Human Growth and Development- Institutional Review Board (IRB)

Posted: December 13th, 2022

Human Growth and Development- Institutional Review Board (IRB)

In a 3-page paper, written in APA format using proper spelling/grammar, conduct research on the topic of the Institutional Review Board (IRB) and address the following: Explain the primary responsibilities and priorities of the IRB. 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 women minorities cognitively impaired subjects 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.Human Growth and Development- Institutional Review Board (IRB)

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Human Growth and Development- Institutional Review Board (IRB)

The IRB refers to the committee that reviews and approves proposals for research studies involving human subjects to ensure that the research adheres to accepted ethical standards (Parker, 2016). The IRB has the role of protecting the rights, welfare, and privacy of human participants during research. The committee approves, monitors, disapproves, and recommends changes in all research activities that are within the committee’s jurisdiction as indicated by the institutional policy and the federal regulations as well. additionally, the IRB has the duty to review authorizations for research and awarding waivers of modifications according to the privacy and confidential regulations stipulated under the HIPPA(Parker, 2016). The IRB can also terminate or suspend a continuing or a previously approved research study if it is not being carried out according to the requirements of the IRB or has been allied to unanticipated harm to the research subjects. The IRB has experts who are competent and knowledgeable about subject populations and other associated factors that allow the risk-benefit ratio to the research participants to be identified as well as the informed consent of the research subjects(Parker, 2016).Human Growth and Development- Institutional Review Board (IRB)

Guidelines/Policies for researching with theCenter for Disease Control and Prevention (CDC)

Women and Minorities

The IRB at CDC should ensure that the minority groups and women are suitably represented in research. the minority groups and women must be adequately represented in all researches in CDC that involve human participants unless a justified reason is provided(Santelli et al., 2000).Human Growth and Development- Institutional Review Board (IRB)

Moreover, women in the reproductive age are not supposed to be routinely or indiscriminatelyexempted from participating in research unless there is reliable information on adverse outcomes for including them in research(Santelli et al., 2000). Thus, pregnancy status should be determined before enrolling participants in some researches and if required, interventions should be implemented to protect the health of participants.Human Growth and Development- Institutional Review Board (IRB)

The inclusion of the minority groups and women in research can be addressed through the inclusion of all suitable groups in one single research or by performing numerous researches. Generally, protocols should use a research design that appropriately represents the minority groups and women to the scientific objectives(Santelli et al., 2000). Researchers at CDC are supposed to evaluate the racial/ethnic group and gender differences within the research proposal. When an adequate proposal of minorities and gender is not possible or unsuitable because of the purpose of the proposed research, the basis for the population should be adequately explained and justified. Similarly, the cost of including the minorities and women is not an acceptable reason to expulse these participants for specific research unless data on these two groups will or has been gathered using other ways to provide data of equivalent quality(Santelli et al., 2000).Human Growth and Development- Institutional Review Board (IRB)

Research Involving Children

In CDC, any research protocol where children are participants should meet the appropriate federal regulations. Consent should be sought from the parents of children before involving them in any research. However, children have the ability to assent or dissent from participating in research(Santelli et al., 2000). Therefore, children should be asked if they wish to take part in the research, especially if they can understand and appreciate the significance of the research. considering all factors like the nature of the study, condition and health status of the potential participants and age, the IRB at CDC should establish for every protocol, if all or some children have the capacity to assent to participation(Santelli et al., 2000). IRBs at CDC require that assent should be sought from all children age 7 years and above.

When the IRB establishes that the research protocol does not necessitate guardian or parental permission to protect children participants such as the neglected children, the usual consent requirement from the parents can be waived. However, a suitable mechanism to protect the children participating in the research should be substituted. The choice of a suitable mechanism would be dependent on the purpose and nature of the research activities stipulated within the research protocol, the anticipated benefits and risks to the research participants, status, health condition, age, and maturity (Santelli et al., 2000).Human Growth and Development- Institutional Review Board (IRB)

Research involving Cognitively Impaired Subjects

The IRBs at CDC review research protocols that involve research participants who are cognitively impaired. Research studies involving cognitively impaired subjects are supposed to follow the regulations provided by the FDA and DHHS and should ensure that mental health practitioners with knowledge of working with these subjects are included in the study(Santelli et al., 2000). Additionally, the IRB should ensure that the additional precautionary measures are implemented in such research studies to protect the welfare and rights of the cognitively impaired subjects.

Moreover, because cognitively impaired subjects may have compromised autonomy, the research should have a direct link to their state mental condition or situations (Rios et al., 2016). Therefore, IRBs at CDC required that the cognitively impaired subjects should not be selected for researches that do not have any relationship to their situation.Human Growth and Development- Institutional Review Board (IRB)

Human Growth and Development- Institutional Review Board (IRB)

The IRB refers to the committee that reviews and approves proposals for research studies involving human subjects to ensure that the research adheres to accepted ethical standards (Parker, 2016). The IRB has the role of protecting the rights, welfare, and privacy of human participants during research. The committee approves, monitors, disapproves, and recommends changes in all research activities that are within the committee’s jurisdiction as indicated by the institutional policy and the federal regulations as well. additionally, the IRB has the duty to review authorizations for research and awarding waivers of modifications according to the privacy and confidential regulations stipulated under the HIPPA(Parker, 2016). The IRB can also terminate or suspend a continuing or a previously approved research study if it is not being carried out according to the requirements of the IRB or has been allied to unanticipated harm to the research subjects. The IRB has experts who are competent and knowledgeable about subject populations and other associated factors that allow the risk-benefit ratio to the research participants to be identified as well as the informed consent of the research subjects(Parker, 2016).Human Growth and Development- Institutional Review Board (IRB)

Guidelines/Policies for researching with theCenter for Disease Control and Prevention (CDC)

Women and Minorities

The IRB at CDC should ensure that the minority groups and women are suitably represented in research. the minority groups and women must be adequately represented in all researches in CDC that involve human participants unless a justified reason is provided(Santelli et al., 2000).

Moreover, women in the reproductive age are not supposed to be routinely or indiscriminatelyexempted from participating in research unless there is reliable information on adverse outcomes for including them in research(Santelli et al., 2000). Thus, pregnancy status should be determined before enrolling participants in some researches and if required, interventions should be implemented to protect the health of participants.

The inclusion of the minority groups and women in research can be addressed through the inclusion of all suitable groups in one single research or by performing numerous researches. Generally, protocols should use a research design that appropriately represents the minority groups and women to the scientific objectives(Santelli et al., 2000). Researchers at CDC are supposed to evaluate the racial/ethnic group and gender differences within the research proposal. When an adequate proposal of minorities and gender is not possible or unsuitable because of the purpose of the proposed research, the basis for the population should be adequately explained and justified. Similarly, the cost of including the minorities and women is not an acceptable reason to expulse these participants for specific research unless data on these two groups will or has been gathered using other ways to provide data of equivalent quality(Santelli et al., 2000).

Research Involving Children

In CDC, any research protocol where children are participants should meet the appropriate federal regulations. Consent should be sought from the parents of children before involving them in any research. However, children have the ability to assent or dissent from participating in research(Santelli et al., 2000). Therefore, children should be asked if they wish to take part in the research, especially if they can understand and appreciate the significance of the research. considering all factors like the nature of the study, condition and health status of the potential participants and age, the IRB at CDC should establish for every protocol, if all or some children have the capacity to assent to participation(Santelli et al., 2000). IRBs at CDC require that assent should be sought from all children age 7 years and above.

When the IRB establishes that the research protocol does not necessitate guardian or parental permission to protect children participants such as the neglected children, the usual consent requirement from the parents can be waived. However, a suitable mechanism to protect the children participating in the research should be substituted. The choice of a suitable mechanism would be dependent on the purpose and nature of the research activities stipulated within the research protocol, the anticipated benefits and risks to the research participants, status, health condition, age, and maturity (Santelli et al., 2000).Human Growth and Development- Institutional Review Board (IRB)

Research involving Cognitively Impaired Subjects

The IRBs at CDC review research protocols that involve research participants who are cognitively impaired. Research studies involving cognitively impaired subjects are supposed to follow the regulations provided by the FDA and DHHS and should ensure that mental health practitioners with knowledge of working with these subjects are included in the study(Santelli et al., 2000). Additionally, the IRB should ensure that the additional precautionary measures are implemented in such research studies to protect the welfare and rights of the cognitively impaired subjects.

Moreover, because cognitively impaired subjects may have compromised autonomy, the research should have a direct link to their state mental condition or situations (Rios et al., 2016). Therefore, IRBs at CDC required that the cognitively impaired subjects should not be selected for researches that do not have any relationship to their situation.Human Growth and Development- Institutional Review Board (IRB)