Investigators are advised to review the general instructions and helpful hints to create a consent form. Contact the ORPC at 5-2737 or firstname.lastname@example.org with questions
Provisions for confidentiality must be specified as well as a description of procedures for protecting privacy, including specific information regarding how data will be stored to ensure security and confidentiality. If data are to be in the form of audio/video tape recordings or photographs, procedures protecting confidentiality should be described. Be sure to describe to participants the steps used to preserve confidentiality. In the course of certain projects, confidentiality may not be absolute or perfect. This must be expressed to participants. There are some circumstances where research staff might be required by law to share information provided by participants. For example, if an interviewer has reason to believe a child or elderly person is being neglected or abused (or has been abused), the interviewer is required by Maryland state law to file a report with the appropriate agencies. Similarly, if a participant reports he/she has been abused in the past, the interviewer may also have to file a report. An interviewer may also find it necessary to warn an intended victim, notify police or seek hospital based treatment for a participant, if a participant threatens serious harm to him/herself of another person. An explanation in the consent form, in this section, must be provided in clear, non-jargon language.
An anonymous study means there is NO WAY ANYONE can tell if a person was a participant in the study and they cannot be identified by the information they give, (including the investigator). Even if data is coded, it can be de-coded and become identifiable. A confidential study means that while their identity potentially could be determined from the information they give, steps will be taken to insure that they will not be identified. Be sure to describe to participants the steps used to preserve confidentiality. A study cannot be both confidential and anonymous. If confidentiality/anonymity cannot be ensured, clearly state this under the “risk” section of the consent form.
Federal regulations at 45 CFR 46.117 require written informed consent, one that is approved by the IRB and signed by the participant or the participant’s legal representative and the principal investigator (or his/her delegate). Consent forms should be signed by the person actually administering consent, at the time consent is administered, attesting to the informed consent conversation. The delegate acts as the agent of the principal investigator and must be able to represent the study with full knowledge and authority to prospective participants; this person should be listed in the “Offer to Answer Questions” section of the consent form, as well as a member of the research team on the protocol application. At no time should the consent forms be pre-signed by the members of the research team.
The originally signed and dated consent document (with the IRB approval stamp sent with protocol approval letters) is valid for the approved time period the subject participates in the research. Participants do not need to re-sign a consent form throughout the term of the protocol approval period. Only subjects who are new and added to the existing pool of participants must sign a consent form.
If your project has an approved “waiver of written consent”, the IRB will expect you to document how and when consent was obtained. This may be in the form of a consent log (paper based, spreadsheet, etc.) that tracks the consent conversation and may be used as part of protocol file. Here is an example of a consent tracking log.
Revisions to previously approved consent forms may occur during a project period due to changes in procedures or identification of serious or adverse events. These revisions must be documented using the protocol modification process or at the time of continuing renewal. In any event, all participants who had previously signed a consent form must be provided this new information with the option of remaining in the study.
Documenting child assent
Children are considered a vulnerable research population because their intellectual and emotional capacities are limited and they are legally incompetent to give valid consent. Special procedures and considerations are, therefore, required by the Federal regulations for the review of research involving children. “Children” are 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 http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#subpartd
In most cases, these are individuals under the age of 21 years. However, in the state of Maryland, individuals are adults and of legal age (released from parental authority), when one attains the age of 18 years. Minors are those individuals who have not attained the age of eighteen years (source: http://mlis.state.md.us/asp/statutes_respond.asp?article=g1§ion=24&Extension=HTML).
In almost all cases, written consent from a parent or legal guardian must be obtained if the research involves children under the age of 18. In cases where child abuse is an issue, the requirement for parental consent can be waived.
Documentation of assent is required for participants between the ages 7 and 18 years of age unless the participant is incapable, either mentally or emotionally, of being reasonably consulted about participating. The assent form, submitted to the IRB for review, should include a simplified version of the elements of informed consent, such as an explanation, at a level appropriate to the child’s age, maturity and condition, of the procedure(s) to be used, their meaning to the child in terms of discomfort and inconvenience, and the general purpose of the research. As mentioned above, if your project has an approved “waiver of written consent”, the IRB will expect you to document how and when consent was obtained.
The consent form (for parents/guardians) and assent form (for minors) must be prepared as two separate documents. (NOTE: Participants under the age of 18 will need to complete an Assent form; a separate parental consent form is required for these participants providing parental permission to participate)
Waiver of Parental Permission and Cosent
A waiver of the requirement for parental permission if the research protocol is designed for conditions or for a subject population for which parental or guardian permission is not a reasonable requirement to protect the subjects (for example, neglected or abused children), provided that an appropriate mechanism for protecting the children who will participate as subjects is substituted, and that the waiver is not otherwise inconsistent with federal or state law (45 C.F.R. 46.408(c)) . When requesting a waiver of written documentation of consent under 45 CFR 46.116, 45 CFR 46.117, or 45 CFR 46.408(c), a justification must be provided. The type of research will need to be minimal risk or less.
Using the consent process in exempt review
Although a study is granted an exemption from IRB review, investigators are ethically bound to follow the principles listed in the Belmont Report, particularly the first principle, respect for persons, which emphasizes the importance of ensuring that subjects are fully informed about the nature of a research project in order to make an informed decision to participate. The use of a signed consent document, for example in cases of anonymous data collection, would not be required, but those participants must be informed about the purpose of the study. An investigator will provide a participant an IRB approved information sheet or use an oral consent script explaining the purpose of the study, how the data will used, how the data will be kept anonymous, etc.
At a minimum, the consent process of exempt studies must provide participants the following:
- Whom to contact about the study
- Brief description about the nature of the study.
- Time required for participation.
- Nature of data recorded (statement that data are recorded anonymously and/or no personal identifying information would be collected).
- Statement that participant can skip any questions.
- Statement that participation is voluntary
- Contact information for the IRB.
Waivers of Informed Consent
Under certain circumstances, the use of written consent documents may be waived or alteration of the consent process may be approved. The IRB will take into consideration the risks and potential harms involved in these requests to approve.
Waiver of Documentation of Signed Informed Consent
- Researchers can request that a participant not be required to sign a consent form prior to participation. In order to waive the signature requirement, referred to as verbal consent, ONE OF THE FOLLOWING must be applicable to the study:
- Informed consent is more of a conversation process, rather than a means for obtaining a signature. Federal regulations require written informed consent (meaning the use of an IRB-approved written consent form which is signed by the participant or the participant’s legal representative). Occasionally there are reasons to waive written consent or to alter the requirements of consent. Researchers are required to inform participants in written or verbal form of the primary purpose of the research project and of any procedures which they will undergo. Additionally, participants are to be informed of their rights regarding the study (voluntary participation, protecting anonymity and privacy) and any risks or benefits associated with the project.
- Research qualifying for exempt review does not require waivers of written consent from the IRB.
- The only record linking a participant to the research is the consent from in studies where the principal risk is a breach of confidentiality.
- The research is minimal risk and only involves procedures for which consent is not normally sought.
- Participants will be wary of signing documents from a cultural perspective.
To apply for a waiver of documentation of informed consent, submit a waiver of written informed consent request with the protocol application.
Waiver or Alteration of Elements of Informed Consent
In specific instances, any of the 8 elements of informed consent may be waived. To do so, ALL OF THE FOUR CRITERIA BELOW must be met:
- The research in its entirety involves no more than MINIMAL RISK to participants.
- The waiver or alteration will not adversely affect the rights or welfare of participants.
- The research could not practically be carried out without the waiver or alteration.
- Wherever appropriate, participants will be provided with additional pertinent information after participation.
To apply for the waiver or alteration, a waiver for alteration of elements of informed consent request must be submitted with the protocol application.
Note: A waiver of for alteration of elements of informed consent request is required for any study using deception. Studies using deception must also include a debriefing statement.
Waiver of the Informed Consent Process
In rare cases, the entire consent process can be waived. To waive the consent process altogether, requests for this waiver must only accompany applications submitted to the IRB for full board review. ALL OF THE FOUR CRITERIA BELOW must be met:
- The research in its entirety involves no more than MINIMAL RISK to participants.
- The waiver will not adversely affect the rights and welfare of participants.
- The research could not practically be carried out without the waiver.
- Whenever appropriate, participants will be provided with additional pertinent information after participation.
Please contact the ORPC at least four (4) weeks prior to submission a full board application if the research procedures will involve the waiver of the informed consent process.
Other consent document instructions and templates
Consent Forms Approved at Other Institutions
Many human research protocols conducted at UMBC involve collaboration with researchers from other institutions. At times, UMBC faculty members, masters and/or dissertation students are listed as a co-investigator on a collaborative project, with that institution’s IRB reviewing and approving the research protocol. External IRB institutional approval is accepted by the UMBC IRB; however, while the faculty member or student is listed on the consent documents as a co-investigator, no information is provided to potential participants of whom to contact at UMBC in the event of asking questions or addressing issues or problems. The purpose of this addition will provide complete and full information to participants about who is involved with the study and whom to contact with questions and concerns. Investigators are reminded to add a statement to the Whom to Contact section of the consent documents such as “ In addition, this study has been reviewed and approved by the UMBC Institutional Review Board (IRB). A representative of that Board, from the Office for Research Protections and Compliance, is available to discuss the review process or my rights as a research participant. Contact information of the Office is (410) 455-2737 or email@example.com”.
Certificates of Confidentiality
Certificates are issued by the National Institutes of Health (NIH) to protect the privacy of research subjects by protecting investigators and institutions from being compelled to release information that could be used to identify subjects with a research project. Certificates of Confidentiality are issued to institutions or universities where the research is conducted. They allow the investigator and others who have access to research records to refuse to disclose identifying information in any civil, criminal, administrative, legislative, or other proceeding, whether at the federal, state, or local level. Additional information and directives for Certificates of Confidentiality may be found at http://www.hhs.gov/ohrp/policy/certconf.html