UHCO INTRANET

Research Involving Human Subjects

Click here for the HIPAA Authorization Form

All UH faculty, staff, or students who plan to conduct research involving the use of human subjects must have approval from the University of Houston Committee for the Protection of Human Subjects (UHCPHS) prior to the initiation of any research project. Projects requiring approval include, but are not limited to, retrospective chart reviews, analysis of archival data, and prospective studies utilizing data from patients’ routine vision examinations, existing tissue samples, in addition to other clinical and basic research involving human subjects.

The College of Optometry also has a human subjects research committee.
NOTE: All applications, revisions, and renewals with revision must be reviewed by the Human Subjects Committee at the College of Optometry prior to their submission to the UHCPHS. Renewals without revision and Final Reports should be submitted directly to the UHCPHS; review at the College level is no longer required. The committee members are Karen Fern (chair), Deb Currie, Adrian Glasser, and Judy Perrigin and Scott Stevenson.

The College Human Subjects Committee strongly encourages all new investigators and those with limited experience in human subjects research to take the on-line training course offered by the University.

www.citiprogram.org

In addition, the College committee members are available to answer any questions that are not answered by resources available from the University (see links below).

The following is a summary of the submission and review process at the College level.

1) The PI completes the UHCO cover sheet in addition to the appropriate University application form

UHCO Cover Sheet
University Application Form For the protection of Committees Human Subjects

2) Prior to submission the PI should carefully review the application and other documents for typographical or grammatical errors and consistency of information. The consent documents must be understandable to laypersons and concise, yet include all elements of informed consent. If the PI is a graduate student, optometry student, or a resident the faculty sponsor must also carefully review the documents before they are submitted.

3) Materials must be submitted to the College of Optometry Human Subjects Committee by the College submission deadline.
Submission Deadlines

4) The PI submits these documents (i.e., UHCO cover sheet, applications, consents, child assents, phone scripts, flyers, advertisements) electronically to humansubjects@optometry.uh.edu. ‘Human Subjects’ is listed as an address in the Outlook address book. If you are unable to submit a document via email (i.e., a survey not available in electronic form) place it in the Committee Chair’s mailbox.

5) The College Human Subjects Committee reviews the submitted documents, identifying any necessary modifications, additions, or clarifications, and returns the documents to the PI with the reviewers’ comments.

6) After needed modifications are made resubmit all documents (with a UHCO cover sheet) via email to the Human Subjects Committee.

7) When the College committee determines that any needed modifications have been made and completes its review, a paper version of the documents must be provided to the College committee chair by the PI. A College stamp will be affixed and the documents returned to the PI.

8) After approval by the College committee the PI must
a) Obtain on the application the signature of the Associate Dean for Graduate Studies
b) Submit the appropriate number of copies and the original to the UHCPHS (third floor of E Cullen building).

The PI can facilitate the review process by:

1) Familiarizing themselves with the human subjects review process, the elements of informed consent, and necessary accompanying documents

2) Reviewing their submission for these commonly noted oversights

    a) Missing documents, particularly phone scripts, flyers, and advertisements related to subject recruitment and child assents for minors.
    b) Inconsistencies between the application and consent documents regarding time commitment, number of visits, study procedures, and remuneration.
    c) Typographical or grammatical errors

3) Submitting application on or before the College deadline

Click here for information on:

University Submission Deadlines
Policies and Procedures for Research Involving Human Subjects
Forms for New Applications, Renewals, and Revisions
On-line Human Subjects Training Program

Information on HIPAA requirements for clinical research Coming Soon.

College of Optometry Human Subjects Committee Members
Karen Fern, Chair
Deb Currie
Adrian Glasser
Judy Perrigin
Scott Stevenson