Consent+Form

=Sample Consent Form=

**CONSENT TO PARTICIPATE IN NON-BIOMEDICAL RESEARCH**
//ITR: Detecting Activity in Homes with Ubiquitous Sensing to Support Aging in Place//

You are asked to participate in a research study conducted by the following researchers from the Department of Architecture and the MIT Media Laboratory at the Massachusetts Institute of Technology (M.I.T.): >> Dr. Stephen Intille, Research Scientist, Architecture >> Kent Larson, Principal Research Scientist, Architecture >> Jennifer Beaudin, Research Scientist, Architecture

You were selected as a possible participant in this study because: You should read the information below, and ask questions about anything you do not understand, before deciding whether or not to participate.
 * You are at least 18 years of age
 * You live in an apartment or home
 * You live within the Greater Boston area at a location easily accessible via public transportation
 * You are not employed by the MIT Department of Architecture or the MIT Media Laboratory

**PARTICIPATION AND WITHDRAWAL**
Your participation in this study is completely voluntary and you are free to choose whether to be in it or not. If you choose to be in this study, you may subsequently withdraw from it at any time without penalty or consequences of any kind. The investigator may withdraw you from this research if circumstances arise which warrant doing so.

**PURPOSE OF THE STUDY**
The purpose of the study is to determine the feasibility of using a large number of simple sensors, distributed throughout the home setting, to recognize everyday activities. We anticipate that this study will help us to design sensors and sensor casings, improve sensor installation procedures, and develop and measure the performance of computer algorithms that can automatically detect everyday activities. This work may eventually lead to the development of new devices for the home that help people live in their homes longer as they age.

**PROCEDURES**
If you volunteer to participate in this study, we would ask you to do one or more of the following things:
 * 1) Have sensor devices, or just the cases that would contain such devices, installed in your home. They will be taken down within ....... days.
 * You may be asked to install the sensors (or sensor cases) following provided instructions
 * Or, we, the researchers, will install the sensors (or sensor cases) in your home under your supervision
 * 1) Wear “on-body” sensors for ....... days during the experiment.
 * 2) Have data collected about your everyday activities by the sensor devices (in your home and/or that you are wearing) for ....... days during the experiment.
 * 3) Answer questions presented to you on a mobile device that you carry with you (also known as doing “experience sampling”) for ....... days during the experiment.
 * 4) Permit collection of audio and/or video data of your home activities from up to five locations in your home.

These procedures are described in more detail below. Not all may be available for this experiment. The investigators have indicated those that are available under the “Payment Participation” section of this form.

> For the purposes of this study, up to 300 small sensor devices and one or more BoxLab kiosks will be temporarily installed in your home. The kiosks are approximately 23x16x21 and have a floorlamp attachment on top that makes it approximately 6 feet high. The sensor devices may be installed by a team of up to four researchers, under your supervision, or, we may ask you to install these sensors yourself using a set of step-by-step instructions.
 * Procedure 1: Installation of the Sensor**

> The sensor boards are approximately 1.5 by 1.5 inches and encased in plastic. These sensors (or just their cases) will be placed or taped on furniture, appliances, and other objects throughout your home. The sensors will be attached using either conventional tape, putty, sticky products (e.g. 3M adhesive), or, in some cases, a special glue that will not cause any damage to your belongings. The sensors will not interfere with your daily activities. These sensor devices can detect changes in activity as described under Procedure 3 below.

> Our ultimate goal is to make these sensor devices easy for non-experts to use, so we may ask you to install the sensors yourself and give us feedback about the process. We will provide instructions and needed materials for the installation. Once you have installed the devices, we will document where and how you installed them. If you are participating in other procedures, we may ask if sensor locations can be adjusted and added, and we may remove other sensors.

> During the experiment period, you may be asked to wear “on-body” sensors: lightweight sensors that can be affixed to the exterior of your body (most typically at your wrist, ankle, and hip) using wrist/anklebands or latex-free elastic bandages. These sensor devices can detect changes in activity as described under Procedure 3 below.
 * Procedure 2: Wearing “On-Body” Sensors**

> You may also be asked to carry a mobile computing device, such as a cell phone or handheld computer. You will be asked to wear the on-body sensors and carry the device throughout the study period, unless the investigators instruct you to remove them for sleeping, bathing, or other activities. These on-body sensors should not disrupt you from your activities or cause you physical discomfort. If the on-body sensors or mobile device do become uncomfortable, you may take them off at any time and return them to the investigators.

> The sensor devices installed in your home may consist of very simple switch, object movement, and illumination level sensors that measure the state of a door, drawer, device, or other object. For instance, a sensor placed on a cabinet door can detect when it is open or closed. A sensor placed on a chair can detect when the chair is moved. A sensor placed on a TV can detect when it is turned on or off. Each sensor device in the home wirelessly sends information about the state of the object to the nearest BoxLab kiosk, where the information is stored.
 * Procedure 3: Collection of Activity Data**

> The sensors that you wear on-body may also record data about changes in activity, such as foot steps taken, body limb movement, heart rate, and exposure to visible and ultraviolet light. The sensors may also detect your position within your home and, if you are asked to carry a GPS device, position in your community. These devices transmit information wirelessly to the laptop computer or to a storage device that you carry with you. The combination of these sources of data provides a description of your activity during the study period. If you express to the researcher that you are uncomfortable with sensors being used in any specific location, those sensors will be removed.

> During the experiment period, we may ask you to carry a mobile computing device, such as a cell phone or handheld computer (i.e., PDA), with you wherever you go, including outside of your home. We will provide a special carrying case you can wear on your belt or put in your purse. The device will frequently “beep,” at which time multiple questions will be presented. The questions may be about your activities, physical or emotional states, opinions, or observations. You can answer the questions by simply pushing buttons on the keypad or screen. You may skip answering if you are too busy for the interruption. This mobile device will be used to make a detailed record of your daily activities and experiences at the same time that the sensors in your home are measuring how you interact with various objects and appliances. It will sample your activities by presenting questions approximately every ....... minutes. The mobile device will also present more extended surveys time(s) a day. The mobile device will save your answers. At night, you may turn off the experience sampling system, so that you can rest without interruptions. You will be asked to complete ....... paper-based surveys or journals during the study. You may decline to answer any questions that make you feel uncomfortable on either the electronic or paper surveys.
 * Procedure 4: Experience Sampling**

> During the experiment period, we may ask you to try-out software applications on a cell phone or computer or devices, such as a special remote control or music player. We will show you how to use these technologies and will try to make them so they integrate well with your current routines and activities. Examples of the kind of technologies we might have you try include a handheld device that provides reminders, a cell phone that presents foreign language vocabulary, or a computer application that presents summary data of your physical activity for the day. We will ask that you report any problems with these technologies so we can fix them promptly. We will also ask for your feedback about these technologies during and at the end of the study. For example, we may ask you whether the technologies were personally useful.
 * Procedure 5: Trying-out Home Technologies**

> During the experiment period, we may ask you to allow us to place up to five BoxLab kiosks in your home. These devices will be used so that researchers can manually annotate the video with your activities so that they may compare the performance of their activity detection algorithms with what you actually did during the time the sensors were installed. Each kiosk may have a microphone and/or camera attached to it. If you agree to this option, we will work with you to find acceptable locations for the cameras and/or microphones and we will show you what the video looks like and audio sounds like. You can request that any or all audio and video cameras not be used. We will also show you how to block the video and turn off the audio during the study as well as to log times when you would like audio and/or video data deleted. Data you mark for deletion will be destroyed prior to any researcher viewing it.
 * Procedure 6: Audio and/or Video Recording**

> During the experiment you will receive up to three daily telephone calls from the investigators asking if you have observed any problems with the installed sensors, the wearable sensors, the mobile device, and/or the technologies you are being asked to try. The investigators can also address any questions or concerns you may have. At the conclusion of the study, up to 4 investigators will visit your home to carefully remove all the home sensors and collect the on-body sensors and computers. Along with your participation in these procedures, you will be asked to complete a debriefing interview at the end of the experiment. During this interview, you may decline to answer any or all questions.

**POTENTIAL RISKS AND DISCOMFORTS**
> During the course of this study, if you are participating in the data collection procedure, you may at times feel uncomfortable about having data collected about your activities. The investigators will provide a logbook that you may use to indicate time periods for which you wish to have data disguised or erased. Data you mark for deletion will never be viewed/used by researchers prior to destruction. If you wish to discontinue data collection altogether, you may withdraw from the study at any time.

> If you are participating in experience sampling, there is a possibility that you may feel stressed by the mobile device. You are free to decline to answer any of the questions that the mobile device presents to you, and you may turn off the device should it become too stressful.

> If you are trying out home technologies, there is a possibility that you may feel they disrupt your regular routines or are difficult to use. The researchers are happy to work with you to make sure the technologies are easy to use and integrate with your daily activities. You may turn off the technologies if they should become too disruptive.

> If you are participating in audio and/or visual recording, there is a possibility that you may feel stressed by the recording devices. You are free to block video and/or disable audio, as the researchers will show you how to do. You may also request that the researchers remove the audio and video recording devices should that component of the experiment become too stressful.

> Any liabilities, losses or damages (including attorney’s fees) resulting from BoxLab kiosks and it’s components is indemnified. This excludes liabilities loss or damage resulting from the gross negligence or willful malfeasance of the research team and excludes any indemnification for any indirect, incidental, consequential, punitive or special damages. See Indemnification for more details.

> If you do not wish a sensor to be installed in any particular spot, you may refuse to have one placed there.

**POTENTIAL BENEFITS**
> By participating in this study, you may learn about novel technologies under development. You may also gain a deeper appreciation of the richness of your everyday activities and how they are supported by your home setting.

> We anticipate that this study will help us to design sensors and sensor casings, improve sensor installation procedures, and develop and measure the performance of computer algorithms that can automatically detect everyday activities. This work may eventually lead to the development of new devices for the home that help people live in their homes longer as they age.

**PAYMENT FOR PARTICIPATION**
> We appreciate your courtesy in having the sensors or sensor cases in your home for the study period and for participating in the selected study tasks. The compensation you will receive is dependant on the specific study procedures in which you are participating. The table below lists compensation amounts for each study procedure; spaces are provided next to each procedure for 1) the investigator to indicate whether it is available for the current experiment and 2) you to indicate that you have selected to participate in the procedure.


 * **Available? (Investigator)** || **Selected? (Participant)** || **Procedure** || **Compensation** ||
 * ||  || You, not the researchers, install the sensors in your home following provided instructions || $15 (one time) ||
 * ||  || Sensors in your home that collect data about your activity.

You have the following sensors in your home: _ Object movement and position sensors _ Electricity use sensors _ Temperature sensors _ Humidity sensors _ Ambient light level sensors _ Ultraviolet light level sensors || $5 per day ||
 * ||  || Sensors that you wear to collect data about your activity.

You wear the following on-body sensors: _ Pedometer _ Accelerometers to detect body-limb motion _ Skin temperature monitor _ Heart rate monitor _ Ambient light monitor _ Ultraviolet (UV) light monitor _ Altimeter _ Barometric pressure monitor _ Indoor house location monitor _ GPS (community location) monitor _ Time-lapse camera || $5 per day ||
 * ||  || You periodically answer experience sampling questions presented to you on a mobile device that you carry with you during the day. || $5 per day ||
 * ||  || You try out software applications or devices that the researchers provide || $5 per day ||
 * ||  || You permit audio and/or video recording in your home during the study, from up to 5 locations || $5 per day ||

> The total compensation for your participation in this study, which will last ....... days, is $ ........

> If you choose, you may also participate in the study without compensation, as a volunteer; please indicate your decision to do so by initialing one of the following blanks: > Paid ....... Unpaid .......

> If you must drop out of the study because the investigator asks you to or because you have decided on your own to withdraw, you will still receive the compensation for all tasks/days completed.

**CONFIDENTIALITY**
> Any information that is obtained in connection with this study and that can be identified with you will remain confidential and will be disclosed only with your permission or as required by law.

> Your responses and sensor data will be referenced by an ID number in order to protect your identity. A study enrollment log will be kept that will include participants’ unique identification numbers, names, telephone numbers and enrollment data. This log will be stored in a locked cabinet in the investigators’ office and will be destroyed 1 year after the completion of the study.

> When the results of the research are published or discussed in conferences, no information will be included that would reveal your identity. Your name will not in any way be associated your data, including photographs, audio and video recordings. Once your data are anonymized, it may be shared with other researchers for future studies.

> Investigators may take still photographs of your home environment, including objects on which they (or you) have installed sensors. With your permission, they may video-tape or audio-record the sensor installation and the post-experiment interview. If you do not wish to be videotaped, audiotaped or have pictures taken of you or your home environment, you may still participate in this study without prejudice. During the study, you can ask the investigator at any time to stop the audio recording and videotaping. You may review any photographs, videotape or audio-recording taken during your experiment and request that tapes be erased or digital images be deleted.

> The videotapes, audiotapes, and photographs will only be used by the investigators for the data analysis tasks of the study and to document that work in academic publications. The media will be under the sole control of the investigators and will be stored in a location accessible only to the investigators. After the investigators have analyzed the results, prior to showing any images or audio in academic and peer-reviewed papers, or anywhere else, they will use standard methods to manipulate the media to protect your identity, such as blurring the face. Any media that cannot be appropriately anonymized will be destroyed within one year after completion of the study.

> Please indicate your consent to have still photography, audio recording, and video taping, during the sensor installation and/or post-study interview by initialing below:

Audio/Video/Photo Consent for Sensor Installation: ....... Decline: .......

> If you are participating in in-home audio and/or video recording, please indicate your consent to have still photography, audio recording, and video taping, during the experiment from up to five locations within your home agreed to by you and the researchers:

Audio/Video/Photo Consent During Experiment: ....... Decline: .......

**IDENTIFICATION OF INVESTIGATORS**
If you have any questions or concerns about the research, please feel free to contact >> Stephen Intille, Ph.D. >> Research Scientist, MIT Dept. of Architecture >> 617-452-2346, intille@mit.edu

>> Kent Larson >> Principal Research Scientist, MIT Dept. of Architecture >> 617-253-9396, kll@mit.edu

>> Jennifer Beaudin >> Research Scientist, MIT House_n >> 617-452-5677, jbeaudin@mit.edu

**EMERGENCY CARE AND COMPENSATION FOR INJURY**
> If you feel you have suffered an injury, which may include emotional trauma, as a result of participating in this study, please contact the person in charge of the study as soon as possible.

> In the event you suffer such an injury, M.I.T. may provide itself, or arrange for the provision of, emergency transport or medical treatment, including emergency treatment and follow-up care, as needed, or reimbursement for such medical services. M.I.T. does not provide any other form of compensation for injury. In any case, neither the offer to provide medical assistance, nor the actual provision of medical services shall be considered an admission of fault or acceptance of liability. Questions regarding this policy may be directed to MIT’s Insurance Office, (617) 253-2823. Your insurance carrier may be billed for the cost of emergency transport or medical treatment, if such services are determined not to be directly related to your participation in this study.

**RIGHTS OF RESEARCH SUBJECTS**
> You are not waiving any legal claims, rights or remedies because of your participation in this research study. If you feel you have been treated unfairly, or you have questions regarding your rights as a research subject, you may contact the Chairman of the Committee on the Use of Humans as Experimental Subjects, M.I.T., Room E25-143b, 77 Massachusetts Ave, Cambridge, MA 02139, phone 1-617-253 6787.

SIGNATURE OF RESEARCH SUBJECT OR LEGAL REPRESENTATIVE

I understand the procedures described above. My questions have been answered to my satisfaction, and I agree to participate in this study. I have also been given a copy of this form.

Name of Subject

Name of Legal Representative (if applicable)

Signature of Subject or Legal Representative Date

SIGNATURE OF INVESTIGATOR

In my judgment the subject is voluntarily and knowingly giving informed consent and possesses the legal capacity to give informed consent to participate in this research study. ......

Signature of Investigator Date