scholarly journals Variations in Institutional Review Board Approval in the Implementation of an Improvement Research Study

2013 ◽  
Vol 2013 ◽  
pp. 1-6 ◽  
Author(s):  
Darpan I. Patel ◽  
Kathleen R. Stevens ◽  
Frank Puga

The purpose of this paper is to report the variance in institutional review board (IRB) reviews as part of the implementation of a multisite, quality improvement study through the Improvement Science Research Network (ISRN) and recommend strategies successful in procuring timely IRB approval. Using correspondence documents as data sources, the level of review was identified and time to submission, time to approval, and time to study start were analyzed. Thirteen of the 14 IRBs conducted independent reviews of the project. Twelve IRBs approved the study through expedited review while two IRBs reviewed the project at a full board meeting. Lastly, 11 of the 14 sites required documented consent. The greatest delay in approval was seen early on in the IRB process with site PIs averaging 45.1 ± 31.8 days to submit the study to the IRB. IRB approvals were relatively quick with an average of 14 ± 5.7 days to approval. The delay in study submission may be attributed to a lack of clear definitions and differing interpretations of the regulations that challenge researchers.

PACEsetterS ◽  
2010 ◽  
Vol 7 (3) ◽  
pp. 22-23
Author(s):  
Kathleen Stevens

2021 ◽  
pp. 002216782110467
Author(s):  
Robert McInerney ◽  
Kelsey Long ◽  
Rachel Stough

We report on our work with the street community of Pittsburgh, specifically, a community-based action initiative we call the Mobile Thriving Respite (Institutional Review Board approval was obtained from our university). For 5 years, student advocate ethnographers from Point Park University have gathered data (e.g., long- and short-term interviews, participant-observations generating fieldnotes). The data revealed and supported the need for thriving beyond surviving homelessness. The data endorsed the creation of the mobile thriving respite. In the first part of this work, we will discuss some critical concepts regarding homelessness as a phenomenon and then argue that while surviving as enduring is necessary, there are some for whom survival is a perpetual, lethal state of being. We will discuss the theoretical foundations to the respite and offer researchers’ ethnographic accounts of the respite’s process and progress (We had to temporarily end the respite during the Covid-19 pandemic. To date, the respite has returned with “pop up” events outside at various locations). We will outline how the mobile thriving respite is a praxis as site of resistance as well as an emergent strategy, and an instantiation of communitas. We will then revisit surviving as collectively bearing witness and testifying to the lived experiences of those living outside.


2014 ◽  
Vol 2014 ◽  
pp. 1-7 ◽  
Author(s):  
Ehud Lebel ◽  
Yuri Mishukov ◽  
Liana Babchenko ◽  
Arnon Samueloff ◽  
Ari Zimran ◽  
...  

Changes of bone during pregnancy and during lactation evaluated by bone mineral density (BMD) may have implications for risk of osteoporosis and fractures. We studied BMD in women of differing ages, parity, and lactation histories immediately postpartum for BMD,T-scores, andZ-scores. Institutional Review Board approval was received. All women while still in hospital postpartum were asked to participate. BMD was performed by dual-energy X-ray absorptiometry (DXA) machine at femoral neck (FN) and lumbar spine (LS) by a single technician. Of 132 participants, 73 (55.3%) were ≤30 years; 27 (20.5%) were primiparous; 36 (27.3%) were grand multiparous; 35 (26.5%) never breast fed. Mean FNT-scores andZ-scores were higher than respective mean LS scores, but all means were within the normal limits. Mean LST-scores andZ-scores were highest in the grand multiparas. There were only 2 (1.5%) outliers with lowZ-scores. We conclude that, in a large cohort of Israeli women with BMD parameters assessed by DXA within two days postpartum, meanT-scores andZ-scores at both the LS and FN were within normal limits regardless of age (20–46 years), parity (1–13 viable births), and history of either no or prolonged months of lactation (up to 11.25 years).


2014 ◽  
Vol 47 (04) ◽  
pp. 840-844 ◽  
Author(s):  
Srobana Bhattacharya

ABSTRACTResearch on political conflict can benefit immensely from fieldwork. However, the Institutional Review Board (IRB) process is elaborate and daunting that discourages rather than encourages this type of research. Existing policies often are insensitive to the many uncertainties related to field research abroad, especially in conflict zones. Three reasons for this are identified in this article. First, the federal regulations to protect human subjects of social science research are most suitable for biomedical sciences. Second, there is huge gap between “procedural ethics” and “ethics in practice.” Third, there is a lack of communication or dialogue between researchers and IRBs. After discussing these reasons, I offer the following suggestions: bridging the gap between the researcher and the IRB; reducing delays in the IRB approval and revision process; encouraging collaboration and dialogue among researchers; and advocating a proactive stance by academic associations.


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