The need for institutional review boards (IRBs). How can they potentially affect or impact a study? Give 3 examples.

However, IRB reviews can potentially affect or impact a study in several ways.

1. Study Design Modifications:
   • IRBs may require researchers to modify their study design to minimize risks to participants or enhance ethical considerations. For instance, if a study involves a potentially vulnerable population, such as children or individuals with cognitive impairments, the IRB may require additional safeguards, such as obtaining assent from participants and consent from their legal guardians.  
   • Example: A researcher planning a study on the effects of a new medication on pregnant women might be required by the IRB to significantly alter the dosage or frequency of administration, or to include additional safety monitoring measures, to protect the fetus. This could potentially affect the study's timeline and the generalizability of its findings.
2. Informed Consent Process:
   • IRBs scrutinize the informed consent process to ensure that participants are fully informed about the study's purpose, procedures, risks, and benefits. They may require researchers to revise the consent form to include clearer language, provide more comprehensive information, or address potential conflicts of interest.  
   • Example: An IRB reviewing a study involving a survey on sensitive topics, such as domestic violence or substance abuse, might require the consent form to include detailed information about confidentiality and data privacy measures. They might also require the researcher to provide participants with resources for support services if they experience emotional distress during the study. This can prolong the starting period of the study.
3. Study Delays or Rejection:
   • IRBs have the authority to delay or reject research proposals that do not meet ethical standards. This can significantly impact the study's timeline and funding. If an IRB identifies serious ethical concerns, they may require researchers to revise their proposal or even halt the study altogether.  
   • Example: A researcher planning a study involving the use of deception might have their proposal rejected by the IRB if they cannot adequately justify the need for deception and demonstrate that the potential benefits of the study outweigh the risks to participants. This can force the researcher to abandon the study or significantly revise their research question and methodology.

In essence, IRBs play a critical role in balancing the pursuit of scientific knowledge with the protection of human participants. While their oversight can sometimes lead to study modifications, delays, or rejections, these measures are essential for ensuring that research is conducted ethically and responsibly. The impact of IRBs on research studies underscores the importance of researchers engaging in thorough and proactive ethical planning throughout the research process.

References

National Academies of Sciences, Engineering, and Medicine. (2023). Human genome editing: Science, ethics, and governance. National Academies Press.

Resnik, D. B. (2020). What is ethics in research & why is it important? National Institute of Environmental Health Sciences. Retrieved

from https://www.niehs.nih.gov/research/resources/bioethics/whatis/index.cfm