QUESTION: What is the Committee for the Protection of Human Subjects?

QUESTION: How do I know if I need to submit an application to CPHS?

QUESTION: Is there more than one committee?

ANSWER: At this time, the University of Houston has 2 approved IRBs. The institutional committee is responsible for the review of all applications from investigators of all colleges/departments with the exception of Social Sciences. This committee consists of 10 members; five faculty, 2 medical reps, 1 graduate student rep, 1 community rep, and 1 non-science member.

The College of Social Sciences CPHS reviews all applications from the departments within Social Sciences. [Exception: the institutional committee must review files that include a medical component since the SOS CPHS does not include medical reps] This committee has 5 members; 3 faculty members, 1 community rep, and 1 non-science member.

Also each committee has a subcommittee consisting of the chair and 1 other committee member. The subcommittees can only review files that qualify for exempt and/or expedited review.

QUESTION: How often do the committees meet?

QUESTION: What is exempt review and how do I know if I qualify?

ANSWER: Based on DHHS regulations, the University has adopted 6 categories of research as exempt from continuing CPHS review. The use of the term exempt refers only to the requirement for annual review, not the general requirements for informed consent and protection of subjects.

Only truly anonymous research is eligible for exempt status provided any additional requirements specified in each category are also satisfied. Either a full committee or a subcommittee can review files that qualify for one of the exempt categories.

QUESTION: What is expedited review and how do I know if I qualify?

QUESTION: When I submit my application, how many copies are required?

ANSWER: The number of copies required is determined by which committee you will be submitting to. Listed below is a breakdown by committee:

1) Institutional committee (all colleges except Social Sciences); original plus 9 copies of the application and all related documents.

2) Social Sciences Committee; original plus 5 copies of the application and all related documents.

3) Both subcommittees; original plus 1 copy of the application and all related documents.

QUESTION: What do I need to attach to my application?

ANSWER: Adequate documentation must be attached to the application to allow the CPHS to weight 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: all relevant informed consent document; 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); any other documentation that you feel might facilitate the committee’s review.

QUESTION: How soon after the committee meeting will I be notified of their decisions?

QUESTION: How do I know if I need to prepare an informed consent?

ANSWER: 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

QUESTION: If I have the parents’ permission, why do I need the child’s assent?

QUESTION: What is a negative consent?

ANSWER: A negative consent requires a subject to decline participation and is not an acceptable procedure.

QUESTION: What type of information should be included in an informed consent?

ANSWER: It is important to remember that informed consent is a process and the written informed consent 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. The consent must be formulated in language that is appropriate for the targeted population. 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 dictates the inclusion of information such as the name and telephone number for a faculty advisor if the investigator is a student, a review statement indicating that the project has been reviewed by the CPHS and provides a telephone number for the CPHS, etc.

Please refer to the Policies and Procedures Handbook for additional information and sample consent forms.

ANSWER: There are several decisions that might be issued by the CPHS. They are:

1) Approval; no changes required. Project must be renewed annually.

2) Exempt ; no changes required. Project must be renewed every 5 years.

3) Contingent Approval/Contingent Exempt; minor changes and/or additions required. Changes do not require additional     committee review. Review of changes and final approval is issued by the CPHS Coordinator.

4) Table ; significant problems and/or missing documentation. Changes must go back to the committee for review and     approval.

5) Disapprove; project does not comply with human subjects’ regulations and the committee is convinced that the     problems can not be corrected.