Full Disclosure

Any person who participates in a study, whether participatory action research, single-subject design, or randomized trial, has the absolute right to full disclosure of the purpose and procedures of the study. Full disclosure means that the investigator must clearly share with the informant, subject, or research participant the types and content of interviews, length of time of participation, types and length of observations, and other data collection procedures that will occur, as well as the scope and nature of the person’s involvement. Full disclosure also means that any risk to a subject, even if the potential is rare or minimal, must be clearly identified and a plan for remediation offered for each risk to every subject.

Identifying and sharing specific study procedures tend to be straightforward in experimental-type research. However, such disclosure can create difficulties for certain forms of naturalistic inquiry. In an experimental-type study, all the procedures are clearly articulated and determined before entering the field. Therefore, the researcher can identify in layperson’s terms the purpose and scope of the study and the types of data collection efforts that will occur. In naturalistic designs, most bounding-type decisions are made in the field and change or evolve over time as knowledge about the context emerges. Researchers who work in this tradition must solve this dilemma in creative, thoughtful, and ongoing ways. In some studies, it may be necessary to introduce a consenting process for each data collection effort.

Discussion in the research literature is ongoing about effective approaches that investigators can use to remain ethical while preserving the integrity of their methodology. All researchers, regardless of tradition, must struggle over the best way to describe the study truthfully without revealing specific aims or hypotheses or introducing biased perspectives that may shape the informant’s responses during the study. For example, although it is necessary to state the overall research objective, it is not appropriate to indicate a directional hypothesis that could influence how an informant responds during an interview.

Full disclosure of study intent and procedures is usually provided when initially enrolling participants into a study and when obtaining informed consent. In addition to consent forms, some investigators also provide an informational sheet to participants as a handy reference that outlines the study purpose and the procedures used. In studies that involve multiple testing occasions, the investigator may restate the study purpose and procedures at each follow-up to ensure that study participants understand what to expect next and at which stage they are in the research study.

Although full disclosure is mandatory in all studies and with all human subjects, it is important to recognize the importance of disclosure, particularly as it concerns vulnerable populations (e.g., children, individuals with cognitive impairments) and minority groups for which there has been a long history of unethical research practices. Take, for example, the Tuskegee syphilis experiment conducted between 1932 and 1972 in Tuskegee, Alabama, by the U.S. Public Health Service. The study recruited 399 poor African American sharecroppers with syphilis to evaluate the natural course of the disease. Even though by 1947, penicillin had become the standard of treatment for syphilis, this information and access to drug treatment was not offered to study participants. The failure to treat study participants resulted in unnecessary suffering and death of participants and their family members. The unethical practices in this and other studies led to major regulatory changes to protect participants of studies, including full disclosure through the informed consent process and accurate and timely reporting of study results including informing participants of changes in risk or treatment discoveries.

Confidentiality

The investigator must ensure that all information shared by a respondent in the course of a study is kept confidential. Confidentiality means that (1) no person other than specified members of the research team can have access to the respondent’s information, unless those who have access to the data are identified to the participants before their participation (usually stated in informed consent), and (2) the information provided by a respondent cannot be linked to the person’s identity. This second consideration, although relevant to all research involving human subjects, is especially important in studies that focus on sensitive topics, such as AIDS research, teenage pregnancy and birth control use, crime, and drug dealing or abuse.

An investigator can ensure confidentiality in several ways. The name of the respondent must be removed from the actual information that is obtained. This procedure ensures that the identity of respondents in your study is protected and that the information they provide will not be linked to their names in the future. One typical way to protect a study participant’s identity is the assignment of identification numbers. However, this action presents some difficulty for studies that primarily use observation as the principal data collection effort. Also, ensuring confidentiality can be difficult when using audio and video recordings as data collection sources. In these instances, the investigator does not usually transcribe names that are recorded. The researcher would more likely establish procedures for coding and storing digital data in locked filing cabinets or offices with restricted access, as well as destroying electronic copies at the conclusion of the study.

Confidentiality of research participants must also be protected when results are reported. In reporting findings from a case study or naturalistic design, the names of individuals and key identifying information are modified so that there is no direct link between the person’s identity and the information the person provides. Most experimental-type studies report findings that reflect summative scores or outcomes of an aggregate of individuals, which makes ensuring confidentiality less challenging in this research tradition than in naturalistic inquiry.

Researchers who investigate controversial topics must carefully plan how information will be stored and reported. Studies about HIV, sexual activity, drug trafficking, or sexual, physical, or substance abuse may obtain information of interest to the legal system. Investigators can refuse to turn over documentation but risk being called into court to testify.

Federal regulations such as the Health Insurance Portability and Accountability Act (HIPAA) also impose confidentiality rules and restrictions on research activity. HIPAA requires that all health-related information obtained in the course of a study be “de-identified” such that it is not possible to link a person’s name to the health information provided. HIPAA also requires that any health information that is shared in the course of a study be documented in the informed consent form that is signed by a participant before entering a study. Furthermore, under HIPAA, researchers are not legally permitted to contact individuals about a study unless that person has given prior permission for such contact to be made. To abide by this regulation, many clinical sites ask patients or clients to sign a form that indicates their willingness to be contacted and informed about a study of potential interest. Researchers are developing similar procedures.

Ensuring confidentiality necessitates that certain office procedures be established. First, written personal identifying information concerning study participants is kept to a minimum. A master list of study participants that includes the assigned identification number (ID#), first and last names, and necessary group designations (e.g., control vs. experimental group) is maintained for tracking purposes on computers and is password protected; hard copies are kept in locked filing cabinets separate from the actual information obtained. In many studies, screening forms and interview cover sheets that include identifying information are used. All this information must be considered strictly confidential and is also kept in locked file cabinets separate from study data. Any information with subject identification that is not needed is shredded.

Second, confidentiality should also be maintained when making telephone contact with study participants or potentially eligible persons. Conversations with or about study participants require commonsense discretion. Attempts to schedule appointments with study participants or telephone conversations discussing issues related to a participant should be conducted in a manner that ensures confidentiality. When talking on the telephone, researchers should keep voices low and should not use last names except as necessary. When possible, they should conduct phone conversations behind closed office doors. If this is not possible, calls can be made when fewer people are in the office or only persons directly involved with the research project are present.

Third, computer files used for tracking study participants can be set up with password protection. Access to such files should be restricted to defined key personnel, and any backup disks must be stored in locked file cabinets.

Fourth, interviewers must be trained and certified in “protection of human subject” procedures before any telephone or face-to-face interviews with study participants. For face-to-face contact, interviewers introduce themselves, explain the study’s purpose and procedures, and review the informed consent. Informed consent must be obtained before collecting any study-related information. For telephone interviews, interviewers must obtain verbal assent, which is recorded on an institutionally approved form.

Voluntary Participation

When humans are involved in studies, their participation must be strictly voluntary. Individuals have the right to choose to participate or not. Also, an individual who initially agrees to participate in a study has the right to withdraw from the study at any point and the right to refuse to answer a particular question or participate in a particular set of procedures. Thus, the voluntary quality of participation must be protected at three points in a study: initial enrollment, continuation in the study, and right to refuse answering specific questions or a particular study procedure. To ensure voluntary participation at each of these points, investigators must develop approaches to recruiting participants that are not coercive and that provide full disclosure of all study procedures.

Although a person may refuse to participate in a study or one of its procedures, it is important for the investigator to understand why refusals occur. Is withdrawal caused by the nature of the procedures or by excessive demands placed on participants? Is the research team offensive in any way? Is withdrawal based on a change in the health status of the participants or their relocation to another geographic region? Reasons for refusal to participate in a study, withdrawal from a study as a participant, or refusal to answer a particular question may have implications for the ethical conduct of the study, interpretation of results, and ability to generalize outcomes to other groups, as well as planning future studies. As such, it is important to keep track of and evaluate the reasons study participants withdraw from a study or refuse participation in a study component. This information enables the investigator to refine ethical plans, evaluate if differences exist between those who participate and those who do not, and prepare for future research.

Refusal to answer a particular question (e.g., “what is your yearly income?”) or to engage in a particular study component (e.g., allow observation of home interactions) presents a methodological challenge that the investigator must be prepared to meet. Missing information can be a greater problem in experimental-type research than in naturalistic inquiry because missing data limit the types of statistical analysis that can be used and the inferences that can be derived from the data. For example, a common question on survey studies is level of income as one indicator of socioeconomic status. However, participants may refuse to disclose this information. Missing information can be handled in numerous ways, including using the mean value of the group or using a statistical program to assign a value randomly.

Missing information is less problematic in naturalistic studies. The refusal to answer a question may be an indicator of the salience (or importance) of that particular topic or area, and its “missingness” becomes, in essence, a type of meaning that enters into an interpretive scheme. For the naturalistic inquirer, however, missing an observation, such as an important community event, may be more problematic. Adjustments in collecting information may need to occur to overcome this issue, such as prolonging engagement in a particular context or obtaining information about the event from newspaper reports, community meetings, and personal interviews.