Consent and Assent Guidelines

Confidentiality

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.

Maryland state abuse reporting guidelines may be found at:

Child Protective Services - http://www.dhr.state.md.us/cps/report.htm

Adult Protective Services - http://www.dhr.state.md.us/how/seradult/protect.htm

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/humansubjects/guidance/certconf.htm

Anonymity

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.

Consent Form Signatures

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) 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.

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.

Click on the below to download consent document instructions and templates:

General instructions and helpful hints to create a consent form 

A blank informed consent document

A sample parental permission (consent) form

An addendum to a currently approved consent form

Waiving or Modfifying the Requirement for Written Consent

Informed consent is more of a process, rather than a means for obtaining a signature.  Therefore, documentation of the consent process may not always be required.  Instead, verbal consent might be more appropriate for certain populations (including non-literate or politically vulnerable populations) or certain types of anonymous, low-risk research.  Verbal consent means that the potential research subject is read a verbal version (script) of the consent form. 
Information sheets may also be used to describe the study and the elements of informed consent may be left with a participant following the informed consent process, but a participant is not required to sign. Investigators must understand that a justification for a waiver is not the risk to a participant in answering the phone, carrying on a conversation, or completing a written questionnaire, but in the content of the questions and possible answers. Only the IRB can make the determination to waive some (written) or all (written and verbal) consent requirements.

Federal regulations at 45 CFR 46.117 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.  Evidence that investigators have provided participants information must be maintained in the protocol file. It is recommended that investigators keep a log of those who were approached about the study and offered verbal consent.  A simple chart, numbered sequentially without identifiers, is sufficient.

Investigators must submit a Waiver or Modification of Consent Form with the protocol application in order to be considered by the IRB.  As described above, an oral consent script or a telephone consent script must be submitted to the IRB for review and approval. Information sheets must be placed on official university letterhead and contain all the same information as a consent form would, except that it is not signed by the subject.  The information sheet must also be submitted to the IRB for review and approval. Samples of the script and the information sheet are found in the Wavier of Written Consent Request form.

To request a waiver of modificatoin to written informed consent, the investigator must specifically address this in the consent section of the IRB application and complete a Waiver or Modification of Consent Form.

The request must address the following criteria:

• The principal risks are those associated with a breach of confidentiality regarding the subject’s participation in the research, and the consent document is the only record linking the subject to the research; and
• Study participation presents minimal risk of harm to the subject, and the activity normally does not require consent except for the fact that this is a research study.

To request a waiver of to obtain or alter elements of informed consent, the investigator must specifically address this in the consent section of the IRB application and complete a Waiver or Modification of Consent Form. The request must address the following criteria:

• the research should pose no more than minimal risk to subjects
• the waiver or alteration will not adversely affect subjects’ rights and/or welfare
• it is not practicable to carry out the research without the waiver or alteration
• information will be provided to the participants after participation is completed. If a debriefing statement is used, submit a copy with the IRB application.

Click on the below to download consent document instructions and templates:

General instructions to request a Waiver of or Modification to Written Consent
A sample web-based survey cover page 
A sample Oral Consent Script
A sample Telephone Consent Script
A sample Information Sheet Consent 

Examples of studies where a waiver of written consent MAY be approved:

• Interviews with potential groups of illegal immigrants about their experience in which these individuals will be interviewed in a safe space.
  Conducting phone or web-based interviews with political staffers (who work in a very public position) about how recent fundraising rules have changed the campaign process.
• A survey of women who have left abusive partners and the goal is to assess factors that affected their ability to leave.

Note that research qualifying for exempt review does not need to obtain waivers of written consent from the IRB.

Waiver to obtain informed consent or modify elements of informed consent

Federal regulations allow for the waiver of both written and verbal consent under certain circumstances. The IRB may approve a consent procedure which does not include some of prescribed elements of informed consent where the research or subject would be jeopardized by full consent procedure.

Examples of studies where a waiver of all consent elements MAY be approved:

• A psychological study that is actually about peer pressure but participants are told the study is about perception of visual phenomenon. Deception is required to adequately measure peer pressure.
• A study that requires covert observation of interpersonal behavior and, if participants know they are being observed, they may alter their behavior.
  

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 Human and Animal Research Protections Office, is available to discuss the review process or my rights as a research participant.  Contact information of the Office is (410) 455-2737 or HARPO@umbc.edu.”

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.htm#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/cgi-win/web_statutes.exe - section § 24).

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.

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)

Click on the below to download assent document instructions and templates:

General instructions and sample to create an assent form 

Waiver of Parental Permission

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.

Click on the below to download waiver document instructions and templates:

General instructions and sample to create a waiver of parental permission form

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