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21. Methods and Procedures – Surveys/Questionnaires/Psychometric Testing

The IRB is required to review all types of measures/instruments used in a proposed research study. Please provide a complete list of the surveys, questionnaires, and/or psychometric instruments that will be used in this study. Include the version numbers or dates, if applicable. Include both standardized instruments and study-specific instruments.  Indicate if the measures have been previously validated.

• Quality of life questionnaires
• Personality tests
• Intelligence tests
• Knowledge assessments
• Psychological rating tests
• Surveys (of opinions, habits, use of services)  
• Health questionnaires
• Symptom rating scales

21.1.1. Attach copies of all measures/instruments that will be used for this study here.

21.2. Indicate the member(s) of the study team who will use these measures/instruments and any necessary qualifications such as special training or licenses.

Surveys, questionnaires and psychometric test measures should be conducted by persons who have the necessary training and expertise depending on the nature of the research tool, the topic of investigation, and the study population. Some instruments require use by professionals with specific licenses. Please provide the following information:

1. The names of the research team members who will be conducting the measures.
2. The specific academic degrees, qualifications, and/or training that qualify the team member to conduct the procedures.
3. The individual(s) will conduct the tests must be listed as study personnel in question #2. These individuals must complete the CITI human subjects training course.

• Study using a published intelligence test with autistic children:
  Mary Jones, Ph.D. will conduct the WPPSI-III with the study subjects. Dr. Jones is a licensed psychologist whose has extensive experience evaluating children with autism in her clinical practice.
• Study seeking feedback on the quality of services at a public school:
  James Smith, a work-study undergraduate student, will provide the parents in this study with the anonymous questionnaires regarding their children’s schools. James has completed the CITI course on human subject protections.

The federal regulations require that IRBs give special consideration to protecting the welfare of particularly “vulnerable” or special classes of subjects, such as children, prisoners, pregnant women, mentally disabled persons, or economically disadvantaged persons (45 CFR 46.111). In addition, the federal regulations describe specific provisions for research involving pregnant women, human fetuses, and neonates (45 CFR 46 Subpart B); prisoners (45 CFR 46 Subpart C); and children (45 CFR 46 Subpart D). These regulations can be accessed at Title 46, Protection of Human Subjects.

The involvement of students, employees, and normal volunteers in research may present special concerns; however, the federal regulations do not provide explicit protections for subjects in these categories. Investigators using special subject populations must consider the ethical conduct of research and the potential for coercion of these subjects. Specific guidance for each of the special subject populations is described in detail below.

The following definitions may be helpful in understanding the categories of subject populations and selecting the appropriate responses in this section:

Human Fetus: The product of conception from the time of implantation until delivery. Here, the term “fetus” will refer to a living fetus unless otherwise specified. The term “fetus” generally refers to later phases of development, and the term “embryo” is usually used for earlier phases of development.

Minor: A person who has not reached the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted. In the state of California, minors are those under the age of 18 years.

Normal Volunteer: Healthy volunteers who are used to study normal physiology and behavior or volunteers who do not have the condition under study in a particular research protocol.

Pregnant Woman: A woman who exhibits any of the pertinent presumptive signs of pregnancy, such as missed menses, until the results of a pregnancy test are negative or until delivery. Pregnancy encompasses the period of time from implantation until delivery.

Prisoner/Detainee: Any individual involuntarily confined or detained in a penal institution or any individual detained pending arraignment, trial, or sentencing. This includes individuals detained in other facilities because of commitment procedures that provide alternatives to criminal prosecution or incarceration in a penal institution. Prisoners and detainees includes both minors and adults.

Ward: An individual, usually a child, for whom the court has appointed a guardian to care for and take responsibility for that individual.

22.1. Special Subject Populations (Check all that apply).

22a: Special Subject Populations – Normal Volunteers

Normal volunteers are healthy people, or people without the condition being studied, who volunteer to participate in research. Basic ethical principles require that possible benefits to subjects are maximized and possible harms to subjects are minimized. Normal volunteers who will receive no benefit from participation in research should, therefore, be exposed to risks that are minimized to the greatest extent possible. Normal volunteers agree to participate in research because they wish to contribute to scientific knowledge for the benefit of society, and this increases the concern about the risks to which they may be exposed.

22a. If this research involves a medical procedure(s), provide a justification for involving normal volunteers in research.

If you are enrolling normal volunteers and using a medical procedure, provide justification by addressing the following issues:

• Why you are using normal volunteers for this research study?
• Is compensation coercive for this subject population?
• What is the likelihood of risk for healthy volunteers participating in this study?
• Are there any risks of loss of confidentiality in this subject population?

FOR UPC: If your research does not involve medical procedures, add “N/A”.

22b: Special Subject Populations – Employees/Students

Inviting students and employees to participate in research introduces the possibility of coercion (feeling pressured to participate). Students may perceive that their decision to participate or not may affect their grades. Employees may feel their decision might affect performance evaluations or job advancement.

• Students are asked to participate in a study that will evaluate teaching methods used by professors and the students are recruited by their own professors
• USC or CHLA employees with no faculty appointment are asked to participate in research that evaluates the performance of their department or division

22b. If you selected Employees or Students, please indicate how you will minimize the potential for them to feel coerced to participate. Discuss how the potential confusion in roles will be addressed.

Researchers should avoid using their own students as research subjects. Researchers who wish to use their own students must be able to provide a good scientific reason, rather than convenience, for selecting their own students as research subjects. For example, the research project should be relevant to the topic of the class and participation should be part of the learning experience for the students.

If you will recruit employees or students in your research, please explain what steps you will take to reduce the possibility of coercion. Explain how you will ensure that employees or students understand your role as a researcher rather than an as an employer, instructor, or professor.

• Post recruitment flyers in public areas rather than directly approaching students or employees
• Arrange for another investigator or qualified member of the study team to obtain informed consent from subjects who are your own students or employees
• Avoid situations where investigators have access to their own employees’ research data
• Ensure that students who participate through “subject pools” will be given the same compensation as if they had been recruited through other methods (such as responding to an advertisement or flyer)
• If you offer extra credit to your own students for participating in the research, provide an alternative and equivalent means of obtaining extra credit for those students who choose not to participate in the research

22c: Special Subject Populations – Adults Not Competent to Consent

Competence refers to the capacity to act on one’s own behalf and the ability to understand information presented, to appreciate the consequences of acting (or not acting) on that information, and to make a choice. Individuals with severe disorders may or may not have the capacity to consent to participate in research. Thus, adults who are not competent to consent constitute a vulnerable population and they require additional protections in research.

22c. Provide a justification for including adults not competent to consent in research.

Explain why it is necessary to enroll adults who are not competent to give consent in order to answer your research questions. Please note that you may enroll adults who are not competent to consent in medical experiments ONLY if your research relates to the cognitive impairment, lack of capacity, or serious or life-threatening diseases and conditions of the research participants.

According to California Health and Safety Code, Section 24178, a Legally Authorized Representative (LAR) must provide consent. Instructions for obtaining consent from an LAR are available in the guidance for question #30.

• This trial will investigate the safety and efficacy of an experimental drug to treat bacterial infections that commonly occur in patients on mechanical ventilators. The subjects to be enrolled in the study will be sedated and unable to communicate because of the mechanical ventilation. This study could not be performed if we limited enrollment to subjects who are competent to give consent.
• We are evaluating rehabilitation techniques in people newly diagnosed with a stroke. Some subjects may not be able to give consent because of the severity of their stroke. For those subjects, we will obtain consent from a legally authorized representative. Because we wish to evaluate the impact of rehabilitation in people with mild, moderate, and severe stroke-related impairment, we will include some subjects who are not competent to consent.

22d: Special Subject Populations – Minors

Children are those who have not attained the legal age to consent to treatment or procedures involved in the research. In the state of California, children are those aged 17 years or younger. Children are considered a vulnerable research population because their intellectual and emotional capacities are limited. Research involving children is governed by the federal regulations at 45 CFR 46 Subpart D, and the IRB can only approve research that satisfies the conditions set forth in Subpart D.

Definitions and additional guidance on research involving children is available at:

• OHRP IRB Guidebook, Chapter 6 Children and Minors
• OHRP Guidance on Children 

22d.1. Provide a justification for involving minors in this research.

Explain why it is necessary to enroll children to answer your research questions.

• We are studying children (from birth to 12 years of age) who were exposed in-utero to HIV and antiretroviral drugs to determine if exposure causes developmental problems. This study can only be conducted in children. 
• We are studying the pharmacokinetics of a new antibiotic for people with methicillin-resistant Staphylococcus aureus infections. Drug pharmacokinetics have been studied in adults and adolescents, but there is no published data on the pharmacokinetics in children.

Research Involving Children – Special Issues

1. Exempt Review. Children can be enrolled in studies that fall under most of the exempt review categories. However, certain activities under exempt category 2, which includes research involving survey or interview procedures or observation of public behavior, do NOT apply to children. These research activities must be submitted for expedited review. Observation of public behavior when the investigator(s) do not participate in the activities being observed does apply to children. The remaining exempt research categories (#1 and #3-6) do apply to research involving children.
2. Phase 1 Drug Trials. The usual approach in drug trials is to study animals, adults, and older children before young children are involved as research subjects. However, there are conditions that occur only in early childhood, and data from studies involving adults or adolescents may not be applicable. The IRB must carefully assess the risks and benefits for studies of potentially life-threatening conditions in children. If the IRB approves a Phase 1 drug trial in children, the consent document must discuss the probability and the magnitude of benefit the child may receive from participating in the trial.

22d.2. Choose the proposed category of permissible research with children.

Research involving children is governed by the federal regulations at 45 CFR 46 Subpart D. The IRB can only approve research involving children that satisfies the conditions set forth in Subpart D.

Information on these categories of research involving children is available at:

• Special Protections for Children as Research Subjects.   
• OHRP IRB Guidebook, Chapter 6 Children and Minors
• OHRP Guidance on Children  

Federal regulations mandate additional safeguards for pregnant women, human fetuses, and neonates involved in research. Research involving these subjects can be approved only if the proposed research satisfies the conditions of 45 CFR 46 Subpart B.

The conditions for pregnant women and fetuses include:

1. Where scientifically appropriate, preclinical studies, including studies on pregnant animals, and clinical studies, including studies on nonpregnant women, have been conducted and provide data for assessing potential risks to pregnant women and fetuses.
2. The risk to the fetus is caused solely by interventions or procedures that hold out the prospect of direct benefit for the woman or the fetus; or, if there is no such prospect of benefit, the risk to the fetus is not greater than minimal and the purpose of the research is the development of important biomedical knowledge which cannot be obtained by any other means.
3. Any risk is the least possible for achieving the objectives of the research.
4. No inducements, monetary or otherwise, will be offered to terminate a pregnancy.
5. Individuals engaged in the research will have no part in any decisions as to the timing, method, or procedures used to terminate a pregnancy.
6. Individuals engaged in the research will have no part in determining the viability of a neonate.

There are additional conditions regarding the informed consent process for research involving pregnant women and fetuses. These conditions are described at Subpart B - Additional Protections for Pregnant Women, Human Fetuses, and Neonates Involved in Research.

Subpart B describes the conditions under which neonates of uncertain viability and nonviable neonates may be involved in research. These conditions are available at Subpart B - Additional Protections for Pregnant Women, Human Fetuses, and Neonates Involved in Research. Neonates who are determined to be viable after delivery are considered children and may be included in research according to the regulations under Subpart D (see iStar section #22d).

22e.1. If applicable, indicate how the measures that will be taken to ensure that the fetus is placed at risk only to the extent necessary to meet the woman’s, neonate’s, and/or fetus’s health care needs. Or, indicate that the risk is minimal and (describe) how the knowledge to be obtained through research cannot be obtained through other means.

Explain whether or not your research intervention has the potential to directly benefit the health of the woman or the fetus. If there is a possibility of direct benefit, explain what steps you will take to ensure that the fetus is exposed to the lowest risk possible. If there is no possibility of direct benefit to the woman or the fetus, the study can be approved only if the risks to the fetus are no greater than minimal. If this is the case, clearly state that the risk to the fetus is minimal, and explain why you cannot obtain the important biomedical knowledge by some other means.   

• There is a 75% mortality rate for fetuses with condition XYZ. Performing this research procedure is estimated to reduce fetal mortality to less than 25%. Risks to the fetus will be minimized by screening the mothers for risk factors, performing the surgery under ultrasound guidance, and using local anesthesia rather than general anesthesia.
• The study involves the collection of small amounts of blood three times during the pregnancy. The risks to the woman and fetus are minimal. Because we are studyingchanges in hematocrit levels during pregnancy, this information can only be obtained by collecting blood from pregnant women.

Under federal regulations, the IRB cannot approve research in which the researchers are involved in any decisions about termination of a pregnancy or viability of a fetus/neonate. If any of the investigators are physicians who treat patients at the study site, they should refer subjects in these situations to another facility or medical practice.

Individuals engaged in the research may not have any part in deciding the timing, method, or procedures used to terminate a pregnancy, nor may they have any part in determining the viability of a neonate. If you will be recruiting women who are undergoing termination of a pregnancy, describe who will be making those decisions and determinations.

The special protections for children set forth in Subpart D of the federal regulations include additional limitations on research involving children who are wards of the state or wards of any other agency, institution, or entity. Where the research involves greater than minimal risk to the subjects with no prospect of direct benefit to individual subjects (45 CFR 46.406), or requires approval by the Secretary of the DHHS (45 CFR 46.407), the research must either (1) be related to the children’s status as wards or (2) be conducted in schools, camps, hospitals, institutions, or similar settings in which the majority of children involved as subjects are not wards (45 CFR 46.409).

The IRB must require that an advocate be appointed for each child who is a ward. This advocate is in addition to any other individual acting on behalf of the child as a guardian or in loco parentis.

Whenever children who are institutionalized might be involved in research, care should be taken to ensure that they are not included as participants simply because of their availability to the investigator.

If you are enrolling wards in your study and the study involves greater than minimal risk to the subjects with no prospect of direct benefit to individual subjects, explain either (1) how the research is related to the children’s status as wards, or (2) that the research will be conducted in schools, camps, hospitals, institutions, or similar settings in which the majority of children involved as subjects are NOT wards.

Explain who you will appoint as an advocate for each child who is a ward. The research appoints an advocate for each child, who: (i) May be the same individual for all of the children; (ii) Has the background and experience to act in (and agrees to act in) the best interest of the child for the duration of the research; and (iii) Is not associated in any way with the research (except as an advocate), the investigators, or any guardian association.

• Judge
• School Psychologist
• Counselor
• Clergy

22f: Special Subject Populations – Prisoners/Detainees

Prisoners are considered to be vulnerable because they are in a restrictive, institutional environment that affords little opportunity for making choices, earning money, communicating with outsiders, or obtaining medical care. Because their autonomy is limited, prisoners may only participate in certain categories of research and special precautions are needed to assure that their consent is informed and voluntary. These categories and safeguards are covered by 45 CFR 46 Subpart C. Additional information is available at: OHRP Guidance on the Involvement of Prisoners in Research.

22f. If you selected Prisoners/Detainees, choose the applicable category of permissible research with prisoners 

When reviewing the study the IRB will determine if the proposed research qualifies for one of the permissible categories of research with prisoners.

If your research does not fall under one of these categories, you cannot enroll prisoners as study subjects.

1. Exempt Review. Research involving prisoners does NOT qualify for exempt status (45 CFR 46.101(b)).
2. Under the California Penal Code, competent adult prisoners are permitted to decide whether or not to participate in behavioral research. However, no biomedical research may be conducted on any prisoner in California. Prisoners may obtain investigational drugs under an IND protocol if a physician determines that the drug or treatment is in the best interest of the prisoner and the prisoner gives consent.

• Conducting a study about juvenile delinquents’ high probability of having a virus that is common among people in confined quarters.
• A research subject in a non-prisoner study becomes incarcerated and the investigator applies to the IRB to continue the subject’s participation in the study. The Subpart C regulations apply whenever any human subject in a research protocol becomes a prisoner at any time during the study.

• Surveys of educational practices of grade school teachers: Potential subjects will be identified through a list of elementary school teachers provided by the XYZ school district. The research assistant will verify with the district office that all of the teachers on the list teach grades 1-6 and are currently teaching in one of the district schools.
  
• Medical Clinical Trial: The principal investigator will identify potential subjects as they present in his/her clinic and make the initial determination of their eligibility for the study from review of their medical records. After the consent process is completed and the subjects are entered in to the study, each subject will have a study screening visit to confirm their eligibility to participate.
  
• Outside referral to study: Potential subjects may also be identified through physician referrals, or in some cases self referred in response to a recruitment flyer or media advertisement. Subjects identified in this manner will contact the study coordinator who will perform an initial screen for eligibility over the phone. If the subject is eligible after the phone screening, the study coordinator will schedule an appointment for the subject to meet with the principal investigator. The PI will make the determination of the subject’s eligibility to participate.

• The study will be performed in the Dana and David Dornsife Cognitive Neuroscience Imaging Center and the Cognitive Neuroscience Imaging Center of Beijing Normal University, which both have state-of-the-art MRI systems, and in Brain and Creativity Institute research-dedicated space.

• School-based data: The attendance officers for XYZ and ABC elementary schools will be asked for a list of students who have missed more than 30 days of school during the 2003-2004 academic year. This list will be used to identify the student performance records that will be analyzed as part of this study. The student guidance officers will supply these records.
  
• Healthcare Data:
  
  
  • Mt. Sinai Hospital has a computerized medical record: The Medical Records staff will use the following variables to select the patient records that will be analyzed for this study: hospitalized for cystic fibrosis during the time periods 1/1/00-12/31/03; ages 0-18 years; received antibiotic therapy.
    
  • Valley Hospital uses paper medical records: Using the patient roster from the Cystic Fibrosis Clinic, the researchers will identify all of the patients who were hospitalized during the time period 1/1/00-12/31/03. The Medical Records department will be asked to provide the records for all patients during this time period who were 0-18 years of age and received antibiotic therapy.

• Name and address of the investigator and/or institution
• Simple explanation of the purpose of the research
• Eligibility criteria
• Time commitment or what will be expected of the subject
• Location of study visit(s)
• General statement that subjects will be compensated for their time
• Who to contact for additional information

• Claims that a drug or device is safe and effective
• The words “new treatment,” “new drug,” or “new device” without explaining that the test article is experimental
• A promise of free medical treatment
• Amount of payment, dollar signs, or the words “free” in large or bold face type. Compensation should not be excessive relative to the nature of the project. (NOTE: The amount of payment is generally allowed for UPIRB submissions due to the low risk / no risk projects. The IRB decides this on a case-by-case basis);”
• Language or graphics that may be coercive or misleading

• The treating physician, with the patient’s permission, will arrange for the study nurse to meet with each patient at the time of his/her scheduled clinic visit. The study nurse will provide the potential subject with the information in the recruitment script provided in section #24.2. If the patient indicates interest in the study, the consent process will be initiated. This timing will give subjects about a week to decide whether or not to participate in the study at the time of their follow-up visit.
• The recruitment flyer provided in section #24.2 with the parental consent will be mailed to the parents of all students at the ABC middle school three weeks before the student survey is scheduled to take place.
• The subjects will be recruited through the Psychology department’s subject pool.

• The advertising materials comply with guidelines of the IRB and the institution(s)
• Only members of the study team are involved in recruitment
• Investigators will not recruit from their own staff
• Investigators will not recruit from their own students
• If the study involves children, only children with parent permission will be contacted to participate

• A new surgical device is being tested in patients undergoing transplant surgery. The surgery and all related costs such as anesthesia and medications will be billed to a third party payor, and the device will be supplied by the sponsor.
• This study will compare Drug X, an investigational drug, to Drug A, an FDA-approved drug that is being used for the labeled indication. Drug A will be paid for by subjects or their third party payor. Drug X will be provided by the sponsor. Drug X is known to cause cardiac toxicities. Therefore, the sponsor will pay for the additional cardiac tests such as echocardiograms and MUGA scans as well as the additional cardiac laboratory tests.

• One-hour Survey: Subjects will be compensated $25 for their time, travel, and parking.
• One-hour Survey: The subjects in this study are 7-12 years of age. Their parents will receive $20 in compensation for the time and expenses of bringing their child to campus to participate in the study. All of the child subjects will receive a gift certificate worth $5 for their efforts.
• Inpatient Therapeutic Study: There is no payment for participation in this study.
• Longitudinal Study: Subjects will be given a total of $150 in department store gift certificates for participation in this study. Payments will be prorated $25/session and provided to each subject at the end of each session.
• Pharmacokinetic Study: Subjects receive an investigational drug and then have their blood drawn a total of 10 times. They receive $150 for each of the first three draws, $100 for each of the next three draws, and $50 for each of the last four draws. Subjects will receive an IRS 1099 tax statement because the total payment exceeds $600 in one year.

• If a patient requires medical treatment as a result of a physical or psychological injury arising from his/her participation in the study, emergency medical care required to treat the injury will be provided. However, the financial responsibility for such care will be shouldered by the patient or his/her insurance provider. No compensation will be provided for any injury that may result as a direct consequence of non-negligent performance of procedures described in the consent form.
• If they require medical care/treatment as a result of injury arising from their participation in this study, emergency medical care/treatment will be provided. The sponsor will pay for the cost of care/treatment for those injuries related to their participation in the study. No other form of compensation will be provided for injuries resulting from their personal conduct or participation in activities outside of the scope of the study protocol. No financial compensation will be provided for such things as lost wages, disability or discomfort, losses claimed by spouses or family members, medical expenses due to treatment of any underlying or unrelated condition or any expense arising from or claimed to be due any research-related injury. The Sponsor is not responsible for the negligence or actions of anyone other than the Sponsor, or for events that the Sponsor does not control. The Sponsor is not responsible for problems caused by the study participant's failure to follow study instructions, including attending all follow-up visits. However, by signing this form they have not given up any of their legal rights.

• Potential subjects will be approached in the clinic waiting room. When subjects express interest, they are taken to an office to see if they meet the inclusion criteria of the study. Subjects will be asked to discuss their personal health backgrounds, including drug/alcohol use. This discussion will take place in a private office with a member of the research staff.

• Identified data means the data being collected includes information that can directly link the data to the identity of the individual (e.g. names, social security #, medical record #, date of birth and address).
• Coded means replacing identifiable information (such as name or social security number) with a number, letter, symbol, or combination thereof (i.e., the code).
• Anonymous means the data being collected does not contain any identifying information or codes that link the data back to the individual.

• The required data will be abstracted from the research participant's medical record and recorded in case report forms. The case report forms are assigned with a unique code by the sponsor and contain only the participant's initials and not the complete name or hospital record number in order to protect the privacy of the participant.The data will be stored in a password protected computer in the PI’s office (Room #12C). Access to the office will be limited to the PI and a study coordinator.
   
• Subjects write their randomly assigned identification code on the physical abuse questionnaire. The questionnaires are kept in a locked file cabinet in STO # 221. The “key” (spreadsheet/log) that contains the subjects name and assigned identification code is kept electronically on the PI’s laptop, which is password protected. Only the PI and the study coordinator have access to the file.  

• The data will kept for a minimum of 3 years after the study is completed. Upon completion, all identifiers will be removed from the data and discarded. All documents containing identifiers will be shredded. Electronic documents will be deleted.
   
• The data will be kept indefinitely. The records will be kept confidential as described in the IRB application question 26.3.

• Information relating to sexual attitudes, preferences, or practices
• Information relating to the use of alcohol, drugs, or other addictive products
• Information pertaining to illegal conduct
• Information that, if released, might be damaging to an individual's financial standing, employability, or reputation within the community or might lead to social stigmatization or discrimination
• Information pertaining to an individual's psychological well-being or mental health
• Genetic information or tissue samples.

1. De-identifying data: Refers to stripping all personal identifiable information (such as name, social security number, birth date, driver’s license, etc) from the data. De-identified data may contain non-identifying code (such as a sequential number). The code can be maintained in a confidential way (for example, in a secured locked cabinet, with a password protected computer database).
2. Anonymizing data: Once you remove all links to the data source, such as the name of the subject or code, then the data have been anonymized.

• Questionnaire, interview, and survey studies
• Pathology studies using existing specimens or specimens to be collected with no personal identifiers
• Retrospective chart reviews
• Collection of biological materials or data through noninvasive means
• Venipuncture

• Therapeutic studies involving chemotherapy, radiotherapy, or surgery
• Investigational drug or device studies
• Invasive collection of biological materials
• Questionnaire or survey studies that gather sensitive data from subjects (i.e. history of drug abuse, HIV status, etc.)

• The treatment group may experience improved visual acuity, improved intraocular pressures, less complications, and less need for additional surgeries. It is possible that subjects will not directly benefit from participating in this study.
   
• There are no direct benefits for participating in this study
   
• Subjects may acquire knowledge that might be of value to them.

• The advancement of knowledge and possible therapeutic benefits to future subjects.
   
• The results of this study may be useful for guiding treatment strategies for other XYZ conditions.

• Other choices may include: getting treatment or care without being in a study, taking part in another study, other treatments such as radiation, getting comfort care also called palliative care. This type of care helps reduce pain, tiredness, appetite problems and other problems caused by the cancer. It does not treat the cancer directly, but instead tries to improve how participant feels and keep participant as active and comfortable as possible.
   
• An alternative is not to participate

CURRENTLY UNDER REVISION.

• CCI: http://www.childrenshospitalla.org/body.cfm?id=239
• HSCIRB: http://www.usc.edu/admin/provost/oprs/hsirb/forms/ (scroll down to “Informed Consent” heading)
• UPIRB: http://www.usc.edu/admin/provost/oprs/upirb/forms/ (scroll down to “Informed Consent Templates” heading)

• Waiver of consent: Select this if you are requesting a waiver of consent for adults (see section #31 for additional information)
   
• Waiver of assent: Select this if: you are enrolling children who are not capable of providing assent; or a waiver involves minimal risk to children and the research could not practicably be carried out without the waiver (see section #32 for additional information)
   
   
• Waiver of parental permission: Select this is you are requesting a waiver of parental permission (see section #33 for additional information)
   
• Waiver of written or signed consent: Select this if you are requesting a waiver of written or signed consent and will use an information sheet, telephone script, or verbal script to inform subjects about the research (see section #34 for additional information)

• Participation in this trial will be offered by the treating physician initially. The study will be discussed in detail with the subjects. Their rights as a potential research participant will be discussed as well. Other members of the research team and participant’s family will be involved in this discussion. The subjects will also be given the written informed consent document and may take it home for further review. They will be given sufficient time to consider their options, frequently requiring additional visits. Their questions and concerns will be addressed by the research team and investigators.
• Subjects will be recruited on XYZ campus through study fliers and advertisements. Those interested in participation will contact the research team to set up a time to discuss study procedures and review the consent documents. A study team member will explain study procedures, their rights as a participant, and answer any questions and allow the subject ample time to consider participation. The consent form will be sent home with the subjects.

• Potential research subjects will be asked questions about their involvement in research, their rights as research participants and aspects of the research to assure that they understand the nature of their involvement in the research. (Include the questions).

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