Omar Bennett
There are various types of scientific studies, including experiments, comparative analyses, observational studies, surveys, and interviews. The type of study chosen depends on the research question being asked. When planning a study, a research question is stipulated first, which involves deciding what will be tested and in which group of people. For example, a researcher from a school of social work may obtain access to students' academic records to assess the effect of drug awareness programs on student academic achievement. This would constitute human subjects research as defined by federal regulations. To protect the privacy of subjects in such studies, researchers can employ methods such as encrypting data and conducting research activities in private settings.
| Characteristics | Values |
|---|---|
| Type of study | Experiments, comparative analyses, observational studies, surveys, interviews, RCTs |
| Considerations | Research question, medical condition, patient's personal situation, cause of condition, natural course of disease, impact of treatment, number of people affected, patient coping mechanisms |
| Ethical considerations | Beneficence, respect for persons, justice, privacy, confidentiality, consent, risk, anticipated benefits |
| Federal regulations | Human subjects defined as living individuals about whom a researcher obtains information through interaction or intervention, observes public behaviour, obtains identifiable private or public information |
| IRB approval | Required for studies involving human subjects, studies without human subjects may not require IRB approval |
| Data protection | Encryption, password-protected files, limited access |
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What You'll Learn
Studies involving identifiable information
For example, a researcher from a school of social work who obtains access to students' academic records (including identifiable information) to assess the effect of drug awareness programs on student academic achievement is conducting a study that constitutes human subjects research.
In the case of coded private information, it is not considered human subjects research if the investigator cannot readily ascertain the identity of the individuals. This could be due to an agreement prohibiting the release of the key to the investigator, or through the use of de-identified, non-coded data.
When the primary potential harm is the breach of individually identifiable data, researchers should protect against such disclosures by encrypting the data and storing it in password-protected files on institutionally maintained servers with limited access.
It is important to note that researchers may be required to release individually identifiable information outside the research setting.
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Studies involving human subjects
To determine whether a study constitutes human subjects research, investigators should refer to the Common Rule, which outlines eight exemption categories. If the research meets the criteria for one or more of these exemptions, it is generally exempt from regulatory requirements. However, investigators should check with their institution's HRPP or IRB office to ensure compliance with any institutional policies that may apply.
In the United States, all research involving human volunteers must follow the Common Rule. Investigators must submit their proposed research to the institution's HRPP or IRB office for determination of whether it meets the criteria for an exemption. Certain exemptions may require a "limited IRB review" to ensure specific conditions are met.
NIH provides specific guidelines for studies involving human subjects, including a questionnaire to assist investigators in determining whether their project involves non-exempt human subjects research. Clinical investigators must submit a Research Plan and a Data and Safety Monitoring Plan for clinical trials. Grants management specialists will also check for a Human Subjects Federalwide Assurance and certification that an IRB or IEC has reviewed and approved all non-exempt human subjects research in the application.
Examples of studies that would constitute human subjects research under federal regulations include a researcher from a school of social work obtaining access to students' academic records (including identifiable information) to assess the effect of drug awareness programs on academic achievement. Obtaining informed consent and conducting research interviews are also considered human subjects research.
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Studies involving vulnerable populations
The World Medical Association characterizes vulnerable groups and individuals as those who “may have an increased likelihood of being wronged or of incurring additional harm”. This includes those who cannot give or refuse consent for themselves, and those who may be vulnerable to coercion or undue influence.
Some examples of vulnerable populations include:
- Prisoners: Due to their incarceration, prisoners may not be free to make a truly voluntary and uncoerced decision about participating in research.
- Economically or educationally disadvantaged individuals: These individuals may be more susceptible to the risks of research, such as being persuaded to participate due to economic compensation or not fully understanding the concepts presented.
- Pregnant women: Studies involving pregnant women may require additional safeguards, especially if there is potential for physical or psychological harm.
- Children: Research with children requires assent from the child in addition to permission from a parent or guardian. Children are considered vulnerable as they may not have the capacity to fully understand the risks and benefits of the research.
- Individuals with impaired decision-making capacity: This includes those with mental illness, cognitive impairments, or dementia. Studies involving these individuals must ensure that additional safeguards are in place to protect their rights and welfare.
When conducting research with vulnerable populations, it is important to ensure that their inclusion is justified and that adequate procedures are in place to minimize risks of physical or psychological harm and breaches of privacy and confidentiality. The research should also be relevant specifically to the vulnerable population being studied and not capable of being carried out with a non-vulnerable population.
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Studies involving informed consent
Informed consent is a critical communication link between the prospective human subject and an investigator. It is a process by which a subject voluntarily confirms their willingness to participate in a particular trial, having been informed of all aspects of the trial that are relevant to their decision.
Informed consent is required for all research involving human subjects. Investigators can include physicians, scientists, nurses, administrative staff, teachers, and students, among others. The informed consent process should be an active exchange of information between the investigator and the prospective subject, and it should continue until the completion of the research study.
The regulations require that the following information must be conveyed to each subject: a statement that the study involves research, an explanation of the purpose of the research and the expected duration of the subject’s participation, a description of the procedures to be followed, and identification of any procedures that are experimental; a description of any reasonably foreseeable risks or discomforts to the subject; a description of any benefits to the subject or others that may reasonably be expected from the research; a disclosure of appropriate alternative procedures or courses of treatment; a statement describing the extent to which confidentiality of records identifying the subject will be maintained; and, for research involving more than minimal risk, an explanation as to whether any compensation and medical treatments are available if injury occurs.
Informed consent must be obtained prior to initiating any research activities, including screening procedures. It is documented by means of a written, signed, and dated informed consent form. This form is required when obtaining informed consent from a community that has a written language. When obtaining informed consent from a community without a written language, an oral presentation of the informed consent form and Bill of Rights in their native language via interpreter is required.
There are three acceptable legal approaches to adequate informed consent: the subjective standard, the reasonable patient standard, and the reasonable clinician standard. Many states use the reasonable patient standard because it focuses on what a typical patient needs to know to understand the decision at hand. However, it is the sole obligation of the clinician to determine which approach is appropriate for a given situation.
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Studies involving research ethics
Research ethics are an important consideration in any study, and there are several key areas that must be addressed to ensure ethical integrity. Firstly, informed consent is crucial. Participants must understand the nature of the research, their role, and any potential risks or benefits involved. This is particularly important when dealing with vulnerable populations, such as children, prisoners, or individuals with cognitive impairments, as they may have limited decision-making capacity or face heightened risks.
Secondly, privacy and confidentiality are essential. Researchers must protect participants' personal information and ensure that data collected remains confidential. This may involve anonymization techniques, secure data storage, and obtaining participants' consent for data usage.
Thirdly, potential risks and benefits must be carefully assessed. Researchers should minimize any physical, psychological, social, or legal risks to participants. This includes ensuring the physical safety of participants and protecting them from psychological harm, such as emotional distress or invasion of privacy. Researchers should also consider the potential benefits of the study and strive to maximize these for participants and society.
Additionally, researchers must ensure that their study design and methodology are ethically sound. This includes considerations of fairness and justice, avoiding any discrimination or bias in participant selection, and ensuring an equitable distribution of benefits and burdens. Researchers should also be aware of potential cultural differences and sensitivities, especially when conducting research in diverse communities or across international borders.
Lastly, transparency and accountability are key. Researchers should disclose any potential conflicts of interest and ensure that their methods, data, and findings are accessible and open to scrutiny. This includes obtaining ethical approval from relevant institutional review boards or ethics committees and adhering to guidelines and regulations governing research ethics, such as the Belmont Report or the Declaration of Helsinki.
By carefully addressing these ethical considerations, researchers can ensure that their studies are conducted with integrity and respect for participants, minimizing potential harm while maximizing the benefits of their research for all stakeholders.
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Frequently asked questions
A researcher from a school of social work who obtains access to students' academic records (including identifiable information) to assess the effect of drug awareness programs on student academic achievement.
Ensuring that risks are reasonable in relation to anticipated benefits.
A method to protect the subjects' privacy in research would be to conduct research activities in a private setting.
A faculty member makes identifiable data about sexual behavior available to graduate students, although the subjects were assured that the data would be de-identified.
