Frequently Asked Questions

What is an Institutional Review Board (IRB)?

An Institutional Review Board (or IRB) reviews all research involving human subjects to implement institutional policies and procedures during research. The primary function of the IRB is to protect the rights of human subjects who participate in research studies.  The Misericordia University IRB is composed of faculty, staff, and community members (scientists and nonscientists) who review and approve research studies, assess the potential risks of research, and minimize those risks for participants. 

The IRB is guided by three ethical principles: respect for persons, beneficence, and justice. These three principals are found in the Belmont Report. A copy of the Belmont Report can be found here. Additionally, the Nuremberg Code and Declaration of Helsinki specifically emphasize that a study is designed so that risks to subjects are minimized and potential benefits justify potential risks giving the IRB an obligation to review study design and scientific quality.  Reference: Bankert, E. A., & Amdur, R. J. (2006). Institutional review board: Management and function (2nd ed.). Boston, MA: Jones & Bartlett.

What is human subjects research?

“Human Research” (according to Department of Health and Human Services (DHHS) includes two components: 
1.    “Research”: A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.
2.    “Human Subject”: A living individual about whom an investigator (whether professional or student) conducting research (1) obtains information or biospecimens through intervention or interaction with the individual, and uses, studies or analyzes the information or biospecimens; or (2) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
In research where information about you (your thoughts, feelings, experiences, reactions to an intervention) is collected, and could contain identifying information about you, you are considered a human subject.  The use of human subjects in research imposes both ethical and legal responsibilities for researchers and at Misericordia University.  The IRB and those conducting the research to ensure that your rights and welfare are protected.

How do I know my rights are being protected during a study?

The IRB reviews and approves research studies, assess the potential risks of research, and minimize those risks to you before studies can begin.  Researchers do all that they can to achieve the ethical principles outlined in the Belmont Report. Generally, researchers protect you from harm by identifying and minimizing the risks involved in the research; assuring that your participation is voluntary; being certain that you are properly informed of what their participation will entail (this is usually conveyed in an informed consent process); selecting subjects fairly (selection should be based on fair procedures so that one group is not overburdened, overused or unfairly favored or discriminated against); and assuring that your identity and response to research procedures are protected.

What if something bad happens to me during the research?

If you feel that your wellbeing or privacy have been compromised in any way, or that the research study is not being conducted in a way that was presented to you during the consent process, notify the principal investigator immediately of your concern.  Contact the IRB Office at irb@misericordia.edu or the IRB Administrator, Jessica Kisenwether, jkisenwether@misericordia.edu, if you feel your rights as a research subject have been jeopardized.

Who do I contact if I have questions about being a research study participant?

You may contact the IRB Office at irb@misericordia.edu or Jessica Kisenwether, Misericordia University IRB Chair and Administrator, at 570-674-8408 or via email at jkisenwether@misericordia.edu. 

What is informed consent? 

Informed consent is not a document; it is a process that begins with recruitment and continues until the subject's participation in the research is completed.  Consent is usually documented on a written consent form but the process could take place via some other media (e.g. video, DVD, computer, etc.). Under some circumstances, the IRB can waive the requirement for documentation of consent, such as when you might take an online survey with consent information but no signature line, where the informed consent form would be the only document linking you to the study, and participation in the study is no more than minimal risk to you.  Adapted from and used with permission: Children’s Hospital of Philadelphia Research Institute. (2020). Informed consent & documentation: The informed consent process. https://irb.research.chop.edu/informed-consent-documentation

What will I find in a consent form?

An informed consent form will outline and contain the following information to help you make an informed decision on whether or not you want to participate in a research study.  This includes:
1.    Researchers and study personnel
2.    Purpose of the study
3.    Duration of the study and detailed description of each step of the research
4.    Compensation, if any
5.    Risks and benefits to participation
6.    How your data will be used and protected
7.    Contact information of the primary researcher and the Institutional Review Board
The informed consent form will also include a section for you to sign, date, or otherwise indicate your consent to participate in the study.

Can my child participate in research / what is assent?

Children (individuals under the legal age of 18 years old) have neither the legal status nor the development capacity to understand many of the issues inherent in providing informed consent. Since no one can consent for another, a substituted process of protections are in place for children, called assent. Parents must provide their permission for a child's participation in research just as they provide permission for clinical care and the child must assent.
Under some circumstances minors are not considered to be children under the research regulations. Whenever they are permitted under state law to consent to their own treatment, they may consent to their own research participation.
Clinicians and investigators must establish procedures to determine who is legally permitted to grant permission (consent) from children and adults with diminished capacity who are unable to consent for themselves.  This policy applies not only to consent for treatment but also to consent for research participation.  Adapted from and used with permission: Children’s Hospital of Philadelphia Research Institute. (2020). Informed consent & documentation: Parental permission and assent. https://irb.research.chop.edu/informed-consent-documentation

What will I find in an assent form?

Information found in an assent form will mirror what is in the informed consent form, which will also need to be completed by the assentee’s parent or legally authorized representative (LAR), for the assentee to participate in a research study.  The language of the assent form should be written in a way that is appropriate to the age and cognitive abilities of the assentee, and must include:
1.    Researchers and study personnel
2.    Purpose of the study
3.    Duration of the study and description of each step of the research
4.    Compensation
5.    Risks and benefits to participation
6.    How your data will be used and protected
7.    Contact information of the primary researcher and the Institutional Review Board
The informed consent form will also include a section for the assentee to sign, date, or otherwise indicate their assent to participate in the study.  Even if the parent or LAR completes their informed consent form, this does not mean the assentee has to participate in the study if they do not want to or will not complete the assent form.

What is a legally authorized representative (LAR)?

A legally authorized representative (LAR) is the individual designated in accordance with state law to consent for an adult who is incapable of providing consent.  Adapted from and used with permission: Children’s Hospital of Philadelphia Research Institute. (2020). Informed consent & documentation: Legally authorized representative. https://irb.research.chop.edu/informed-consent-documentation

Are there any groups of people for whom participation in research creates a higher risk that I should be aware of before deciding to participate in a study?

Yes.  The Misericordia University IRB follows federal guidelines in considering whether or not research can be conducted with vulnerable populations, including:
1.    Pregnant women
2.    Human fetuses
3.    Neonates
4.    Prisoners
5.    Children
6.    Individuals with physical disabilities
7.    Individuals with mental disabilities or cognitive impairments
8.    Economically disadvantaged
9.    Socially disadvantaged
10.    Terminally ill or very sick
11.    Racial or ethnic minorities
12.    Institutionalized persons (for example, persons in correctional facilities, nursing homes or mental health facilities)
Federal guidelines and the Misericordia University IRB require extra protections for studies that involve these groups before the study can be approved.  
Though there are no federal regulations that provide explicit protections for Misericordia University students as participants in research studies, the involvement of students as research participants may present special concerns as outlined in the IRB Policies and Procedures document.  Adapted from and used with permission: Swarthmore College. (2020). Vulnerable populations. https://www.swarthmore.edu/institutional-review-board/vulnerable-populations

What training/education is required for the researchers?

All researchers who are Misericordia University faculty, staff, students, individuals obtaining consent, or key research personnel, must complete training in the protection of human research participants, specifically Collaborative Institute Training Initiative (CITI) courses, prior to obtaining IRB approval. Information on this training can be found under CITI Training Information. All Misericordia University affiliates have free access. All student researchers must have a faculty advisor to conduct research at Misericordia University.

Who will have access to my personal details or health information?  

Access to your personal or health-related information disclosed to researchers as part of the study are outlined in the informed consent document and vary from study to study.  If you have questions about who will have access to your personal information, ask the principal investigator of the study for more information.

Will my personal information be published or presented to others outside of the study?

Human subjects research is often conducted to present new information in a scientific or academic arena, generally shared through the publication or presentation of the study’s results.  How your own personal information will be used individually, or grouped with others, in identifiable or de-identified formats is outlined in the informed consent document.  If you are concerned about your identifiable personal information being shared, contact the principal investigator of the study for more information.  

Can I withdraw from a study?

Yes.  You may withdraw from any study, at any time, for any reason, with no penalty to services or benefits to which you are otherwise entitled.  You can request that your identifiable data be removed from the study, by asking the principal investigator of the study to do so.  In many cases, however, if your data have already been de-identified (that is, all information that can be linked to you personally has been removed), it may be impossible to remove your specific information.

Should I talk to my doctor before participating in a study?

If you are concerned that participating in a research study may exacerbate an existing condition, interfere with a current course of treatment, or if you have medically relevant questions, please consult with a physician before enrolling in a study.  Studies will sometimes require you to do so before participating as outlined in the study’s recruitment and/or informed consent materials.

Do I get paid for participating?  What are the benefits to me?

Any direct benefit or compensation to you will be outlined in the study’s recruitment and/or informed consent materials.  Please contact the principal investigator of the study for more information.  

Are there any direct risks to me for participating in a study?

The IRB reviews and approves research studies, assess the potential risks of research, and minimize those risks to you before studies can begin.  Any direct risks to you for participating in a study will be outlined in the study’s recruitment and/or informed consent materials.  Please contact the principal investigator of the study if you have any specific concerns. 

What is an intervention?

A physical procedure by which data are gathered (for example, a therapeutic session), and you or your environment are adjusted for research purposes.

What is an interaction? 

Communication or interpersonal contact between investigator and subject.  This could be done in person, email, phone, or any other means of communication.

What is private information?

Information about behavior that occurs when you can reasonably expect that no observation or recording is taking place.  Also, information which has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (for example, a medical record).

What is identifiable private information?

Private Information for which the identity of the subject is or may readily be found out by the investigator or associated with the information.

What is an identifiable biospecimen?

A biospecimen for which the identity of the subject is or may readily be ascertained by the investigator or associated with the biospecimen.

How are information or data de-identified?

The Department of Health and Human Services (DHHS) provides the following information on de-identification:
The process of de-identification, by which personal identifiers (such as your name, birthdate, address, contact information, biometrics, etc.) are removed from your data, reduces privacy risks to individuals.  Sometimes de-identified data can be used in the future for secondary purposes of data for comparative effectiveness studies, policy assessment, life sciences research, and other endeavors.  Even when properly applied, de-identified data retains some risk of identification.  Although the risk is very small, it is not zero, and there is a possibility that de-identified data could be linked back to the identity of the participant to which it corresponds.  Reference: Office for Civil Rights Headquarters. (n.d.). Guidance regarding methods for de-identification of protected health information in accordance with the Health Insurance Portability and Accountability Act (HIPAA) privacy rule. U.S. Department of Health and Human Services. https://www.hhs.gov/hipaa/for-professionals/privacy/special-topics/de-identification/index.html

What is anonymous information?

Anonymous means entirely without name or identifier, so that you cannot be discerned in any way by anyone. No one can link an individual person to the responses of that person, including the investigator. For this reason, face-to-face interviews are never anonymous. If phone numbers or other identifiers are not stored, then telephone interviews could be considered anonymous. Mailback questionnaires are considered anonymous only if no tracking codes are utilized.  Web-based surveys that are accessed through a common URL for the survey (instead of via individualized passwords or tracking codes) may be considered anonymous if they do not ask the respondent for any identifying information. However, some Web survey tools could collect the IP address of the respondent’s computer, and this factor must be considered when determining the anonymity of the data collection process.  Adapted from and used with permission: American Association for Public Opinion Research. (2020). IRB FAQs for survey researchers: Q. What is the difference between 'anonymous' and 'confidential'? How can confidentiality be maintained? https://www.aapor.org/Standards-Ethics/Institutional-Review-Boards/IRB-FAQs-for-Survey-Researchers.aspx#question8

What is confidential information?

Confidential means that the investigator can (or could) identify individuals who participated in a study, perhaps through a code sheet.  However, the investigator will not share confidential information to anyone other than authorized individuals. Although the identities may be recorded, data can be kept confidential if they are carefully coded, if face sheets (paper questionnaire cover sheets with respondent identifiers) and consent documents are separated from survey instruments, if computer printouts that show respondent identifiers and other papers are properly disposed, if access to identifiable data is limited, if research staff are educated about the importance of protecting confidentiality, and if records are stored in secured locations. More elaborate procedures may be appropriate for research involving sensitive data that may involve a greater risk to the participant should confidentiality be breached.
Confidential surveys may, for instance, still be eligible for exemption if any disclosure of the human subjects' responses outside the research could not possibly place them at risk of criminal or civil liability or be damaging to their financial standing, employability, or reputation.  Adapted from and used with permission: American Association for Public Opinion Research. (2020). IRB FAQs for survey researchers: Q. What is the difference between 'anonymous' and 'confidential'? How can confidentiality be maintained? https://www.aapor.org/Standards-Ethics/Institutional-Review-Boards/IRB-FAQs-for-Survey-Researchers.aspx#question8