HRPP Guidance

SDSU/UCSD Joint Faculty or Student Review-Reliance Agreements

The SMART IRB platform has replaced the JDP coversheet for documenting IRB review-reliance for faculty and for graduate student research proposed for thesis or dissertation that engages both SDSU and UCSD in human subjects research. 

A brief description of how to initiate review-reliance:

  • For faculty, the review-reliance agreement is initiated by the PI at the reviewing IRB's insitution via the SMART IRB platform: https://smartirb.org/reliance.
  • For students, determine which IRB is to review the research proposal (review item two (2) of this document to determine. The reliance agreement is initiated using the affiliation of the reviewing IRB. For example, if UCSD is to be the reviewing IRB, then the student would request access to SMART IRB using their UCSD affilation and the reliance agreement would originate using their UCSD affiliation. 
  • For faculty or students: Request Investigator Access to the SMART IRB platform at: https://smartirb.org/reliance.
  • Submit the research proposal to the reviewing IRB
  • Submit the request for review-reliance using the SMART IRB platform. Specific details can be found in the video on the SMART IRB page on this website or at the link above. 

Failure to follow th steps outlined above, may result in delayed IRB approval. 

Steps to IRB Proposal Submission

  1. Request an InfoEd Account
  2. Take CITI training –CITI Training must be completed by all study members prior to submitting your research proposal to the IRB. Click here for more information on how to sign up. 
  3. Develop your research plan and write your consent form and any other supporting documents such as recruitment flyers, emails, or scripts and questionnaires or surveys.
    • Consent and assent form templates are found here
    • While the HRPP office does not have templates for research recruitment flyers, emails, or scripts, information on what to include in research recruitment advertisements may be found in the Human Research Program (HRPP) Standards and Practices found at the link below under SDSU IRB Policies and Procedures.
  4. Submit your research proposal to the IRB via InfoEd. Videos on How to submit a proposal via InfoEd are found here.

Demographic guidelines

Due to ongoing changes in campus culture and climate, including in research, the SDSU HRPP Office has put together guidance for researchers of options they can include when collecting data from human subjects research participants.

 

Zoom Video Conferencing Best Practices

Information about recording on the cloud and Zoom may be found here.

Note that if you are using the HIPAA compliant version of Zoom this option is disabled. 

*For data security purposes and participant privacy, after transcriptions of cloud recordings, the transcription should be downloaded locally on to your computer, and then moved to the SDSU Google drive. Finally, recordings saved on the Zoom cloud must be deleted.  Research proposals must be clear and fully describe this when using the transcription services in Zoom.*

Cancer Relevant Studies - Protocol Review and Monitoring Committee (PRMC)

Request ePRMC Account

PRMC Decision Tree

PRMC Review Chart

 ePRMC Users Manual

HHS Office of Research Integrity - Human Subjects RCR Training Guidance

human Subjects researcher faqs

The HHS regulations for the protection of human subjects in research at 45CFR 46 include five subparts. Subpart A, also known as the Common Rule, provides a robust set of protections for research subjects; subparts B, C, and D provide additional protections for certain populations in research; and subpart E provides requirements for IRB registration.

Human subject means a living individual about whom an investigator (whether professional or student) conducting research:

(i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
(ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

Research means 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. 
Activities designed to draw general conclusions, inform policy beyond an internal program, or generalize outcomes beyond a specific group, entity, or project that are important factors in identifying or expanding truths, facts, information that are universally applicable.

There are three types: full committee review, expedited review, and exempt studies. These protocols are reviewed by the IRB committee at a convened meeting.

Full committee review is required for: Greater than minimal risk studies OR studies that are minimal risk, but do not fit in an expedited review category.

Expedited review studies are reviewed by a small number of IRB reviewers in the HRPP Office. Expedited review is appropriate for studies that according to 45 CFR 46.110 and 21 CFR 56.110: Involve no greater than minimal risk AND fit into one (or more) of the following nine specific expedited review categories.

HHS regulations in 45 CFR 46.104 identify several different categories of minimal risk research as being exempt from federal policy for the protection of human subjects. Federal HIPAA regulations, California state law and SDSU institutional policies further limit exempt research categories.

There are seven expedited categories that may be used for initial IRB review if the research is minimal risk, the resesarch only includes procedures in one or more of the seven categories, and identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal risk.

The use of categories eight and nine are lmited to continuing review.

  1. Clinical studies of drugs and medical devices only when certain conditions are met
  2. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture in certain populations and within certain amounts
  3. Prospective collection of biological specimens for research purposes by noninvasive means
  4. Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves.
  5. Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for non-research purposes
  6. Collection of data from voice, video, digital, or image recordings made for research purposes
  7. Research on individual or group characteristics or behavior or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies
  8. Continuing review of research previously approved by the convened IRB as follows:where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects; or where no subjects have been enrolled and no additional risks have been identified; or where the remaining research activities are limited to data analysis.
  9. Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.

 Your research may be exempt if it meets the criteria in one or more of the categories in the chart below. 

Exempt chart

 

See the OHRP website for the mentioned charts. Contact the SDSU for further guidance if you think your research applies.

Under 45 § 46.102(f), minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

Greater than Minimal Risk to subjects means that the probability and magnitude of harm or discomfort anticipated in the research risks are more than minimal risk, but not significantly greater. Studies that fall under this category will range in their probability of a moderate-severity event occurring as a result of study participation (and the level of safety monitoring will depend on that probability) but there are adequate surveillance and protections in place to identify adverse events promptly and to minimize harm. 

  1. Data collection for internal departmental, school, or other University administrative purposes. Examples: teaching evaluations, customer service surveys.
  2. Service surveys issued or completed by University personnel for the intent and purposes of improving services and programs of the University or for developing new services or programs for students, employees, or alumni, if the privacy of the subjects is protected, the confidentiality of individual responses is maintained, and survey participation is voluntary. This would include surveys by professional societies or University consortia. Note: If at a future date, an opportunity arose to contribute previously collected identifiable or coded survey data to a new study producing generalizable knowledge; IRB review may be required before the data could be released to the new project.
  3. Information-gathering interviews where questions focus on things, products, or policies rather than people or their thoughts regarding themselves. Examples: canvassing librarians about their libraries’ inter-library loan policies or periodical purchases or interviews with company engineers or managers about how a product is made.
  4. Course-related activities designed specifically for educational or teaching purposes, where data are collected as part of a class exercise or course requirement. If you have any question as to whether your project meets this definition, contact the IRB office prior to beginning the project.      
  5. Biography research involving a living individual that is not generalizable beyond that individual.
  6. Research involving cadavers, autopsy material or biospecimens from now deceased individuals. Note: Some research in this category, such as genetic studies providing private or medical information about live relatives, may need IRB review. Please contact the IRB for further information.
  7. Innovative therapies except when they involve "research" as defined by the above criteria. (An innovative clinical practice is an intervention
    designed solely to enhance the well-being of an individual patient or client. The purpose of an innovative clinical practice is to provide diagnosis, preventative treatment, or therapy to individuals, or when the innovative therapy is investigational.) Note: When innovative therapies differ significantly from routine practice it should be viewed and treated as such with appropriate safeguards in place to protect the rights and welfare of the patients.
  8. Quality improvement projects are generally not considered research unless there is a clear intent to contribute to generalizable knowledge and use the data derived from the project to improve or alter the quality of care or the efficiency of an institutional practice. Any individual who is unsure whether a proposed quality improvement project should be classified as research should contact the IRB for guidance. If the data are re-examined or re-analyzed and new information surfaces that would contribute to generalizable knowledge, an application must be submitted to the IRB.
  9. Case history or Case Study which are published and/or presented at national or regional meetings are not considered research if the case is limited to a description of the clinical features and/or outcome of a three or fewer patients and do not contribute to generalizable knowledge. Note: Investigators should contact the IRB if they are uncertain as to whether they are contributing to generalizable knowledge.
  10. Publicly available data do not require IRB review. Examples: census data, labor statistics. Note: Investigators should contact the IRB if they are uncertain as to whether the data qualifies as “publicly available.”
  11. Coded private information or biological specimens that were not collected for the currently proposed projects do not need IRB review if the investigator cannot link the coded data/specimens back to individual subjects. If the data/specimen provider has access to the identity of the subjects (e.g., subjects’ names, addresses, etc.), the investigator must enter into an agreement with the data/specimen provider that states under no circumstances will the identity of the subjects be released to the investigator. Note: Investigators cannot independently make this determination. These projects require verification from the IRB.(http://www.hhs.gov/ohrp/policy/checklists/decisioncharts.html#c1)
  12. Some examples of Non-Engagement in Research include when an institution’s employees or agents act as consultants on research but at no time obtain, receive, or possess identifiable private information, perform commercial services for the investigators, or inform prospective subjects about the availability of research.

Note: the examples above are not an all-inclusive listing.(http://www.hhs.gov/ohrp/policy/cdebio.pdf)