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:

Institutional Review Boards (IRBs) and self-governing Ethics Committees (IECs) are charged with protecting the rights and safety of scientific trial participants.
The system that guide the review, endorsement, and behavior of person 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 part of their person investigate Protection Program (HRPP).
Similarly to the IRB, these programs have as their primary assignment the defense of human research subjects.
Composition:
The IRB must consist of at least five member reflecting diversity of technical and non-scientific backgrounds and specialized specialties and also cultural interests, include both sexes, and have at least one member who is not affiliated with the institution directly or from side to side a family member (usually referred to as the community member).
The minimum number of members is set at five, most IRBs will consist of slightly more to house additional expertise and to assure that a quorum can be convened to conduct the meeting.
The International Conference on Harmonisation (ICH), the Department of Health and Human Services (DHHS), and the Food and Drug Administration (FDA) require that IRBs consist of members who collectively have sufficient expertise to evaluate the excellence of the science, checkup aspects of the proposed research, and the ethics of conduct a study.
IRBs are permitted to use an alternate member system, where the alternate member may attend if the primary member is not available.
Also, the IRB may invite outside consultants if necessary to provide insight into scientific or ethical issues that are beyond the expertise of the convened committee.
IRB membership is also influenced by the inhabitants eligible to contribute in the protocol.
Vulnerable populations specifically addressed in the DHHS, FDA, or ICH system include children, prisoners, pregnant women, fetuses, and the handicapped and mentally impaired.
Procedures:
Most surveys do meet the federal definition of research. In defining human subjects research activities, two separate determinations must be made.
The first determination is whether or not the activity can be careful investigate. If the answer is "yes," investigators must follow up with a next determination: Does the research involve human subjects?

Both determinations must be made using the definitions of the terms "research" and "human subjects" in 45 CFR 46.
A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable information.
Activities which meet this definition constitute research, whether or not they are conducted or supported under a program which is considered research for other purposes." Investigators unsure of whether an activity constitutes human research should contact their IRB.
Protection of human subjects:
The process for the protection of human research subjects is multifaceted.
The underlying principles for the protection of research subjects are found in the Nuremberg Code, the Declaration of Helsinki, and the Belmont Report.
The charge to IRBs is to apply these principles in the evaluation of every aspect of the proposed research activity to protect the rights, safety, and well-being of study participants.
As part of the research approval process, IRBs will also consider issues that might not appear directly related to research risks such as investigator and/or institutional conflicts of interest, the scientific validity of a study, as well as the secure storage of and appropriate access to research records.
Increasingly many sponsored trials request the collection and storage of biological specimens for future research, which presents another series of challenges for IRBs.
This may be particularly problematic when studies using DNA are reviewed because of the potential to stigmatize certain ethnic or cultural groups.
It has been suggested that IRBs consider the risks to third parties depending on the degree of risk to them.
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.

Related Questions

Navigate

• Browse (All)
• Browse P
• Subjects

Integrity-first tutoring: explanations and feedback only — we do not complete graded work. Learn more.