Completing Application Package
- Complete application found on the website. Submit to IRB email
- Consent documents. Example found on the IRB webpage
- Change in protocol, primary investigator, or study parameters: submit memo to the IRB email. Include the following information: Title of Study, IRB file number assigned to study, the name of the primary investigator
- Renewal of IRB application. Please submit a renewal form.
- Injuries occurring during the investigation: Notify the Chair and Co-Chair of the IRB immediately.
Keeping Electronic Data Secured
In addition to maintenance of hard copies of data, researchers should ensure that computers are secure. Some recommendations for securing data include:
- Set passwords on your computer(s) and any digital files that include sensitive information. Additionally, set your computer to go to a password-protected screensaver (or to go blank) when it is idle for some time. This is only a minimum-security step! A determined intruder can readily bypass these passwords.
- Set up a working firewall on your computer.
- Verify that any computer on which you will work is free of any spyware, trojan malware or viruses.
- For very sensitive material, follow all of the steps above and work from a separate, more secured account on your computer and do not access the internet from that account.
- When the project is complete, be sure to securely destroy all original data in accordance with Clarion University IRB guidelines. While shredding paper is one obvious way to destroy some kinds of data, digital data require more attention. Deleting files is not a secure way to destroy digital copies of your research data or working files.
Use of Emails in Research
Email may be used in a variety of ways during a study, including for recruitment, scheduling study visits, or as part of general study participation. The following guidelines apply to all uses of email for research purposes. Additional information on situation specific use of emails is provided below.
- Only secure, university-issued or approved email accounts should be used, such as @clarion.edu, @eagle.clarion.edu Personal email accounts, such as @gmail.com, may not be used.
- Auto-reply messages should be set in advance whenever email is used to communicate for research purposes and the inbox will not be monitored for more than a day.
Sensitive Information within Emails
- Prior to using email to convey information about subjects’ health or which will elicit information about subjects’ health, permission for email must be obtained from subjects. Such permission may be obtained orally or in writing. If permission is obtained orally, the study team must document subjects’ oral agreement to use email. Prior to obtaining permission, subjects must be informed that use of unencrypted email is not a secure method of communication and that there are many ways for unauthorized users to get access to email.
- Subjects should never be asked to provide sensitive information such as social security numbers or discuss stigmatizing health information (e.g. communicable disease status or sensitive laboratory test results) through email. This includes sending information such as inclusion and exclusion criteria to subjects to confirm eligibility, when such information is sensitive or stigmatizing.
- Email scripts sent to the general public may contain limited information about the conditions being researched. For example, the subject line of the email could state “Seeking participants for an Irritable Bowel Syndrome Study.” However, when subjects are being targeted by email specifically because they have a condition, the email should not reference the health conditions of the potential subjects. For example, the subject line of an email to individuals known to have IBS should read "Seeking participants for a Clarion University Research Study” instead of "Seeking participants for an Irritable Bowel Syndrome Study."
- Absent prior permission from the recipient, attachments that contain health information – such as informed consent forms and information sheets – cannot be sent by email.
- If detailed or sensitive health information needs to be obtained from subjects through methods other than in-person communication – such as through a health questionnaire document – the study team should investigate the use of alternative, more secure mechanisms for collecting information. As an example, an email to subjects could include a link to a questionnaire in a secured online forum.
- Do not include multiple recipients on an email. Recipients should never see another subject’s or potential subject's email address. The blind copy (bc:) function should be used to protect subject privacy.
- The following disclosure language should also be included at the end of all email communications with subjects (the language in brackets should be revised to be study-specific).
Email is generally not a secure way to communicate sensitive or health related information as there are many ways for unauthorized users to access email. You should avoid sending sensitive, detailed personal information by email. Email should also not be used to convey information of an urgent nature. If you need to talk to someone immediately or would prefer not to receive study communication by email, please contact [Name, Title, Phone Number].
Use of Email for Initial Subject Recruitment
Email can be used both directly and indirectly as a recruitment tool. Direct email recruitment includes obtaining potential subjects’ email addresses and sending IRB approved recruitment material to the subject by email. Indirect email recruitment includes listing a study-related email address in recruitment flyers, brochures, or study information sheets for subjects to use to contact the study team.
- Indirect recruitment: As with any other recruitment materials, a description of how email will be used to communicate with potential subjects for recruitment purposes should be included in the IRB application along with any recruitment materials, including email templates that will be used to respond to initial inquiries about the study. Remember that the subject line and content of these emails should not contain any references to health information or request health information from the subject through email.
- Direct recruitment of Potential Participants:
Information to include in the application for direct recruitment: Study teams must describe who will send the emails, i.e. the researchers themselves or another entity on behalf of the researchers. Additionally, study teams should provide:
- The source of the email list
- The targeted population of the email
- How frequently the email will be sent and the total number of emails that may be sent
- In cases when an email will be sent more than once regarding a specific study:
- Include a method for individuals who do not wish to receive additional emails to be taken off the list, or
- If it is not possible to remove individuals from the list, include a statement in the email that they cannot be removed and if they are not interested in participation, they should delete future emails. In addition, a copy of the proposed email text should be included with the IRB application. The following guidelines should be followed when drafting the email template:
- Include the email address from which the email will be sent, the subject line, and any graphics used.
- The subject line of the email should clearly state that it is an advertisement for a research study, such as: "Seeking participants for a research study" or "Information about a Research Opportunity."
- The text of the email should clearly identify the source of the email list, such as “You are receiving this email because you are a member of X organization. Your email address was obtained from X organization.”
- The email message should contain a brief description of the main study interventions. If the study involves testing experimental drugs or devices, identify them as such. In addition, if some subjects will receive placebo, ensure that this is mentioned in the email as well.
- Include a statement that that the email has been approved by the Clarion University Institutional Review Board.
- Adhere to the other requirements outlined in Clarion University’s guidelines and policy for recruitment of research participants.
If a research team receives complaints from a recipient of a recruitment email, the individual can be referred to these email recruitment guidelines. If the recipient does not accept these guidelines, the complaint should be reported to the IRB that approved the research study.
Use of Email to Schedule Initial Study Visits
Study teams may want to use email to schedule or confirm initial study visits. While this is an easy and effective way to coordinate with subjects, it also presents issues with privacy and confidentiality. If email will be used to schedule initial study visits the following guidelines should be followed:
- A copy of the email script(s) and a description of how the email script(s) will be used should be included in the recruitment section of the application for review by the IRB. Included in the description should be an explanation of how permission will be obtained from subjects to use email for this purpose. Permission may be obtained through email by asking subjects if they agree to set up an appointment by email before sending scheduling information. If subjects are contacted by phone, the phone recruitment script should include a description of how email will be used along with the request for subjects to provide their email address.
- The email to schedule an initial study visit may not convey any information about subject’s health unless the subject has first given permission to use email for this purpose Absent such permission, care should be taken not to indirectly include health information in any appointment reminder. Even with subject permission, the email should contain as little health information as is necessary to convey the intended message.
- Obtaining permission from subjects to use email as part of recruitment and to schedule initial study visits does not authorize the study team to use email to communicate with subjects generally. Permission to use email for purposes other than recruitment or scheduling of initial study visits is required as described below.
Collecting and Using Email as Part of Study Participation
Researchers may wish to communicate with subjects by email during the course of a study for purposes such as scheduling additional study visits, sending study reminders, and providing links to complete online surveys. Study teams are allowed to use email to communicate with subjects during the course of the study in accordance with the following guidelines:
- The “Research Design” section of the IRB application should describe how email will be used for the research. Templates of emails that will be sent to subjects after informed consent is obtained do not need to be included in the application, but all emails should contain the disclosure statement included above in the General Requirement for Emails section.
- The consent form must include information on how email will be used in the study and the study team must obtain permission to communicate with the subject by email.
- Subjects cannot be required to provide an email address in order to participate in a research study unless the study cannot be carried out without access to email. Additionally, subjects may request – AT ANY TIME – that email no longer be used to communicate about the study, without any loss or penalty.
- Emails may not convey any information about subject’s health or elicit information about subject’s health unless the subject has first given permission to the use of email for this purpose. Even with subject permission, the email should contain as little health information as is necessary to convey the intended message. There are often better ways to communicate with subjects if health information must be included or elicited as part of the communication.
Researchers frequently use online surveys as a method of data collection. Researchers should ensure that the online platform is secure. Please include a description of privacy settings that will be used for the survey. SurveyMonkey provides information related to IRB submissions and the use of their online surveys. https://help.surveymonkey.com/articles/en_US/kb/How-does-SurveyMonkey-adhere-to-IRB-guidelines