IRB Guidance

Standard Operating Procedures (SOP) Manual

View the SOP Manual.

Informed Consent Information

What is the consent form?

The consent form provides potential research subjects sufficient written information to decide whether to participate in a research study or not based on an explanation of the proposed research and the nature of the participation that is requested of them.

Key features in the consent form.

The informed consent process involves three key features: (1) disclosing to potential research subjects’ information needed to make an informed decision; (2) facilitating the understanding of what has been disclosed; and (3) promoting the voluntariness of the decision about whether to participate in the research. Informed consent must be legally effective and prospectively obtained. 

What are the basic elements of the consent form (bold words on the template)?

• a statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject’s participation, a description of the procedures to be followed, and identification of any procedures which are experimental.
• a description of any reasonably foreseeable risks or discomforts to the subject.
• a description of any benefits to the subject or to others which may reasonably be expected from the research.
• a disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.
• a statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained.
• for research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained.
• an explanation of whom to contact for answers to pertinent questions about the research and research subjects’ rights, and whom to contact in the event of a research-related injury to the subject; and
• a statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

What is a waiver or alteration of informed consent?

The regulations allow the IRB to waive the requirement for obtaining informed consent or parental permission or to approve a consent procedure that leaves out or alters some or all the elements of informed consent otherwise required.

Waiving the requirement for obtaining informed consent or parental permission means that the IRB has determined that investigators need not obtain the subjects’ informed consent to participate in research. For example, some research about natural behavior may require that subjects be unaware that the research is taking place. Such research can only be approved by the IRB if the research meets the criteria for a waiver of informed consent under the Human Research Protection Program (HRPP) regulations and for approving research according to HRPP.

An IRB may approve research for which some or all the elements of informed consent have been altered, or for which some elements have been left out. For example, some research designs require that subjects be left unaware of the particular purpose of the research, because the subjects’ responses might be biased if they know in advance what the investigators are seeking. Such research designs do not preclude offering potential subjects some information about the research and giving them the opportunity to decide whether to participate. The IRB may approve such research in which investigators will leave out or alter elements of informed consent, so long as the research meets the criteria for approving research and the research meets the criteria specified in the HRPP regulations for leaving out or altering those elements.

Privacy and Confidentiality Information

Overview

The Department of Health Human Services oversees the protection of human subjects for biomedical, behavioral, clinical, and other research as cited in Public Health Service Act §301(d), 42 U.S.C. §241(d). To meet federal requirements, the IRB committee must consider both privacy and confidentiality in reviewing a study in its entirety. Below we identify terms and strategies for researchers related to private information, privacy, and confidentiality. 

Private Information

Private Information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (e.g. a medical record) [45 CFR 46.102(e)(4)]. Private information must be considered in addressing the privacy of human subjects.

Privacy

Privacy is the state or condition of being free from being observed or disturbed by other people. The term privacy in research refers to the individual’s right to control personal information and their identity. To maintain a subject’s privacy, the researcher must consider how to store and disseminate research findings to maintain confidentiality. 

Confidentiality

Confidentiality is the protection of research participants’ privacy from disclosure of their personal, sensitive, or private information to unauthorized persons. This includes methods used to ensure that information obtained by researchers about their research participants is not improperly divulged.

Strategies to Maintain Privacy and Confidentiality

Per the U.S. Department of Health & Human Services guidelines, the researcher should explain the following in the IRB submission:

• Where data will be stored,
• Who will have access to the data collected, and
• How the identity of participants will be kept private, for example, using a coding system on data records, limiting access to records, or storing identifiers separately from data.

For further information related to acceptable IRB language and practices, please visit the U.S. Department of Health & Human Services.

Compensation Information

24.1 Compensation can include remuneration that is monetary (cash, gift cards, vouchers, etc.) and/or non- monetary (gifts/promotional items, course credit, extra credit, etc.).  Rewards such as course credit or goods with local monetary value should be forms of payment to study participants. Usually, researcher level the payment amount on the average wage in the location where the research is conducted. For monetary or gift, recommended value starts $10 to $50 depends on the degree of participation.  The appropriate level of payment is contingent upon a variety of factors. However, it should be a reasonable amount of value that cannot affect to subject’s decision to participate in the research.  Payment should not depend on the degree of risk with participation. 

24.2 TAMUT prohibited finder’s fees or referral fees to colleagues.  University employees may not accept gifts, payments, or in-kind support including financial payments, gift certificates, books, conference attendance and payment of travel expenses.

24.3 Investigators with only $200 to compensate 100 subjects need to propose a drawing for two $100 prizes rather than paying each subject $2. University research projects cannot distribute of prizes to the research subjects via chances purchased by the human subjects or obtained by them in exchange for something of value (e.g., money, human tissues, or blood samples).  Use of incentives such as “door prizes” may be considered by the IRB on a case-by-case basis for research studies of minimal risk if the proposed incentives do not have potential for coercion or undue influence.  While the incentive should avoid terms like “lottery” or “raffle,” acceptable terminology might include a reference to a “drawing based on chance in which each subject has equal odds of receiving [the incentive].”

24.4 Social security number (SSN) might be used when the SSN is collected as required by law, to comply with internal Revenue Service (IRS) reporting requirements or may be collected as a unique identifier to help match research datasets. SSN should not be collected until the need for the SSN has been clearly documented and approved by the IRB.

24.4.1 Per university policy, investigators are required to collect and report SSN and related information when total payment(s) to an individual research subject will exceed $200 per calendar year.  Use as a unique identifier for a national registry or database where there is a potential for duplicate registration and not other means of unique identification exists.

24.4.2 For amounts that will total less than $200 per calendar year, investigators are not required to collect SSN if payments are made using a cash advance approach (e.g., gift cards or “petty cash” accounts).  However, SSN must be collected for checks of any amount issued through the Accounts Payable system.  SSN collection forms are explained in the SOP (pg. 86).