Part 3 – Informed Consent and Confidentiality

        Informed Consent Process

        An Informed Consent document will be prepared by the Principle Investigator and approved by the IRB to educate potential study participants about everything they will be expected to do in the study, any potential risks or benefits to them, what the data is being used for, how their information will be handled, what institution is conducting the research, who to contact for concerns, and other pieces of information. This must be affirmed before they can participate in the research study to any capacity.

        This document is a key element of human research and should not be signed quickly and dismissed. Most study parameters will require the entire Informed Consent document to be read aloud to the potential participant and then signed, dated and stored securely. It is very important that they potential participants be allowed to ask questions about the study, and you may be expected to be provide factual answers. It is also important to speak to a level of which the subjects can understand: it is not enough for them to simply read a document, they must comprehend it.

        If a research involves minors, in most circumstances it will require a parent to sign the consent document, and a second document be signed by the child (if old enough), which is known as “assent.” Depending on the approved study parameters, it may be documented verbally or be a signed paper.

        In many instances, simply participating in a study can be considered private information. For instance, if a woman is going through the informed consent process for a study for abused women, even that she is participating in this study would pose risk to her if this information is made publicly available. Therefore, it is important that the identities of research participants not be discussed outside the study and the informed consent document be kept secure and private. In some studies the informed consent document will not be signed or retained for this reason, which will be a decision made by the PI and IRB. The subjects will still need to be read an Informed Consent document before deciding to proceed in most circumstances, however.

        Finally, it is important as a research aide or assistant to not create any type of influence on the potential participants that may sway them to participate or not. This includes the setting of which the consent process is done: if it is done loudly and publicly in an area surrounded by peers, the subject may not be willing to participate. If the consent process is done in a crowded room with lines to tables, the subjects may feel it would be unpleasant or awkward to be the only one to decline to participate and leave, and be swayed to participate. The tone of voice or how questions are answered and the responses phrased may also sway their response as well. As a research aide or assistant, it is important to be discerning and in tune with the potential participants to abide by the principle of respect for persons and remove any influence the process may have on their decisions. Finally, having a personal relationship with a subject will likely impact the informed consent process or responses in studies. Therefore, if at all possible, in these circumstances the participant should be referred to another assistant.

 

        Confidentiality

        As stated earlier, the primary risk associated with most social science research is a breach in confidentiality. This word in social sciences is used to mean the understanding that private information will not be made public and that the research team is committed to taking the proper steps to make sure this is the case. Discussing participants, their responses or anything about their time in the study outside of the study is usually strictly prohibited.

        This requires that all responses and informed consent documents (as stated earlier) be kept secure. Paper copies should be secured in a locked office or, if in a filing area accessible by many people, should be stored in a locked container. Information stored digitally should be password protected and possibly encrypted. An overabundance of caution is necessary for even information that may not seem sensitive or degrading. Oftentimes, “Direct Identifiers,” or information that allows someone to immediately know who a subject is (such as a name or address) may be removed from the data set, and also Indirect Identifiers, which are pieces of information that can be used to deduce the subject’s identity. If a research aide or assistant suspects information has been stolen or hacked, it is important to immediately notify the PI. This also applies for information that is misplaced or lost.  Failure to do so may result in disciplinary action.

        Finally, it is important to note that some studies will deal with information that may involve illegal activities. This includes things like drug use. Some studies may have secured a Certificate of Confidentiality, a government issued document that allows these things to be discussed without fear of criminal prosecution. However, there are other categories known as “Mandated Reporting Categories,” which may include things like specific communicable diseases, child abuse, elder abuse, or suicidal ideation. This must be reported without exception, regardless of confidentiality standards. Check with the PI to know what mandated categories may appear during research and what course of action to take when they come up.