Each potential research subject must be provided with a complete and understandable explanation of the study and an opportunity to have all their questions answered.
The potential subject should have sufficient opportunity to read the approved informed consent and, if qualified, freely decide to enter the study. In most studies, the potential subject should have the opportunity to take the consent home for further consideration.
Informed consent must be obtained and documented before the initiation of any study-related procedures. Written consent must be obtained from a fully informed subject or, if the Board determined that it is appropriate, from the subject’s parent/guardian(s) or Legally Authorized Representative (LAR). The informed consent process must be recorded in the source documentation.
In large research settings, investigators may choose to provide research information in a group setting. However, individual discussions of private information as well as decision to participate must be conducted in a private one-on-one setting.
It is the investigator’s responsibility to explain the role of the IRB to potential subjects. As part of the explanation, the investigator must inform potential subjects that they may contact Schulman by phone or mail with any questions they may have regarding their rights as research subjects or with regard to complaints they may have about the study. Schulman lists a toll free telephone number and address in all Schulman-approved informed consent documents.
Informed consent is an ongoing process. Investigators are responsible to provide subjects with an ongoing explanation of the research and any new information that may arise — verbally and in writing — that would affect their willingness to continue participating in the research. Schulman has the authority to observe the consent process and may request to do so at any time.
For information on specific informed consent activities, please review:
Additional Protection for Children
Federal regulations require additional protections for children involved in research, which require the reviewing IRB to further evaluate the research to determine the appropriateness of enrolling children.
Federal regulations define children as persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted. Although the assumption is commonly made, capacity to consent for medical treatments or procedures is generally limited to the specific situation involved and should not normally be relevant to capacity to consent to participate in research. The only clear standard for capacity to consent to research is the age of majority in the jurisdiction where the research will be conducted. This standard equates minors, according to local laws, to children, as defined by federal regulations.
Investigators and research sites are responsible for knowing and following the applicable laws in their jurisdiction that establish the age of majority. Additionally, many local laws provide for an emancipated minor exception. Emancipation refers to a legal process of freeing a minor from parental/guardian control before reaching the age of majority. The process for emancipation varies by jurisdiction and investigators and research sites are responsible for identifying these individuals according to applicable laws in their jurisdiction as well.
While investigators and research sites are strongly encouraged to consult with local attorneys or government offices with questions about the legal age of majority in their jurisdiction, Schulman offers the following resources to assist:
In reviewing research involving children, the IRB must determine the risk and prospect of direct benefit to the individuals. Additionally, the IRB must determine that adequate provisions are made for soliciting the assent of the children and the permission of each child’s parents or guardian.
Parent means a child’s biological or adoptive parent. Guardian means an individual who is authorized under applicable state or local law to consent on behalf of a child to general medical care. Investigators and sites should be cautious in allowing legal guardians to consent for children, as guardianship documents may not address the issue of consent to participate in research studies and would, therefore, be insufficient for this purpose. We advise investigators to obtain and review a copy of the guardianship document to determine if the guardian is authorized to consent to the child’s participation in research. A copy of the guardianship document should be attached to the IC.
Permission means the agreement of the parent(s) or guardian(s) to the participation of their child in research. Depending on the IRB determinations, one or both parents/guardians must give permission for the child to participate in the study and sign the Informed Consent (IC). For instance, both parents must give permission if the IRB determines that the research involves more than minimal risk with no prospect of direct benefit for the child.
Assent means a child’s affirmative agreement to participate in research. The IRB determines if assent is required for a particular study, but in most cases children should be asked to provide assent. Depending on the child’s age, he or she may be asked for verbal assent and to sign a separate assent form or sign an assent signature line on the main IC. In certain cases the IRB may waive the requirement to obtain assent where it is determined in the best interest of the child.
In an attempt to avoid undue influence in the recruitment of children for research, Schulman does not allow recruitment materials for studies involving children to contain references to specific compensation/reimbursement amounts. When applicable, Schulman does allow a site to state in its recruitment materials, “You will be compensated for participation in this study” or “You may be reimbursed for time and travel.” When possible, any compensation/reimbursement should be allocated to both parent(s)/legal guardian(s) and child.
Consent via LAR by Telephone
In certain situations, the IRB may allow a Legally Authorized Representative (LAR) to consent on behalf of a subject. If the LAR cannot be present, the consent discussion may be conducted via telephone. The investigator or designee should first contact the LAR to obtain, via fax, documents such as health care power of attorney or a copy of the court document appointing the LAR as legal guardian and personal identification. Once the identifying documents are received, the Informed Consent (IC) must be faxed to the LAR prior to the consent discussion. The investigator or designee must review the IC and conduct a complete consent discussion with the LAR over the telephone. An independent witness (an individual not employed by the research site) must participate in the telephone call to attest to the understanding of the LAR. The LAR must sign the IC and fax it back to the site and then mail the original within 24 to 48 hours of the discussion. The person conducting the consent discussion and the independent witness must sign the IC and note that the discussion occurred via telephone. A copy of the signed IC should be faxed back to the LAR
Mailing an Informed Consent
You must obtain the Board’s approval prior to presenting an Informed Consent (IC) to a subject by mail. To request approval, provide written rationale for not presenting the IC in person, and the sponsor’s approval (if applicable). The request must reference the approval date or Schulman version date of the consent.
Pregnant Partner Consent
Schulman IRB regards the pregnant partner of a human research participant about whom a researcher seeks to collect information to be a “human subject” as that term is defined in DHHS regulations 45 CFR § 46.102. Human subject means a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual or (2) identifiable private information. Schulman also regards the pregnant partner to be a “participant” in the research under FDA regulations 21 CFR § 50.3 (g).
Accordingly, Schulman’s position is that legally effective informed consent must be obtained from such individuals prior to any interaction by an investigator or study team with a pregnant partner of a human research participant.
When, during the course of a study, a pregnant partner is identified, Schulman will work with clients to develop an appropriate form of consent and Board approved consent process suited to the individual case.
The Board will not prospectively review a pregnant partner consent when no pregnant partner has yet been identified.
To request Schulman’s template pregnant partner consent document, please contact Submissions.
To request Board review of a pregnant partner consent, please complete and submit the Pregnant Partner Request Form