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Informed Consent is a Process, not Just a Piece of Paper.
Informed consent is necessary for all subjects in a human research study to ensure that they have been fully informed of their rights and their level of participation. Participants must be given all information regarding the study that would be relevant to their decision in order to make an informed decision to participate.
Changes to Common Rule
Effective January 21, 2019, the requirements for informed consent will change, with the addition of:
- Key information to be presented at the beginning of the consent form
- New consent elements
- Changes to waiver criteria and documentation (plus other process changes)
- A broad consent option for unspecified future use of identifiable data/bisopecimens
The intent of these changes is to facilitate the subjects' understanding of the proposed research and also ensure that they understand how their data and biospecimens may be used.
NEW: Key Information
The preamble to the Final Rule (revised) lists five (5) factors as suggested "key information" that would likely assist a potential subject in understanding the nature of the project and in determining participation:
- A statement that the project is research and participation is voluntary
- A summary of the research, including:
- List of procedures
- Reasonable, foreseeable risks or discomforts
- Reasonable, expected benefits
- Alternative procedures or course of treatment, if any
How a study team applies the "key information" requirement, and to what level of detail, will depend on the complexity of the research project. The Final Rule preamble includes some considerations regarding the application of this requirement, but further federal guidance is expected at a later date.
NEW: Revised Consent Elements
When your project will involve the collection of identifiable private information, the informed consent must include a statement indicating whether identifiers may be removed and de-identified information may or may not be used or shared for future research.
NEW: Broad Consent
Broad consent relates to storage, maintenance and use of data or specimens. The use of Broad Consent is optional and The College at Brockport will not be adopting it at this time.
NEW: Use of Identifiable Private Information
A waiver of informed consent for the secondary use of identifiable private information must justify why the use of identifiers is necessary to carry out the research. Use of identifiable information to identify potential subjects (i.e., screening for recruitment purposes) is allowed without informed consent under certain circumstances.
Current Guidelines for Informed Consent
Consent shall be documented by the use of a written consent form approved by the IRB and signed by the participant and/or their legally authorized representative. In the case of minors (17 years of age or younger), the parent or legal guardian must give consent as well as the minor. A copy of the consent form will be given to the person signing the form, and the original signed form must be maintained in a place designated in your project description.
Waiver or Alteration of Documentation of Informed Consent
When informed consent is required, the IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either:
- That the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research and the subject’s wishes will govern; or
- That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context (e.g., asking a therapy patient about pain level, or asking shoppers in a mall about the ambient lighting or temperature)
Some subjects might refuse a copy of the consent form once signed out of concern that their possession of the form could compromise their privacy. This is fully consistent with the idea behind one of the bases for a waiver of the requirements for documentation of informed consent--that harm would result to the subject if his/her identity were compromised by the documentation itself. The investigator may document that the subject refused a copy of the informed consent document and still include the subject in the study.
Informed consent can be presented verbally or in writing. Consent can also be obtained electronically. Even when signed informed consent is waived for a given study, a statement of informed consent is still required.
IRB Approval of Consent Form
The final consent form that you plan to use must first be approved by the Institutional Review Board before it can legally be administered, and the IRB must by law retain in its records a sample copy of that form. Approval by the IRB applies only to the procedures submitted in the proposal.
Waiver or Alteration of Informed Consent
A researcher may request a waiver or alteration of the elements of informed consent if ALL of the following apply:
- Research is no more than minimal risk;
- Research could not be carried out without requested waiver/alteration;
- Waiver/alteration will not adversely affect the rights and welfare of participants; AND
- When appropriate, additional information will be provided to participants after they have completed the study.
In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects or the parents of children who are subjects with a written statement regarding the research.
The following elements must be included in the informed consent form.
- A statement that the project is research and participation is voluntary.
- Statement that the research is being conducted through the College at Brockport.
- Official name of any institution fully spelled out (e.g., Greater Rochester Collaborative Masters in Social Work Program through SUNY Brockport and Nazareth College).
- Explanation of the purpose of the research and the expected duration of the participant's involvement (e.g., how long will it take to complete the survey and number of questions).
- Description of the procedures to be followed and identification of any procedures which are experimental.
- Alternative procedures or course of treatment, if any
- Description of any benefits to the participant or to others which may reasonably be expected from the research.
- Description of any reasonably foreseeable risks and discomforts to the participant, including loss of time.
- Statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained, stored for how long, and how destroyed.
- For research involving more than minimal risk, an explanation as to whether any medical treatment is available if injury occurs; or counseling available for questions that might be sensitive, and if so, what they consist of, or where further information may be obtained.
- Statement that refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled.
- Statement that participant may discontinue participation at any time without penalty or loss of benefits to which the participant is otherwise entitled.
- Name, phone number, and email information of whom to contact for answers to pertinent questions about the participant’s rights, and whom to contact in the event of a research-related injury to the participant.
Please note the following additional items that should be included in any consent form if applicable to your project:
- Studies conducted in classrooms/school settings/institutions When appropriate, include a statement that participation in the research will not affect participants' grades, services or class standing.
- Taping (audio and video) If you are audio- or videotaping, you have two options.
a) If you require participants to consent to the taping in order to participate, you should clearly state this in the consent form in the study description section.
b) If it is acceptable for participants to refuse taping and still participate, you should include a separate section for taping information at the end of the consent form with a separate signature line for consent to the taping, as well as a description of how you will collect information without taping.
- Compensation for participation Include the type and description of the compensation and the procedures to obtain compensation. Please note whether participants will receive compensation even if they don't complete the study. If you are paying participants more than $600 annually, please review compensation guidelines on this website.
- Referrals If the study has the potential to arouse questions and concerns in participants (e.g., questions about substance use, gender issues, etc.), you must include an agency and phone number for participants to contact if they feel the need to do so, such as the College Counseling Center.
- Focus Groups Please include the following statement: “Confidentiality cannot be guaranteed in group situations. Other participants in your group will know how you answer questions. While we will discourage anyone from sharing this information outside of the group, we cannot guarantee confidentiality by other group members. We will do our best to keep all of your personal information private and confidential but absolute confidentiality cannot be guaranteed.”
If the research cannot practically be completed without some or all of these requirements being waived or altered, please explain why in your proposal and include a debriefing procedure.
Consent form templates can be found on the Forms page of the IRB site.
When working with minors:
If you will be working with minors, you must provide two separate forms: 1) an informed consent for parent/guardians; 2) a statement of assent for minors (17 years of age and younger).
The minors’ form should be in language that is developmentally appropriate. The essential information given to the child must include a description of the procedures and clear indication that their participation is voluntary. If the research is being conducted in schools, it must be clearly stated that this research is not part of the child's regular school program, not being conducted by the school, and that participation—of lack thereof—will not affect the child's grade.
In cases where there is inconsistency between the consent of the parent and the agreement of the child, the following rule will be followed: A "no" from the child overrides a "yes" from the parent, but a "yes" from the child does not override a "no" from the parent.
There are examples of assent forms for elementary, middle and high school students on the IRB website that can be adjusted for your needs.
When working with a class or group:
When research is being conducted as part of a class or group, the investigator must detail alternatives for those in the class not participating in the research (whether or not minors are involved). For example, if extra credit is being offered for participation, then the researcher must detail how those not participating will have an alternative method of obtaining extra credit. This is to minimize coercion to participate.
If an investigator is conducting research in a classroom where s/he will be observing, interviewing and taping the class, please explain the procedures to be followed for those children in the class whose parents have not given permission, or where the child does not agree to participate in the research.
Templates that meet the federal criteria for informed consent are in the Forms section of the IRB website, as well as a document that lists all the requirements of informed consent if the PI wishes to draft their own document(s). The IRB encourages researchers to use these templates.
Please note that informed consent must be at a reading level that is comprehensible to all potential participants whether it is read by or to the participants. In general, ordinary language should replace technical terms (e.g., upper extremities are better referred to as arms, venipuncture as taking blood from your arm with a needle, and so forth). If you will be presenting the consent form to study participants who do not speak or read English, the consent form must be translated accordingly.
There are also examples of statements of minor assent available at Forms.