Human Subjects - FAQs
- Where are the forms?
- What Should a Submission Include?
- Should I save a form, consent form template, or protocol template to my desktop?
- Is there a different e-formapplication for medical and social and behavioral research?
- Are there different forms for exempt studies, expedited studies, and full board studies?
- Do I have to use the informed consent template?
- Do I have to submit the consent form on department letterhead?
- There are two consent form templates. How do I know which consent template to use?
- What is "minimal risk"?
- What are some examples of minimal risk?
- Why isn't there an assent template?
- I want to enroll someone who does not speak English. What are the consent form requirements?
- Do I have to have a witness during the consent process and therefore a witness signature line in the consent form?
- How do I write a protocol?
- What is an Investigator 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?
- What happened to the electronic Adverse Events reporting system and what information do I need to report to the IRB?
- How do I complete Practice Runs Training?
Consent Form Questions
Adverse Events Questions
- How do I submit the forms?
- When will my item be reviewed?
- I'm teaching a class which involves a classroom project/activity. Do I have to submit an application to the IRB?
- How do I know if the classroom project activity is research?
- What are some examples?
- Where is the waiver of HIPAA authorization form?
- 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?
- Should I use the checklists and worksheets?
- What if I'm not sure whether my activity is human subjects research?
- What if I want more information on the IRB?
- How do I know whether my study will be reviewed by Temple IRB or WIRB?
- My study was approved by the Temple IRB. Can I switch the IRB to WIRB?
- Where can I find the WIRB forms?
- If my study is eligible to WIRB review, do I submit directly to WIRB?
- If it's a WIRB study, do I need to submit everything on page 3 of Temple's Application for Human Research e-form?
Questions Regarding Submitting the Forms
Questions Regarding the Review Process
Classroom Activities or Projects
Where are the forms?
New applications for new human research protocols must be filled out as e-forms with an eRA submission. The IRB no longer accepts the Word versions of the Application for Human Research or the Classroom Projects/Activities forms. Templates for all other documentation that should be included with an application can be found on the Forms and Templates page of our website.
What Should A Submission Include?E-forms are the electronic versions of the mandatory IRB forms that you would have previously downloaded from the IRB's website and printed out to submit on paper. There are certain e-forms that are mandatory for each type of submission. They are as follows:
- Initial Submission (new application) – either the Application for Classroom Project OR the Application for Human Research e-form.
- Continuing Review – Continuing Review e-form.
- Modification – Modification of Approved Human Research e-form.
- Reportable New Information – Reportable New Information e-form.
- Close Protocol – Final Report e-form.
The mandatory e-forms will appear in bold type when you choose Add Institution Forms/Supporting Documents. All other supplemental documents (protocols, consent forms, HIPAA forms, etc.) are available as downloadable templates that can be modified and then uploaded as supplemental documents to the e-forms. Section III of the Application e-form lists the supplemental documents that may or may not be included with your initial application.
Please see the eRA Training Resources and User Guides section of our website for more information on making IRB submissions in eRA.
Should I save a form, consent form template, or protocol template to my desktop?
No. The reason is 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 e-form for medical and social and behavioral research?
No. We have one Application e-form that covers medical and social and behavioral research and one Classroom Projects/Activities Application that covers medical and social and behavioral classes. These application e-forms must be filled out within eRA. All other supplemental documents to the application e-form (i.e. consent forms, protocols, etc.) can be found on the Forms and Templates page. These templates can be downloaded from the IRB’s website and included as supplemental documents with your eRA submission.
Are there different forms for exempt studies, expedited studies, and full board studies?
No. You only need an initial application via eRA, and include all supplemental documents required in addition to your e-form 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 initial 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?
There are two consent form templates. How do I know which consent form template to use?
Use the Minimal Risk consent form template if the study has minimal risk. If the study has more than minimal risk, use the other consent form template. Contact the IRB Office if you have any questions about what is considered "minimal risk".
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. Note that only the IRB can make the final determination as to whether a study qualifies as minimal risk.
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.
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.
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.
How do I know which protocol template to use?
The choice in protocol template is based off the level of risk. If your study is minimal risk, use the Minimal Risk Protocol Template. If your study is more than minimal risk, use the Main Protocol Template. If you have any questions about what is considered "minimal risk", please contact the IRB Office.
Adverse Events Questions
What happened to the electronic Adverse Events reporting system and what information do I need to report to the IRB?
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. Investigators are obligated to report the following information items to the IRB within 5 business days of learning of the information.
Any information that meets all of the following three criteria:
- Unanticipated or unexpected, in terms of nature, severity, or frequency, given the research procedures that are described in the protocol-related documents (e.g., the IRB-approved research protocol and informed consent document) and the characteristics of the subject population.
- Related or possibly related to participation in the research (there is a reasonable possibility that the incident, experience, or outcome may have been caused by the procedures involved in the research).
- And suggests that the research places subjects or others at a greater risk of harm (including physical, psychological, economic, or social harm) than was previously known or recognized.
Information that indicates a new or increased risk, or a safety issue. For example:
- New information (e.g., an interim analysis, safety monitoring report, publication in the literature, sponsor report, or investigator finding) that indicates an increase in the frequency or magnitude of a previously known risk, or uncovers a new risk.
- Withdrawal, restriction, or modification of a marketed approval of a drug, device, or biologic used in a research protocol.
- Protocol violation that harmed subjects or others or that indicates subjects or others might be at increased risk of harm.
- Complaint of a subject that indicates subjects or others might be at increased risk of harm or at risk of a new harm.
- Any changes significantly affecting the conduct of the research.
- Non-compliance with the federal regulations governing human research or with the requirements or determinations of the IRB, or an allegation of such non-compliance.
- Audit, inspection, or inquiry by a federal agency.
- Written reports of study monitors to the investigator; data safety monitoring board reports; changes to the investigator brochure, package insert, or device labeling; or written reports of sponsors to investigators (excluding Medwatch reports sent to the FDA).
- Failure to follow the protocol due to the action or inaction of the investigator or research staff.
- Breach of confidentiality.
- Change to the protocol taken without prior IRB review to eliminate an apparent immediate hazard to a subject.
- Incarceration of a subject in a study not approved by the IRB to involve prisoners.
- Complaint of a subject that cannot be resolved by the research team.
- Premature suspension or termination of the research by the sponsor, investigator, this institution, or another institution.
- Unanticipated adverse device effect (any serious adverse effect on health or safety or any life-threatening problem or death caused by, or associated with, a device, if that effect, problem, or death was not previously identified in nature, severity, or degree of incidence in the investigational plan or application (including a supplementary plan or application), or any other unanticipated serious problem associated with a device that relates to the rights, safety, or welfare of subjects.)
How do I complete the Practice Run Training?
The Practice Runs training is completed through CITI (www.citiprogram.org). Once you log into your account on the CITI website, you'll need to add the Practice Runs course to your curriculum. The actual training consist of two portions: 1) watching a webinar, 2) reading the definition of Practice Runs. When you start the course in CITI, you will see two links directing you back to our website. Once both portions of the training are completed, you will need to return to the CITI website to record your training. You will be prompted to complete a quiz. The quiz consists of two questions: 1) Did you watch the webinar? 2) Did you read the definition? Note that you will need to complete the quiz in order to receive credit for completing the course. Please contact the IRB Office if you have any questions about this.
Questions Regarding Submitting the Forms
How do I submit the forms?
All submissions must be made in eRA. Please see the eRA Training Resources and User Guides section of our website for complete instructions on making IRB submissions through eRA.
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 submit an application to IRB?
You must submit an application using the "Classroom Project/Activity" e-form 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.
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 template for instructions on requesting a waiver of HIPAA authorization.
What if the protocol is designed and written by the sponsor (a for-profit entity/company)?
If the study is industry sponsored and non-oncology, it will be forwarded to WIRB for review. Submit the new study application to the Temple IRB via eRA with the Temple-specific attachments (e.g., consent form and HIPAA authorization form) along with the WIRB Initial Submission Form. Once the application is reviewed for completeness, it will be forwarded to WIRB for review.
Should I use the checklists and worksheets?
The checklists and worksheets are reference materials. These are what the IRB reviewers use to complete their reviews. If a form refers you to a checklist or worksheet, please use it. This will let you see the criteria we use to determine whether something can be approved. 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 email@example.com 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 firstname.lastname@example.org.
How do I know whether my study will be reviewed by Temple IRB or WIRB?
If the protocol is an industry sponsored, non-oncology study, it will be reviewed by WIRB. However, all WIRB studies are submitted to the Temple IRB. Once they go through an administrative review, they will be forwarded to WIRB. See the WIRB Information Sheet for more details.
My study was approved by the Temple IRB. Can I switch the IRB to WIRB?
Yes, if the protocol is an industry sponsored, non-oncology study, you have the option to switch to WIRB. However, the Temple IRB will not force a change in IRB if the sponsor does not want to switch IRBs.
If you want to switch IRBs, please submit a Temple IRB modification request e-form via eRA. Include all of the study materials with the modification request form. We will forward the entire study file to WIRB.
Where can I find the WIRB forms?
The WIRB Initial Review Forms can be found at documents can be found at: http://www.wirb.com/Pages/DownloadForms.aspx. If youhave additional questions about using WIRB, please review the WIRB Information Sheet.
Do I submit a WIRB study to WIRB?
No.Submit the WIRB study to the Temple IRB and we will forward it to WIRB. See the WIRB Information Sheet for more details.
If it's a WIRB study, do I need to submit everything listed in Section 3 of Temple's Application for Human Research e-form?
No. See the WIRB Information Sheet for the Temple forms that should be submitted with WIRB studies.
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