Human Subjects - FAQs

The Temple IRB is now accepting electronic submissions - including new applications for human subjects protocols, continuing reviews, Reportable New Information submissions, requests for modifications to approved human subjects research, initial (only) WIRB reviews, and study closures. Please visit the eRA Documentation & Training page and review the training materials and tutorial videos for more information and instructions on how to submit items electronically to the IRB.

While the system is currently open for use to all Temple University researchers, electronic submissions will become mandatory on the following dates:
April 1, 2013 - College of Medicine
May 1, 2013 - all other Colleges on the Health Science Campus
June 1, 2013 - Main Campus and all other campuses

FAQs

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Basic Questions

Where do I start?

A good place to start is to read the FAQs, which give a nice overview. After you read the FAQs, view the Powerpoint presentation on Investigators' Responsibilities. When you're ready to complete a form, refer to our Form Grid and note that we have a form for Classroom Projects/Activities.

Where are the forms?

The forms are on our homepage: http://www.temple.edu/research/regaffairs/irb/index.html

Do I have to use the forms?

We understand that you may have already started a submission and used the prior forms. Consequently, we will accept the prior forms until June 1st, 2012. After June 1st, 2012, the new forms will be required. Submissions after June 1st, 2012 that use the old forms will be returned.

Should I save a form, consent form template, or protocol template to my desktop?

No. The reason is that the forms, consent form templates, and protocol templates are often revised. Using only the current version found on the IRB website will minimize delays in the review process.

Is there a different application for medical and social and behavioral research?

No. We have one Application that covers medical and social and behavioral research and one Classroom Projects/Activities Application that covers medical and social and behavioral classes.

Which forms should I use?

There are seven forms that you will use most often:

• Application - use this for new study applications (i.e. a new study or clinical trial). Note that page three of the form may require that you provide supporting documents.
• Classroom Project/Activities Application - Use this form if the classroom project or activity is human subjects research.
• Continuing review progress report or final report - use this form to submit either a continuing review or a final report.
• Modifications - use this form to submit modification requests to an approved study.
• Modifications required to secure approval - use this form to reply to requests made by the Board, the Chairperson, or IRB staff. The Board's requests may relate to a new study, modification, etc.
• Reportable new information - use this form to report new information within five business days of learning it. See page two of the form to determine whether the information is considered "new information" that must be reported.
• HIPAA authorization form - use this form when you are seeking the subject's authorization to use their PHI in the research.

• Use Contact info if you are adding an individual to our database or updating contact information for someone already in our database.
• Use IRB member information if you are a new IRB member.
• Use HUD if you are submitting a Humanitarian Use Device Exemption for approval.
• Use Continuing review or final report for an HUD if you are submitting a continuing review or final report for a Humanitarian Use Device Exemption.
• Use Modification of an HUD if you are submitting a modification for a Humanitarian Use Device Exemption.
• Use Modifications required to secure approval of an HUD - if you are replying to a request made by the Board, the Chairperson, or IRB staff regarding a Humanitarian Use Device Exemption.

Are there different forms for exempt studies, expedited studies, and full board studies?

No. You only need to submit the form called "Application." The IRB will decide whether the study can be classified as exempt, expedited, or full board. As a reminder only the IRB can make the termination of exempt status. Consequently, even if you believe that your study falls under the exempt review status, you still must submit an Application for review.

Consent Form Questions

Do I have to use the informed consent template?

We encourage you to use the informed consent form template. Since it's a template, you can modify it according to your study's needs. For example, many sections may be irrelevant or inapplicable; delete those sections from the template. Note that substantial variations regarding subject injury or confidentiality may result in a delay of the review process.

If your subject injury language needs to be revised from the template language and the study is an industry-funded/outside sponsor study, please contact the Office of Clinical Research Administration at (215) 707-9639 for the appropriate language.

Do I have to submit the consent form on department letterhead?

No.

There are two consent form templates. How do I know which consent form template to use?

Use the minimal risk social and behavioral consent form template if the study is a social and behavioral study and the study has minimal risk. If the study is a medical study or a social and behavioral study that has more than minimal risk, use the other consent form template.

What is "minimal risk"?

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 the daily life of normal persons or during the performance of routine physical or psychological examinations or tests in normal persons.

What are some examples of minimal risk?

Examples of procedures that are minimal risk can be found in the CHECKLIST: Eligibility for review using the expedited procedure.

Why isn't there an assent template?

The assent form should be an explanation of the proposed research procedures in a language that is appropriate to the child's age, experience, maturity, and condition. The explanation should include a discussion of any discomforts and inconveniences, in non-technical terms, the child may experience if she or he agrees to participate. Due to these variables, the investigator is in a better position to draft the assent form.

I want to enroll someone who does not speak English. What are the consent form requirements?

See our SOP Informed Consent Process for Research.

Do I have to have a witness during the consent process and therefore a witness signature line in the consent form?

The IRB does not routinely require a witness to be present when consent is obtained and therefore does not routinely require a witness signature in the consent form. However, the IRB requires a witness signature in the following circumstances:

• The subject is illiterate
• The subject is non-English speaking
• It is also possible that the IRB may require a witness signature for select studies.

For those situations where the IRB requires a witness, the witness signature section should be marked as "Required" on the consent form to ensure that a witness signature is obtained.

If the IRB does not require a witness signature, the absence of a witness signature does not violate IRB policy.

The investigator has the option to include a witness signature line on the consent form. The investigator might elect this option in the following situations:

• The study's risk profile is particularly large
• The investigator feels more comfortable obtaining a witness signature in this subject population or with a specific subject

When a witness signature is obtained, investigators should include, in the medical record, the reason why a witness signature was obtained.

For detailed information on witness signatures, refer to the Standard Operating Policy Informed Consent Process for Research.

Protocol Questions

How do I write a protocol?

Please refer to the Protocol Templates section of the Forms Page. Since it's a template, you can modify it according to your study's needs. For example, many sections may be irrelevant or inapplicable; delete those sections from the template.

There are three protocol templates. How do I know which protocol template to use?

If the study is a medical study that is sponsored, use the Investigator Protocol Template for Sponsored Medical Studies.

If the study is a medical study that is investigator-initiated (non-sponsored), use the Investigator Protocol Template for Investigator-Initiated (non-sponsored) Medical Studies.

If the study is a social and behavioral study, use the Investigator Protocol Template for Social and Behavioral Studies.

What is an Investigator Protocol?

If the study is not sponsored, the Investigator Protocol is simply the protocol that you will follow at Temple.

However, if the study is sponsored, the Investigator Protocol describes how the study will be operationalized or done at Temple University. These operational issues include: information regarding the study facilities; patient population; the expected number of local subjects; recruitment methods; who will recruit the subjects; and how much time will be devoted to recruitment. The Investigator Protocol is therefore distinct from the sponsor protocol.

My study has both medical and social and behavioral aspects. How do I know whether the study is considered medical or social and behavioral?

If the principal investigator's department is on the Health Sciences Campus, use the Investigator Protocol Template for Medical Studies. If the principal investigator's department is on the main campus, use the Investigator Protocol Template for Social and Behavioral Studies.

Adverse Events Questions

What happened to the electronic Adverse Events reporting system?

Federal guidance clarified that only a small subset of adverse events occurring in human research subjects are unanticipated problems that must be reported under 45 CFR part 46. The guidance helps ensure that the review and reporting of unanticipated problems occur in a timely, meaningful way so that the human subjects can be better protected from avoidable harms, while reducing unnecessary burden on IRB members. The vast majority of adverse events occurring in human subjects are not unanticipated problems, or alternatively put, are anticipated problems; a small proportion of adverse events are unanticipated problems; and unanticipated problems can include other incidents, experiences, and outcomes that are not adverse events. In short, refer to page 2 of the "Reportable New Information" form for the information that needs to be reported to the IRB.

Questions Regarding Submitting the Forms

How do I submit the forms?

Investigators can upload their submissions into the new ERA InfoEd module. Submissions via the new ERA InfoEd module will become mandatory on the following dates:

• April 1, 2013 - College of Medicine
• May 1, 2013 - all other Colleges on the Health Science Campus
• June 1, 2013 - Main Campus and all other campuses
• The link to the system and training tools can be found here:
• http://www.temple.edu/research/regaffairs/irb/irb_era_training.asp

How many copies of the form do I submit?

Submit one of each document requested (e.g., application, consent form, etc). If we need more copies for full board review, we'll contact you. Your cooperation will allow us to place the item on the next available Board.

Can I submit the forms online?

Not yet, but we look forward to implementing an electronic system.

Questions Regarding the Review Process

When will my item be reviewed?

We place items requiring full board review on the next available Board. Note that "next available Board" means the next Board's agenda that is not already full. Exempt and expedited items are assigned to the Chairperson or a designated reviewer.

Classroom Activities or Projects

I'm teaching a class which involves a classroom project/activity. Do I have to complete the "Classroom project/activity" application?

You must complete the "Classroom Project/Activity" application if the classroom project/activity is human subjects research. Please refer to the human research determination worksheet.

The analysis is based upon the behavior and actions of the classroom activity. Publication, presentation, and dissemination of the results are irrelevant to the analysis. For example, if students in a class are creating survey questions and testing the questions, this activity is research methods, rather than research, and IRB review is not required. On the other hand, if students in a class develop a hypothesis, write a plan, implement the plan, and analyze the results of the plan, the activity is research and IRB review is required, even if the professor's intent was to teach research methods.

How do I know if the classroom project activity is research?

Classroom activities or projects can be human subjects research. If the professor did the same project outside the class, would IRB review be required? If yes, the classroom activity is human subjects research; if not, the classroom activity may not be human subjects research.

The analysis is based upon the behavior and actions of the classroom activity, not the publication, presentation, or dissemination of the results.

What are some examples?

Examples of classroom projects/activities that are not human subjects research:

If a professor teaches research methods by "blackboard instruction" i.e., discussing different research methods and designs with the students.

If students in a class create survey questions and test the questions on themselves.

If students in a class create a questionnaire and use the questions to promote classroom discussion.

Example of a classroom project/activity that is human subjects research:

If students in a class develop a hypothesis, write a plan, implement the plan, and analyze the results of the plan, even if the professor's intent was solely to teach research methods.

Miscellaneous Questions

Where is the waiver of HIPAA authorization form?

The criteria for requesting a waiver of HIPAA authorization should be reflected in your protocol. Please refer to the "Protocol Instructions" found on our website for the waiver of HIPAA authorization criteria.

What if the protocol is designed and written by the sponsor (a for-profit entity/company) and the protocol is a Phase III or IV clinical trial?

Submit the new study application to the Temple IRB with the Temple-specific attachments (e.g., consent form and HIPAA authorization form) and contact WIRB for the WIRB forms.

Should I use the checklists and worksheets?

If a form refers you to a checklist or worksheet, please use it. However, you do not need to submit checklists or worksheets.

What if I'm not sure whether my activity is human subjects research?

Email a synopsis of the activity to irb@temple.edu and the IRB will respond with a written determination.

What if I want more information on the IRB?

"The Human Research Protection Program Plan" provides more information and the "Investigator Manual" provides even more detailed information. They can be accessed on our website. If you still have a question, please contact us at (215) 707-3390 or irb@temple.edu.

WIRB

How do I know whether to submit a study to the Temple IRB or WIRB?

If the protocol is designed and written by the sponsor (a for-profit entity/company) and the protocol is a Phase III or IV clinical trial, use the WIRB forms. However, all WIRB studies are submitted to the Temple IRB. See the WIRB Information Sheet for more details.

Where can I find the WIRB forms?

The link to the WIRB forms can be found in the WIRB Information Sheet.

Do I submit a WIRB study to WIRB?

No. Submit the WIRB study to the Temple IRB. See the WIRB Information Sheet for more details.

If it's a WIRB study, do I need to submit everything on page 3 of Temple's Application for Human Research form?

No. See the WIRB Information Sheet for the Temple forms that should be submitted with WIRB studies.

Can I modify the Temple University consent form template?

Yes, but note that deviations to the "confidentiality" or "subject injury" sections of the consent form template require approval from Temple legal counsel before WIRB approval. This approval from Temple legal counsel may delay the study approval. Consequently, we strongly recommend that you use the "confidentiality" and "subject injury" sections of the consent form template. See the WIRB Information Sheet for more details.

If you have suggestions for other questions for the FAQ page, please email irb@temple.edu