Elements of research to know about
The purpose of the consent form is to make sure that you understand the project you are choosing to participate in. Years ago, much research was conducted without participants’ consent, which included some very unethical research behavior. This led to very understandable suspicion about the intent of research and researchers. In 1962, the first US law requiring informed consent changed these practices. Now research is required to be evaluated by a review board, whose job it is to assure that risks are minimized, and that potential participants are clearly informed about risks, benefits, costs, alternatives to participation, and their right to opt out of participation at any time without penalty.
The set of questionnaires we use in ALIVE is designed to help us understand the characteristics of people responding, and current lifestyle behaviors of participants so we can see how you change along your ALIVE journey (we’ll ask these same questions at the beginning and end of the program). We ask questions about things like employment, income, race, and neighborhoods because we know from previous research that not all programs work with all people. That is the whole purpose of Community-Based Participatory Research – to assure that the research we are doing and the programs we develop are relevant to the community. We need to understand the characteristics of the community in order to say at the end that our program worked with this group of people. The lifestyle questionnaires assess energy, vitality, stress, food choices, physical activity, beliefs about health, and relationship with God. We will also take some physical measures – height, weight, waist size, and blood pressure. We will not do any blood tests, or anything more invasive than the measures listed here. All of these measures are validated, which means that they are based on what researchers know to be important about a given area, and the set of questions has been tested on multiple groups of people to assure they measure what they are supposed to measure.
We collect information called “Personal Health Information,” (name, age, ethnicity, contact information – anything that identifies you specifically) separately from your responses to the questionnaires so that when we look at the data, we cannot identify any individual based on their responses. All of the data that we report will be about the group, not any individual. No one on the research team will be looking at your PHI along with your responses, so we won’t know what your individual responses are. All of this data is kept in a locked cabinet in a locked office suite at Rush.