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Protection of Human Subjects

The Belmont Report Principle #1: Respect for Persons

There are two issues to consider under this principle:

  1. Informed Consent
  2. Protecting Privacy and Confidentiality

Informed consent

Give as much information as might be needed to make an informed decision about participating in the research.

Participants should be informed about

  • the general purpose of the study;
  • possible risks (known and unknown), i.e., discomfort, anxiety, career risks, loss of privacy, embarrassment, inconvenience, etc.;
  • probable benefits;
  • why they were selected (it must be an equitable distribution where the sample should not be too large);
  • what will be done with the collected information; and
  • the voluntary nature of participation.

Remember that when acquiring informed consent, the researcher should not be in a position to influence the subject. Think about teacher-student relations as an example:

When the teacher asks for the consent of students to participate in a research study on which classes they like the best in a program, he or she should not force them to participate in the study. Nor should the teacher should try to influence the responses. It is possible that the teacher could influence the students due to his or her position, so the teacher should request someone else to administer the survey, and the student responses should be anonymous with no identifying information on the survey. This way, the students (respondents) will be assured that the teacher will not be able to link their responses with their identify.

Note that the federal laws allow exemptions of informed consent for large surveys, like nationwide and statewide surveys. However, Penn State rules do not allow this exemption.

How to develop an informed consent form

Keep in mind the following points when developing the consent form to protect the human participants of the study.

  • All wording must be at an 8th grade reading level or below.
  • In the form, you should clearly declare and/or include
    • purpose of the study;
    • procedures to be followed;
    • discomforts or risk;
    • statement that participants may withdraw their participation at any time;
    • statement that participants can decline to answer specific questions; and
    • information about how confidential information will be kept as such.

See the PSU ORP website for additional information about informed consent: Research at Penn State

Protecting Privacy and Confidentiality

Protecting privacy and confidentiality is integral to the Belmont Principle#1: Respect for Persons.

This need is an issue spelled out in federal regulations as well. According to the Federal Food and Drug Administration (FDA), there are three kinds of risks for harming research participants: physical, psychological, and informational. Typically, when you conduct a research study in public administration, public policy, health administration, or a similar field, participants would not be harmed physically. It is more likely to harm them by releasing their personal information. They may also be harmed psychologically. The following quote from an FDA document explains the three ways people may be harmed:

Most research risks to the individual can be categorized into one of three types: physical, psychological, and informational risks. (Although there are other harms, such as legal, social, and economic harms, these can usually be viewed as variations on those core categories.) Physical risks are the most straightforward to understand—they are characterized by short term or long term damage to the body such as pain, bruising, infection, worsening current disease states, long-term symptoms, or even death. Psychological risks can include unintentional anxiety and stress including feelings of sadness or even depression, feelings of betrayal, and exacerbation of underlying psychiatric conditions such as posttraumatic stress disorder. Psychological risks are not necessarily restricted to psychiatric or social and behavioral research.

Informational risks derive from inappropriate use or disclosure of information, which could be harmful to the study subjects or groups. For instance, disclosure of illegal behavior, substance abuse, or chronic illness might jeopardize current or future employment, or cause emotional or social harm. In general, informational risks are correlated with the nature of the information and the degree of identifiability of the information. The majority of unauthorized disclosures of identifiable health information from investigators occur due to inadequate data security. (Source: Federal Register.gov)

 
FDA
Confidentiality and Anonymity

There are two key concepts in understanding the issues in protecting information about research participants: confidentiality and anonymity. You need to clearly understand the difference between confidentiality and anonymity. Confidentiality is an issue when the researcher knows who the participant is, but decides to keep this information undisclosed to protect the participant’s privacy. In the case of anonymity, the researcher does not know who the respondent is; so the researcher cannot possibly make any link between the information collected and the individual who provided the information.

Think about this example: A researcher mails a survey questionnaire to 100 individuals. To keep her data organized she assigned a unique number to each individual survey questionnaire. She made a note of each questionnaire’s serial number and its corresponding address and the individual’s name in a data file. In this case, when a survey is returned to the researcher, she will be able to link the identity of the individual and the responses to the questions. For example: Survey #005 is back. The database shows that Survey #005 was sent to John Doe.

Confidentiality is relevant in this case. Why? Because the researcher knows the participant’s identity, and she can reveal it to others (for example, to the public) if she wants to. Her obligation, according to basic research rules is to keep it confidential to protect the participant.

Think about an alternative scenario. No unique survey number is linked to any participant’s address or name. In that situation, there is no way the researcher would know who sent the survey questionnaires back and who did not. Among the questionnaires that are returned, she cannot identify who sent back which one. She cannot reveal the identity of the respondents or what each respondent said, even if she wants to. In this case, the results are anonymous.  

The mantra for most researchers is that anonymity is preferred (in terms of protecting research participants), but it may not be possible. Think about a research project in which the researcher interviews participant face-to-face. Then, it is impossible to maintain anonymity as the researcher knows who is being interviewed.

Confidentiality is a more important concept in the previous example than anonymity, because confidentiality is more applicable. When considering how to ensure confidentiality in your research project, think carefully about all possible ways personal information may be released, intentionally or unintentionally. For example, think about the possibility of deductive disclosure. The question is this:

Could information about a participant be unintentionally linked to his/her identity?

Think about this scenario: In your research report, you mention that a 21-year-old blonde male who is the single son of his single-parent mother in Community X told you that he had used illegal substances. There is only one “21-year-old blonde male who is the single son of his single-parent mother in Community X.” You did not reveal his name, but someone who knows the community can identify that person and this identification may potentially harm the participant. You should think about possibilities like this one and take all possible precautions to protect the confidentialities of research participants.

Note that the federal laws do not necessarily make a researcher’s job easy. Many of the federal laws about confidentiality and privacy are equivocal. They want you to protect the privacy of respondents, but the rules may be contradictory. For example:

  • Research records can be subpoenaed by courts. Thus private information will be revealed at least to the judge and jury members.
  • Market researchers are allowed to disclose individual information. They can sell the addresses and telephone numbers they have. This is why you keep receiving unsolicited mail and telephone calls from advertisers.

In July 2011, The U.S. Food and Drug Administration proposed new guidelines for "Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators". It is yet to be seen to what extent these news guidelines will reduce the contradictions and clarify the rules.


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