| Membership |
Borovecki et al (2005):1) IRB membership information: age, sex, occupation 2) Number of members in the committee |
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Catania et al (2008): 1) The composition of each IRB committee administered by their office: total members per committee, number of non-institutional members, number of non-institutional members without a science background |
| Time |
Ahmed et al (1996): 1) Time taken (days) to obtain ethical approval |
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Al-Shahi et al (1999): Delay from application to- 1) Calling an LREC meeting 2)Initial LREC decision 3) Final LREC approval |
| Cost |
Byrne et al (2006): Number of units of various resources that were used at a given IRB. 1)Travel 2)Supply and equipment purchases 3) Space used |
| Cost |
Chakladar et al (2011): 1) Number of sheets of A4 paper distributed to committee members and used during requested amendments or resubmissions. 2) Paper use during IRB process. 3) Paper use during study conduct |
| Variation |
Angell et al (2006): 1) Patterns of agreement in decisions, descriptively and using the kappa statistic. |
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Fitzgerald et al (2006) (62): 1) Comparison between centralized and decentralized systems: administrative and the review process |
| Satisfaction |
Mosconi et al (2006):1) Average level of satisfaction on the interactions with the REC for each of the following aspects: bureaucratic and secretarial, ethical, scientific and methodological, education aspects and training activities |
| Policy Adherence |
Abbott et al (2011) 1) Process studies examining the extent to which federal regulations are implemented by the IRB |
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Ateudjieu et al (2010) 1) Difficulties in applying regulations |
| Working Hours |
Ah-See et al (1998): 1) Frequency of meetings |
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Kirigia et al (2005): 1) Frequency of scheduled meetings 2) Number of times the committee actually met last year |
| Outcome |
Czarkowski et al (2009): 1) Number of negative assessments given |
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Russ et al (2009): 1) Frequency of formal and content-related objections in the decisions of coordinating ethics committees after first application |
| Training |
Ateudjieu et al (2010): 1) Training on research ethics evaluation. 2) Types of Training. 3) Training Content. 4) Perceived importance of targeted groups for training. 5) Training objectives |
| Knowledge |
Banos et al (2010): 1) Degree of improvement in the knowledge of those attending seminars |
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Borovecki et al (2006): 1) Self assessment of the knowledge of each respondent in the field of biomedical ethics. 2) Participants’ knowledge on the field of biomedical ethics, bioethics issues |
| Structures and procedures |
Foster et al (1998): 1) Policies regarding multi-centre research |
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Jones et al (1996): 1) Policies concerning scientific misconduct |
| Number of Protocols |
Boyce (2002) 1) Number of new and continuing applications discussed at each meeting |
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Catania et al (2008) 1) Types and volume of protocols received in the past year. 2) Total number of protocols [new and prior] 3) Number of new [all types] and of new full-committee review protocols |
| IRB Member Views |
Abou-Zeid et al (2009) 1) Self-rated capacity to perform committee activities |
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Allen et al (1983): 1) Present and retired IRB member general attitudes towards ethical committees and their functions |
| Researcher Views |
Douglass et al (1998): 1) Researcher experiences of the ethics review process |
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Kallgren et al (1996): 1) Student researcher reactions to going through the IRB process |
| Participant views |
Berry (1997): 1) Did the patients know that they were research subjects? 2) Had they been given enough information and enough time to give valid consent? 3) Had they been told what to do if there was a problem? |
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Karunaratne et al (2006):1) Were there any parts which you found difficult to understand? 1) Which activities do you think ethics committees are involved in? |
| IRB Decision Making |
Boyce (2002): 1) Reasons for condition approval/deferral |
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Czarkowski et al (2009): 1) Basis on which decisions concerning research projects were made. 2) Basis for reviewing applications |
| Post Approval Monitoring |
Arda (2000): 1) Methods used to monitor the progress of projects |
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Gibson et al (2008) 1) Assessment of need for ongoing monitoring of registry by REB 2) Types of information that would need to be reported |
| Number of RECs in Region |
Vulcano (2012) 1) Assessment of the number IRBs using a database |
| Views of HCPs |
Allen et al (1983): 1) Doctors who have never been members of an ethical committee views towards ethical committees and their functions |
