Product evaluation is an important step to ensure that a product will meet the q

Question

Product evaluation is an important step to ensure that a product will meet the quality, features, and overall design that is acceptable to the consumer. Imagine that you are an evaluator for a new product. Describe common challenges that you will find in a controlled and in a natural environment setting among users. Suggest actions that you can take in order to address or prevent these challenges.

An Institutional Review Board (IRB) is concerned with how human participants in an evaluation are treated and how the collected data is analyzed and stored. Not every country has IRBs. Provide your opinion on how studies conducted in countries with no IRBs should be perceived. Suggest whether or not data collected during those studies would be reliable. Justify your response.

Explanation / Answer

Answer:

The regulations that guide the review, approval, and conduct of human research refer to these independent boards as IRBs or IECs. Since that time many institutions have reorganized the various support and review services connected with human subject research including the IRB as one component of their Human Research Protection Program (HRPP). Similarly to the IRB, these programs have as their primary mission the protection of human research subjects.   

Composition:

Procedures:

Protection of human subjects:

Final Thoughts:

Investigators and sponsors often experience frustration in dealing with local IRBs. Although some IRBs appear to have the mission of blocking clinical research, this is rarely the case. Sponsors, investigators, and IRB members each work to meet regulatory mandates and ‘follow the rules.’ Unfortunately, the rules are not always very specific and sometimes seem to come from different games. The sponsors’ chances for success are improved by selecting investigators who have established relationships with their local IRB and understand the information that is needed to assure a timely and thorough review.

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