Frequently Asked Questions
- Protocol Review Process
- If my study does not involve human subjects research, how can I get documentation for my records?
- Can I switch to Exempt or Non-Exempt review once I have submitted my protocol?
- How long does the review process take for a new protocol application?
- If I am in the data analysis phase of my research do I need to renew my protocol?
- What is Exempt Category #7 for UC Berkeley?
- Examples of Projects That Fit Under Exempt Category #7
- Ten (10) Year Approvals
- Conducting Research Outside of UC Berkeley
- What if I will be engaged in human subjects research at another UC campus?
- What if I will be engaged in human subjects research at a non-UC institution?
- What if I am an unaffiliated researcher wanting to recruit subjects from the UCB community?
- What if I am collaborating on human subjects research at UCB?
- eProtocol Application Questions
- I am a student investigator. What training verification do I need to provide in my protocol application?
- I am a student investigator who will be withdrawing from enrollment in order to conduct my human subjects research. What are some considerations I need to make regarding my protocol?
- What documents need to be translated if I will be recruiting subjects in a non-English language?
- How do I get information on confidential and secure data storage?
- How do I comply with CA State CPHS data security requirements?
- Can I collect/analyze existing data posted on the Internet without human subjects review/approval?
- Where do I get information about Biohazard Use Authorization (BUA) numbers?
- What is the difference between privacy and confidentiality?
- What is anonymous data collection?
- What are clinical trials?
- How long should I keep my research records?
- What constitutes “identifiable information”?
- What research falls under FDA regulations?
- How can I pay subjects using campus funds?
- What does “normal education practices” mean in the context of Exempt Category 1?
- Can I invite students taking the course I teach to be in my research study?
- How should I use the “Working with Research Study Participants: An Overview” PowerPoint presentation in order to train non-UCB collaborators?
- How can electronic signatures be used to document informed consent?
Protocol Review Process
1. If my study does not involve human subjects research, how can I get documentation for my records?
If your study is not human subjects research and you would like to get confirmation and documentation of that, please email your request to email@example.com with a summary of your research purpose, procedures, and data collection. If you are unsure if your study involves human subjects research, you should call the Analyst of the Day at 510-642-7461.
2. Can I switch to Exempt or Non-Exempt review once I have submitted my protocol?
No. If it is determined that your study needs to change to Exempt or Non-Exempt review from its original submission, a brand new protocol application under the appropriate level of review will need to be submitted.
3. How long does the review process take for a new protocol application?
For new Exempt applications, it may take up to 8 weeks for review depending on the quality and completeness of the application, the complexity of the study, and the work load of the assigned analyst, as protocols are reviewed in the order in which they are received. After analysts send researchers their initial revision comments, the time to obtain approval is highly variable.
Non-Exempt - Expedited Studies
For new Expedited applications, it may take up to 8 weeks or longer for review depending on the quality and completeness of the application, the complexity of the study, and the work load of the assigned analyst and the CPHS reviewer (who provides final review/approval), as protocols are reviewed in the order in which they are received. After analysts send researchers their initial revision comments, the time to obtain approval is highly variable.
Non-Exempt - Full Board Studies
Additional review time should be allowed for Full Board protocols. Full board applications are subject to deadlines for review at a particular meeting. UCB’s IRB has two committees -- CPHS 1 and CPHS 2 -- that each meet once a month August through June of the academic year. Please refer to the committee meeting calendar to see deadlines and take into account these limited meeting times when preparing to submit your protocol application.
Busy seasons at CPHS/OPHS may also lengthen the time of a review. If you have timing concerns about your study, please contact your reviewing analyst directly.
4. If I am in the data analysis phase of my research do I need to renew my protocol?
It depends. If you still have access to identifiable data you must continue to renew your eProtocol application until all analyses are complete or all identifiers have been destroyed. Identifiable data include audio/video recordings as well as coded data where the identifier key is retained. If all identifiable data fields have been destroyed and data analysis will be conducted using only de-identified data, no renewal application is necessary and the protocol may be closed.
5. What is Exempt Category #7 for UC Berkeley?
- What is Exempt Category 7?
Exempt Category 7 is a new category for exempt review and was created to reduce researcher burden. This category, which the Committee for Protection of Human Subjects (CPHS) and Office for Protection of Human Subjects (OPHS) has added to the six categories of exemption described in federal regulations, is allowed within the flexibility available under UC Berkeley’s Federalwide Assurance (FWA).
UC Category 7 is defined as:
Research that involves no greater than minimal risk to subjects, but does not conform to a specific category under 45 CFR 46.101(b), and does not fall within the exclusions listed below (see point c).
- When is a protocol eligible for Exempt Category 7?
The Office for Protection of Human Subjects (OPHS) staff, upon review of an application for Exempt Status submitted by the investigator, will determine whether or not a protocol may receive an exempt determination under Category 7.
To qualify for exemption under UCB Category 7, a human subjects research project must be non-federally funded or regulated and comprised only of minimal-risk activities that will not induce distress beyond that of daily life and that could not reasonably place the subject at risk of criminal or civil liability, be damaging to the subject’s financial standing, employability, insurability, or reputation, or be stigmatizing in any other way.
These activities may include (but are not limited to) non-physically invasive interventions or performance of tasks such as:
- Reading/writing/drawing tasks.
- Physical activities such as walking, sitting, or manipulating an object.
- Computer tasks and/or Internet searches.
- Talking and/or listening to words, then making selections, or “think-aloud” exercises.
- Viewing media.
- Completing a specific physical or mental action (“imagining”).
- Passive monitoring of space (environment) with sensors.
- Playing a game.
- Height/weight measurements.
A research project will not qualify for Exempt Category 7 if they include any of the following:
- Children/minors as subjects.
- Prisoners as subjects.
- Federally funded research.
- Research involving Federal personnel or the Department of Veterans Affairs.
- Procedures, devices, or drugs subject to FDA oversight.
- Biomedical procedures.
- Clinical interventions.
- An NIH-issued Certificate of Confidentiality to protect identifiable research data.
- Deception to subjects.
- Identifiable, private existing data.
- The information obtained is recorded in such a manner that subjects can be identified, directly or through identifiers linked to the subjects, and any disclosure of the subject’s responses outside of the research could reasonably place the subject at risk of criminal or civil liability, be damaging to the subject’s financial standing, employability, insurability, or reputation, or be stigmatizing in any other way.
If there is a change (e.g., the addition of one or more exclusions outlined in point #3 above) to a protocol that causes it to become ineligible for Exempt Category 7 approval, the PI must immediately cease research activities and submit a new, non-exempt application. The CPHS will then review and issue a new approval letter, as appropriate.
For more detailed information, please see CPHS Determination of Exemption Policy and CPHS Exempt Research Guidelines.
If you have questions about Category 7 exempt research, please call the OPHS Analyst of the Day at (510) 642-7461 or email us at: firstname.lastname@example.org.
6. Examples of Projects That Fit Under Exempt Category #7
In general, Exempt Category #7 activities are those that involve no greater than minimal risk to subjects, but do not conform to a specific Exempt Category under 45 CFR 46.101(b) and do not fall within the Category #7 exclusions. Surveys involving experiments/intervention were previously excluded from Exempt review because Exempt Category #2 does not cover the intervention element; however, as noted below, surveys involving experiments/intervention may now qualify for exemption under Category #7.
What are common examples of research activities that qualify for Exempt Category #7?
(A). Survey experiment/intervention. Survey experiments in which participants are randomly assigned to a condition (e.g., a treatment group vs. a control group), and/or surveys that include intervention procedures and survey questions are intended to evaluate the impact of the intervention. In order to be eligible for exemption, survey experiments/interventions must not involve the use of deception.
- EXAMPLE A: Online survey participants randomly receive one of three versions of a short article on Uber. One article frames the company in a positive light, the second article focuses on negative press, and the third article presents neutral facts. After reading the article, participants answer the same set of questions regarding their opinions on Uber. Framing of the articles is meant to affect participants’ responses.
- EXAMPLE B: Survey participants view pictures of fictional political candidates and answer questions based on the pictures shown. Pictures vary according to gender, age, or race/ethnicity. Survey questions are intended to evaluate the impact of the pictures on participants’ responses.
(B). Viewing media. Studies in which participants view media (e.g. videos, photographs, pictures, video games, etc.) and answer questions about the contents of the media. Media may be embedded within survey instruments, or used in addition to interview, focus group, and/or survey procedures.
- EXAMPLE A: Participants view short videos of media coverage of a popular news story, and then describe their thoughts/opinions of the news story following each video clip.
- EXAMPLE B: Participants view photographs of artifacts and answer questions about whether the photographs help them to recall memories of past events.
(C). Software/usability testing. Studies in which participants interact with a software prototype, web application, and/or computer interface in order to test its efficacy.
- EXAMPLE A: Participants evaluate a non-functional software prototype that promotes healthy eating. After exploring the interface, they answer follow-up questions about their experiences using the prototype.
- EXAMPLE B: Participants engage with an application interface to view and manage nature photographs and provide feedback on ways to improve the interface.
(D). Non-invasive data collection (body). Studies in which participants wear a non-invasive device that records non-sensitive health data. The device must not be used to provide participants with any health diagnoses.
- EXAMPLE A: Participants wear LASCAR or HOBO data loggers* for a period of 24 hours to measure changes in body temperature.
*Data loggers are electronic devices intended to record data over time. LASCAR and HOBO are brand-name devices for recording temperature data.
- EXAMPLE B: Participants breathe into a spirometer* to measure air capacity of the lungs.
*A spirometer is an instrument used for measuring air volume during inhalation and exhalation.
Ten (10) Year Approvals
1. When is a protocol eligible for a 10-year approval?
UC Berkeley’s Federalwide Assurance (FWA) allows some flexibility in applying human subjects federal regulations to non-federally supported research. As such, the UCB Human Research Protection Program – as administered by CPHS/OPHS – has implemented a procedure for granting approval of up to 10 years for research that:
- involves no more than minimal risk to participants (as defined by 45 CFR 46.102);
- is not supported by federal funds;
- is not subject to federal oversight;
- is not subject to FDA oversight;
- is not required to have more frequent review by the funding agency, sponsor (see list of agencies), or by an institution relying on UCB’s IRB;
- does not involve federal personnel or the Department of Veterans Affairs;
- does not involve a Certificate of Confidentiality; and
- researchers do not have a financial conflict of interest (if unsure, please refer to the Conflict of Interest Committee website).
2. When is a protocol not eligible for a 10-year approval?
The following DO NOT qualify for a 10-year approval period:
- research projects that CPHS determines are “greater than minimal risk” studies;
- federally funded research, or research with funding from non-Public Health Service (PHS) agencies (e.g., foundations) that adhere to federal regulations in their award contracts (see list of agencies);
- research involving procedures, devices, or drugs subject to FDA oversight;
- research involving relying institutions, sponsors, or other contractual restrictions that require annual review;
- research involving federal personnel or the Department of Veterans Affairs;
- research involving a Certificate of Confidentiality;
- research involving a conflict of interest (COI) for any study personnel;
- any industry-sponsored research or studies with other individuals, entities, or institutions to which UCB charges a fee for IRB review; or
- any studies where researcher is a paid consultant for the company providing the software being studied for the research.
3. What if my protocol is given a 10-year approval and later becomes ineligible?
If there is a change (e.g., new federal funding) to a protocol that causes it to become ineligible during the course of the 10-year approval, the PI must immediately submit a Continuing Review Application with an amendment to add the federal funding or other relevant addition. The CPHS will then review and issue a new approval letter with a shortened approval period, as appropriate.
4. What are other expectations?
Amendments: Investigators are still expected to modify and/or update their protocols through an amendment (or through the continuing review process if the protocol becomes ineligible for 10-year approval). This must be done in advance of implementing any change planned to the protocol (e.g., in procedures, design, personnel, subjects, sites, funding, recruitment or data collection materials, consent materials, etc.). It is the investigator’s responsibility to ensure that the protocol at all times accurately reflects the research study.
Reporting requirements: If there is an unanticipated problem involving risks to subjects or others, or a serious adverse event, it must be reported as usual. Likewise, any deviation from the approved protocol must also be reported.
Monitoring: CPHS/OPHS reserves the right at any time to monitor research processes and/or audit research records (e.g., consent forms) to ensure compliance with the 10-year approval period conditions.Other limitations: This 10-year approval period will not be available to any collaborating institution or investigator relying on UCB’s review unless verified in writing as acceptable by the other IRB (an email from the relying IRB is sufficient for this purpose).
Conducting Research Outside of UC Berkeley
1. What if I will be engaged in human subjects research at another UC campus?
PIs conducting human subjects research at another UC campus must either get IRB approval from UCB or have an active reliance (formerly NOITR or Notice of Intent to Rely on One UC IRB) under the UC MOU. Please visit our information page on the UC MOU and the UC Reliance Registry.
2. What if I will be engaged in human subjects research at a non-UC institution?
PIs conducting human subjects research at a non-UC institution must either get IRB approval from UCB or enter into an Inter-Institutional Agreement (IIA) which allows UCB to rely on the other institution’s IRB review. Please visit our information page on Inter-Institutional Agreements.
3. What if I am an unaffiliated researcher wanting to recruit subjects from the UCB community?
If you are a non-UCB researcher who wishes to recruit from the UCB community but are not collaborating with a UCB PI, then UCB is not engaged in the research and no IRB review is needed. The non-UCB researcher is responsible for abiding by the policies of his/her home institution’s IRB and for obtaining appropriate permission to recruit from UCB groups and organizations.
4. What if I am collaborating on human subjects research at UCB?
Non-UCB researchers who wish to collaborate on research at UCB must have an eligible UCB principal investigator to serve as the sponsor who will submit a protocol to UCB’s IRB for approval. Non-UCB researchers are responsible for obtaining IRB approval from their home institutions.
eProtocol Application Questions
1. I am a student investigator. What training verification do I need to provide in my protocol application?
All UCB student investigators or key personnel engaged in human subjects research must complete either of the following CITI courses: Group 1 Biomedical Research Investigators and Key Personnel or Group 2 Social Behavioral Research Investigators and Key Personnel. Additional guidance for student researchers can be found at OPHS’s Student Investigators Guide. For information on the CITI Responsible Conduct of Research course for NSF-funded studies, please refer to RAC’s resource on training.
2. I am a student investigator who will be withdrawing from enrollment in order to conduct my human subjects research. What are some considerations I need to make regarding my protocol?
As a student, you are required to have a faculty sponsor serve as the PI of your study. Before you withdraw from enrollment, you must ensure that your PI is willing to be responsible for keeping your protocol current in your absence because withdrawn students do not have access to eProtocol.
You and/or your PI will need to submit an Amendment in which your name/information is moved from the “Student/Postdoctoral Investigator” field to “Other Personnel” in the “Personnel Information” section before you withdraw. Additionally, any subsequent Amendments or Continuing Review applications that may be needed while you are on withdrawn status will need to be submitted by your PI.
3. What documents need to be translated if I will be recruiting subjects in a non-English language?
For Non-Exempt protocol applications that have non-English literate subject populations, CPHS requires translated versions of all consent documents appropriate for your subject population(s). Translations should be submitted to and approved by CPHS prior to their use in the field. Certified translations are not required. However, PIs are responsible for affirming the accuracy of any translated documents. UCB does not provide translation/verification services.
4. How do I get information on confidential and secure data storage?
Please refer to our data security policy for guidelines on how identifiable information should be stored based on the storage device, location of the storage device, and who has access to the storage device.
5. How do I comply with CA State CPHS data security requirements?
When research projects need to use personally identifiable research data (PID) from California state agencies, state CPHS requires researchers to comply with a specific set of data security requirements before releasing PID. Campus Information Security Office has developed an assessment program to help researchers to comply with these data security requirements. Please go to California State CPHS Data Security Assessment Service for more information on how to meet state CPHS data security requirements.
6. Can I collect/analyze existing data posted on the Internet without human subjects review/approval?
Use of public internet data such as the National Center for Health Statistics or National Center for Biotechnology Information data does not require IRB review. However, collecting or analyzing an individual’s identifiers or opinions from the Internet for research purposes may require IRB review if there is an expectation of privacy and/or if obtaining data requires special permission. Please review our Internet-Based Research guidance for more information.
7. Where do I get information about Biohazard Use Authorization (BUA) numbers?
For Biomedical Non-Exempt researchers, please refer to UC Berkeley’s Environmental, Health and Safety website for information regarding BUA numbers.
8. What is the difference between privacy and confidentiality?
Privacy is control over the extent, timing, and circumstances of sharing oneself (physically, behaviorally, or intellectually) with others. Confidentiality pertains to the treatment of information that an individual has disclosed in a relationship of trust and with the expectation that it will not be divulged to others without permission in ways that are inconsistent with the understanding of the original disclosure. Examples of protecting subject privacy include conducting interviews in private areas or closing exam room curtains when conducting physical exams. Examples of minimizing the likelihood of a breach of confidentiality include sharing subject data only with other study team members, encrypting and password-protecting data files, and maintaining lists of subject names/study identification numbers in a separate, secure location from all other private study data.
9. What is anonymous data collection?
Anonymous data collection means that no identifiable information (e.g. name, address, student ID number, email address, phone number) is connected to the data either directly or through a coding system at any point in the study. In addition to videotapes and photographs, audio recordings are not considered to be anonymous. It is also possible that multiple pieces of information, none of which are identifiable on their own, may uniquely identify a person when brought together; in this case, the data would not be considered anonymous. For more information on de-identified data sets, please visit our Secondary Use of Existing Data guidance document.
10. What are clinical trials?
(1) Controlled, clinical investigations of a drug or biologic subject to FDA regulation; and
(2) Controlled trials of devices with health outcomes and pediatric post-market surveillance.
An “applicable” clinical trial defined by the Food and Drug Administration is a trial that must be posted on clinicaltrials.gov. These are clinical trials as defined above excluding Phase 1 drug or biological studies and small feasibility studies of devices.
11. How long should I keep my research records?
Research record retention length varies depending on sponsor, population, use of protected health information, federal regulations, and the Food and Drug Administration regulations when applicable. Please refer to the University of California Office of the President Administrative Records Relating to Research: Retention and Disposition Requirements document for requirements.
1. What constitutes “identifiable information”?
Information is identifiable when (1) it can be linked to specific individuals, or (2) a combination of the information/characteristics could allow others to ascertain the identities of individuals. Examples of directly identifiable information may include (but are not limited to):
- Contact information (e.g., home address, work address, fax number, email address, phone number, license plate number, driver’s license number)
- ID numbers (e.g., student ID, employee ID, social security number, IP address, IMEI number [unique number associated with a cell phone], user name, account number)
- Voice (e.g., audio recording)
- Facial features (e.g., photograph and video recording)
- GPS tracking data and location data
In some cases, elements of information/characteristics that are not regularly identifiable alone can be considered “identifiable” when combined. For example, a combination of age, gender, ethnicity, and place of employment might allow identification of certain individuals in some situations.
Regulations under the Health Insurance Portability and Accountability Act (HIPAA) are more stringent than the requirements for protection of human subjects under 45 CFR 46 and 21 CR 50 & 56. Therefore, when conducting research involving Protected Health Information (PHI), researchers should refer to HIPAA and Human Subjects Research and the list of 18 identifiers to determine whether the information is considered “identifiable.”
2. What research falls under FDA regulations?
A human subjects research study falls under FDA regulations if it meets one of the categories listed below.
- Research involving the administration, dispensation, or use of a drug, such as:
- research conducted under an Investigational New Drug (IND) application; or
- certain research involving marketed drug products that are exempt from the IND regulations.
- Device research conducted to determine the safety/effectiveness of a device or support a research/marketing application to the FDA, such as:
- a device study that is exempt from the IDE regulations;
- a non-significant risk device study; or
- a significant risk device study.
See Drugs and Medical Devices in Research for additional information.
3. How can I pay subjects using campus funds?
The Berkeley Human Subject Prepaid Card Program (HSPC) allows researchers to pay study participants using Berkeley funds. In order to be eligible to participate, researchers must submit a request to Cash Handling and Banking Services for each research study for which they plan to issue payment. This request must include proof of CPHS approval, as well as a user agreement to register each employee who will have access to the Prepaid Card Program portal and the IP address of his/her workstation.
There are three types of payment options for researchers to choose from:
- Instant Issue Plastic
Departments will issue a Visa debit card directly to subjects after they perform an easy-to-use activation and load process.
- Personalized (Bulk) Plastic
Visa debit cards will be mailed directly to the subjects. This program is designed to pay a large number of study subjects.
- Virtual Payment
Subjects will be provided virtual card payment information via email notification to allow for online purchases or the option to transfer funds to their personal bank accounts.
4. What does “normal education practices” mean in the context of Exempt Category 1?This category may include research on established teaching methods, curriculum content and commonly-accepted classroom management techniques that are planned and implemented by the teacher/instructor. Normal educational practices are activities that would occur regardless of whether the research is conducted. Therefore, a study that involves implementing a new instructional strategy and/or untested curriculum would not constitute “normal education practices.” Studies that involve surveys and interviews with minors that focus on the characteristics of the children themselves rather than the educational activity being evaluated would not qualify for an exemption.
5. Can I invite students taking the course I teach to be in my research study?
The research regulations require that informed consent be sought in circumstances that minimize the possibility of coercion or undue influence (45 CFR 46.116). Due to the power differential between students and instructors, it is very likely that students will feel pressured to participate. For example, they may believe that failure to do so will negatively affect their grades and/or relationship with the instructor. Additionally, even though ongoing voluntary participation is emphasized in the consent process, students who wish to withdraw may find it difficult to do so when this involves informing the instructor of their decision. For these reasons, it is generally preferable for instructors to conduct research with individuals who are not taking their courses (e.g., recruit students from another class).
In certain situations, the use of an instructor’s own students is integral to the research question (e.g., introducing a new teaching strategy or novel content into an existing course). If an instructor does wish to conduct research with his or her students, the eProtocol application should include a rationale as to why the study should be conducted with these particular students. The rationale should be accompanied with a detailed description of the instructor’s plan to minimize the potential for student subject coercion/undue influence to participate. The consent document should also include appropriate language to address these issues.
Ways to minimize coercion and undue influence in a classroom setting include the following:
- Having an independent third party (e.g., research colleague who has no pre-existing relationship with the students) announce the study and conduct the informed consent process, including the distribution and collection of the consent documents. This individual will need to be added as personnel in the eProtocol application and complete appropriate human subjects training.
- These activities should occur at a time when the instructor is out of the room.
- The third party individual should be sufficiently familiar with the study to serve as the contact person for all study-related questions.
- Arranging for a colleague to run the study and collect all of the data (at time[s] when the instructor is not present. This individual will need to be added as personnel in the eProtocol application and complete appropriate human subjects training.
- Blinding the instructor to who did and who did not participate – at least until final grades have been assigned.
Researchers may wish to consult with OPHS staff concerning further ways to minimize coercion and undue influence within the context of your own particular study design.
Quality assurance/quality improvement on the effectiveness of the curriculum—unless there is an intent to generalize the results—may not rise to the level of human subjects research. Researchers should contact OPHS staff to discuss the intent of the activity.
6. How should I use the “Working with Research Study Participants: An Overview” PowerPoint presentation in order to train non-UCB collaborators?
- Applicability: The PowerPoint may be used when UCB researchers elect to provide human subjects research (HSR) training to eligible external collaborating staff (e.g., enumerators; non-profit agencies which assist with recruiting, interviewing and/or running focus groups). The presentation topics include the ethical principles of the Belmont Report, recruitment, informed consent, and privacy and confidentiality. Please note the following:
- This is an alternative to asking the collaborating staff to take the UCB CITI training modules.
- If external collaborators are affiliated with an institution that has an HSR training program in place, the collaborators should comply with the training requirements set by their home institution (i.e., the UCB PI is not responsible for providing the training).
- Training modality: The PowerPoint is designed for the UCB PI/designee to use during an in-person session or, if necessary, via a video chat service. This approach facilitates discussion and fosters team building.
- The PowerPoint presentation should not merely be forwarded to collaborators as a self-study tool.
- The presentation template includes optional Speaker’s Notes and Presenter Tips for some (but not all) slides. To access these Notes/Tips, from the View menu, select Notes Page.
OPHS welcomes feedback regarding researchers’ experiences with using this PowerPoint presentation. We would also appreciate suggestions for future iterations.
7. How can electronic signatures be used to document informed consent?
Electronic signature means a computer data compilation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual's handwritten signature (21 CFR 11). Electronic signatures can be created using a wide variety of methods including, but not limited to, user name and password combinations, biometrics, computer-readable ID cards and digital signatures.
Federal regulations allow for electronic consent signatures as documented consent when the subject’s identity can be verified (see Use of Electronic Informed Consent: Questions and Answers). The regulations do not specify any particular method for verifying the identities of individual subjects when obtaining electronic signatures and accepts a number of methods.
An electronic consent signature obtained from a subject whose identity cannot be verified is not documented consent. In this situation, investigators must either obtain a handwritten consent signature* or ask the IRB for a waiver of documented consent. Federal regulations allow investigators to request a waiver of documented consent for minimal risk studies, and for certain greater than minimal risk studies, according to the below waiver criteria:
A. The only record linking the subject and the research would be the consent document AND the principal risk of the research would be potential harm resulting from a breach of confidentiality (criterion A is not described in 21 CFR 50 and therefore does not apply to FDA-regulated research).
B. The research presents no more than minimal risk of harm to subjects AND involves no procedures for which written consent is normally required outside of the research context.
*A handwritten signature means the scripted name or legal mark of an individual handwritten by that individual and executed or adopted with the present intention to authenticate a writing in a permanent form. The act of signing with a writing or marking instrument such as a pen or stylus is preserved. The scripted name or legal mark, while conventionally applied to paper, may also be applied to other devices that capture the name or mark (21 CFR 11). For example, a handwritten signature obtained on a tablet device is treated as documented consent, just as it would be if obtained as an ink signature on a paper consent form.