November 2007 Important Updates to SBU's Human Subject Protections Program (HSPP)
Released November 13, 2007
Our Human Subject Protection Program (HSPP) has many active participants, including Principal Investigators and their study teams, staff of the Office of Research Compliance (ORC), and the membership of our Institutional Review Boards (IRBs). Our combined efforts continue to help ensure that our HSPP is solid and effective in keeping safe those individuals who volunteer to participate in our research activities at SBU.
The ORC and the IRBs are constantly evaluating the program to assess the need for clarifications of current SBU policies and procedures, promulgation of new policies and procedures, and dissemination of new federal guidance and regulations. The following is a summary of such actions that have been taken, including some clarifications of unchanged policies and procedures, since our last update in June 2007.
It is extremely important that you review this information with all members of your study team.
The ‘go live’ date for SBU’s use of the electronic, web-based program for IRB administration and management has been set. Use of IRBNet for submission of new and continuing applications (exempt, expedited and full review) will be required effective December 21, 2007.
Paper submissions will be accepted by ORC after that date only for amendments, adverse events, and other revisions that are being submitted for currently approved studies (i.e., studies that have not yet undergone continuing review via the IRBNet system).
If you anticipate applying for IRB approval or continuing approval in the next few months, IRBNet has general training materials for researchers ("Resources for Researchers") available at http://www.irbnetresources.org/training.html . The username and password may be obtained by e-mailing Judy.Matuk@Stonybrook.edu.
If, after reviewing these materials, you would like additional training, please contact the Office of Research Compliance at 2-9036 to schedule an appointment.
In the next few weeks, IRB-approved principal investigators, chairs, deans and division heads will receive an e-mail with SBU-specific instructions for using IRBNet to ensure that local policies and procedures are followed when using this electronic system (e.g., electronic signature requirements, etc). At that time, we will also provide the live IRBNet link so that you can complete the simple registration process and begin creating studies using the IRBNet system.
II.Revised SBU Policy: Who can give permission in the research setting on behalf of adults with diminished capacity?
Over the past many months, the issue of who can give permission for research participation on behalf of adults who have diminished capacity and cannot consent for themselves has been hotly debated.
Here are the laws:
At the federal level, the regulations state, at 45 CFR 46.116, that ‘no investigator may involve a human being as a subject in research covered by this policy unless the investigator has obtained the legally effective informed consent of the subject or the subject's legally authorized representative.’
At the state level, NYS law states, at Article 24A; section 2442 that 'If the human subject be otherwise legally unable to render consent, such consent shall be subscribed to in writing by such other person as may be legally empowered to act on behalf of the human subject'
In revisiting this issue, review of policies at other institutions in NYS has led us to the following decision:
Absent a legal case that helps interpret the ambiguous laws mentioned above, we must rewrite our policy to simply reflect said laws. Therefore, section 13, subsection G of our CORIHS Handbook for Investigators, at http://www.research.sunysb.edu/HSG/HSGsec13.html#13.G has been rewritten to indicate that, where adults with diminished capacity are permitted by the IRB to be included in the research,
The following individuals can give permission on their behalf to participate in said research:
- a legally authorized/legally empowered representative;or
- an individual who is designated as a representative/agent through a health care proxy signed by both the subject and the appointed representative/agent. For a health care proxy to be effective:
- it must have been signed at a time when the subject had decision making capacity.
- it must not specifically prohibit research.
- CORIHS must approve the study with a specific determination that the research activity provides potential therapeutic benefit to the subject.
III. New SBU Guidance on Minor Assent
A subcommittee of IRB, ORC, and investigator representatives has drafted guidance to assist you in knowing the general protocol parameters under which assent would be required, and what type of age-dependent documentation should be used when assent must be obtained. In all cases below where assent is required, CORIHS expects that the person obtaining assent first assesses the child’s capability to assent (e.g., maturity, mental and physical state, age, etc).
In reviewing this guidance, please note that each protocol is unique and is reviewed by CORIHS accordingly. As such, the IRB’s decision regarding assent (and documentation thereof) may necessarily vary from that provided in the guidance below. But, in general:
A. Assent will be required for:
(a) Non-therapeutic protocols. Assent must be documented as follows:
- For 12-17 year olds: via an assent form (containing highly simplified 'consent' information) that the child signs
- For 7-11 year olds: a note in the subject's research record that the assent discussion has occurred and the child's agreement has been obtained
(b) Potentially therapeutic protocols involving either FDA-approved, or experimental, drugs, devices or procedures where there are alternatives available outside of the research with similar risk/benefit profiles. Assent must be documented as follows:
- For 12-17 year olds: via an assent form (containing highly simplified 'consent' information) that the child signs and
- For 7-11 year olds: via a note in the subject's research record that the assent discussion has occurred and the child's agreement has been obtained
(c) Potentially therapeutic protocol involving FDA- approved drugs, devices, radiation, procedures, etc. used in an experimental way (dosages, scheduling etc). Assent must be documented as follows:
- For 12-17 year olds: via an assent form (containing highly simplified 'consent' information) that the child signs, or alternatively, via an assent 'short form' (see section below 'About the Assent Short Form'-this latter method must be specifically approved by the IRB for this category of research)
- For 7-11 year olds: via a note in the subject's research record that the discussion has occurred and the child's agreement has been obtained
(d) Protocols that do not fit into categories Ia, Ib, or Ic above, but where assent is none-the-less required by NCI CIRB (for cooperative oncology protocols). Assent must be documented as follows:
- For 12-17 year olds: via an assent 'short form' (see section below, 'About the Assent Short Form')
- For 7-11 year olds: via a note in the subject's research record that the discussion has occurred and the child's agreement has been obtained.
B. Assent is waived for:
(a) Non-therapeutic protocols where results of biological tests are required in order to determine eligibility for potentially therapeutic protocols (certain COG protocols)
(b) Potentially therapeutic protocols involving an experimental drug or procedure where there are no standard alternatives available, or where the risk/benefit profile of the standard alternatives that are available are such that participation in the protocol would be important to the health or well-being of the children.
About the Assent Short Form:
Where CORIHS approves use of an assent short form process, an assent discussion is held with the minor subject. The 'script' to be followed in that discussion must be reviewed and approved by CORIHS. If the minor agrees to be in the study, the short form is signed, along with a witness (not the person assessing ability and obtaining assent). The witness should also sign a copy of the script that was used in the process.
Departmental letterhead
Title of Study:
Principal Investigator:
____________________ has talked with me, using words I know, about me being in a research study. I’ve been told:
1. I don’t have to be in this research study if I don’t want to be.
2. What will happen to me if I agree to be in this study, and how long this study will go on for me.
2. The bad things, if any, that may happen to me by being in this study.
3. The good things, if any, that may happen to me by being in this study.
4. What my choices are, if I don’t want to be in this study.
5. That my being in this study will be mostly kept a secret. If anyone needs to know I’m in this study, I was told who, and why they have to know.
6. What happens if I get hurt while in the study.
If I have questions, or want to talk about this study with Dr. ________, I can do this by calling:
If I want to talk to someone else about being in this study, I can do this by calling Judy Matuk, someone who helps people who are in research studies, at 631-632-9036, or judy.matuk@stonybrook.edu.
I know I don’t have to be in this study if I don’t want to be. If I say yes now, I can change my mind at any time without getting in any trouble. If I say no, Dr. ________ will still be my doctor.
I will get a copy of this form, and it will be attached to the consent form that has all the information in it that was used to explain the study to me.
I do do not agree to be in this study.
____________________________ _______________________
Printed Name of Minor Subject/Date Signature of Minor subject
________________________ _______________________
Printed Name of Witness /Date Signature of Witness
IV. What guidance do YOU need?
Please e-mail me at jmatuk@notes.cc.sunysb.edu if you would like to see a particular topic covered in future updates. We will do our best to comply!
As always, the ORC Website has all the current information and current applications you need:
http://www.stonybrook.edu/research/humans/humansubjects.html
Our Human Subject Protection Program (HSPP) is always undergoing review and is frequently updated. When you need to complete an application or form, always download it directly from the web, to ensure you are using the most current version. The best way to stay up to date with changes made to our HSPP is to visit the website often.
If you have any questions about any of the information above, please feel free to contact me at jmatuk@notes.cc.sunysb.edu, phone (631) 632-9036.