter and Oral statement of Assurance (used with minors)
0 Provided all proposed data-gathering instruments (s): Observation, Interview, or Survey with clear permissions or documentation of ability to use
0 Where appropriate, provided receipt for payment of instrument or documentation of ability to use instrument (email permission, print out of public domain status, etc.)
0 Attached a conflict of Interest Disclosure Statement
0 Included the CRP or Dissertation Chairperson/Research Supervisor’s signature as well as the principal Investigator’s signature
0 Included CITI training forms for both applicant and research chair on project
0 Attached a copy of all recruitment materials
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