Policies, Procedures, and Guidance

Required Elements:

• Study title and IRB study number
• The word “research.” Make it clear that this is a research study.
• “California Lutheran University” should be noted in the material, ie, Flyer, Email
• The Principal Investigator’s name (this cannot be an undergraduate student)
• A contact name with either a phone number or e-mail address
• Eligibility/inclusion criteria, if applicable, should be noted briefly.  Especially if payment depends on meeting these criteria.  For example, “English speaking only,” “Women only,” etc.
• State whether participants will be paid for their time and effort
• Acceptable language:

• "You will be compensated for your participation.”
• “You will receive a gift card to X for [amt.] for your participation.”
• “Participants will be compensated.”
• The amount of payment may be included but should not be the most prominent element on the page.  Compensation should not be excessive considering the nature of the project.  Payment should be stated as a range of amounts or stated as “at least” or “up to” for payments dependent on the amount of participation.

Recommended Elements:

• Purpose of the study
• What is expected of the participant
• The time commitment
• The location where the research will take place
• Avoid phrases such as “help needed” or “subjects wanted.”
• The recommended wording is “You are invited” or “Participants invited.”

Elements That Are Not Allowed:

• Offers of compensation that would involve a coupon good for a discount on the purchase price of the product once it has been approved for marketing (applicable for Clinical Research Trials)
• Claims that state or imply a certainty of a favorable outcome or other benefits beyond what is outlined in the consent document and protocol
• Claims that the drug, biologic or device is safe or effective for the purpose under investigation (applicable for Clinical Research Trials)
• Claims, either explicitly or implicitly, about the drug, biologic, or device under investigation that are inconsistent with FDA labeling (applicable for Clinical Research Trials)
• Use of the term “new treatment”, “new medication”, or “new drug” in reference to a drug or device without explaining that the test article is investigational
• Use of the term “free” in reference to treatment or procedures
• Use of exculpatory language (language in the advertising whereby prospective subjects waive or appear to waive any of their legal rights)
• Use of bold or enlarged print or other means to emphasize payment or the amount to be paid

 Teaser Advertisements:

For online recruitment, projects may use teaser ads placed on social media sites such as where character length is limited:

• the teaser mentions that it is a research project;
• the teaser does not use inflammatory language or misleading statements; and
• the teaser refers the potential participant to a full flyer with all the required elements

Social media can be defined as any online and mobile resource that provides a forum for generating, sharing, or discussing ideas and content; variably grouped as online communities (e.g., patient support groups, population-specific dating services); social networking (e.g., Facebook; Twitter); professional networking (e.g. LinkedIn); content production and sharing (e.g., YouTube, Tumblr, blogs); location-based services (e.g. Tinder, Grindr); and others.

Ensure that proposed social media recruitment strategies respect all relevant ethical norms, including:

• Proposed recruitment does not involve deception or fabrication of online identities
• Research studies are accurately represented in recruitment overtures
• Proposed recruitment does not involve members of research team ‘lurking’ or ‘creeping’ social media sites in ways members are unaware of
• Recruitment will not involve advancements or contact that could embarrass or stigmatize potential participants

New Class Policy as of Spring 2020

California LutheranUniversity has implemented a new policy for human subjects research undertaken by student investigators for the sole purpose of obtaining course credit (projects involving human subjects research in Psychology, Research Methods, Exercise Science, etc.). Classroom Research Projects that meet certain requirements may be excluded from review and approval by the Cal Lutheran IRB. In such cases, no forms or documents need to be submitted to the IRB.  The faculty/instructors take full responsibility for overseeing the project and assuring ethical principles are adhered to in the conduct of the project’s activities.

The complete list of requirements for Classroom Projects can be found in the Classroom Research Projects Checklist in the Templates and Forms” section.

PLEASE NOTE:  The IRB cannot retroactively provide an approval or Exempt determination for a study that has already been conducted. Classroom projects do not meet the definition of "research" as defined by the Federal Regulations and are not intended for dissemination outside the institution.

Any Human Subjects research conducted in another country or in collaboration with another country, other than the U.S., is required to be reviewed by the Full IRB Committee.  Please consider your timeline and plan accordingly when submitting to the IRB.

Please visit the site below to learn more about Human Subjects Research regulations in other countries.

OHRP International Research Standards

Always keep in mind how you will maintain the privacy/confidentiality of the subjects in your study.  The data collected is identifiable and not anonymous 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) the following:

• Name
• 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
• Fingerprints

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.

It is recommended that you add “potential loss of confidentiality” as a Risk within the Protocol and Informed Consent Form.

All proposed survey research that includes a sample population from CLU requires scheduling and a sample draw (contact list) from the Educational Effectiveness and Institutional Research office (EE&IR) even if the research project has IRB approval. Please refer to the EEIR Website for further guidance on research using surveys.

If you are conducting research at or through an organization or institution, an authorized representative must formally allow access to the population (employees, students, etc.) from which you plan to collect data. You must contact someone at the organization prior to beginning any type of IRB Application and inquire into their policies for their permission and obtain permission. 

If you are recruiting from an organization but not conducting research on site, you need Recruitment Permission.

If you are conducting research within a childhood educational setting, e.g., preschool or K-12 school, you must obtain permission from an appropriate authority designated by each school and/or district. K-12 schools operate independently and retain the authority to accept or reject any proposed human subjects research conducted at their site and/or involving their teachers, staff, or students. School districts generally require District Office or Superintendent approval if you are contacting employees or conducting research on site.

Organization/Recruitment/District permission letters must include the following:

• The letter must  be on the site’s letterhead
• The letter should be dated
• The letter must be provided by an Administrator-level employee of the site
• The letter must include the title of the Research Protocol
• The letter must indicate that the organization understands the topic of the research and the research procedures ( you can specify specific procedures to be used, ie. Survey)
• The letter must include a statement permitting recruitment of employees/students and/or the research to be conducted at the site
• If the study involves accessing private records (including medical records) a statement of permission to do so must be included and that the site adheres to HIPAA regulations (this may not be applicable)
• You must have the signature, printed name and title of the person providing the permission

Researcher Guidance for the Use of Zoom in Data Collection 

Guidance provided by California Lutheran University’s Institutional Review Board (IRB) to protect  the privacy and confidentiality of participants during the use of Zoom for research. This guidance  may be updated with additional information as it becomes available. 

Introduction:  

The use of virtual platforms to conduct research has become increasingly commonplace. The  online platform Zoom is a frequently used host for the collection of primary data through  interviews and other types of virtual communication. As with most online platforms, privacy and  security risks exist unless steps are taken to mitigate these risks by the researcher. This guidance  document lays out a variety of ways that researchers can change settings or initiate their virtual  meetings over Zoom to provide maximum protection to their research participants. This is even  more important when collecting sensitive information and/or working with subjects that are  considered part of a vulnerable population. 

Privacy and Security Tips:  

1. Create private meetings. Using your Personal Meeting ID (PMI) that is specifically tied to your  account allows anyone with the number to enter your personal meeting at any time. Avoid  sharing this number and instead provide a new, private meeting code for each meeting. If you  are a student researcher, you may need to use your Faculty Advisor’s Zoom account. Please do  not create a personal account but rather access Zoom through CLU. 
2. Disable screen-sharing. By default, anyone who is entering into a meeting with you can  automatically share their screen with the group. To avoid this, the host can go into settings and  disable screen-sharing for other participants.  
3. Understand what Zoom’s encryption policy means. Although others will not be able to access  any audio or video content created from your encrypted meeting, this information is not private  from Zoom itself. Zoom may have access to data it collects as part of their business. In addition,  CLU Administrators will have access to any Zoom recordings, up to 30 days after deletion of the  recordings by the researcher. Please make sure your participants understand this and that this  is clear in the Informed Consent Form.
4. Use a meeting password. By using a password, you can ensure that only those with the  password are able to enter your meeting. All researchers are expected to use this feature.  
5. Turn on waiting rooms. This feature makes it so the host must approve each new attendee  prior to them having access to the meeting room. 
6. Lock meetings. Once all participants have entered the meeting, the host can lock the meeting  which will not allow anyone else to join.  
7. Limit research interactions that collect highly sensitive data and/or work with vulnerable  subject populations. Remember that Zoom and CLU may have access to any audio or video  collected on Zoom. 
8. Logging on Anonymously. Subjects can be directed to log on to the Zoom and not use their  own name. 
9. Audio Sessions Only. Subjects can be directed to call into the Zoom using the provided phone  numbers. 
10. Do not use Zoom for file transfers. This is highly recommended so participants do not  accidentally share confidential information.  
11. Limit the use of the Record function. Recording sessions presents additional security and  privacy risks when not handled properly. Only use this function when absolutely necessary, and  be clear with your participants when sessions will be recorded. This information should be  provided in the Informed Consent Form. 
12. When using Record function, always record to the computer. Though you will have the  option to record to the cloud, please refrain from doing so. All recorded meetings should be saved  to the computer and then promptly transferred to secure storage. 
13. When using Record function, please make sure all participants consent. The meeting room  should require permission and/or alert participants that they are being recorded, however, all  researchers are expected to verbally consent participants prior to recording any session. No  participants should be recorded that have indicated they do not want this function used. Please  also make sure that it is clearly stated in the Informed Consent whether or not you will be  recording any Zoom sessions.

Collaborating with California Lutheran University

Cal Lutheran researchers collaborating with investigators from other institutions may or may not need to obtain IRB approval from all engaged institutions.

When Cal Lutheran investigators are conducting collaborative, non-exempt research (i.e., requiring Expedited or Full Board IRB review) involving human subjects, it may be possible to establish an IRB Reliance Agreement allowing one institution to rely on IRB review conducted by the other institution. This helps avoid duplicative review and streamlines the review process across research sites. The Reliance Agreement outlines the responsibilities of both the relying and reviewing institutions, regarding research review, reporting, and oversight. In order for the IRB to consider such an arrangement, both IRBs must have a Federal-Wide Assurance from the OHRP and enter into an Reliance Agreement. Reliance Agreements do not apply for international research collaborations which require separate review for each collaborating site.

For Exempt research, each institution must follow its own practices for Exemptions.

SMART IRB

California Lutheran University is a participating institution in the SMART IRB master reliance agreement. SMART IRB is a platform that offers a master IRB reliance agreement (the SMART IRB Agreement) and a web-based system (SMART IRB's Online Reliance System) that provides a central process for participating institutions and their investigators to request, track, and document study-specific reliance arrangements. Contact the IRB at irb@CalLutheran.edu  for additional information.

California Lutheran University as a Site for External Researchers

An outside researcher (not affiliated with Cal Lutheran) wishing to conduct research at Cal Lutheran or with Cal Lutheran students or employees, must submit the following to the Cal Lutheran IRB Office:

• IRB approval or Exemption letter from the external institution.
• The full set of application documents submitted to the external IRB including:
• The IRB protocol application;
• Informed Consent form or information sheet;
• Recruitment materials;
• Instruments or measures to be used; and
• Any additional supporting documentation.

In addition, please complete the following form: IRB Review for Non-CLU Investigators. Please email the form and other requested documents to the CLU IRB at irb@CalLutheran.edu. 

The IRB reviews the value of compensation and method of disbursement to ensure that neither are coercive or constitute undue influence. The appropriateness of a particular sum of money or other form of payment should be based upon the time commitment, inconvenience to the subject, and reimbursement of expenses incurred while participating. It should not be so large as to constitute a form of undue influence. When offering compensation, the following should be considered:

1. When possible, investigators should pro-rate compensation – i.e., offer partial compensation for partial or incomplete participation in specific study activities or in the study as a whole. Making compensation contingent upon completion of all study activities may constitute coercion or undue influence.
2. Subjects participating in the same study and completing the same tasks should be compensated equitably.
3. Because providing compensation may require the use of personally identifiable information (e.g., email addresses used to distribute gift cards, Social Security Numbers required for tax reporting purposes), the methods of compensating participants can contribute to risks associated with a loss of privacy or breach of confidentiality. Researchers should develop procedures for compensating subjects that reduce the exposure to these risks.
4. Unless it creates undue inconvenience or undue influence, compensation to subjects who withdraw from the study should be made at the time they would have completed the study, had they not withdrawn.
5. The amount and timing of compensation, as well as any prorating/scheduling of payments should be clearly described in the Study Protocol Submission and the Informed Consent Form.
6. Finder’s fees and bonus payments of any kind are not permitted.
7. Compensation is not considered a benefit of research participation and must not be described as such.

To protect researchers, the CLU IRB reviews all applications involving the use of secondary data with the intent to produce generalizable knowledge.

Please refer to the document below for further guidance:

Guidance for Research Involving the Use of Secondary (Existing) Data Sets

If using a Restricted Data Set, please make sure to complete the following form and submit to the IRB, as well as attach to your Cayuse submission.

Data Use Agreement Request Form

 

If you are conducting a study that requires you to document consent, you must ensure that participants’ electronic consents can be traced to their verified identities for the electronic signature to be legally effective. The ability to verify identity and show that the signature is attributable to the study participant is important to consider when designing the consent process for the study and choosing the electronic platform/program to use for the consent process. An email address alone may not be considered adequate to verify identity.

Your protocol must also provide a basic explanation about how an application or platform keeps participant data secure.

If using Qualtrics, you can add a “signature question” which allows the user to handwrite a name in the box. However, if the potential participant’s identify is not verified in some way (for example, by visual interaction with the study team or through digital identifiers), then writing a name in the box does not qualify as a legally effective electronic signature. Other frequently used applications for collecting electronic signature include DocuSign, REDCap, or AdobeSign.  These applications have developed processes for collecting electronic signatures that are connected to individual’s identity and are often a good choice for documenting legally effective consent signatures electronically.  

Unique to studies using electronic signatures is the requirement to obtain an agreement from the participant to sign the consent electronically.  This may be done in a separate form or within the consent document itself. The statement/notification for the participant’s agreement to sign electronically should be clearly displayed and separately agreed to (e.g., with its own “I agree” button).

Ultimately, if your study requires that written consent be collected from participants and you plan to do the process electronically, then you will need to document how this will be accomplished within the protocol.  It’s important to plan this process and confirm that the application the study team will use to collect electronic signatures is capable of collecting legally effective signatures, will appropriately respect participant privacy, and that the records of these electronically signed consent forms will be retained with the study documents for the duration of the required record retention period.

The Board can grant a waiver of documentation of consent for studies which have been determined to be no more than minimal risk.  This means that the requirement to collect a written signature (documentation of consent) has been waived (is not required) and for that study, the study team is not required to document a written signature on the consent form.  This type of consent process can be helpful for remote studies that are minimal risk. Please refer to the "Waiver of Documentation of Informed Consent" section of the Investigator Manual.

Please remember that collection of written signature (whether wet-ink or electronic) from a person to document their informed consent to participant in the study is always the default expectation. The study team should clearly indicate in their protocol if they would like to request the IRB to grant a waiver of documentation of consent.