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Institutional Review Board-Human Growth Module 1

Institutional Review Board-Human Growth Module 1

Primary Roles and Responsibilities of the Institutional Review Board

The Institutional Review Board (IRB) is a board in research that protects the welfare and human rights during research. This applies mainly in cases where the participants of the research are humans (Domenech et al., 2017). For the Institutional Review Board to achieve its primary roles and responsibilities, the members should be well informed on the protection rights of humans, biomedical research ethics, behavioural ethics, IRB procedures, and policies. The IRB gives more information to the research investigators, for example, their roles in protecting the welfare of the human subjects even when their lives are at risk. They familiarize them with the procedures or protocols followed when choosing who is eligible for the risks.

The board gives training to researchers on how to carry out research whose participants are humans and oversee the most probable adverse events during the research. They are also tasked with investigating the complaints put across by the research participants. They ensure consent forms are signed by research participants before any research is carried out. With the consent document form, telephone numbers of the Human Subject Protection Advocate and principal investigator are provided for participants to call in case of any complaints or concerns. When investigating the complaints raised, they are also responsible for filling in the participant’s complaint form.

The IRB has the upper hand in approving and disapproving any research proposal written by the researchers. To secure approval, the institution review board also requires any modifications for the data collection process. They ensure that the IRB policies and procedures are carried out and implemented in an ethical manner. There are ethical principles that have to be adhered to when carrying out any research whose subjects or participants are humans. They help guide and protect their rights since humans are a sensitive group. Some of these ethical principles include autonomy, beneficence, confidentiality, Do no harm protocol, and justice or equity. Autonomy refers to giving the participants an opportunity or a chance to make decisions on whether to take part or not. For these participants to make the right decisions, research details and information are important. The minority group is more vulnerable when it comes to respect for autonomy. The researchers do not give them a chance to make informed decisions, therefore not respecting the IRB policies and procedures. The researchers should also stick to the beneficence principle, where the research carried out should be helpful to society instead of causing harm to mothers, children, those with cognitive impairments, and minority groups. The IRB team closely ensures they follow the appropriate steps in protecting human rights and human welfare as the federation monitors researchers. consistently, the Institution Review Board lays out the research protocol during the data collection process to regulate the researchers. This is because researchers may overstep the rights of the participants in an attempt to get the details or matters the participants would like confidential.

The John Hopkin’s Research Organization

John Hopkin’s Research organization is a research hospital that carries out medical research. Most subjects of this research are human and are either children, minorities, women, and cognitively impaired human subjects. Since most of its subjects are humans, there is a need to protect human rights and human welfare, according to the federation. Sometimes, researchers are insensitive and subject all their participants to risky attempts causing harm to their health. Specific guidelines and policies have therefore been laid down in an attempt to preserve the human subjects. Some of the guidelines that govern all four participants are the access of the subject’s data, assessment of study records of cognitive impairments, approval by the John Hopkins Medicine IRB, and signing of informed consent forms.

Most of these policies and guidelines cut across these populations. One of the policies at John Hopkins Hospital during research on research is a policy on exempt research (Whicher et al., 2015). All human subjects must be approved by the IRB after being reviewed. The federal regulations must exempt the research participants. Those subjects who qualify for the exemption criteria have their details submitted to John Hopkin’s Medical IRB.

The other organizational policy is one involving Human embryonic cells, stem cells, and germ cells. This policy states that all the research involving somatic cell nuclear transfer of human cells, human induced pluripotent stem cells, human embryonic stem cells, and the introduction of new cells into any sick mother or child needs approval. The introduction of stem cells to the central nervous system policy to manage impaired cognition must be approved by the committee of John Hopkin’s Medicine IRB committee before research is done. They then rule out those who are not fit for the study. 

References

Domenech Rodríguez, M. M., Corralejo, S. M., Vouvalis, N., & Mirly, A. K. (2017). Institutional Review Board: Ally Not Adversary. Psi Chi Journal of Psychological Research22(2).

Whicher, D., Kass, N., Saghai, Y., Faden, R., Tunis, S., & Pronovost, P. (2015). The views of quality improvement professionals and comparative effectiveness researchers on ethics, IRBs, and oversight. Journal of Empirical Research on Human Research Ethics10(2), 132-144.

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Question 


Institutional Review Board-Human Growth Module 1

Written in APA format using proper spelling/grammar, conduct research on the topic of the Institutional Review Board (IRB) and address the following:

  1. Explain the primary responsibilities and priorities of the IRB.
  2. Identify an organization, such as a research hospital or pharmaceutical company, that involves human research subjects including all of the following at-risk populations:
    • children

      Institutional Review Board-Human Growth Module 1

    • women
    • minorities
    • cognitively impaired subjects
  3. Describe the organization’s specific guidelines/policies regarding conducting research on each of the at-risk, human populations listed above.

Be sure to include APA citations for any resources you used as references.

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