Frequently Asked Questions
The Committee serves as the University's Institutional Review Board (IRB). An IRB is a specially constituted review body established or designated by an entity to protect the welfare of human subjects recruited to participate in behavioral or biomedical research.
The committee does not have a set meeting schedule because most of the reviews are handled by at least two members of the committee. The committee typically meets once at the start of the academic year and then as needed to review applications that require a full board review.
Researchers are people who ask questions about particular topics. A research study is a way of collecting and analyzing data to answer those questions. Research studies can take many different forms. Some research studies involve interviewing people, making observations of a person, people, or place, investigating diseases or conditions, or giving a survey.
The Department of Health and Human Services defines "research" as "a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program that is considered research for other purposes.
All research projects involving the use of human subjects (including projects utilizing archival or existing data) must be submitted to the CPHS for approval. Human subjects are individuals whose physiologic or behavioral characteristics and responses are the object of study in a research project. Under the federal regulations (45 CFR 46.102[f]), human subjects are defined as living individual(s) about whom an investigator conducting research obtains: (1) data through intervention or interaction with the individual; or (2) identifiable private information. If you're not sure if your research study requires IRB approval, please review the Human Subjects Decision Chart released by the Department of Health and Human Services. We also encourage you to contact the current Chair of the UHD Committee for the Protection of Human Subjects at humansubjects@uhd.edu.
Based on DHHS regulations, the University recognizes 6 categories of research as exempt from continuing CPHS review. Only truly anonymous research is eligible for exempt status, provided any additional requirements specified in each category are also satisfied. The use of the term "exempt" refers only to the requirement for annual review, not the general requirements for informed consent and the protection of subjects. Either a full committee or a subcommittee can review files that qualify for one of the exempt categories. Please refer to the "Exemption Categories" portion of this website for further information.
Based on DHHS regulations, the University recognizes 9 categories of research for which review can be expedited because they involve procedures posing no more than minimal risks to subjects, for which clear standards can be set. Either a full committee or a subcommittee can review files that qualify for expedited review. However, standard requirements for informed consent and the protection of human subjects apply regardless of the type of review. Please refer to the "Expedited Review Categories" portion of this website for further information.
Based on DHHS regulations, the University recognizes that a full board review is required for research that is not eligible for exempt or expedited review. In short, research that is judged to involve more than minimal risk, or involves protected populations such as children, prisoners, or disabled individuals, must undergo a full board review.
A research subject is a person who voluntarily decides to participate in a research study. Research subjects are vital to helping researchers answer the questions they are investigating. However, it is important to know your rights and remember that you can quit a research study at any time for any reason without fear of negative repercussions.
A protocol is the instructions that must be followed to conduct a research study safely. The protocol tells researchers and participants what can and cannot be done during the study. Research must submit protocols for review and approval by the Institutional Review Board to protect research subjects.
Research studies typically have a list of who can and cannot be included in a study. In order to protect research subjects, only people who qualify can be in a study.
The PI, or Principal Investigator, is the person who in charge and conducts a research study. The PI can be a faculty or staff member or even an undergraduate or graduate student associated with UHD. The PI is responsible for making sure all procedures for the study are done properly. The PI is also in charge of other persons who help with the study.
IRB stands for Institutional Review Board (IRB), but is also known as the Committee for the Protection of Human Subjects (CPHS) at UHD. The primary role and responsibility of CPHS is protect individuals who volunteer to participate in research studies and to ensure that all the federal rules and guidelines that are set up to protect human subjects are followed by the Principle Investigator and any other individuals who are conducting the research study. This special committee is made up of a group of faculty and staff from UHD representing all the departments on campus and some community members who represent special groups of people such as prisoners and people with disabilities. When someone associated with UHD wants to conduct a research study with human subjects, they must submit an application to CPHS for review and approval. CPHS reviews every research application before a study is conducted on or with any people. Some research studies involve risk. Members of CPHS read through research applications to make sure the potential risks to subjects are justified and minimized.
If you decided to volunteer to participate in a research study, an individual coordinating the project will give you an informed consent form. This form is very important, and we strongly encourage you to read it carefully. This form should present key information about the research study in clear, easy to read and understand language. This includes having the form available to you in your home language, if that language is other than English. The informed consent form should clearly describe the purpose of the research study, the how long your will be participating, describe all the procedures, describe any foreseeable risks or discomforts, and describe any potential benefits to you. Most importantly, this form should make it clear that your participation in the research study is voluntary and that you should not feel pressured to participate by anyone. Additionally, the informed consent form should remind you that you have the right to quit the project at any time without negative repercussions. Finally, individuals conducting research studies associated with UHD must have the name and contact information for the current chair of UHD's IRB Committee who you can reach via email at humansubjects@uhd.edu. Still have questions about informed consent? Take a look at the Health and Human Services Informed Consent FAQs .
No subject may be involved in research without the legally effective informed consent of the subject or the subject's legally authorized representative. This consent shall be sought under circumstances that provide sufficient opportunities for the subject to freely consider whether or not to participate. If the subject is a minor (less than 18 years of age), written parental consent is required. In addition to the parental consent, the investigator must also obtain the assent of the child, unless the child is too young or incapable of giving assent.
Out of respect for children as developing persons, children should be asked whether they wish to participate in a research project. In order to minimize undue influence, parental consent and child assent should be obtained through separate procedures. No subject may be involved in research without the legally effective informed consent of the subject or the subject's legally authorized representative. This consent shall be sought under circumstances that provide sufficient opportunities for the subject to freely consider participating in research. If the subject is a minor (less than 18 years of age), written parental consent is required. In addition to the parental consent, the investigator must also obtain the assent of the child, unless the child is too young or incapable of giving assent.
Negative consent requires a subject to decline participation, rather than actively agreeing to participate. It does not adequately assure that subject participation is truly voluntary. As a best practice, researchers always want to be sure that there is no undue pressure on individuals to participate in a research project.
It is important to remember that informed consent is a process, and that the written form serves to document this process. The informed consent document must include sufficient information to allow the potential subject to understand what he/she is being asked to do and to weigh any risks against the potential benefit before agreeing whether or not to participate. Federal regulations require the inclusion of certain information, such as the number of potential subjects, how much time will be required, risks, benefits, etc. University policy requires the inclusion of other information, such as the name and telephone number of the faculty advisor if the investigator is a student, and a statement indicating that the project has been reviewed by the CPHS which includes a contact number. Please refer to the templates available on this website for more information and model forms.
Please visit the UHD Participant Bill of Rights page.
Please visit the Research Subject Responsibilities page.
Adequate documentation must be attached to the application to allow the CPHS to evaluate the following factors: (1) that the rights and welfare of the subjects will be adequately protected; (2) that the risks to the subjects are reasonable in relation to anticipated benefits; and (3) that the informed consent of subjects will be obtained by adequate and appropriate methods.
Documentation must include: Up-to-date CITI certificates for all researchers named on the application, all relevant informed consent documents; copies of any and all questionnaires or research instruments (if appropriate); a list of questions for interviews (if appropriate); copies of recruitment ads; copies of approval from cooperating facilities or institutions (such as a school district); and any other documentation that you feel might facilitate the committee's review.
Applications are first reviewed by the CPHS Chair to determine if the application is complete and if the application requires a full-board review. Applications not requiring a full board review are sent to two reviewers (members of CPHS). Reviewers are given 10 working days to review the application and issue a decision to the Chair. The Chair then provides a letter to the lead researcher - usually in the form of a PDF sent via email - as soon as both reviews are received. Note: Letters to graduate students are emailed to both the student and the faculty sponsor. Committee decisions are not given over the telephone.
Applications are first reviewed by the CPHS Chair to determine if the application is complete and if the application requires a full-board review. Applications not requiring a full board review are sent to two reviewers (members of CPHS). Reviewers are given 10 working days to review the application and issue a decision to the Chair. The Chair then provides a letter to the lead researcher - usually in the form of a PDF sent via email - as soon as both reviews are received. Note: Letters to graduate students are emailed to both the student and the faculty sponsor. Committee decisions are not given over the telephone.
There are six possible decisions: (1) exempt (no changes required) (2) contingent exempt (minor changes and /or additions required) (3) approval (no changes required; must be renewed annually); (4) contingent approval (minor changes and/or additions required; must be reviewed annually); (5) table (significant problems and/or missing documentation; must be reviewed by the full committee again after materials are corrected and/or added); (6) disapprove (project does not comply with human subjects' regulations and the committee is convinced that the problems cannot be corrected).