Recruitment and Informed Consent
Recruitment of Subjects
Many research studies involve recruiting potential subjects by advertising in newspapers, posting messages on websites, using flyers on bulletin boards, or through other media. Recruitment may also involve contacting individuals listed on rosters provided by organizations. In classroom research, the recruitment material used could be a verbal script. Such advertising is an extension of the consent process for the research, and investigators should keep in mind that these procedures are subject to review and approval by the IRB. Investigators are not permitted to proceed with recruitment of subjects until an Approval or Exemption Determination letter is first provided by the IRB/ ORP.
Investigators are permitted to discuss the use of a particular site in their research to prepare for and/or to determine viability of the research prior to obtaining approval or exemption determination from the IRB/ORP.
What Does "Informed Consent" Mean?
Informed Consent is an agreement made voluntarily by subjects to join a research study. The goal of the consent process is to provide sufficient information about the procedures, risks, benefits, and other relevant topics in the study such that a subject can make an informed decision about whether or not to enroll in a study. Being fully informed is a basic requirement in all human subjects research, and the information provided must be presented in a manner that is understandable to subjects.
What Types of Informed Consent Exist?
Signed Informed Consent- Used most commonly, signed informed consent allows prospective subjects to document their agreement to take part in research activities by signing and dating the consent document.
Waiver of Written Documentation of Informed Consent- A waiver of written documentation of informed consent is a request whereby informed consent will be obtained from subjects; however, subjects are not required to sign a consent form. Examples include verbal and implied consent processes. In order to approve a waiver, the study must meet one of the following criteria (The IRB will determine this based on the information provided by the investigator in the proposed research protocol):
The only record linking the research subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality (participant must be asked if he/she want documentation) OR
The research presents no more than minimal risk of harm to subjects and involves no procedure for which written consent is normally required outside of the research context (for example, minimal risk surveys or interviews)
PLEASE NOTE: The IRB will take into consideration the risks and potential harms involved in the research and consent process before granting a waiver of documentation of informed consent.
Waiver or Alteration of the Consent Process- A waiver of informed consent is a request to: (1) alter some or all of the required elements of informed consent or (2) completely waive the requirement to obtain informed consent. The IRB may approve a consent procedure which does not include or alters some or all of the required elements of informed consent provided all of the following are true:
The research involves no more than minimal risk
The waiver of informed consent will not adversely affect the rights and welfare of the subjects
It is not practicable to conduct the research without the waiver or alteration
Whenever appropriate, subjects will be provided with additional pertinent information after their participation
Examples of types of studies in which some or all elements of consent have been waived include retrospective chart reviews, studies of existing pathology specimens, ethnographic research, studies that require deception or passive (opt-out) consent. PLEASE NOTE: The IRB will take into consideration the risks and potential harms involved in the research and consent process before granting any waiver.
The consent form templates are located in the IRB Library (within the "Templates" tab) in CATS-IRB. Additionally, please refer to theInvestigator Manual (HRP-103) for information regarding development of consent documents and documenting participant consent.
To Access the IRB Library:
- Go to CATS-IRB
- Log in with your Penn State Access Account Username and Password
- Click on "IRB" (below the CATS logo in the upper left-hand side of page)
- Click on "Library" (left margin)
- Click the appropriate tab (Standard Operating Procedures, General, Worksheets, Checklists, Templates)
Please see FERPA for additional consent requirements when accessing student educational records.
For additional information regarding recruitment and informed consent, please see the Investigator Manual, located in CATS-IRB