Selected appropriate level of review (exempt = archival; expedited = minimal risk w/ general population; full = at risk population or more than minimal risk)

Selected appropriate level of review (exempt = archival; expedited = minimal risk w/ general population; full = at risk population or more than minimal risk)

 

Included principal Investigator and Faculty Research Supervisor’s names and contact information

 

Provided a proposed start date for the project

 

Explained purpose of the study & purpose seems reasonable

 

Offered a brief but detailed summary of the project, including methodology

 

Proposed protocol’s time required, compensation provided and activities seem appropriate

 

Described participant demographics (Anticipated sample size & if members of special groups –institutionalized, protected, age, health status, etc.)

 

Indicated that deception will or will not be used in the study

 

Indicated that audio or videotapes will or will not be used in the study

 

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

 

Described procedures where confidentiality may be broken by law (e.g., child abuse, suicidal intent).

 

Described where the research will take place

 

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

 

Described any possible physical, psychological, social, legal, economic or other risks to participants

 

Described procedures implemented for correcting harm potentially caused by participating in the study

 

Explained the potential benefits of the study (to participant and to professional audience)

 

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)

 

Consent is written at an appropriate level for the proposed participant pool (generally 8^th grade level)

 

If non-English speakers are part of the participant pool, consent is in their native language

 

Participant is told clearly why he or she was selected

 

Participant is given a clear estimate of the number of expected participants

 

Participant is given a clear explanation of why the research is being done

 

The principal investigator clearly notes that the study is being done for doctoral studies or other applicable reasons (participant will want to know what the principal investigator gains by doing this study)

 

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)

 

Participant is given a clear explanation of exactly what participation will involve (time required, type of activities expected, type of questions asked, etc.)

 

Participant is told that he or she has the right to choose not to participate, and can withdraw at any time without harm

 

Where applicable, participant is told that if child or dependent adult abuse is detected, abuse will have to be reported

 

Participant is given a clear explanation of potential risks or discomforts and an estimate of likelihood of same

 

As applicable, participants are told how to request results or how they will receive results, and these processes are appropriate and not unduly onerous

 

Participant is told exactly how privacy/confidentiality/anonymity will be maintained, including who will see the data

 

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).

 

Participant is told that his or her decision to participate will not affect any relationship that seems relevant

 

Participant is given full contact information for principal investigator and faculty research supervisor

 

Participant is given IRB contact information including reason why one might use same

 

The Attachments

 

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)

 

Attached a Letter of Informed Consent and (where necessary) Parent/guardian Permission Letter and Oral statement of Assurance (used with minors)

 

Provided all proposed data-gathering instruments (s): Observation, Interview, or Survey with clear permissions or documentation of ability to use

 

Where appropriate, provided receipt for payment of instrument or documentation of ability to use instrument (email permission, print out of public domain status, etc.)

 

Attached a conflict of Interest Disclosure Statement

 

Included the CRP or Dissertation Chairperson/Research Supervisor’s signature as well as the principal Investigator’s signature

 

Included CITI training forms for both applicant and research chair on project

 

Attached a copy of all recruitment materials