Guidelines for Completing an Application for IRB Review
The following provides guidance on what the IRB will typically be looking for in its review of applications. These guidelines address the most comon types of issues that have triggered the need for revisions. Not all sections have guidelines provided. Sections that have typically not been problematic are not addressed.
Checking your application and making sure that it conforms with all the guidelines below before submission will minimize the need for revisions and help expedite the review of your application. The need for revisions and further review significantly adds time to the overall review process.
Before submitting your protocol, please check that the readability index of the informed or online consent is at the 8th grade level or below (<9.0) based on the Flesch-Kincaid readability index.
If the readability is 9.0 or higher the informed consent will require revisions before it can be approved.
Note, guidance on how to determine the Flesch-Kincaid readability level and also on how to reduce it can be found in the document “Tips on Adjusting Readabiltiy” on the IRB web site.
This section should contain a general summary of the study procedures to be carried out. More detailed information about the procedures should be expanded in the “Study Procedures” section.
Please provide background information that describes the context, significance, and need for the work proposed. This should be academic in nature and based on a review of the relevant literature in the field. Proper use of citations and a list of works cited are expected. (Note, background on study instruments to be used should be provided in the "Study Instruments" section).
Check all descriptors of the target population that apply. If there are other characteristics of the target population that are not included in the list, please select “Other” and identify the appropriate characteristics. Note, studies that involve certain populations are not eligible for an expedited review and will trigger a full review by the IRB. Examples of such populations are those that include children under 18 years of age, pregnant women, LGBTQ, prisoners, persons who may be compromised in the ability to make decisions, and subjects in studies that take place outside of the United States (international studies).
Please provide the anticipated sample size for the project. If the project involves different groups or populations, please provide the anticipated number for each group as well.
Please list criteria for participation in the study related to your target population. For example, sophomore college students, able to read and write in English, 18 or over, etc…
List criteria for exclusion from study participation. For example, under 18 years of age, or subjects with certain medical conditions that would confound study results or increase risk. Note, studies that involve populations that are considered at increased risk will trigger a full review by the IRB. If certain racial/ethnic groups or genders will be excluded, the rationale for exclusion must be justified.
Describe how participants will be recruited to be in the study including:
Method of contact – Describe how participants will be recruited: e.g using flyers, email, an announcement in a class or meeting, in person, etc…?
Method of identification – If you need information or access to identify or contact potential subjects that meet the criteria for your target population, you need to describe how you will obtain such information or access. If you need permission to obtain or access such information, you need to document permission.
For example, you want to do a study on high achieving students at Messiah and want to recruit among all students who have a 4.0 GPA. In order to contact such students, you might have to request that the Registrar’s Office send out a recruitment email on your behalf to all students that fit this criterion. You would also need documented permission from the Registrar’s Office to access this information and conduct this study.
Permissions – You need to provide documentation of any permissions that may be required in order to recruit (i.e. you need to provide some documentation of that permission from the appropriate sources, you cannot simply say your will obtain this information or that you will ask for it, you need to provide documentation of such permission). In addition to the example above, another common example is recruiting potential subjects from a class. In this case, if you are not the instructor of the class, you would need documented permission from the instructor that you have permission to do so. As another example, f you will be recruiting subjects from a primary or secondary school, you would need to document permission from the principal of the school as well as the teacher of the class.
Recruitment language and materials – please provide the language to be used in recruitment. If emails will be used, provide the subject line and body of the text to be used. If a flyer will be used, provide a copy of the finished flyer. If an announcement will be made (for example, in a class), provide the language of the announcement to be used. If recruitment will be via personal contact, provide of the anticipated script to be used in recruitment. The actual language or copy of the recruitment materials to be used must be provided for review. If this is not provided with the application upon submission, it will delay the processing of the application until such materials are received.
Recruitment language must contain certain elements to pass IRB review. It should contain the following elements:
1. It should indicate that this is for a research study or project.
2. It should provide a brief description of the purpose of the study. It should not be misleading about the purpose of the study.
3. It should provide a brief description of the procedures involved, including what participation entails (for example, take a survey, attend a focus group, participate in an experiment, etc…)
4. It should include an estimate of the anticipated time commitment. If participation will require multiple sessions or components, it should state how many sessions and the time required for each and/or the anticipated total time commitment.
5. It should provide pertinent inclusion and exclusion information so that people who are ineligible or not part of the target population don’t apply. For example, will you require only adults 18 years of age or older? Then state that in the recruitment language.
6. It should indicate that participation is voluntary and not required.
7. If applicable, it should indicate if participation is anonymous or confidential (see section on anonymity and confidentiality for clarification on the important distinction between these terms).
8. It should include contact information for the researcher(s) (including a name and a method of contact) in case anyone has any questions about the study before deciding to participate. If you are recruiting by email, you should still provide contact info (whether your email address or other contact info) in the text of the email itself. For example, if you recruit via a mass email system, potential participants will likely not be able to simply reply to the mass email to contact you.
9. It should identify the location of where the study will take place (if applicable).
10. It should identify the institution(s) with which the study is associated (e.g. Messiah University).
11. It should identify any risks associated with participation that is beyond a minimal risk.
12. If applicable, it should identify any compensation/remuneration involved with participation. HOWEVER:
13. It should NOT have anything that draws undue attention to or emphasize any compensation or remuneration. This can be in the form of using certain types of words that are used to entice (common examples are “free” and “win” and “exciting”), using certain types of punctuation (!), or using certain types of formatting (for example, bolding, underlining, italicizing, using larger or more visible fonts, or using colors that draw attention to potential compensation or make it stand out). Enticement or undue attention on compensation or remuneration can be perceived as coercive.
DO: Refreshments will be provided.
DON’T: FREE PIZZA!!!!!
DO: Participants will be eligible to enter a drawing for a gift certificate.
DON’T: WIN A FREE GIFT CARD!!!
Social media can be an excellent tool for the recruitment of human subjects for research. The Messiah IRB will consider the use of social media recruitment methods that include a clear justification and meet the guidelines outlined below. Since the online environment is constantly changing, these guidelines may not address all possible scenarios. Each IRB submission utilizing social media for recruitment will be reviewed individually to ensure adherence to University standards and HHS regulations.
- Justification – It is important for researchers to carefully consider the use of social media and explain to the IRB how this method of recruitment will be an appropriate and effective means for reaching the target study population. Recruitment, including social media recruitment, must adhere to the principles of justice, respect for persons and beneficence. When deciding to use social media for recruitment, researchers should consider whether online recruitment may create a biased sample. It is also important to consider which social media platform will most effectively reach the target audience.
- Description – The IRB submission should include a complete description of how social media platforms will be used during recruitment. The description should include a list of all social media platforms that will be utilized and an explanation for how the research team will interact with users on the platform. (Examples: Will comments be disabled? Will the researchers answer questions on the platform? Will potential participants be re-routed to another website for more information?)
- Recruitment Language – All recruitment materials, including social media recruitment, should meet the requirements outlined in the recruitment section of the IRB website. In short, all recruitment materials should include the following information: indication that this is a research study, a brief description of the purpose of the study, a brief description of the procedures involved including the time commitment for research subjects, inclusion and exclusion criteria, a statement on voluntariness of participation, the location of the study, the institutional sponsor of the study, risks, compensation, contact information for the researcher and a statement as to whether the participants’ identity will be confidential or anonymous. The exact recruitment post should be included in the IRB submission. It is also important to ensure that the text of the recruitment post will fit within the social media platform’s text restrictions. For some platforms it may be necessary to include a link to a different site with more complete information about the study. If different recruitment materials will be created for different social media platforms, each one must be submitted to the IRB for review.
- Privacy – Researchers should not use personal social media accounts to post recruitment materials for research studies. Research is official business of the University and should be kept separate from personal accounts. Researchers may choose to create a social media account specifically for the research study.
- Accessibility – Recruitment materials should be accessible to all individuals in compliance with Messiah’s commitment to inclusive excellence and the Americans with Disabilities Act. When possible, recruitment materials should be text based. If images must be used, those images should include alt-text for e-readers.
- Permissions – If researchers will be asking groups/pages/organizations to share the recruitment post on their social media sites, the IRB submission should include evidence that permission was received from those entities.
- Security – Recruiting human research participants using social media platforms increases the possibility of invalid research results due to ‘bad faith’ or bot submissions. Researchers may consider the use of screening questions to determine eligibility, collection of IP addresses to screen out repeat responders, and/or the structuring of survey questions to help identify unusual, repetitive, or inconsistent responses.
Copies of any study instruments that will be used must be provided. For example, if you are conducting a survey, you need to provide a copy of the actual survey to be used. If you will be conducting a focus group or one on one interview, you need to provide an anticipated script or set of questions to be asked.
You can provide a copy of the instruments to be used or, if an online survey will be conducted, you may provide an active link to the survey. Note, if you are providing a link to the actual online survey, please make sure that the entire survey, in its final form, is accessible for multiple rounds of access (in case the IRB or different members of the IRB need to access the survey multiple times for review purposes), and that you discard any “results” that may have been submitted by the IRB during review before data collection begins.
If the study instrument has been previously published, you need to provide proper citation for the instrument. If you will modify a published instrument, then you should indicate this. If you will construct your own study instrument, then please indicate this as well. The final version of the study instrument(s) must be submitted for review. If it is not included with the initial application submission, it will delay the review of the proposal.
Describe each of the study procedures in detail, expanding on info from the “Summary of Procedures.” Please attach surveys, interview questions, focus group questions, or other study instruments that will be used in the research. Procedural details that should be included (where applicable) include:
*Nature of procedures (for example, surveys, interviews, online surveys, focus groups, physiological tests, etc…).
*Location(s) where research is to be carried out.
*Time commitments of participants (for example, there will be 3 one hour long focus group sessions and each participant will attend one focus group session).
*Duration of study.
*Sequence of events for the entire study and details on the actual procedures to be done.
*Description of how and when the informed consents will be administered (if applicable).
*If there is any risk above minimal risk, what measures will be in place to minimize risk to subjects (for example, if a physiological test is being carried out that could present a health risk to the subjects, what is the protocol for ensuring the safety of the subject, or if identity of subjects will be coded to keep the study confidential, what type of coding system will be used).
*If the research will be carried out by student researchers and if the faculty supervisor will not be present, a clear response protocol of what will trigger the response protocol, whom the student research will contact, and the time frame in which such contact will occur needs to be provided. For example, if a physiological test is being done and there is a possibility that a subject might faint, then there should be a clear protocol that in such event the student researcher will contact 911 or the Department of Safety immediately and then immediately contact the faculty supervisor.
Select ALL of the potential risks involved in your study. Note, some potential risks, such as use of deceptive techniques, will automatically trigger a full review by the IRB.
Include a description of how you will handle an adverse or unexpected outcome that could potentially be harmful (e.g.: suicidal ideation).
If any deception, i.e., withholding of complete information, is required for the validity of this research, explain why this is necessary, and attach debriefing statement - how and when the participants will be told the true purpose of the research and the reason for the deception.
If you will be coding the identity of the participants to preserve confidentiality (for example, assigning pseudonyms or code numbers to each participant), please describe the system you will use.
Describe the potential benefits that may be gained by any individual participant, as well as benefits that may accrue to society in general as a result of the planned work. If “none”, state “none”. Remuneration/compensation is NOT a benefit.
Explain whether and/or how participants will be compensated for participation in the study, e.g.: cash, gift certificate, required course credit, extra course credit, etc… Note, description of remuneration/compensation in any recruitment materials must not be enticing or draw undue attention, it should just be simply stated. Any remuneration or compensation must not be emphasized. Otherwise, such remuneration/compensation could be perceived as coercive. See comment in the Recruitment section.
If participation is required for a course, an alternate assignment for the same point value must be available for those students who choose not to participate that does not require participation in any research study. For example, it is not appropriate to require students in a course to participate in a research study as a required part of a course because this would be coercive (the student has no choice but to participate or suffer a penalty in their grade for the course). Likewise, the same holds true for situations where extra credit is offered as an incentive for participation. In such cases, an alternative assignment that would take comparable time and effort must be made available as an option to the students who do not wish to participate in any research study. Otherwise, there will be a penalty or loss of potential benefit from not participating in the research study.
There is a distinction between the terms anonymous and confidential that is often misunderstood. A study is anonymous when there is no linking information between the subjects and the data and there is no way for the subjects to be identified, including by the researchers. For example, a study that collects data from an online survey that does not collect any identifying information from the respondents (no name, email, etc…) would be anonymous. There is no way for the researcher or anyone else to associate the data collected with the individual respondents.
A study is confidential when linking information between the subjects and the data exists, but the identity of the subjects is protected and not disclosed by the researchers. The researcher has access to the identity of the subjects, but the identity of the subjects is not linked to the data in the presentation of the results. Sometimes a researcher will obscure the identity of the subjects by assigning pseudonyms or codes to the subjects. For example, a study that has subjects provide identifying information (e.g. name) and survey responses, but where the researcher assigns a random code number to each subject to obscure their identity, would be confidential. The actual identities of the subjects are not used in the analysis or presentation of the data, but the researcher retains linking information of the subjects’ identities and their assigned code numbers. Some examples of why a researcher might keep such linking information are: (a) in case the researcher needs to verify information or follow up with a subject, or (b) in case a subject chooses to withdraw from a study and the researcher needs to identify the relevant data to withdraw it from the study. The existence of such linking information, however, leaves room for the possibility of a breach of confidentiality.
The standard for the secure storage of data is to keep data under “double lock.” For physical data (such as paper data or hard copies of informed consents or audio or video tapes), this means that there should be at least two layers of security protecting the physical data from inadvertent or unauthorized access. An example of such a double layer of security would be keeping physical copies of data in a locked filing cabinet in a locked office.
For storage of digital data (e.g. electronic data files), the standard of keeping data stored under a double layer of security should also be followed as much as possible. For digital data, restricting access by using password protection would represent a layer of security. Some programs allow you to place password protection on the files themselves (for example, you can password protect Microsoft Office files). An example of having a double layer of security on digital data files would be password protecting the file and storing it on a computer that also requires a password to access. Similarly, storage of a password protected data file on a network drive that has password restricted access would also satisfy this standard.
For storage in the cloud (for example, Google files on Google Drive), it is not always possible to password protect individual files since access to the files are limited to access to the overall cloud account. Additionally, since storage in the cloud can be accessed from any computer or device with access to the internet, password restrictions to specific computers or devices do not constitute a sufficient layer of security. In such cases, storage of data in the cloud is acceptable as long as (a) the access to the account is password protected and (b) the account is based on a Messiah College email account. It is not suitable to use a cloud storage account that is linked to a personal email that may or may not be shared or accessible by other persons (for example, use of a personal email account that may be accessed by other members of your family). If data will be stored in the cloud (for example, on Google Drive), the email associated with the cloud storage should be indicated.
For storage of data on certain types of third party accounts, such as survey data from online survey applications like Qualtrics, password protected access to the account and data will be sufficient. Some online survey applications like Qualtrics also allow account owners to download data. Security for downloaded data should be the same for storage of all digital files on local drives outlined above.
For student researchers, faculty mentors and supervisors should always be allowed access to data.
Federal guidelines specify that data must be maintained at least 3 years for audit purposes. Data maintenance times shorter or longer than 3 years need to provide an explanation of why.
Please indicate clearly and specifically how each type of data will be destroyed. For example, if you have paper/hardcopy data, will it be shredded? If you have digital files, will they be securely deleted from your hard drive or storage device?
Participation must be voluntary and not required. Consent is ongoing. Even if a subject gives consent initially at the beginning of the study (e.g. signs the informed consent), they must still be free to withdraw from the study at any point in the process.
There can be no penalties or loss of benefits for withdrawal. If any remuneration or compensation was given as an incentive to participation, the participant must not lose any such benefit as a result of withdrawal. For example, if a gift card, or the chance to enter a drawing, or course participation (or extra) credit was offered for participation, and a subject started the study but at any point decided to withdraw for any reason, that subject must still receive the full benefits of participation. Receipt of any benefits cannot be contingent upon completion of the study. If information regarding provision of a benefit is collected at the end of a survey or experiment (for example, collection of contact information for the purposes of issuing a gift card or for entering a name into a drawing), then there must be a mechanism whereby a withdrawn subject can provide such information without completing the survey or experiment.
Normally, data collected from a withdrawn subject is removed from the study. If you want to use data already collected from a subject after a subject withdraws, you must obtain a separate consent from the withdrawn subject to do so. This consent must be separate from the initial informed consent and obtained after the decision to withdraw as the subject may have different feelings regarding the inclusion of any of their data at the point of withdrawal.
If informed consent will be used, then after reading or being presented with the information on the informed consent, the participants must sign and the researchers must collect the signed consent forms. The informed consent must contain all the elements required to be present in an informed consent, so it is highly recommended that you used the informed consent template found on the IRB website. It comes template with all the typical sections required on an informed consent so it is less likely that any necessary elements will be missing. You may draft your own consent document, but please make sure all the necessary elements are included.
If you will be conducting an online survey for which it will not be feasible to easily collect a signed consent form, then you may use an online consent form instead. The online consent needs to have all the same elements as a written informed consent but does not require the participants to sign or the researcher to collect them. The same consent template found on the IRB site can be used to draft the online consent, except that the signature blocks at the end should be removed and replaced with language suitable for administering consent online. For example, the signature blocks could be replaced by a button that, when clicked, indicates consent and allows the participant to proceed to the actual survey. The online consent document should be the very first page of an online survey that the participant must indicate consent on and navigate past in order to access the survey.
The readability of the consent document (written informed consent or online consent) must be at the 8th grade level or below. The readability level can be assessed using various indices that quantify the reading level. We use the Flesch-Kincaid index to measure readability levels and the consent documents must have a score in the 8th grade range or below (a FK score of <9.0).
The document “Tips on Adjusting Readability” that can be found on the IRB site provides detailed guidance on how to determine the readability level of a document and also on how to adjust the readability level down. It is very likely that the initial draft of your consent document using normal “everyday” language will have a Flesch-Kincaid readability score that is too high and your document will have to be revised in order to adjust the FK score down. Please make sure you determine the FK readability score of your consent document before you submit your application to the IRB for review and revise the language until it falls within the acceptable range (8th grade level or below, which is <9.0).
Not having checked the readability score and submitting consent documents for which the readability level is too high is one of the most common issues that requires revisions and increases the turn-around time for processing applications.
A waiver of the informed consent may be obtained only in certain situations, not simply because a researcher requests one. Justification must be provided if a waiver is requested and the request would only waive the requirement to collect a signed, written consent form. It does not waive the requirement of the researcher to provide all the information normally found in an informed consent form to the subjects nor to requirement of the researcher to obtain an informed consent from the participant. It just waives the requirement of obtaining such informed consent in writing (i.e. the participant does not have to sign and the researcher does not have to collect the signed consent form). If you are conducting an online survey, you should still inform the participants of their rights by using an online consent.
It is highly recommended that you use the informed consent (or online consent) template that can be found on the IRB website as it has all the necessary elements required in an informed consent. You can draft your own informed consent, but it must contain all the necessary elements. If it does not, it will require revisions to do so before your protocol can be approved.
Researchers should utilize recordings or photographs of particpants only when necessary for the purposes of the research.
Researchers must obtain explicit consent from participants for taking audio or video recordings or photographs. This consent is in addition to the consent obtained for participation in the research. The informed consent document should include a separate signature line for consent to recordings or photographs. The informed consent document should provide information about who will have access to the recordings, how they will be used, where they will be stored and how/when they will be destroyed.
Researchers should make it clear to prospective participants during recruitment that recordings and/or photographs will be part of the research process.