Protecting Human Research Participants (PHRP)

Protecting Human Research Participants (PHRP)

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Protecting Human Research Participants (PHRP)

Qualitative research helps us understand phenomena that cannot be precisely measured with numerical data. 1 To generate the data needed for informative qualitative findings, researchers ask human research participants (HRPs) to disclose private information or provide physical samples.

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This includes information, such as medical history, historical accounts of personal events, private opinions, or other verbal facts. In some cases, physical DNA samples might be collected. When an individual agrees to participate in a qualitative inquiry and provide their data *1, they make themselves vulnerable to the actions of the researcher.

Researchers should remain cognizant that the rights of HRPs are no less important than the goals of qualitative inquiry. The researcher-participant relationship should be based on honesty, trust, and respect, and the PHRP training informs on how these characteristics can be established.

Research Activities Involving Human Subjects

Many research activities involve human participation, so researchers might wonder if they need to abide by the principles in PHRP. Typically, HRPs are used when an individual or group gathers coded private information or specimens that either can be linked to living individuals or which were collected for the specific purpose of research. Research that is not considered as using HRPs are situations in which the coded information or specimen was collected for other purposes, or when the researcher cannot link this information to an individual. *2

How to Minimize the Risks Posed by a Research Project

Risk to HRPs in qualitative studies include physical, psychological, social, legal, and economic. One way to minimize the risk posed by a research project is to acquire the informed consent of HRPs. Consent should inform the participant about the purpose, risks, and potential benefits of the research. HRPs consent must be fully voluntary (not influenced by the researcher or another person). *3

The HRP must also be able to comprehend their consent. Consent should be considered as an on-going process; the participant does not waive their rights when signing a consent form, but retains the right to withdraw their consent at any time during or after the study. *4 The consent process may be completed through a written form, an oral presentation, a video presentation, or by providing educational materials following the completion of participation.

The U.S. Department of Health and Services requires that the researcher disclose the following to the participant:

1.The purpose of the study

2. Any reasonably foreseeable risks to the individual

3.Potential benefits to the individual or others

4. Alternatives to the research protocol

5. The extent of confidentiality protections for the individual

6. Compensation in case of injury due to the protocol

7. Contact information for questions regarding the study, participantsʼ rights, and in case of injury

8. The conditions of participation, including right to refuse or withdraw without penalty *5

Disclosing these details helps mitigate risks associated with research and empowers the HRP to act on their own behalf.

Additional Protections Needed for Vulnerable Populations

Throughout history, researchers have exploited vulnerable populations in their projects. During the Holocaust, Nazi’s conducted mass involuntary medical examinations on prisoners in concentration camps. In 20th century America, hundreds of African American men were deceived into thinking they were being treated for syphilis, when they were actually being studied to understand the long-term effects of untreated syphilis. While many safeguards have been enacted to ensure these atrocities aren’t repeated, several groups remain vulnerable in research participation.

Today’s most vulnerable groups include children, cognitively or medically impaired people, pregnant women, prisoners, and minority groups.

Researchers might seek participation from these populations to further the knowledge on areas that could improve their lives.

In addition, the inclusion of vulnerable groups into large-scale inquiries is necessary to ensure that any intervention accounts for minority experiences. Researchers might also consider how their findings might impact these groups in ways not experienced by the general public.

In addition, these populations have either a diminished capacity to provide informed consent, or are disproportionately vulnerable to various risks of research. Children, for instance, often do not have the capacity to consent.

Consequently, the researcher might not be able to mitigate risks through the informed consent process.

Study Design in the Protection of Research Participants

In their infancy, researchers should design their studies to ensure that the potential benefits of the findings outweigh the potential risks to HRPs. Any unmitigated risks should be justified if they have potential to bring benefit to an individual or community. *6

Some research participants may sacrifice a significant amount of time and money when traveling to and participating in a study. Research institutions should establish compensation standards. While compensation should not be presented as a benefit of the study, it can be used to reduce the financial risk of participation. Institutions should be cautious as to not provide excessive financial compensation which could lead a participant to ignore the risks of the study in order to earn money.

Researchers might ask themselves the following questions when considering compensation: What incentivizes does the individual have to participate in this inquiry? Is the participation truly voluntary if the HRP is in need of money? The answer to these questions largely depends on the research design.

Researchers and institutions should establish a way to secure the privacy of the individual and the confidentiality of their data. HRP data should be stored securely, with limited access, and disposed of when no longer needed. Private and identifiable information should not be publicly disclosed at any point during or after the publication of the research. Regardless of the research topic, ensuring privacy and confidentiality will help protect the safety of HRPs.

All staff at Landmark Associates Inc. have completed the Protecting Human Research Participants (PHRP) training in order to maintain the protection of HRPs through the entire research process. Each academic institution likely had their own ethical guidelines that include protections for research participants.

In addition, many local and federal regulations are in place to protect HRPs. For comprehensive information regarding these laws, please visit the Office for Human Research Protections at the U.S. Department of Health and Human Service.

Resources

  1. Peou, S., 2014. Human Security Studies: Theories, Methods, And Themes. Singapore: World scientific publishing co., p.189.
  2.  Harvard University, 2020. Harvard University Non-Affiliate Protecting Human Research Participants Training: Adapted From The Online Course Previously Offered By The NIH Office Of External Research. pp. 77. Available here.
  3. Ibid: 64-69.
  4. Ibid: 43
  5. HHS, 2020. 45 CFR 46. [online] HHS.gov. Available at: HHS [Accessed 30 June 2020].
  6. Harvard University, 2020. Harvard University Non-Affiliate Protecting Human Research Participants Training: Adapted From The Online Course Previously Offered By The NIH Office Of External Research. pp. 70. Available here
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