When do I need to get the subjects’ informed consent?

a) Researchers should first determine if subjects could be identified through the way the information is recorded, and/or if the subjects are being asked to disclose or provide information that they might otherwise reasonably expect would be private. If you’re sending out anonymous surveys, for example, and no one could tell whose answer was whose, you don’t need an informed consent form. BUT: if there’s any way that someone could identify whose answer belonged to whom, and being identified through the data could cause problems for the subject, then yes, you need an informed consent form, even if you’re “only” doing a survey. If you intend to record what people say in any way, whether on audiotape, videotape, or any other means, then you certainly do need to get their consent; the very act of recording them has made them identifiable. See a later section for more information on informed consent.

b) It should be noted that no recorded information, even if it is anonymous, is automatically inaccessible to the legal process. Any material can be subpoenaed, given sufficient cause. Most law enforcement agencies will, however, respect the confidentiality promised in an informed consent form. The consent form ought to follow the model used by the National Institute of Justice, though, if you think there could be real danger to your subjects if the material was requested by law enforcement. See http://www.ojp.usdoj.gov:80/nij/humansubjects/hs_11.html for the NIJ guidelines. If your research is being done with money from the Department of Justice, then you will have had to submit a request for a Privacy Certificate, and your data will then be protected anyway.

All research approved by the Committee in which the subjects could be identified from the data collected, and could possibly be harmed in some way by being so identified, must include obtaining informed consent from subjects either through the use of a written consent form or through an alternative oral procedure. There may be times when the research cannot be conducted if the subjects are told that they must sign something. If for that, or some other, compelling reason, informed consent forms cannot be used, but conducting the research will bring benefits to human knowledge that outweigh the risks, then the subject must be read a statement or script that includes the mandatory elements of informed consent. A copy of the proposed statement or script must accompany the protocol, along with an explanation of why this approach needs to be used. A copy of the written informed consent form must also accompany the protocol. In all cases, there are 8 mandatory elements of consent that must always be included:

1. A statement that the study involves research, an explanation of the purposes 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 which are experimental.
2. A description of any reasonably foreseeable risks or discomforts to the subject. Risks should be explained to subjects in language they can understand, and be related to everyday life.
3. A description of any benefits to the subject or to others which may reasonably be expected from the research.
4. A disclosure of appropriate alternative procedures of courses of treatment, if any, that might be advantageous to the subject.
5. A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained.
6. For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained.
7. An explanation of whom to contact for answers to pertinent questions about the research and research subjects’ rights, and whom to contact in the event of a research-related injury to the subject. The HSC requires that the name and phone number of the responsible faculty investigator be included for this purpose, or the faculty supervisor, if a student is the investigator.
8. A statement that participation is voluntary and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled. If the subject is a patient or client receiving medical, psychological, counseling or other treatment or services, there should be a statement that a refusal to participate will not jeopardize or affect any treatment or services the subject is receiving or may receive in the future. If the subject is a prisoner, there should be a statement indicating that participation or nonparticipation in the research will have no effect on the subject’s current or future status in the institution. If some questions deal with sensitive issues the subjects should be told that they may refuse to answer individual questions.

If the project involves the use of video or audio taping of the subjects, the consent form should clearly state that this will be the case, and should also clearly explain what use will be made of the tapes. This should include who will see/hear the tape, how it will be used (for example, in a classroom, in a professional meeting, etc), and where and for how long it will be stored. If the investigator wants permission for the tape to be viewed by anyone other than the project’s research staff, or if it involves sensitive material, subjects should also be given an opportunity to view or listen to the tape themselves after it is completed. Permission for the tape to be more widely seen or heard should then also be obtained from the subject.

Signatures on consent forms should be immediately below the text of the form. They should not be separated from the text by any lines or other barriers. Lines might give the impression that the signature portion is to be torn off. Each subject must be given a complete copy of the consent form. The investigator should also keep one copy of the consent form, and they are required to keep this copy on file for seven years following the completion of the research.

The consent form must be worded so that the person signing it can really understand it. This requirement means that: 1) if the subject’s primary language is NOT English, then they must be given a consent form to read and sign that IS in their primary language; 2) as much as is humanly possible, the text should NOT include professional and technical terms and academic jargon, while being as accurate as possible; 3) the form should NOT be written in the first person (that is, “I understand that this research project involves…”); 4) the form should NOT guarantee anonymity to the subject, unless the research truly is completely anonymous. If the research is completely anonymous, then there is NO WAY that the investigator can connect the research results with the individual subjects who provided the data. If there are codes or a master list, the use of which would enable the investigator to identify the individual subject, then the research really isn’t anonymous. Obviously, someone who is participating in a focus group discussion as a subject, or who is being videotaped, also cannot be guaranteed anonymity.

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