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Information For Research Participants

Research participants are a valued part of all successful human subjects research.

The University of Texas at El Paso recognizes the importance of your decision whether or not to participate in research.

Your participation is voluntary and you may choose not to participate or to stop participating at any time.

Your decision whether or not to participate will not affect your current or future relations with The University of Texas at El Paso.

We hope this webpage will answer any questions you may have.

Thank you for your interest in our research.

Students, staff and faculty across campus, and members of the surrounding community may be asked at one time or another to participate in research.

Our research includes both national and international participants.

Participation might require filling out a survey, responding to service or opinion questionnaires, or being interviewed.

Participants respond online, in person, by phone, or email.

Some research involves kinesthetic, physiological, or psychological experiments.

The level of risk involved in research depends on its

  • design
  • methodology
  • subject matter
  • intervention or interaction with human subjects.

Consider the level of risk in research and compare it to any benefits when deciding if you should participate in human subjects research.

The researcher conducting the study should provide you with answers to specific questions about the study. You may contact the researcher with questions at any time before, during or after the study.

If you would like general information about a research project, or if you have questions, concerns, complaints or want to discuss problems or your rights as a research subject with someone unaffiliated with the study, contact the IRB Office.

If you are asked to consent to be a subject in research, or if you are asked to consent for someone else, you have the right to:

     Learn the nature and purpose of the experiment (also called project, study or clinical trial).

     Receive an explanation of the procedures and any drug or device to be used.

     Receive a description of any discomforts and risks that you could experience from the study.

     Learn about any benefits you might expect from the study.

     Learn about the risks and benefits of any other available procedures, drugs or devices that might be helpful to you.

     Learn what medical treatment will be made available to you if you should be injured because of the study.

     Ask any questions about the study or the procedures involved.

     Quit the study at any time.

     Receive a copy of the signed and dated consent form.

     Decide to consent or not to consent to a study without feeling forced, obligated, or coerced.

What interests me in this study?

Why would I want to or need to participate in the study?

When does this study take place?

Where does the study take place?

How long does the study last?

Is this study safe?

Do I feel that I can trust the researchers?

Who gains from my participation?

Does this study have IRB approval?

Am I feeling pressure or obligation to participate in the study?

Who can I contact with questions or concerns that is not involved in the research study?

If I really wanted to quit would I be able to?

Am I learning anything from participating?

How will I be notified if risks or benefits to the study change?

How is my privacy being protected?

Is this study confidential or anonymous?

What is a research study?
A research study is a very careful way of looking at something and collecting data about what is being looked at. It can be something as simple as asking questions, giving a survey or looking at a particular behavior. On the other hand, it can be more complicated and may look at a specific disease or condition.
What is a research subject?
A research subject is a person who decides to participate in a research study. This is completely voluntary. You are helping the researcher look at the questions he/she wants to study. You can quit participating in the study at any time you want.
What is a protocol?
All research studies follow a protocol. A protocol is like a cookbook. It tells the researcher what can and cannot be done when he/she is conducting the study. All of this is done to protect the research subject, and this protocol is reviewed by the Institutional Review Board.
Can anyone be in a research study?
Each study has a list of who can and cannot be included in that study. This is written in the protocol. In order to protect research subjects, only people who qualify can be in the study.
What is a PI?
The PI, or Principal Investigator, is the person who conducts the research study. The PI is also the person who is responsible for making sure everything is done properly. Along with the PI, there may be other persons who help with the study. There may be people who look at all the data that is collected in the study and other individuals involved in operating the study.
What is an IRB?
The Institutional Review Board (IRB) is made up of a group of people such as scientists, non-scientists, and some community people. The IRB looks at every protocol or research study before it is conducted on any people. Because some research studies involve risk, the IRB looks at the study to make sure the risks are justified and minimized. In addition, the IRB wants to make sure the Principal Investigator follows all the rules the federal government has set up to protect human subjects who so kindly volunteer to participate in a research study.
What is an informed consent?
If you decide to volunteer in a research study, the facts of the study will be given to you in a consent form. This is to help you understand exactly what will happen to you in the research study. It is designed to help you make up your mind about participating, or not participating, in the study. The informed consent document will outline all the rights you have as a volunteer in a research study. Giving a research subject a consent form to read is a helpful process because it gives you enough time to ask as many questions as you want to about your voluntary participation in the study. You will be told about all the risks, any benefits that may exist, and even alternative options to the study. After reading the consent form, you can make your final decision about participating in the proposed study.
The Principal Investigator (PI) is the individual who assumes full responsibility for a research project.
Conduct the IRB approved research protocol.
Obtain informed Consent.
Effectively train and mentor student researchers in ethical conduct.
Obtain approval for any changes, additions, or deletions to the study.
Retain research records for 3 years after study completion date.
Promptly report all unanticipated problems or injury to the IRB.
Follow all University procedures for the ethical conduct of human subjects research.
Respond promptly to all participant concerns and questions.
Maintain subject confidentiality.
Inform subjects of changes to risks or benefits.
Maintain cultural sensitivity.
Design research methodology appropriate to your desired research setting.
Get permission to use intellectual property and/or private data.
Different sites have different rules and expectations; know your site and follow appropriate guidelines.
Participants in research studies have certain responsibilities once they’ve agreed to participate.
Read the consent form and ask the Principal Investigator (PI) any questions you may have. You should understand what will happen before you agree to participate.
Contact the PI if you want to stop doing a study..
Know the start and end dates of your participation.
If you have complaints or concerns, contact the PI or email the IRB Office at 
Report any and all problems to the PI immediately.
Do the responsibilities of participation as written on the consent forms, unless you stop participating in the study.
Confirm that you got extra credit points or monetary compensation.
Keep a copy of the consent form for your records.
Be honest and ethical in your participation.
Carefully weigh the possible benefits of participation (if any) against actual risk of participating.
Children are a population that is protected by federal, state, or local law.
Children as research subjects must meet one of the following categories (as determined by the IRB):
  1. Minimal Risk. 
  2. Greater than Minimal Risk with a potential for direct benefit (to each individual subject). 
  3. Greater than Minimal Risk without potential for direct benefit, but might provide information about a disorder or condition and:
    1. The risk represents a minor increase over minimal risk.
    2. The intervention or procedure presents experiences like the subjects’ actual or expected medical, dental, psychological, social, or educational experience.
    3. The intervention or procedure yields general knowledge about the subjects’ disorder or condition that is vital to understanding or improving the subjects’ disorder or condition.
    4. Adequate provisions must be made for obtaining assent of the children. parents, or guardians (Permission Form).
  4. Greater than Minimal Risks without potential for direct benefit and does not meet condition 3 above. If it presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children it must meet the following requirements:
    1. The IRB must find that the research presents a reasonable opportunity to further the understanding, prevention, or alleviation of a serious problem affecting the health and welfare of children.
    2. A request must be made by the PI, through the IRB, to the Secretary of HHS or the Commissioner of FDA to approve the research.
    3. The Secretary or Commissioner, after consultation with experts in pertinent disciplines and following opportunity for public comment, may approve the research.
Most research at UTEP falls under categories 1 or 2.
Child assent requirements (by age):
  • Under 7 years old: Verbal assent.
  • 7-12 years old: A simple assent form and verbal assent. The child does not have to sign the assent form.
  • 13-17 years old: A simple assent form and verbal assent. The child must sign the assent form.
Parental Permission Requirements:
  • If the research falls under 1 or 2 above, the IRB will determine if one parent's permission is enough or if both parent's permission is needed; unless one parent is deceased, not reasonably available, or when only one parent has legal responsibility for the child.
    • Parents can override a child's decision not to participate if the IRB waives the requirement for child assent. 
  • If the research is falls under 3 or 4 above, both parents must sign the parental permission form, unless one parent is deceased, not reasonably available, or when only one parent has legal responsibility for the child.
    • Parents cannot override a child’s decision not to participate if the research falls under these conditions.
A legal guardian can only give permission for a child's participation if the document granting guardianship authorizes the person to give permission for “medical care including research".

Exceptions

Child Assent Requirements

If the IRB determines that assent is not required for some, or all children in a study, it is usually because:

  • The children are not capable of providing assent based on their age, maturity or psychological state.
  • The intervention or procedure holds the prospect of direct benefit that is important to the health or well-being of the child and is available:
    • only within the context of the research and
    • the child's capability is so limited that they cannot reasonably be consulted.
  • Assent can be waived using the criteria for waiver of the consent process.

Parental Permission Waivers

Generally, written documentation of parental permission is required when recruiting and enrolling children in research. The documentation must signify “active” permission. The parent specifically signs the document granting permission for the child to participate in the research. “Passive” permission, where the researcher assumes permission is given if the permission form is not returned, is not allowed.

However, the IRB will consider requests for a waiver of the requirement for parental permission and/or a waiver of the requirement to obtain written documentation of consent on a case-by-case basis.

The IRB may determine that the research is designed for conditions or a subject population where parental permission is not a reasonable requirement to protect the subjects and may approve a waiver. The researcher must take appropriate steps to protect the children participating in the research and the waiver must be consistent with federal, state, and local law.

A waiver of parental permission and/or written documentation of parental permission may not be allowable under the requirements of the Protection of Pupil Rights Amendment for research conducted in a school setting.

Compensation to Children and/or Parents

For many studies, especially those conducted in schools, reimbursement is generally not appropriate.

However, if the PI believes that reimbursement is appropriate, the following general guidelines will be followed:

  • Any compensation should not be based on the subject completing the study, it should accrue as the study progresses.
  • Unless it creates undue inconvenience or a coercive practice, compensation to subjects who withdraw from the study should be made at the time they would have completed the study, had they not withdrawn.
  • Compensation given as a “bonus” or incentive for completing the study is acceptable if the amount is not so large as to be coercive or represent undue influence.
  • The amount and schedule of compensation should be clear in the assent and parental permission forms.
  • The amount or type of compensation will not be so large or novel that the child will assent to participate based only on the compensation.
  • The compensation will not be so large or novel that parents might give permission based only on the compensation or pressure the child to assent to participate.
  • The PI will consider that compensation may be coercive in some situations and not coercive in others and will establish a compensation amount and schedule that does not affect the child’s decision to participate or the parent’s decision to give permission for a child’s participation.

When a Child Reaches the Age of Consent While Enrolled in a Study

Informed consent should be viewed as an ongoing process throughout the duration of a research project. When a child reaches the legal age of consent (18 years old in Texas) during research, they are considered to be an adult. Requirements for child assent or parental permission no longer apply.

Unless the IRB determines that the requirements for obtaining informed consent can be waived, the PI get legally effective informed consent for any ongoing interactions or interventions with the subject. Informed Consent is also required if the research does not involve any ongoing interactions or interventions with the subjects, but continues analysis of specimens or data for which the subject’s identity is readily available to the PI.

Wards

Children who are wards of the state or any other agency, institution, or entity can be included in research in categories 1 or 2 above.

Wards may participate in categories 3 or 4 above only if the research is:

  • Related to their status as wards; or
  • Conducted in schools, camps, hospitals, institutions, or similar settings in which the majority of children as subjects are not wards.

An advocate will be appointed for each ward, in addition to a guardian or in loco parents. One advocate may represent more than one child. The advocate must have the background and experience to agree to act in the best interests of the ward for the duration of the research and is not associated (except in the role as advocate or member of the IRB) with the research, the PI(s), or the guardian organization.