Document No.: / Edition No.: / Effective Date: / Page:
HRP–421 NH / 001 / 8 September 2016 / Page 1 of 2
Use for New Proposals
Title of Study:
IRB ID:
Principal Investigator (PI):
Select all/any that apply to your research.
1. Activities Not Considered Research
The activities include:
/ Program Evaluation: Assessments of the success of established programs in achieving objectives when the assessments are for the use of program managers (e.g., a survey to determine if program beneficiaries are aware of the availability of the program services or benefits.)
/ Customer satisfaction surveys: Surveys of program users or customers to obtain feedback for use by program/office managers. Similar to program evaluation.
/ Class Projects: Academic class projects or student assignments involving collection of data from human subjects when the data is used solely for the purpose of teaching course content and not intended to be used to develop or contribute to generalizable knowledge.
/ Case Reports: Information collected for regular/normal clinical/classroom activities rather than research activity, and presented on no more than three individuals. Case reports are generally done by retrospective review of records (medical or academic) and highlights a unique treatment, condition, case, or outcome. The examination of the case(s) is usually not systematic and there is usually no data analysis or testing of a hypothesis. Investigators must ensure that the HIPAA or FERPA privacy rules are followed with respect to using or accessing PHI or PEI. A waiver may be required (check with the IRB for more information.)
/ Community Outreach: While the primary intent of research is to generate or contribute to generalizable knowledge, the primary intent of non-research community outreach activity is to prevent or control disease or injury, improve health or education, and/or to improve an on-going community outreach program or service. In some cases, that knowledge may be generalizable, but the primary intention of the endeavor is to benefit participants in the outreach program (health or education) or a population by controlling a problem in the population from which the information is gathered.
/ Health Surveillance: Health surveillance is an on-going part of the medical care and public health care functions closely integrated with timely dissemination of these data to those responsible for preventing and controlling disease or injury. This may include emergent or urgently identified or suspected imminent health threats to the population to document the existence and magnitude.
/ Routine Quality Improvement (QI): Systematic, data-guided activities designed to bring about immediate, positive changes in the delivery of health care OR education. QI involves deliberate actions to improve care, or education; guided by data reflecting the effects (e.g., types of problem solving; evidence-based management; the application of science of how to bring about system change; review of aggregate data at student/patient, teacher/provider, grade/unit, school/institution level to identify changes expected to improve care/education.
/ Medical Quality Assurance: Activities particular to an institution’s QA program, such as those activities protected from disclosure by the Dept. of Veteran Affairs as part of its confidential medical quality-assurance program or other equivalent programs (e.g., see VHA directives or equivalent university or institutional policy).
/ Other (Describe):
2. Research Activities Not Considered Human Research by DHHS or FDA regulations
/ Using anonymous pre-existing data or specimens (anonymous materials are those with no personally identifiable information contained in the original data or attached to the original specimen).
/ Using coded pre-existing or coded prospective data or specimens. (If this choice is selected, choose the applicable statements below.)
/ The private information/specimens were not/will not be collected specifically for the currently proposed research through interaction or intervention with living individuals.
/ The investigator(s) never obtains identifiable data/specimens because (select one below):
The holder of the key (to decipher the code) destroys the key before the data is provided to the investigator.
The investigators and the holder of the key enter into an agreement prohibiting the release of the key to the investigators under any circumstances, or until the individuals are deceased. (Attach a signed agreement between the source of anonymous pre-existing data/specimen sets and the investigator.)
There are laws or IRB-approved written policies for a repository/data management center that prohibit the release of the key to the investigators under any circumstances, until the individuals are deceased.
3. Summary of research - Provide a summary of the proposed research activity. Provide sufficient detail for the reviewer to verify whether or not the activity requires IRB approval as you have indicated above. If a separate research description/written plan is available, attach it to this document.
Enter summary here.
Submission Requirements
Provide the following documents with this application:
· For grant supported studies, include the grant application, research description, and data collection instruments to be used.
· Prior to implementing any changes to the study (following IRB initial approval), you must revise and submit the revised documents to for further approval.
Investigator Assurance Confirmation
By submitting this form, investigator acknowledges and confirms compliance with "INVESTIGATOR GUIDANCE: Investigator Obligations (HRP-800)" throughout the conduct of the study.
MSWord Document version (by UTSA IRB office) 9/8/16
Created by WIRB Copernicus Group, Inc. for University of Texas San Antonio