45 CFR 46.116(b)

Except as provided in paragraph (d), (e), or (f) of this section, in seeking informed consent the following information shall be provided to each subject or the legally authorized representative:

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 that are experimental;
2. A description of any reasonably foreseeable risks or discomforts to the subject;
3. A description of any benefits to the subject or to others that may reasonably be expected from the research;
4. A disclosure of appropriate alternative procedures or 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;
8. A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled; and
9. One of the following statements about any research that involves the collection of identifiable private information or identifiable biospecimens:
   1. A statement that identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject or the legally authorized representative, if this might be a possibility; or
   2. A statement that the subject’s information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.

45 CFR 46.116(c)

Except as provided in paragraph (d), (e), or (f) of this section, one or more of the following elements of information, when appropriate, shall also be provided to each subject or the legally authorized representative:

1. A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) that are currently unforeseeable;
2. Anticipated circumstances under which the subject’s participation may be terminated by the investigator without regard to the subject's or the legally authorized representative’s consent;
3. Any additional costs to the subject that may result from participation in the research;
4. The consequences of a subject’s decision to withdraw from the research and procedures for orderly termination of participation by the subject;
5. A statement that significant new findings developed during the course of the research that may relate to the subject’s willingness to continue participation will be provided to the subject;
6. The approximate number of subjects involved in the study;
7. A statement that the subject’s biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit;
8. A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions; and
9. For research involving biospecimens, whether the research will (if known) or might include whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen).

This consent is being given to you for a research study.  Consenting to take part in this study is voluntary.

The purpose of this research study is to find out if a drug called ABC-123 is safe and to determine the safest, most effective dose of the drug.   If you choose to participate you will be in this study for [insert total length of participation here].

Depending on when you enroll in this study, you will receive higher doses of ABC-123 until the safest and best tolerated dose is reached.  ABC-123 is given via i.v. infusion in the [insert location(s)].  You will have tests, exams and procedures that are part of your standard care and for study purposes. Each clinic visit will last 4-5 hours.  Infusions of study drug will be given during week 1 of each 3-week cycle.  After two cycles, you will be evaluated and you may be able to continue receiving ABC-123 if you have had no bad reactions to the study drug or disease progression.

There are risks to this study drug that are described in this document. Some risks include: nausea, diarrhea, low white & red blood cell count, being tired & weak, fever, muscle pain and radiation risks from CT scans.

If you are interested in learning more about this study, please continue reading below.

The purpose of this research study is to determine the effectiveness of physical therapy in the treatment of patients with ABC.  Participants will undergo a 2-day screening that includes a blood draw, exercise testing, and completion of quality-of-life surveys.  Once screening is complete, participants will complete a physical therapy program that will require visits three times each week for 16 weeks, for a total of 48 visits.  Each visit will take about 2 hours. Participants will also be asked to complete a pain diary and have blood draws every 4 weeks throughout the study.  Follow-up phone calls from the study team will occur at 4 weeks and 8 weeks after completion of the physical therapy program.  Total study duration is about 6 and one-half months.

The greatest risks of this study include the possibility of injury during the physical therapy program and loss of confidentiality.

If you are interested in learning more about this study, please continue to read below.

The purpose of this study is to compare the gastrointestinal (GI) tract in children with Inflammatory Bowel Disease (IBD) and healthy children.  The information we learn by doing this study may help us to develop some target treatments for GI complications in children with IBD. 

Participants in this study will have a blood sample collected and a small piece of tissue removed from their intestine during their clinically scheduled procedure. The comparison of tissue from IBD and healthy children will be done in the laboratory after collection of the tissue. Parents of participating children will also be asked to complete a questionnaire. Your child’s participation is complete once the medical record and questionnaire have been reviewed, and the tissue and blood sample have been collected.

There is a risk of bleeding after the tissue from the intestine is removed. Risks of taking the blood sample are discomfort and/or bruising; infection, excess bleeding, clotting, or fainting are also possible.

If you are interested in learning more about this study, please continue to read below.

The purpose of this research study is to determine the effect of treating depression on how one’s body responds to stress. People with known depression and who are willing to seek treatment for their depression are being recruited for this study. If you choose to take part, you will be asked a series of questions about your mental health and asked to complete surveys about your mental and physical health. You will also have your height, weight, blood pressure and waist circumference measured.

After the screening is complete and if you qualify to take part in the study, you will return to the study site on another day to complete a mental stress test as well as additional surveys. You will be asked to complete two challenging mental tasks while your heart rate and blood pressure are measured. You will be videotaped performing these tasks. Once this study visit is completed you will receive twelve weeks of cognitive behavioral therapy for your depression. At the end of the twelve weeks you will undergo another mental stress test.

The research study visits will be conducted at [location] and each visit will take anywhere from 1-2 hours. People who are depressed are at a greater risk of hurting or killing themselves. This represents one of the greatest risks of this study. Other risks include strong negative emotions that may arise during therapy and the possibility of loss of confidentiality.

If you are interested in learning more about this study, please continue to read below.